Co-operative Evaluation of a Desktop Virtual Reality System, Workshop on User Centered Desi
教师资格《英语学科知识与教学能力(初级中学)》模拟试题及答案四
教师资格《英语学科知识与教学能力(初级中学)》模拟试题及答案四(实用版)编制人:__________________审核人:__________________审批人:__________________编制单位:__________________编制时间:____年____月____日序言下载提示:该文档是本店铺精心编制而成的,希望大家下载后,能够帮助大家解决实际问题。
文档下载后可定制修改,请根据实际需要进行调整和使用,谢谢!并且,本店铺为大家提供各种类型的实用资料,如职业道德、时事政治、政治理论、专业基础、说课稿集、教资面试、综合素质、教案模板、考试题库、其他资料等等,想了解不同资料格式和写法,敬请关注!Download tips: This document is carefully compiled by this editor.I hope that after you download it, it can help you solve practical problems. The document can be customized and modified after downloading, please adjust and use it according to actual needs, thank you!In addition, this shop provides you with various types of practical materials, such as professional ethics, current affairs and politics, political theory, professional foundation, lecture collections, teaching interviews, comprehensive qualities, lesson plan templates, examquestion banks, other materials, etc. Learn about different data formats and writing methods, so stay tuned!教师资格《英语学科知识与教学能力(初级中学)》模拟试题及答案四一、单项选择题1.Classification of vowels are made up of the followings EXCEPT__________.A.the position of the tongueB.the openness of the mouthC.the shape of the lipD.the width of the Vowels2.A sound which is capable of distinguishing one word or one shape of a word from another in a siven language is a__________.A.phonemeB.allophoneC.phoneD.allomorph3.Which of the foHowing does not belong to abilities of learning?A.Observation ability.B.Cognitive ability.C.SeIf-studv ability.D.Problem-solving ability.4.Which of following concepts does not meet the middle school English curriculum criteria?A.Teaching based on students.B.Teaching based on language.C.Teaching based on teachers.D.Teaching practice based on theories.5.When some relevaIlt subject theories are used in English teaching,we need the help of__________.A.philosophersB.statisticiansC.1inguists or foreign language teachersD.relevant scholars6.The sun light was coming in__________the window.A.pastB.passC.throughD.across7.This book is _____more difficult for the students inGrade One.A.ratherB.quiteC.tooD.very8.A lot of people in the world are__________in the future of China.A.interestB.interestingC.interestsD.interested9.Would you please keep silent?,The weather report__________and l want to listen.A.is broadcastB.is being broadcastC.has been broadcastD.had been broadcast10.Paradise Lost is a masterpiece by__________.A.Christopher MarlowB.John MiltonC.William ShakespeareD.Ben Johnson11.Mrs Black__________and didn’t look up when her husband entered the room.A.went on to writeB.went on with writingC.went on writingD.went on write12.I never drive __________ 60km on the road.A.more fast thanB.faster thanC.much fast thanD.more faster than13.She can’t do it __________ ,but she could ask someone else to do it.A.sheB.herC.hersD.herself14.Alas!It was not__________easy__________all that.A.very;asB.so;asC.too;toD.such;as15.He was so_________that he couldn’t even afford the carfare(车费).A.poorB.richC.cleverD.bright16.Forming comprehensive language application ability is based on the integrated deVeloPment of language skills.1anguage knowlfldge,emotional attitude,learning strategics and culture aware’ness.Among__________is the prerequisite of improving learning efficiency and deVeloping independent study ability.A.1anguage skillsB.emotional attitudeC.1earning strategicsD.culture awareness17.The functions of teaching objectives are to guide the measurement and evaluation,__________,and to guide students’learnin9.A.to guide the application of teaching strategyB.to guide teachers’lesson preparationC.to guide teacher to find out teaching ruleD.to guide students to master tPaching rule18.What’s the starting point and destination of English course?A.habit formationB.1anguage usageC.knowledge impartationD.students’ development19.Teachers and students should consider correction as__________.A.a form of punishmentB.a form of criticismC.a form of encouragementD.a form of motivation20.Which of the following statements about assessment is NOT true?A.Summative assessment is mainly based on testin9.B.Testing is a pan of assessment,only one means of gathering information about a student.C.English teaching should put summative assessment atfirst.D.Formative assessment focuses on the final product or result of learning rather than the process of learning.请阅读Passage One。
分析三联、四联药物方案治疗胃溃疡的临床效果
系统医学 2023 年 12 月第 8 卷第 24期分析三联、四联药物方案治疗胃溃疡的临床效果王昌盛1,陈兰2,廖小红21.广东药科大学附属第一医院药学部,广东广州510062;2.广东三九脑科医院药剂科,广东广州510510[摘要]目的探讨胃溃疡患者选择四联药物治疗后的临床效果。
方法选取2022年1月—2023年8月广东药科大学附属第一医院收治的76例胃溃疡患者为研究对象,依据投掷硬币法分组,参照组(38例)选择三联药物治疗,研究组(38例)选择四联药物治疗,比较两组治疗总有效率、胃灼痛评分、胃溃疡面积、上腹疼痛评分、临床症状改善时间。
结果研究组治疗总有效率为97.37%,明显高于参照组,差异有统计学意义(χ2= 6.176,P<0.05)。
治疗后,研究组胃灼痛评分、胃溃疡面积、上腹疼痛评分、临床症状改善时间均低于参照组,差异有统计学意义(P均<0.05)。
结论同三联药物比较,胃溃疡患者接受四联药物治疗,可显著提升临床效果,有效改善疾病症状,可促进胃溃疡患者的良好预后。
[关键词]胃溃疡;三联药物;四联药物;疗效[中图分类号]R573 [文献标识码]A [文章编号]2096-1782(2023)12(b)-0175-03 Clinical Effect of Triple and Quadruple Drug Regimens in the Treatment of Gastric UlcerWANG Changsheng1, CHEN Lan2, LIAO Xiaohong21.Department of Pharmacy, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guang⁃dong Province, 510062 China;2.Department of Pharmacy, Guangdong Sanjiu Brain Hospital, Guangzhou, Guangdong Province, 510510 China[Abstract] Objective To investigate the clinical effect of quadruple drug therapy in patients with gastric ulcer. Methods Seventy-six patients with gastric ulcer admitted to the First Affiliated Hospital of Guangdong Pharmaceuti⁃cal University from January 2022 to August 2023 were selected as the research object and divided into groups ac⁃cording to coin tossing method. The reference group (38 cases) received triple drug therapy, and the study group (38 cases) received quadruple drug therapy. The total effective rate, the score of heartburn pain, the area of gastric ulcer, the score of upper abdominal pain and the improvement time of clinical symptoms were compared between the two groups. Results The total effective rate of the study group was 97.37%, which was significantly higher than that of the reference group, and the difference was statistically significant (χ2=6.176, P<0.05). After treatment, the score of heartburn pain, the area of gastric ulcer, the score of upper abdominal pain and the improvement time of clinical symptoms in the study group were lower than those in the reference group, and the differences were statistically sig⁃nificant (all P<0.05). Conclusion Compared with triple drug, quadruple drug treatment for gastric ulcer patients can significantly improve the clinical effect, effectively improve the disease symptoms, and promote the good prognosis of patients with gastric ulcer.[Key words] Gastric ulcer; Triple drug; Quadruple drugs; Curative effect对于胃溃疡疾病而言,其属于一种胃肠道高发病[1-2]。
晚期创伤生命支持的创伤
1/00
7
B. Breathing &Ventilation
* Airway patency does not assure adequate v e n t i l a t i o n .
C. Circulation with HemorrhageControl.
1 . Blood Volume &Cardiac Output a. level of consciousness. b. skin color c. Pulse.
1/00
17
5. Abdomen *excessive manipulation of the pelvic should be avoided.
1/00
16
2. Maxillofacial Injury no NGtube, d e f i n i t e airway?
3. Cervical Spine & Neck
*Pt with maxillofacial or head trauma should be presumed t o have and unstable cervical spine.
Simple Mnemonic t o describe l eve l of consciousness A: alert V: Responds t o Vocal stimuli P : Responds t o Painful stimuli U: Unresponsive to a l l stimuli
*Blood a t the penile meatus
*Perineal ecchymosis
*Blood in the scrotum
医护英语考试题及答案
医护英语考试题及答案一、选择题(每题2分,共20分)1. What is the most common symptom of the common cold?A. FeverB. CoughC. Sore throatD. All of the above答案:D2. Which of the following is NOT a vital sign?A. Blood pressureB. PulseC. Respiratory rateD. Body temperature答案:D3. What does the acronym "ICU" stand for?A. Intensive Care UnitB. International Clinical UnitC. Immediate Care UnitD. Inpatient Clinical Unit答案:A4. The term "diabetes" refers to a condition characterized by:A. High blood sugar levelsB. Low blood sugar levelsC. High blood pressureD. High cholesterol levels答案:A5. A patient is said to be "anemic" if they have:A. Too much red blood cellsB. Too few red blood cellsC. Too much white blood cellsD. Too few platelets答案:B6. What is the medical term for a surgical incision?A. IncisionB. AmputationC. BiopsyD. Excision答案:A7. Which of the following is a method of sterilization?A. Washing with soap and waterB. BoilingC. Using alcohol swabsD. All of the above答案:D8. The abbreviation "MRI" stands for:A. Magnetic Resonance ImagingB. Medical Radioactive ImagingC. Multiple Radioactive IndicatorsD. Medical Radio Imaging答案:A9. What is the primary function of the liver?A. To filter bloodB. To produce bileC. To regulate blood sugar levelsD. To produce red blood cells答案:B10. A "thermometer" is used to measure:A. Blood pressureB. Body temperatureC. Respiratory rateD. Pulse答案:B二、填空题(每题1分,共10分)11. The medical term for a broken bone is ____________.答案:fracture12. A person with a severe allergy to penicillin would be given a warning to avoid contact with this medication, known as a(n) ____________.答案:allergy alert13. The abbreviation "HIV" stands for Human Immunodeficiency ____________.答案:Virus14. A healthcare professional who specializes in the diagnosis and treatment of diseases of the heart is called a ____________.答案:cardiologist15. The process of removing waste products from the body is known as ____________.答案:excretion16. A patient's medical history is recorded in their____________.答案:medical record17. The practice of washing hands with soap and water to prevent the spread of disease is called ____________.答案:hand hygiene18. A(n) ____________ is a healthcare professional trained to provide emergency medical services.答案:paramedic19. The abbreviation "OT" stands for Occupational____________.答案:Therapy20. A patient's condition is assessed and monitored throughregular ____________.答案:check-ups三、简答题(每题5分,共30分)21. What are the four stages of the nursing process?答案:The four stages of the nursing process are assessment, planning, implementation, and evaluation.22. Explain the difference between a virus and a bacterium.答案:A virus is a microscopic infectious agent that can only replicate inside the living cells of an organism, while a bacterium is a single-celled microorganism that can exist independently and can be beneficial, neutral, or harmful to humans.23. What is the purpose of a stethoscope in medical practice?答案:A stethoscope is used by healthcare professionals to listen to the sounds produced by the body, such as the heartbeat and breathing, to diagnose or monitor various conditions.24. Describe the role of a registered nurse in a hospital setting.答案:A registered nurse in a hospital setting providesdirect patient care, administers medications, monitors patients' conditions, collaborates with physicians and other healthcare professionals, and educates patients about theirhealth conditions and treatments.四、翻译题(每题5分,共20分)25. 请将以下句子翻译成英文:医生建议他每天服用阿司匹林以预防心脏病。
超声检查指南说明书
UltrasoundThe more you see, t he more you knowThe Focused Assessment with Sonography in Trauma (FAST) exam is a critical component of the initial evaluation for hemoperitoneum in unstable traumapatients. The FAST exam can be performed at the bedside, allowing the physician to rapidly determine if free intraperitoneal fluid or a pericardial effusion is present.1,2 The FAST exam is included in the Advanced Trauma Life Support (ATLS) protocol developed by the American College of Surgeons.Quick guide FAST examMichael B. Stone, MDLegacy Emanuel Medical Center, Portland OR Patricia Henwood, MDBrigham and Women’s Hospital, Boston MAThe Core FAST windows Standard anatomic regions evaluated during the FAST exam include Right upper quadrant (RUQ) Left upperquadrant (LUQ)Pelvis S ubcostalwindows can be performed in any order, and ensuring a complete evaluation of each potential space is far more important than proceeding in a predetermined sequence.It is the authors’ practice to begin with a right upper quadrant window in cases of adult blunt trauma, a subcostal window in cases of penetrating thoraco-abdominaltrauma, and a pelvic window in cases of pediatric blunt trauma.IndicationsClinical indications for performing the FAST examination include • Blunt torso trauma • Penetrating torso trauma 3• Concern for ruptured ectopic pregnancy • Undifferentiated hypotension• Trauma in pregnancyThe basics of the FAST examTransducer selectionA low-frequency curvilinear arraytransducer can be used. Alternatively, a low-frequency phased array transducer can be used. Some clinicians find the phased array transducer particularly helpful for obtaining upper quadrant windows through the intercostal spaces. Sequencing of the FAST examThe FAST exam is typically performed during the circulatory assessment in the primary trauma survey, after assessment of airway and breathing. The FASTIn cases where an additional evaluation of the chest for pneumothorax and hemothorax is included, the examination is termed “E-FAST,” denoting it as an extended FAST exam. Detailed information on the use of ultrasound for thoracic assessment can be found in the POC lung ultrasound tutorial by Dr. Mike Stone.• The transducer is initially placed in the right mid-to-anterior axillary line at the level of the xiphoid process 4 with the directional indicator oriented superiorly toward the patient’s axilla. • The transducer is then aimed so the ultrasound beam is directed downward, towards the patient’s back, using theliver as an acoustic window to visualize Morison’s pouch (the interface of theliver and right kidney).• Morison’s pouch is typically locatedbetween the 7th and 9th ribs. To obtain an ideal view the transducer may need to be rotated so it is parallel to the ribs.Ultrasound technique – RUQNormal RUQInitial transducer placement for the RUQ view • The RUQ view is only considered complete after visualization of the diaphragm, Morison’s pouch, the inferior pole of the right kidney, and the inferior tip of the liver.• FAST is positive if anechoic-free fluid is identified in Morison’s pouch.• Fluid cephalad to the diaphragm is inthe thoracic cavity, and should raise concern for hemothorax in trauma.Angulation of the transducer to obtain the RUQ viewPositive RUQ. Complex fluid with internal echoes representing acute hemorrhage• The left upper quadrant view is often more technically challenging, as the spleen affords a much smaller acoustic window as compared to the liver. • The transducer is placed in the left posterior axillary line, at the level of the xiphoid process, with thedirectional indicator oriented towards the patient’s axilla.• The transducer is then rotated clockwise to obtain an angle parallel to the ribs.Ultrasound technique – LUQ• A tilting motion should be used so that visualization of the subphrenic area, inferior tip of spleen, and splenorenal recess is achieved. • Of note, due to the splenorenal ligaments, fluid will preferentially accumulate in the subphrenic space before spreading to the splenorenal recess.Normal LUQInitial transducer placement for the LUQ view Angulation of the transducer to obtain the LUQ viewPositive LUQ. Anechoic fluid surrounding the spleen.• Place transducer just cephalad to the pubic symphysis.• Obtain both a transverse view(directional indicator oriented to the patient’s right) and longitudinal view (directional indicator oriented to the patient’s head).• The transducer must be tilted caudal to look down over the pelvic brim and into the area of the bladder and surrounding structures.• In males, the vesicorectal space is evaluated, just cephalad to the prostate and seminal vesicles, deep to the bladder.• In females, the rectouterine space (pouch of Douglas) is evaluated, just deep to the uterus.Ultrasound technique – pelvisNormal male pelvic transverse view Transducer placement for transverse view • Tilt the transducer to thoroughlyinvestigate the area in the transverse and longitudinal planes.• Ideally, this view is performed before catheterization and decompressionof the bladder.Normal male pelvic longitudinalviewNormalfemale pelvic transverseview Normalfemale pelvic longitudinal viewTransducer placement for longitudinal view• The subcostal view optimally evaluates the dependent regions of the pericardial space.• The transducer is placed immediately caudad to the xiphoid process, with the directional indicator oriented to the patient’s right.• Hold the transducer with an overhand grip to help depress it into the abdomen. The plane of the transducer should be kept as parallel as possible to theabdominal wall.Ultrasound technique – subcostalNormal subcostal viewTransducer placement for subcostal view Positive subcostal view. Anechoic fluid in the pericardial space, most visible in the near field adjacent to the right ventricular free wall.Note: the parasternal view is an alternative to the subcostal view.Detailed information on how to obtain the parasternal view can be found in the Intro to POC echo quick guide by Dr. Anne-Sophie Beraud.Clinical pearls• Each window of the FAST exam is associated with specific pitfalls that may lead to false positive interpretations.– In the RUQ, perinephric fat may be mistaken for free fluid or organizing hematoma.Perinephric fat tends to have uniform thickness with a characteristic echotexture of linear hyperechoic foci. In contrast, organizing hematoma is typically associated with areas of free fluid. If in doubt, log-roll the patient and repeat the exam,observing for a change in the appearance of the area of interest that wouldsuggest movement of clot and fluid (perinephric fat should appear unchanged).– In the LUQ, be cautious not to confuse the splenic hilum or gastric contentsfor free fluid.– In the pelvic view, the seminal vesicles are hypoechoic and located posterior to the bladder, and may be mistaken for free fluid. However, they have smooth, curved borders, are symmetrical, and predictably located just cephalad to the prostate– When obtaining the pelvic view, it is often necessary to decrease the far-field gain as the bladder allows intense “through transmission” of the ultrasound waves(an artifact knows as posterior acoustic enhancement). If uncorrected, this may result in an excessively high gain deep to the bladder, which can obscurethe presence of free fluid.• Depth and gain often need adjustment while moving between the different views. • The exact minimal volume of free intraperitoneal fluid required for detection using ultrasound is unknown, with reports ranging from 100 to over 600 mL.• Although scoring systems have been developed to help quantify the amount offree fluid visualized in hopes of predicting patients who will require a therapeutic laparotomy,5 these lack external validation and the overall clinical context remains the most accurate guide to patient management decisions.• In stable patients, small to moderate amounts of free fluid are often managedafter further evaluation with CT imaging, especially given the growing popularityof non-operative management for solid organ injury.– However, unstable patients with positive FAST exams are likely to benefitfrom laparotomy, with larger volumes of free fluid predicting more severeintra-abdominal hemorrhage.• Importantly, the retroperitoneum is not reliably evaluated during the FASTexam, and retroperitoneal hemorrhage remains a possibility in the settingof a negative FAST.Clinical pearls• Pericardial effusions in trauma can accumulate rapidly and result in cardiactamponade despite relatively small volumes.• Beck’s triad (low blood pressure, distended neck veins, and distant muffledheart sounds) occurs late and inconsistently, and the detection of any significant pericardial fluid in a patient with penetrating chest trauma should raise concern for hemopericardium.• Penetrating cardiac injuries with significant lacerations to the pericardial sacmay result in decompression of bleeding into the thoracic cavity, and the absence of detectable pericardial fluid on ultrasound evaluation, despite the presence of a cardiac injury.6• Remember that the FAST exam detects free intraperitoneal fluid, but doesnot differentiate ascites from peritonitis from hemorrhage. As always, the clinical context remains the most important tool for differentiation between these entities.In patients with known or suspected cirrhosis and a positive FAST exam in the setting of trauma, diagnostic paracentesis may be performed if the patient isunstable or clinical suspicion for hemoperitoneum is high.• The small amount of free fluid associated with bowel perforation is ofteninsufficient to allow detection during the FAST exam, and patients with suspected intestinal injury may benefit from serial FAST exams in addition to otherimaging modalities.References1. Rozycki GS, Ballard RB, Feliciano DV, Schmidt JA, Pennington SD. Surgeon-performed ultrasound for the assessment of truncal injuries:lessons learned from 1540 patients. Ann Surg. 1998 Oct;228(4):557-67.2. Porter RS, Nester BA, Dalsey WC, et al. Use of Ultrasound to Determine Need for Laparotomy in Trauma Patients; Annals of EmergencyMedicine. 1997 29:323-330.3. Rozycki G, Feliciano D, Ochsner MG, et al. The Role of Ultrasound in Patients with Possible Penetrating Cardiac Wounds: A ProspectiveMulticenter Study. J Trauma. 1999 46(4)0:543-552.4. Shokoohi H, Boniface KS, Siegel A. Horizontal subxiphoid landmark optimizes probe placement during the Focused Assessmentwith Sonography for Trauma ultrasound exam. Eur J Emerg Med. 2012 Oct;19(5):333-7.5. McKenney KL, McKenney MG, Cohn SM, et al. Hemoperitoneum Score Helps Determine Need for Therapeutic Laparotomy.J Trauma. 2001 50:650-656.6. Ball CG, Williams BH, Wyrzykowski AD, Nicholas JM, Rozycki GS, Feliciano DV. A caveat to the performance of pericardial ultrasoundin patients with penetrating cardiac wounds. J Trauma. 2009 Nov;67(5):1123-4.©2017 Koninklijke Philips N.V. All rights are reserved.Philips reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting fromthe use of this publication. Trademarks are the property of Koninklijke Philips N.V. or their respective owners./CCEMeducationPublished in the USA. * FEB 2017This quick guide document reflects the opinion of the author, not Philips.Before performing any clinical procedure, clinicians should obtain the requisite education and training, which may include fellowships, preceptorships, literature reviews, and similar programs. This paper is not intended to be a substitute for these training and education programs, but is rather an illustration of how advanced medical technology is used by clinicians.。
高考试卷英语选择题
第一部分:选择题Section A以下每小题各有一项选择,请从每题的四个选项中选出最佳答案。
1. My brother always keeps a ________ diary, which records his daily activities.A. accurateB. detailedC. simpleD. brief2. The teacher's explanation was so ________ that even the students who were not good at math understood it.A. difficultB. clearC. complicatedD. simple3. The government has announced a new policy to ________ the pollution in the city.A. reduceB. eliminateC. increaseD. control4. She ________ her phone and missed the important call.A. leftB. foundC. lostD. returned5. The company is planning to ________ its production line to improve efficiency.A. extendB. expandC. reduceD. decrease6. Despite the bad weather, the football match ________ as scheduled.A. was heldB. was canceledC. was postponedD. was played7. It's important to ________ your body with exercise and a healthy diet.A. strengthenB. weakenC. strainD. fatigue8. The museum ________ a new exhibition on ancient Chinese art next month.A. is holdingB. will holdC. heldD. has held9. The students were asked to ________ their papers and hand them in before the bell rings.A. finishB. writeC. collectD. correct10. The doctor recommended that the patient ________ more water to stay hydrated.A. drinksB. drinkC. drinkingD. had drunkSection B以下每小题各有一项选择,请从每题的四个选项中选出最佳答案。
OSHA现场作业手册说明书
DIRECTIVE NUMBER: CPL 02-00-150 EFFECTIVE DATE: April 22, 2011 SUBJECT: Field Operations Manual (FOM)ABSTRACTPurpose: This instruction cancels and replaces OSHA Instruction CPL 02-00-148,Field Operations Manual (FOM), issued November 9, 2009, whichreplaced the September 26, 1994 Instruction that implemented the FieldInspection Reference Manual (FIRM). The FOM is a revision of OSHA’senforcement policies and procedures manual that provides the field officesa reference document for identifying the responsibilities associated withthe majority of their inspection duties. This Instruction also cancels OSHAInstruction FAP 01-00-003 Federal Agency Safety and Health Programs,May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045,Revised Field Operations Manual, June 15, 1989.Scope: OSHA-wide.References: Title 29 Code of Federal Regulations §1903.6, Advance Notice ofInspections; 29 Code of Federal Regulations §1903.14, Policy RegardingEmployee Rescue Activities; 29 Code of Federal Regulations §1903.19,Abatement Verification; 29 Code of Federal Regulations §1904.39,Reporting Fatalities and Multiple Hospitalizations to OSHA; and Housingfor Agricultural Workers: Final Rule, Federal Register, March 4, 1980 (45FR 14180).Cancellations: OSHA Instruction CPL 02-00-148, Field Operations Manual, November9, 2009.OSHA Instruction FAP 01-00-003, Federal Agency Safety and HealthPrograms, May 17, 1996.Chapter 13 of OSHA Instruction CPL 02-00-045, Revised FieldOperations Manual, June 15, 1989.State Impact: Notice of Intent and Adoption required. See paragraph VI.Action Offices: National, Regional, and Area OfficesOriginating Office: Directorate of Enforcement Programs Contact: Directorate of Enforcement ProgramsOffice of General Industry Enforcement200 Constitution Avenue, NW, N3 119Washington, DC 20210202-693-1850By and Under the Authority ofDavid Michaels, PhD, MPHAssistant SecretaryExecutive SummaryThis instruction cancels and replaces OSHA Instruction CPL 02-00-148, Field Operations Manual (FOM), issued November 9, 2009. The one remaining part of the prior Field Operations Manual, the chapter on Disclosure, will be added at a later date. This Instruction also cancels OSHA Instruction FAP 01-00-003 Federal Agency Safety and Health Programs, May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045, Revised Field Operations Manual, June 15, 1989. This Instruction constitutes OSHA’s general enforcement policies and procedures manual for use by the field offices in conducting inspections, issuing citations and proposing penalties.Significant Changes∙A new Table of Contents for the entire FOM is added.∙ A new References section for the entire FOM is added∙ A new Cancellations section for the entire FOM is added.∙Adds a Maritime Industry Sector to Section III of Chapter 10, Industry Sectors.∙Revises sections referring to the Enhanced Enforcement Program (EEP) replacing the information with the Severe Violator Enforcement Program (SVEP).∙Adds Chapter 13, Federal Agency Field Activities.∙Cancels OSHA Instruction FAP 01-00-003, Federal Agency Safety and Health Programs, May 17, 1996.DisclaimerThis manual is intended to provide instruction regarding some of the internal operations of the Occupational Safety and Health Administration (OSHA), and is solely for the benefit of the Government. No duties, rights, or benefits, substantive or procedural, are created or implied by this manual. The contents of this manual are not enforceable by any person or entity against the Department of Labor or the United States. Statements which reflect current Occupational Safety and Health Review Commission or court precedents do not necessarily indicate acquiescence with those precedents.Table of ContentsCHAPTER 1INTRODUCTIONI.PURPOSE. ........................................................................................................... 1-1 II.SCOPE. ................................................................................................................ 1-1 III.REFERENCES .................................................................................................... 1-1 IV.CANCELLATIONS............................................................................................. 1-8 V. ACTION INFORMATION ................................................................................. 1-8A.R ESPONSIBLE O FFICE.......................................................................................................................................... 1-8B.A CTION O FFICES. .................................................................................................................... 1-8C. I NFORMATION O FFICES............................................................................................................ 1-8 VI. STATE IMPACT. ................................................................................................ 1-8 VII.SIGNIFICANT CHANGES. ............................................................................... 1-9 VIII.BACKGROUND. ................................................................................................. 1-9 IX. DEFINITIONS AND TERMINOLOGY. ........................................................ 1-10A.T HE A CT................................................................................................................................................................. 1-10B. C OMPLIANCE S AFETY AND H EALTH O FFICER (CSHO). ...........................................................1-10B.H E/S HE AND H IS/H ERS ..................................................................................................................................... 1-10C.P ROFESSIONAL J UDGMENT............................................................................................................................... 1-10E. W ORKPLACE AND W ORKSITE ......................................................................................................................... 1-10CHAPTER 2PROGRAM PLANNINGI.INTRODUCTION ............................................................................................... 2-1 II.AREA OFFICE RESPONSIBILITIES. .............................................................. 2-1A.P ROVIDING A SSISTANCE TO S MALL E MPLOYERS. ...................................................................................... 2-1B.A REA O FFICE O UTREACH P ROGRAM. ............................................................................................................. 2-1C. R ESPONDING TO R EQUESTS FOR A SSISTANCE. ............................................................................................ 2-2 III. OSHA COOPERATIVE PROGRAMS OVERVIEW. ...................................... 2-2A.V OLUNTARY P ROTECTION P ROGRAM (VPP). ........................................................................... 2-2B.O NSITE C ONSULTATION P ROGRAM. ................................................................................................................ 2-2C.S TRATEGIC P ARTNERSHIPS................................................................................................................................. 2-3D.A LLIANCE P ROGRAM ........................................................................................................................................... 2-3 IV. ENFORCEMENT PROGRAM SCHEDULING. ................................................ 2-4A.G ENERAL ................................................................................................................................................................. 2-4B.I NSPECTION P RIORITY C RITERIA. ..................................................................................................................... 2-4C.E FFECT OF C ONTEST ............................................................................................................................................ 2-5D.E NFORCEMENT E XEMPTIONS AND L IMITATIONS. ....................................................................................... 2-6E.P REEMPTION BY A NOTHER F EDERAL A GENCY ........................................................................................... 2-6F.U NITED S TATES P OSTAL S ERVICE. .................................................................................................................. 2-7G.H OME-B ASED W ORKSITES. ................................................................................................................................ 2-8H.I NSPECTION/I NVESTIGATION T YPES. ............................................................................................................... 2-8 V.UNPROGRAMMED ACTIVITY – HAZARD EVALUATION AND INSPECTION SCHEDULING ............................................................................ 2-9 VI.PROGRAMMED INSPECTIONS. ................................................................... 2-10A.S ITE-S PECIFIC T ARGETING (SST) P ROGRAM. ............................................................................................. 2-10B.S CHEDULING FOR C ONSTRUCTION I NSPECTIONS. ..................................................................................... 2-10C.S CHEDULING FOR M ARITIME I NSPECTIONS. ............................................................................. 2-11D.S PECIAL E MPHASIS P ROGRAMS (SEP S). ................................................................................... 2-12E.N ATIONAL E MPHASIS P ROGRAMS (NEP S) ............................................................................... 2-13F.L OCAL E MPHASIS P ROGRAMS (LEP S) AND R EGIONAL E MPHASIS P ROGRAMS (REP S) ............ 2-13G.O THER S PECIAL P ROGRAMS. ............................................................................................................................ 2-13H.I NSPECTION S CHEDULING AND I NTERFACE WITH C OOPERATIVE P ROGRAM P ARTICIPANTS ....... 2-13CHAPTER 3INSPECTION PROCEDURESI.INSPECTION PREPARATION. .......................................................................... 3-1 II.INSPECTION PLANNING. .................................................................................. 3-1A.R EVIEW OF I NSPECTION H ISTORY .................................................................................................................... 3-1B.R EVIEW OF C OOPERATIVE P ROGRAM P ARTICIPATION .............................................................................. 3-1C.OSHA D ATA I NITIATIVE (ODI) D ATA R EVIEW .......................................................................................... 3-2D.S AFETY AND H EALTH I SSUES R ELATING TO CSHO S.................................................................. 3-2E.A DVANCE N OTICE. ................................................................................................................................................ 3-3F.P RE-I NSPECTION C OMPULSORY P ROCESS ...................................................................................................... 3-5G.P ERSONAL S ECURITY C LEARANCE. ................................................................................................................. 3-5H.E XPERT A SSISTANCE. ........................................................................................................................................... 3-5 III. INSPECTION SCOPE. ......................................................................................... 3-6A.C OMPREHENSIVE ................................................................................................................................................... 3-6B.P ARTIAL. ................................................................................................................................................................... 3-6 IV. CONDUCT OF INSPECTION .............................................................................. 3-6A.T IME OF I NSPECTION............................................................................................................................................. 3-6B.P RESENTING C REDENTIALS. ............................................................................................................................... 3-6C.R EFUSAL TO P ERMIT I NSPECTION AND I NTERFERENCE ............................................................................. 3-7D.E MPLOYEE P ARTICIPATION. ............................................................................................................................... 3-9E.R ELEASE FOR E NTRY ............................................................................................................................................ 3-9F.B ANKRUPT OR O UT OF B USINESS. .................................................................................................................... 3-9G.E MPLOYEE R ESPONSIBILITIES. ................................................................................................. 3-10H.S TRIKE OR L ABOR D ISPUTE ............................................................................................................................. 3-10I. V ARIANCES. .......................................................................................................................................................... 3-11 V. OPENING CONFERENCE. ................................................................................ 3-11A.G ENERAL ................................................................................................................................................................ 3-11B.R EVIEW OF A PPROPRIATION A CT E XEMPTIONS AND L IMITATION. ..................................................... 3-13C.R EVIEW S CREENING FOR P ROCESS S AFETY M ANAGEMENT (PSM) C OVERAGE............................. 3-13D.R EVIEW OF V OLUNTARY C OMPLIANCE P ROGRAMS. ................................................................................ 3-14E.D ISRUPTIVE C ONDUCT. ...................................................................................................................................... 3-15F.C LASSIFIED A REAS ............................................................................................................................................. 3-16VI. REVIEW OF RECORDS. ................................................................................... 3-16A.I NJURY AND I LLNESS R ECORDS...................................................................................................................... 3-16B.R ECORDING C RITERIA. ...................................................................................................................................... 3-18C. R ECORDKEEPING D EFICIENCIES. .................................................................................................................. 3-18 VII. WALKAROUND INSPECTION. ....................................................................... 3-19A.W ALKAROUND R EPRESENTATIVES ............................................................................................................... 3-19B.E VALUATION OF S AFETY AND H EALTH M ANAGEMENT S YSTEM. ....................................................... 3-20C.R ECORD A LL F ACTS P ERTINENT TO A V IOLATION. ................................................................................. 3-20D.T ESTIFYING IN H EARINGS ................................................................................................................................ 3-21E.T RADE S ECRETS. ................................................................................................................................................. 3-21F.C OLLECTING S AMPLES. ..................................................................................................................................... 3-22G.P HOTOGRAPHS AND V IDEOTAPES.................................................................................................................. 3-22H.V IOLATIONS OF O THER L AWS. ....................................................................................................................... 3-23I.I NTERVIEWS OF N ON-M ANAGERIAL E MPLOYEES .................................................................................... 3-23J.M ULTI-E MPLOYER W ORKSITES ..................................................................................................................... 3-27 K.A DMINISTRATIVE S UBPOENA.......................................................................................................................... 3-27 L.E MPLOYER A BATEMENT A SSISTANCE. ........................................................................................................ 3-27 VIII. CLOSING CONFERENCE. .............................................................................. 3-28A.P ARTICIPANTS. ..................................................................................................................................................... 3-28B.D ISCUSSION I TEMS. ............................................................................................................................................ 3-28C.A DVICE TO A TTENDEES .................................................................................................................................... 3-29D.P ENALTIES............................................................................................................................................................. 3-30E.F EASIBLE A DMINISTRATIVE, W ORK P RACTICE AND E NGINEERING C ONTROLS. ............................ 3-30F.R EDUCING E MPLOYEE E XPOSURE. ................................................................................................................ 3-32G.A BATEMENT V ERIFICATION. ........................................................................................................................... 3-32H.E MPLOYEE D ISCRIMINATION .......................................................................................................................... 3-33 IX. SPECIAL INSPECTION PROCEDURES. ...................................................... 3-33A.F OLLOW-UP AND M ONITORING I NSPECTIONS............................................................................................ 3-33B.C ONSTRUCTION I NSPECTIONS ......................................................................................................................... 3-34C. F EDERAL A GENCY I NSPECTIONS. ................................................................................................................. 3-35CHAPTER 4VIOLATIONSI. BASIS OF VIOLATIONS ..................................................................................... 4-1A.S TANDARDS AND R EGULATIONS. .................................................................................................................... 4-1B.E MPLOYEE E XPOSURE. ........................................................................................................................................ 4-3C.R EGULATORY R EQUIREMENTS. ........................................................................................................................ 4-6D.H AZARD C OMMUNICATION. .............................................................................................................................. 4-6E. E MPLOYER/E MPLOYEE R ESPONSIBILITIES ................................................................................................... 4-6 II. SERIOUS VIOLATIONS. .................................................................................... 4-8A.S ECTION 17(K). ......................................................................................................................... 4-8B.E STABLISHING S ERIOUS V IOLATIONS ............................................................................................................ 4-8C. F OUR S TEPS TO BE D OCUMENTED. ................................................................................................................... 4-8 III. GENERAL DUTY REQUIREMENTS ............................................................. 4-14A.E VALUATION OF G ENERAL D UTY R EQUIREMENTS ................................................................................. 4-14B.E LEMENTS OF A G ENERAL D UTY R EQUIREMENT V IOLATION.............................................................. 4-14C. U SE OF THE G ENERAL D UTY C LAUSE ........................................................................................................ 4-23D.L IMITATIONS OF U SE OF THE G ENERAL D UTY C LAUSE. ..............................................................E.C LASSIFICATION OF V IOLATIONS C ITED U NDER THE G ENERAL D UTY C LAUSE. ..................F. P ROCEDURES FOR I MPLEMENTATION OF S ECTION 5(A)(1) E NFORCEMENT ............................ 4-25 4-27 4-27IV.OTHER-THAN-SERIOUS VIOLATIONS ............................................... 4-28 V.WILLFUL VIOLATIONS. ......................................................................... 4-28A.I NTENTIONAL D ISREGARD V IOLATIONS. ..........................................................................................4-28B.P LAIN I NDIFFERENCE V IOLATIONS. ...................................................................................................4-29 VI. CRIMINAL/WILLFUL VIOLATIONS. ................................................... 4-30A.A REA D IRECTOR C OORDINATION ....................................................................................................... 4-31B.C RITERIA FOR I NVESTIGATING P OSSIBLE C RIMINAL/W ILLFUL V IOLATIONS ........................ 4-31C. W ILLFUL V IOLATIONS R ELATED TO A F ATALITY .......................................................................... 4-32 VII. REPEATED VIOLATIONS. ...................................................................... 4-32A.F EDERAL AND S TATE P LAN V IOLATIONS. ........................................................................................4-32B.I DENTICAL S TANDARDS. .......................................................................................................................4-32C.D IFFERENT S TANDARDS. .......................................................................................................................4-33D.O BTAINING I NSPECTION H ISTORY. .....................................................................................................4-33E.T IME L IMITATIONS..................................................................................................................................4-34F.R EPEATED V. F AILURE TO A BATE....................................................................................................... 4-34G. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-35 VIII. DE MINIMIS CONDITIONS. ................................................................... 4-36A.C RITERIA ................................................................................................................................................... 4-36B.P ROFESSIONAL J UDGMENT. ..................................................................................................................4-37C. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-37 IX. CITING IN THE ALTERNATIVE ............................................................ 4-37 X. COMBINING AND GROUPING VIOLATIONS. ................................... 4-37A.C OMBINING. ..............................................................................................................................................4-37B.G ROUPING. ................................................................................................................................................4-38C. W HEN N OT TO G ROUP OR C OMBINE. ................................................................................................4-38 XI. HEALTH STANDARD VIOLATIONS ....................................................... 4-39A.C ITATION OF V ENTILATION S TANDARDS ......................................................................................... 4-39B.V IOLATIONS OF THE N OISE S TANDARD. ...........................................................................................4-40 XII. VIOLATIONS OF THE RESPIRATORY PROTECTION STANDARD(§1910.134). ....................................................................................................... XIII. VIOLATIONS OF AIR CONTAMINANT STANDARDS (§1910.1000) ... 4-43 4-43A.R EQUIREMENTS UNDER THE STANDARD: .................................................................................................. 4-43B.C LASSIFICATION OF V IOLATIONS OF A IR C ONTAMINANT S TANDARDS. ......................................... 4-43 XIV. CITING IMPROPER PERSONAL HYGIENE PRACTICES. ................... 4-45A.I NGESTION H AZARDS. .................................................................................................................................... 4-45B.A BSORPTION H AZARDS. ................................................................................................................................ 4-46C.W IPE S AMPLING. ............................................................................................................................................. 4-46D.C ITATION P OLICY ............................................................................................................................................ 4-46 XV. BIOLOGICAL MONITORING. ...................................................................... 4-47CHAPTER 5CASE FILE PREPARATION AND DOCUMENTATIONI.INTRODUCTION ............................................................................................... 5-1 II.INSPECTION CONDUCTED, CITATIONS BEING ISSUED. .................... 5-1A.OSHA-1 ................................................................................................................................... 5-1B.OSHA-1A. ............................................................................................................................... 5-1C. OSHA-1B. ................................................................................................................................ 5-2 III.INSPECTION CONDUCTED BUT NO CITATIONS ISSUED .................... 5-5 IV.NO INSPECTION ............................................................................................... 5-5 V. HEALTH INSPECTIONS. ................................................................................. 5-6A.D OCUMENT P OTENTIAL E XPOSURE. ............................................................................................................... 5-6B.E MPLOYER’S O CCUPATIONAL S AFETY AND H EALTH S YSTEM. ............................................................. 5-6 VI. AFFIRMATIVE DEFENSES............................................................................. 5-8A.B URDEN OF P ROOF. .............................................................................................................................................. 5-8B.E XPLANATIONS. ..................................................................................................................................................... 5-8 VII. INTERVIEW STATEMENTS. ........................................................................ 5-10A.G ENERALLY. ......................................................................................................................................................... 5-10B.CSHO S SHALL OBTAIN WRITTEN STATEMENTS WHEN: .......................................................................... 5-10C.L ANGUAGE AND W ORDING OF S TATEMENT. ............................................................................................. 5-11D.R EFUSAL TO S IGN S TATEMENT ...................................................................................................................... 5-11E.V IDEO AND A UDIOTAPED S TATEMENTS. ..................................................................................................... 5-11F.A DMINISTRATIVE D EPOSITIONS. .............................................................................................5-11 VIII. PAPERWORK AND WRITTEN PROGRAM REQUIREMENTS. .......... 5-12 IX.GUIDELINES FOR CASE FILE DOCUMENTATION FOR USE WITH VIDEOTAPES AND AUDIOTAPES .............................................................. 5-12 X.CASE FILE ACTIVITY DIARY SHEET. ..................................................... 5-12 XI. CITATIONS. ..................................................................................................... 5-12A.S TATUTE OF L IMITATIONS. .............................................................................................................................. 5-13B.I SSUING C ITATIONS. ........................................................................................................................................... 5-13C.A MENDING/W ITHDRAWING C ITATIONS AND N OTIFICATION OF P ENALTIES. .................................. 5-13D.P ROCEDURES FOR A MENDING OR W ITHDRAWING C ITATIONS ............................................................ 5-14 XII. INSPECTION RECORDS. ............................................................................... 5-15A.G ENERALLY. ......................................................................................................................................................... 5-15B.R ELEASE OF I NSPECTION I NFORMATION ..................................................................................................... 5-15C. C LASSIFIED AND T RADE S ECRET I NFORMATION ...................................................................................... 5-16。
Draft Guidance for Industry and Food and Drug Administration Staff
Draft Guidance for Industry and 1 Food and Drug Administration2 Staff3 45 eCopy Program for Medical Device6 Submissions78 DRAFT GUIDANCE910 This guidance document is being distributed for comment purposes only.11 Document issued on: [use release date of FR Notice]1213 You should submit comments and suggestions regarding this draft document within 30 days of 14 publication in the Federal Register of the notice announcing the availability of the draft guidance. 15 Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug 16 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic17 comments to . Identify all comments with the docket number listed in 18 the notice of availability that publishes in the Federal Register . 1920 For questions regarding this document, contact the Premarket Notification (510(k)) Section or 21 the Premarket Approval Section of CDRH at 301-796-5640 or CBER’s Office of 22 Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800. 23 2425262728U.S. Department of Health and Human Services 29 Food and Drug Administration 30 Center for Devices and Radiological Health 31 Center for Biologics Evaluation and Research32Preface3334Additional Copies3536Additional copies are available from the Internet. You may also send an e-mail request to37dsmica@ to receive an electronic copy of the guidance or send a fax request to 301-38827-8149 to receive a hard copy. Please use the document number (1797) to identify the39guidance you are requesting.4041Additional copies of this guidance document are also available from the Center for Biologics42Evaluation and Research (CBER), Office of Communication, Training and Manufacturers43Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by44calling 1-800-835-4709 or 301-827-1800, or from the Internet at45/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/defau 46lt.htm.4748Table of Contents491.Introduction (1)502.What is an eCopy? (2)513.Are differences between the contents of an eCopy and paper submission acceptable? 2 524.For what submission types would an eCopy be required? (3)535.What submission types would FDA consider exempt from submission of an eCopy? .4 546.What submission types or applicants should be eligible for an eCopy waiver? (4)557.How many copies of a submission would be needed? (4)568.What are the processing steps for an eCopy? (5)57a. What are the standards for an eCopy? (5)58b. How do I know if my eCopy meets FDA’s standards for acceptance?? (6)59c. What if there is another processing party involved? (6)60d. How do you submit an eCopy to FDA? (6)61e. How does FDA process an eCopy? (7)629.What if your device is regulated by CBER? (7)63a. Will the new eCopy Program apply? (7)64b. Can you submit an electronic submission instead? (7)65c. How do you prepare and submit an electronic submission to CBER? (8)66Attachment 1 –Standards for eCopies (7)67A. Cover Letter that accompanies an eCopy (10)68B. Volume versus non-volume structure (11)69C. Folder naming convention for volume-based submissions that house PDF files (13)70D. Adobe Acrobat PDF file format (14)71E. Non-PDF file formats (15)72F. PDF file naming convention (16)73G. PDF file size limit (17)74H. Creating a PDF version from the source document (17)75I. Bookmarks and hypertext links within PDFs (20)76J. PDFs created from scanning paper documents (21)77K. Common mistakes in creating an eCopy (22)7879Guidance for Industry and Food and Drug 80Administration Staff8182eCopy Program for Medical Device83Submissions84851.Introduction86The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical 87device submissions. At this time, submission of an eCopy of a medical device submission is88voluntary. However, section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C89Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act90(FDASIA) (Pub. L. 112-144), requires the submission of eCopies after this guidance is finalized.91This draft guidance describes how the Food and Drug Administration (FDA) plans to implement 92the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is93expected to improve the efficiency of the review process by allowing for the immediate94availability of an electronic version for review rather than relying solely on the paper version.9596This draft guidance provides, among other things, the standards for a valid eCopy under section 97745A(b)(2)(A) of the FD&C Act. In accordance with section 745A(b), following the issuance of98a final guidance on this topic, submission types identified in the final guidance must include an99eCopy in accordance with the standards provided by this guidance for the submission to be100processed and accepted for review by FDA. Submissions submitted without an eCopy and101eCopy submissions that do not meet the standards provided in this guidance will be placed on 102hold until a valid eCopy is submitted to FDA and verified to meet the standards, unless a waiver 103or exemption has been granted. While the submission is on hold, the review clock will not104begin.105106In Section 745A(b), Congress granted explicit statutory authorization to FDA to implement the 107statutory eCopy requirement by providing standards, criteria for waivers, and exemptions in108guidance. Accordingly, to the extent that this document provides such requirements under109section 745A(b) of the FD&C Act (i.e., standards, criteria for waivers, and exemptions),110indicated by the use of the words must or required,this document is not subject to the usual111restrictions in FDA’s good guidance practice (GGP) regulations, such as the requirement that 112guidances not establish legally enforceable responsibilities. See 21 CFR 10.115(d).113114However, this document also provides guidance on FDA’s interpretation of the statutory eCopy 115requirement and the Agency’s current thinking on the best means for implementing other aspects 116of the eCopy program. Therefore, to the extent that this document includes provisions that are 117not “standards,” “criteria for waivers,” or “exemptions” under section 745A(b)(2), this document 118does not create or confer any rights for or on any person and does not operate to bind FDA or the 119public, but will represent the Agency’s current thinking on this topic when finalized. The use of 120the word should in such parts of this guidance means that something is suggested or121recommended, but not required. You can use an alternative approach if the approach satisfies 122Draft – Not for Implementationthe requirements of the applicable statutes and regulations. If you want to discuss an alternative 123approach, contact the FDA staff responsible for implementing this guidance. If you cannot124identify the appropriate FDA staff, call the appropriate number listed on the title page of this125guidance.126127To comply with the GGP regulations and make sure that regulated entities and the public128understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard 129language explaining that guidances should be viewed only as recommendations unless specific 130regulatory or statutory requirements are cited. FDA is not including this standard language in 131this draft guidance because it is not an accurate description of all of the effects of this guidance, 132when finalized. This guidance, when finalized, will contain both binding and nonbinding133provisions. Insofar as this guidance, when finalized, provides “standards,” “criteria for waivers,” 134and “exemptions” pursuant to section 745A(b) of the FD&C Act, it will have binding effect. For 135these reasons, FDA is not including the standard guidance language in this draft guidance.136137The eCopy Program is not intended to impact (reduce or increase) the type or amount of data the 138applicant1 includes in a submission to support clearance or approval. Please refer to other FDA 139device or program-specific guidance documents from CDRH140(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/defau 141lt.htm) and CBER142/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida 143nces/General/ucm214106.htm) for the appropriate contents for submissions.1441452.What is an eCopy?146An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and 147submitted on a compact disc (CD), digital video disc (DVD), or in another electronic media148format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the 149complete original paper submission.21501513.Are differences between the contents of an eCopy and152paper submission acceptable?153While an eCopy is defined as an exact duplicate of the paper copy, there are limited cases in154which differences between the eCopy and the paper copy may be justified because a paper copy 155is not practical or appropriate for analysis purposes (e.g., raw data and statistical analysis156programs,3 data line listings to facilitate a bioresearch monitoring review) or is not feasible (e.g., 157videos, x-rays). The critical attribute of an eCopy is that it must include in electronic form all 1581 For the purposes of this guidance, applicant includes “submitter,” “sponsor,” or “holder.”2 An eCopy is not considered to be an electronic submission. For information on eSubmissions, refer to “FDAeSubmitter” (/ForIndustry/FDAeSubmitter/default.htm) and “Regulatory Submissions inElectronic Format for Biologic Products”(/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685.htm).3 For information on electronically submitted data, refer to “Clinical Data for Premarket Submissions”(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissi ons/ucm136377.htm).Draft – Not for Implementationdata required for that submission type.4 In other words, the eCopy must include all of the159required information for FDA review, whereas the paper copy can include a page cross-160referencing the location of certain information in the eCopy.161162The cover letter must contain the eCopy statement described in Attachment 1 and describe any 163differences between the paper version and the eCopy. The paper version must also have a164placeholder (e.g., a piece of paper printed with the appropriate section title or a divider165appropriately cross-labeled to the table of contents) that cross-references the eCopy to indicate 166that there are additional data/information in the eCopy and where in the eCopy that information 167is located.168169FDA will consider the eCopy loaded into the appropriate Center’s official document repository 170to be the official record. Any undisclosed differences between the eCopy and the paper version 171may need to be rectified and could delay the review of the submission.1721734. For what submission types is an eCopy required?174Once FDA finalizes this guidance, section 745A(b) of the FD&C Act, as added by section 1136 175of FDASIA, will require an eCopy for the following submission types5:176•Premarket notification submissions (510(k)s), including third party 510(k)s;177•Evaluation of automatic class III designation petitions (de novos);178•Premarket approval applications (PMAs)6;179•Modular PMAs;180•Transitional PMAs;181•Product development protocols (PDPs);182•Investigational device exemptions (IDEs);183•Humanitarian device exemptions (HDEs), including Humanitarian Use Device184designation requests (HUDs);185•Certain investigational new drug applications (INDs)7;186•Certain biologics license applications (BLAs)8; and187•Pre-Submissions9.1884 For example, the content requirements for a 510(k) submission are found in 21 CFR 870.87 and 807.92; those fororiginal PMA submissions are found in 21 CFR 814.20.5 Although not subject to the eCopy legislation, FDA accepts and strongly encourages eCopies for Master AccessFiles (“MAF” submissions), 513(g) Requests for Classification (“C” submissions), and Clinical LaboratoryImprovement Act (CLIA) Categorization – Exempt Device submissions (“X” submissions). If you choose to submit an eCopy, it must meet the standards outlined in Attachment 1.6 This includes all PMA submission types, including, but not limited to, original PMAs, panel-track supplements,180-day supplements, manufacturing site change supplements, and post-approval study supplements.7 Applicable only to those devices regulated by CBER that are also biologics under section 351 of the Public HealthService (PHS) Act and that also require submission of an IND prior to submission of a BLA. Such devices aregenerally those intended for use in screening donated blood for transfusion transmissible diseases.8 Applicable only to those devices regulated by CBER that are also biologics under Section 351 of the PHS Act,including those that do not require submission of an IND prior to the submission of the BLA. Such devicesgenerally include those reagents used in determining donor/recipient compatibility in transfusion medicine inaddition to those for use in screening blood for transfusion transmissible diseases.9 Refer to the draft guidance entitled, “Medical Devices: The Pre-Submission Program and Meetings with FDAStaff” (/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm310375.htm).Draft – Not for Implementation189eCopies for all subsequent submissions to an original submission, including amendments,190supplements, and reports10 to the submission types identified above would also be required even 191if the original was submitted to FDA prior to implementation of the eCopy requirement.1921935.What submission types does FDA consider exempt from 194submission of an eCopy?195Due to the potential urgent nature of the following types of submissions, FDA considers these to 196be exempt from the requirement for an eCopy:197•Compassionate use IDE submissions;198•Emergency use IDE submissions11; and199•Emergency Use Authorizations (EUAs)12.200201However, we encourage you to submit eCopies of these submissions, when feasible, in order to 202facilitate the review process. In addition, this exemption would not preclude you from sending 203in pertinent electronic information, such as imaging data, as supporting information for these 204submission types when an eCopy is not submitted.2052066.What submission types or applicants are eligible for an207eCopy waiver?208FDA believes that, given the widespread availability of software to enable the creation of an209acceptable eCopy at little to no cost, all applicants should have the ability to provide an eCopy. 210Therefore, at this time, FDA does not anticipate the need for waivers, except as described in211Section 9.2122137.How many copies of a submission are needed?214The eCopy Program would not change the overall number of copies to submit to FDA. Upon 215finalization of this guidance document, an eCopy (with a signed cover letter) will serve as one of 216the required number of copies for the various submission types. (See Table 1 below.) FDA will 217accept additional eCopies (each with a signed cover letter) in lieu of additional paper copies as 218long as at least one paper copy is submitted along with the eCopy and the total number of219required copies remains the same.22022110 Reports include all reports submitted to an applicable submission type, including annual/periodic and post-approval reports. Section 745A(b) of the FD&C Act does not apply to Medical Device Reports submitted under 21 CFR Part 803 .11 Please refer to CDRH’s device advice page entitled “IDE Early/Expanded Access”(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDevi ceExemptionIDE/ucm051345.htm#compassionateuse) and FDA’s “Guidance on IDE Policies and Procedures”(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080202.htm) for additional details on compassionate and emergency use IDE submissions.12 Refer to the guidance entitled, “Emergency Use Authorization of Medical Products”(/RegulatoryInformation/Guidances/ucm125127.htm) for more information on EUAs.Draft – Not for ImplementationFor submission types for which only two copies are required to be submitted, one must be an 222eCopy and the other must be a paper copy. For submission types requiring more than two223copies, this policy would allow additional flexibility in how the application is submitted. For 224example, for an original PMA, you would submit: (1) one eCopy and five paper copies; (2) five 225eCopies and one paper copy; or (3) any other combination that results in six total copies as long 226as there is at least one eCopy and one paper copy.227228Table 1, provides the total number of copies to be submitted to FDA. As explained above, you 229must submit at least one eCopy and one paper submission. The format for the remaining copies 230(i.e., eCopy or paper) is your choice.231232Table 1 – Number of Copies for Submission233Submission Type Total Number ofCopies510(k)s 213Third Party 510(k)s 213Original PMAs and Panel-Track Supplements 614Other PMA supplement types 315PMA reports 2Modular PMAs 3HDEs Same as PMAs,16except for HUDdesignationrequests, whichrequire two.17PDPs Same as PMAsIDEs 318INDs 319BLAs 3Pre-Submissions 32348.What are the processing steps for an eCopy?235Below are the processing steps for the submission and acceptance of an eCopy.236237a.What are the standards for an eCopy?238With regard to the standards for an eCopy submitted to FDA, please refer to Attachment 2391. Because an eCopy cannot be accepted by our eCopy loading system if it does not meet 240the standards, you should carefully review this information.24124213 See 21 CFR 807.90(a)(3)(c).14 See 21 CFR 814.20(b)(2).15 See 21 CFR 814.39(c).16 See 21 CFR 814.104(b)(4).17 See 21 CFR 814.102(d).18 See 21 CFR 812.20(a)(3).19 See 21 CFR 312.23(d).b.How do I know before submission whether my eCopy meets FDA’s243standards for acceptance?244To confirm that your eCopy will meet FDA’s standards, we strongly encourage you to 245use the new free eSubmitter-eCopies tool available on FDA’s website at246/ForIndustry/FDAeSubmitter/ucm317334.htm. One of the benefits of 247utilizing the eSubmitter-eCopies tool is that it creates an eCopy in real-time that is248consistent with the standards. Use of the eSubmitter-eCopies tool is intended to prevent 249delays in review of your submission due to the need to resolve technical issues.250Although it is highly encouraged, you will not be required to utilize the eSubmitter-251eCopies tool and may choose to skip the eSubmitter step.252253Should you have any technical questions when generating your eCopy, please contact 254cdrhesub@ prior to submission of the eCopy to FDA.255256c.What if there is another processing party involved?257In the case that another party (e.g., law firm, consultant) submits a submission on behalf 258of an applicant, the eCopy must still meet the standards for an eCopy in order to be259successfully processed whether accomplished by you (the applicant) or the submitting 260party. While the applicant may or may not include their own cover letter as part of the 261eCopy, our standards require that the submitting party include a signed cover letter with 262an eCopy statement, as described in Attachment 1.263264In the case of Third Party 510(k)s, two separate CDs comprise the eCopy. The first CD 265includes the applicant’s submission and should be clearly marked as such. The contents 266of the CD must include a cover letter with an eCopy statement, as described in267Attachment 1, that the applicant has provided. The second CD includes the Accredited 268Person’s review records and should be clearly marked as such. The Accredited Person is 269responsible for ensuring that the CDs meet the standards in Attachment 1 for an eCopy. 270In addition, the Accredited Person is responsible for providing a signed cover letter that 271includes an eCopy statement, as described in Attachment 1, that speaks to both: (1) the 272Accredited Person’s portion of the eCopy and (2) the presence of the eCopy statement 273provided by the applicant. It is not sufficient for the Accredited Person to address only 274one of these two eCopy statement issues in their cover letter.275276d.How do you submit an eCopy to FDA?277An eCopy is submitted simultaneously with the paper submission(s). First, attach the 278signed cover letter with the eCopy statement to your eCopy. Then attach this eCopy279package to the paper submission(s) and send them to CDRH’s or CBER’s Document280Control Center20 (DCC). An eCopy that is sent to the DCC without a cover letter and 281accompanying paper submission(s) will be placed on hold.282283If more than one eCopy is to be submitted, then you must attach a signed cover letter as 284described above to each additional eCopy.28528620 Refer to 21 CFR 807.90 for the DCC addresses for CDRH and CBER.e.How does FDA process an eCopy?287If an eCopy passes the validation check, the cover letter and eCopy contents will be288loaded into the appropriate Center’s official submission repository.289290If an eCopy fails the validation check (i.e., is rejected), we will notify you in writing291(e.g., by email or fax) of the reason(s). The notification will describe the logistics for 292submitting a replacement eCopy, including how to properly mark it as a replacement293eCopy, the address to which to send it, and the submission number to write on it. It is 294important that you follow these directions to avoid delays in processing the replacement 295eCopy. The submission will be placed on hold until a valid replacement eCopy is296submitted to FDA and verified to meet the standards.2972989.What if your device is regulated by CBER?299a.Will the new eCopy Requirement apply?300Yes, unless your submission is an entirely electronic submission exempted under this 301guidance, as described below. Upon implementation of the statutory requirement, all 302medical device submission types listed in Section 4 must be accompanied by an eCopy 303regardless of the Center in FDA in which the submission will be reviewed unless the304requirement is waived or exempted. Accordingly, submissions for devices subject to 305review under the FD&C Act and submitted by filing paper copies with CBER’s DCC 306must be accompanied by an eCopy, except where exempted as described below.307308While many submissions made to CBER are still in paper format and require submission 309of multiple copies, CBER is also currently able to receive and manage submissions that 310are entirely electronic.311312Submissions for devices that are subject to licensure under the Public Health Service313(PHS) Act, including biologics license applications and supplements, investigational new 314drug applications, and EUAs and pre-submissions for these devices, may be submitted as 315entirely electronic submissions as detailed in sections 9b and 9c below. FDA will316exempt such entirely electronic submissions from the eCopy requirement.317318FDA additionally waives the eCopy requirement to submit paper copies of any entirely 319electronic submission made to CBER. Accordingly, entirely electronic submissions that 320comply with CBER guidance identified in Section 9.c. below do not need to be321accompanied by paper copies.322323b.Can you submit an electronic submission instead?324Yes, and there are several advantages for both industry and for CBER staff when you 325choose to make submissions electronically.326327The main advantage to you is in the financial savings that will likely result. The costs 328associated with printing, binding, labeling, and shipping multiple paper copies can be 329significant, especially for submissions that contain a great deal of supporting330Draft – Not for Implementationdocumentation. Likewise, we anticipate that FDA will recognize financial savings in that 331FDA avoids the costs associated with tracking, routing, and storing large amounts of332paper when you choose to submit electronically.333334Another advantage with the use of the electronic submission process is that all parties 335involved in the submission and review are referencing the same document – the336electronic one. There is no question about whether the paper copy is an exact copy of the 337eCopy. Electronic submissions may also reduce the need for reviewers to request re-338submission of previously submitted information due to an inability to read or interpret the 339information on the paper copy, as sometimes occurs when documents are photocopied. 340341c.How do you prepare and submit an electronic submission to CBER?342CBER has several resources available to applicants who choose to submit electronic343submissions as outlined in the document “Regulatory Submissions in Electronic Format 344for Biologic Products.”345(/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685 346.htm). Thus, specific details are available in the cited references and will not be repeated 347in this guidance.348349For devices that are regulated under the PHS Act and require the submission of a BLA, 350consult the guidance document entitled “Providing Regulatory Submissions to the Center 351for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics352Marketing Applications”353(/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulator 354yInformation/Guidances/General/UCM192413.pdf) for details on preparing your355electronic submission. Note that certain sections of this guidance, for example, those on 356pharmacology and toxicology, are generally not pertinent to licensed devices.357358For guidance on preparing electronic submissions for other device submissions (e.g.,359510(k)s, PMAs) sent to CBER, please see “Guidance for Industry: Providing Regulatory 360Submissions in Electronic Format - General Considerations”361(/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances 362/UCM072390.pdf) and “CBER SOPP 8110: Submission of Paper Regulatory363Applications to CBER”364(/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformati 365on/ProceduresSOPPs/ucm079467.htm), which includes information about providing366electronic copies to CBER.367368We are currently developing additional, updated guidance for other electronic369submissions sent to CBER and have issued a revised, updated draft guidance document 370for comment entitled, “Draft Guidance for Industry: Providing Regulatory Submissions 371in Electronic Format-General Considerations”372(/RegulatoryInformation/Guidances/ucm124737.htm). When373finalized, this document will provide an additional resource for applicants preparing374electronic submissions.375376。
妇产科英语试题及答案
妇产科英语试题及答案一、选择题(每题1分,共10分)1. Which of the following is a common gynecological examination?A. Blood pressure testB. Pap smearC. Chest X-rayD. Electrocardiogram2. What is the medical term for the first stage of labor?A. Latent phaseB. Active phaseC. Transition phaseD. Expulsion phase3. The hormone responsible for the development of female reproductive organs is:A. EstrogenB. ProgesteroneC. TestosteroneD. Insulin4. Which of the following is not a symptom of polycystic ovary syndrome (PCOS)?A. Irregular menstrual cyclesB. AcneC. InfertilityD. Excessive thirst5. What is the term used to describe the process of a fertilized egg implanting into the uterine lining?A. ImplantationB. ConceptionC. EmbryogenesisD. Parturition6. The most common type of birth is:A. Vaginal birthB. Cesarean sectionC. Breech birthD. Forceps-assisted birth7. Which of the following is a prenatal diagnostic test?A. UltrasoundB. AmniocentesisC. Blood pressure monitoringD. Fetal heart rate monitoring8. The hormone that stimulates the production of breast milk is:A. OxytocinB. ProlactinC. EstrogenD. Cortisol9. What is the medical term for the surgical removal of the uterus?A. HysterectomyB. OophorectomyC. SalpingectomyD. Cystoscopy10. Which of the following is a risk factor for gestational diabetes?A. Family history of diabetesB. SmokingC. Alcohol consumptionD. All of the above二、填空题(每空1分,共10分)1. The process of childbirth is divided into three stages: the _______ phase, the _______ phase, and the _______ phase.2. The medical condition characterized by the presence of cysts in the ovaries is known as _______.3. A _______ is a type of imaging technique used to visualize the fetus during pregnancy.4. The hormone _______ is responsible for the thickening of the uterine lining during the menstrual cycle.5. A _______ is a surgical procedure used to remove fibroids from the uterus.6. The _______ is the process by which a baby is born through the vagina.7. The _______ is a condition that affects the female reproductive system and can cause infertility.8. The _______ is the process of a woman's body preparing for childbirth.9. The _______ is a condition where the cervix opens too early during pregnancy, leading to a risk of preterm birth.10. The _______ is the period of time after childbirth when the mother's body returns to its pre-pregnancy state.三、简答题(每题5分,共20分)1. Explain the difference between a Pap smear and a colposcopy.2. Describe the stages of labor and the signs that indicate the onset of labor.3. What are the common symptoms of menopause, and how are they managed?4. Discuss the importance of prenatal care and the types of tests that are typically performed.四、论述题(每题15分,共30分)1. Discuss the various methods of contraception and their effectiveness, side effects, and suitability for different individuals.2. Elaborate on the role of a midwife in the process of childbirth and the importance of continuous support during labor.五、病例分析题(共30分)A patient presents to the gynecologist with complaints of heavy menstrual bleeding and severe cramps. She also mentions that she has been experiencing these symptoms for the pastsix months. Based on the information provided, discuss the possible causes of these symptoms, the diagnostic tests that may be performed, and the potential treatment options.答案:一、选择题1. B2. A3. A4. D5. A6. A7. B8. B9. A 10. A二、填空题1. First, second, third2. Polycystic ovary syndrome (PCOS)3. Ultrasound4. Progesterone5. Myomectomy6. Vaginal delivery7. Endometriosis8. Childbirth9. Cervical insufficiency10. Postpartum period三、简答题1. A Pap smear is a screening test for cervical cancer, whilea colposcopy is a more detailed examination of the cervix using a magnifying instrument.。
必写作业和选写作业英语
In an educational context,assignments are typically categorized into two types: mandatory or required and elective or optional.Heres a detailed look at both types of assignments in English:Mandatory Assignments必写作业1.Definition:These are tasks that students must complete as part of their coursework. They are often graded and contribute to the final grade in a class.2.Importance:Mandatory assignments are crucial for students to demonstrate their understanding of the subject matter and to meet the learning objectives set by the course.3.Examples:Essays:Students may be required to write essays on specific topics to develop critical thinking and writing skills.Research Papers:These involve indepth investigation into a subject and are often used in higherlevel courses.Problem Sets:Common in math and science classes,these assignments involve solving problems to apply theoretical knowledge.Lab Reports:In science courses,students may be required to perform experiments and write detailed reports on their findings.4.Consequences of NonCompletion:Failure to complete mandatory assignments can result in a lower grade,academic probation,or even failure of the course.5.Submission:These assignments usually have strict deadlines and are submitted througha specified method,such as a learning management system or in person.Elective Assignments选写作业1.Definition:These are tasks that students can choose to complete for additional credit or to deepen their understanding of the subject.2.Importance:While not required for course completion,elective assignments can enhance a students learning experience and provide opportunities for extra practice or exploration of topics of interest.3.Examples:Extra Credit Projects:These may include presentations,additional essays,or creativeprojects that go beyond the standard coursework.Advanced Reading:Students might choose to read beyond the assigned texts to gain a deeper understanding of the subject.Peer Review:Students can opt to review and provide feedback on their peers work, which can be a valuable learning experience.4.Benefits:Completing elective assignments can lead to a better understanding of the material,improved grades,and a more engaging educational experience.5.Submission:The submission process for elective assignments may be more flexible than for mandatory assignments,and they may not always be graded.6.Incentives:Teachers may offer incentives for completing elective assignments,such as bonus points or the opportunity to choose a topic for a future assignment.Both types of assignments play a significant role in a students educational journey. Mandatory assignments ensure that students meet the minimum requirements of their courses,while elective assignments offer the chance to go above and beyond,enriching the learning experience and potentially boosting academic performance.。
高二年级英语名词短语辨析单选题40题
高二年级英语名词短语辨析单选题40题1. In our school, there is a(n) _____ for students to show their talents once a month.A. opportunityB. occasionC. chanceD. situation答案:A。
解析:“opportunity”强调机会是符合某种目的、有利于做某事的时机,通常有一定的计划性,这里学校每月一次让学生展示才华是一种有计划的机会;“occasion”侧重于特殊的时刻、场合,比如婚礼、节日等场合;“chance”侧重于偶然的、意外的机会;“situation”指的是一种状况、形势,与题意不符。
所以选A。
2. We should respect different _____ in different countries when we travel abroad.A. customsB. habitsC. traditionsD. practices答案:A。
解析:“customs”指一个国家、民族或社会群体在社会行为方面长期形成的风俗习惯,多与国家等概念联系在一起,这里出国旅游要尊重不同国家的风俗,用“customs”合适;“habits”侧重于个人的习惯;“traditions”更多指世代相传的传统,如文化、宗教方面的传统;“practices”可表示惯例、常规做法,但在表示国家层面的习俗时不如“customs”准确。
所以答案为A。
3. The _____ of this small town is very beautiful, especially in spring.A. viewB. sceneC. sceneryD. sight答案:C。
解析:“scenery”指一个地区的整体自然风景,常用来描述某个地方美丽的景色,这个小镇的整体风景很美,用“scenery”;“view”侧重于从某个特定位置看到的景色;“scene”更多表示场景,比如戏剧、事故等场景;“sight”多指眼见的景色、奇观,常指人造景观或者视力范围之内的景色。
循证文献检索与药物评价答案-2024年执业药师继续教育答案
循证文献检索与药物评价2024年执业药师继续教育答案一、单项选择题(下列每小题备选答案中,只有一个符合题意的正确答案。
多选、错选、不选均不得分。
)1.以下不属于原始研究类型的是(B)A.随机对照试验B.卫生技术评估C.队列研究D.病例报告2.牛津大学循证医学中心证据水平分为多少级?(D)A.2B.3C.4D.53.按照GRADE标准,证据水平分为为多少级?(C)A.2B.3C.4D.54.临床指南的质量评价工具为(D)A.QUOROMB.PRISMAC.MOOSED.AgreeII5.可以检索到英文杂志的JCR分区的数据库为(C)ctmedB.UpToDateC.WebofScienceD.Micromedex二、多项选择题(下列每小题备选答案中,有一个货多个符合题意的正确答案。
错选、不选均不得分。
)1.临床问题拆解的PICOS原则包括(ABCD)A.patient/problemB.intervention/prognosticfactor/exposureparisonsD.outcomes2.文献的质量评价包括(ABC)A.真实性评价B.重要性评价C.临床实用性评价D.安全性评价3.原始研究的偏倚来源包括(ABCD)A.选择偏倚B.实施偏倚C.失访偏倚D.测量偏倚4.减少原始研究偏倚的措施包括(ABCD)A.随机分配B.分配隐藏C.盲法D.ITT分析5.卫生技术评估报告包括(ABCD)A.有效性评价B.安全性评价C.经济学评价D.社会、伦理评价。
2023年英语中考卷子
2023年英语中考卷子一、You will hear a conversation about a weekend trip. What activity do they plan to do?A. Go hiking in the mountains.B. Visit a museum in the city.C. Have a picnic in the park.D. Attend a music festival.(答案:C)二、In the next dialogue, two friends are discussing their favorite subjects. Which subject does neither of them like?A. MathematicsB. HistoryC. ScienceD. Art(答案:A)三、Listen to the description of a school event. When is the event scheduled?A. Next MondayB. This FridayC. Last weekendD. The following Thursday(答案:D)四、You will hear a news report about environmental protection. What measure is being promoted to reduce pollution?A. Using public transportation more often.B. Cutting down more trees for construction.C. Increasing the use of single-use plastics.D. Encouraging people to waste water.(答案:A)五、In the conversation, two students are talking about their future plans. Where does the second student want to study abroad?A. In the United StatesB. In FranceC. In AustraliaD. In Canada(答案:B)二、Reading Comprehension (阅读理解)六、Read the passage and answer the question: What is NOT mentioned as a benefit of reading?A. Improving vocabulary.B. Reducing stress levels.C. Enhancing creativity.D. Increasing screen time.(答案:D)七、According to the article, which of the following is true about the ancient civilization mentioned?A. It was located in Europe.B. It invented the wheel.C. It had no written language.D. It disappeared without a trace.(答案:B)八、In the text, the author discusses the impact of technology on education. Which statement does NOT reflect the author's view?A. Technology has made learning more accessible.B. Technology has replaced traditional teaching methods entirely.C. Technology can enhance student engagement.D. Technology offers new ways of assessing learning.(答案:B)九、Based on the information in the passage, what is the main challenge faced by wildlife conservationists?A. Lack of funding.B. Overpopulation of certain species.C. Habitat destruction.D. Public opposition to conservation efforts.(答案:C)十、The article talks about the benefits of exercise. Which of the following is NOT listed as a health benefit?A. Improved cardiovascular health.B. Stronger muscles and bones.C. Better mental health.D. Instant weight loss.(答案:D)。
《小学英语教学评价》课件
CATALOGUE
目录
Evaluation of Extracurricular Activities in Primary School EnglishThe impact of teaching evaluation on teaching quality
Overview of Primary School English Teaching Evaluation
Specific indicators
The enthusiasm and frequency of students participating in classroom activities
Students' interest and enthusiasm for learning English
Learning outcomes
Feedbackห้องสมุดไป่ตู้and suggestions
Follow up assessment
The impact of teaching evaluation on teaching quality
Specific indicators
Evaluation of Extracurricular Activities in Primary School English
04
Resource allocation
Assess the allocation of human, material, and financial resources for the event
Student engagement
Observe and assess how the students are engaged during the activity
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
NEA/WPEC–13ECN-RX--98-014 I n t e r n a t i o n a l E v a l u a t i o n C o-o p e r a t i o nV O L U M E13INTERMEDIATE ENERGY DATAA report by the Working Partyon International Evaluation Co-operationof the NEA Nuclear Science CommitteeC O-ORDINATORA.J. KoningNetherlands Energy Research Foundation (ECN) NETHERLANDSC O-ORDINATORT. FukahoriJapan Atomic EnergyResearch Institute (JAERI)JAPANM ONITORA. HasegawaJapan Atomic EnergyResearch Institute (JAERI)JAPANNUCLEAR ENERGY AGENCYORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENTORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT Pursuant to Article 1 of the Convention signed in Paris on 14th December 1960, and which came into force on 30th September 1961, the Organisation for Economic Co-operation and Development (OECD) shall promote policies designed:− to achieve the highest sustainable economic growth and employment and a rising standard of living in Member countries, while maintaining financial stability, and thus to contribute to thedevelopment of the world economy;− to contribute to sound economic expansion in Member as well as non-member countries in the process of economic development; and− to contribute to the expansion of world trade on a multilateral, non-discriminatory basis in accordance with international obligations.The original Member countries of the OECD are Austria, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States. The following countries became Members subsequently through accession at the dates indicated hereafter; Japan (28th April 1964), Finland (28th January 1969), Australia (7th June 1971), New Zealand (29th May 1973), Mexico (18th May 1994), the Czech Republic (21st December 1995), Hungary (7th May 1996), Poland (22nd November 1996) and the Republic of Korea (12th December 1996). The Commission of the European Communities takes part in the work of the OECD (Article 13 of the OECD Convention).NUCLEAR ENERGY AGENCYThe OECD Nuclear Energy Agency (NEA) was established on 1st February 1958 under the name of OEEC European Nuclear Energy Agency. It received its present designation on 20th April 1972, when Japan became its first non-European full Member. NEA membership today consist of all OECD Member countries, except New Zealand and Poland. The Commission of the European Communities takes part in the work of the Agency.The primary objective of the NEA is to promote co-operation among the governments of its participating countries in furthering the development of nuclear power as a safe, environmentally acceptable and economic energy source.This is achieved by:− encouraging harmonization of national regulatory policies and practices, with particular reference to the safety of nuclear installations, protection of man against ionising radiation andpreservation of the environment, radioactive waste management, and nuclear third party liabilityand insurance;− assessing the contribution of nuclear power to the overall energy supply by keeping under review the technical and economic aspects of nuclear power growth and forecasting demand and supplyfor the different phases of the nuclear fuel cycle;− developing exchanges of scientific and technical information particularly through participation in common services;− setting up international research and development programmes and joint undertakings.In these and related tasks, the NEA works in close collaboration with the International Atomic Energy Agency in Vienna, with which it has concluded a Co-operation Agreement, as well as with other international organisations in the nuclear field.©OECD 1998Permission to reproduce a portion of this work for non-commercial purposes or classroom use should be obtained through the Centre français d’exploitation du droit de copie (CCF), 20, rue des Grands-Augustins, 75006 Paris, France, Tel. (33-1) 44 07 47 70, Fax (33-1) 46 34 67 19, for every country except the United States. In the United States permission should be obtained through the Copyright Clearance Center, Customer Service, (508)750-8400, 222 Rosewood Drive, Danvers, MA 01923, USA, or CCC Online: /. All other applications for permission to reproduce or translate all or part of this book should be made to OECD Publications, 2, rue André-Pascal, 75775 Paris Cedex 16, France.FOREWORDA Working Party on International Evaluation Co-operation was established under the sponsorship of the OECD/NEA Nuclear Science Committee (NSC) to promote the exchange of information on nuclear data evaluations, validation, and related topics. Its aim is also to provide a framework for co-operative activities between members of the major nuclear data evaluation projects. This includes the possible exchange of scientists in order to encourage co-operation. Requirements for experimental data resulting from this activity are compiled. The working party determines common criteria for evaluated nuclear data files with a view to assessing and improving the quality and completeness of evaluated data.The parties to the project are: ENDF (United States), JEF/EFF (NEA Data Bank Member countries) and JENDL (Japan). Co-operation with evaluation projects of non-OECD countries, specifically the Russian BROND and Chinese CENDL projects, are organised through the Nuclear Data Section of the International Atomic Energy Agency (IAEA).Subgroup 13 of the working party was initiated with the objective to assess nuclear data needs in the intermediate energy range. The major tasks of the subgroup were to identify the needs for experimental and evaluated data, the suitable data formats to be used, and the methodology to be used in data calculations. The assembly of a pilot evaluation was also being scheduled in a second phase of the project.The opinions expressed in this report are those of the authors only and do not necessarily represent the position of any Member country or international organisation. This report is published on the responsibility of the Secretary-General of the OECD.3TABLE OF CONTENTS1.Introduction (7)2.General scope (8)3.Activities and their status (10)3.1Data needs (10)3.2High-Priority Nuclear Data Request List forIntermediate Energies (10)3.2.1Nuclides (11)3.2.2Energies (11)3.2.3Cross-sections (11)3.2.4Future (13)3.3Compilation of experimental data (14)3.4Nuclear models (14)3.5Specialist meetings and benchmarks (15)3.5.1NEA Specialist Meeting on the Nucleon-NucleusOptical Model up to 200 MeV (15)3.5.2International codes and model comparison forintermediate energy activation yields (15)3.5.3Thick target benchmark (16)53.6Data formats and evaluated data libraries (16)3.6.1ENDF format for high energies (16)3.6.2High-energy transport files: Status in May 1998 (17)3.6.3MENDL and WIND activation/transmutation libraries (17)4.Final status: Summary (18)5.Recommendations (18)REFERENCES (21)6INTERMEDIATE ENERGY DATA1.IntroductionSubgroup 13 (SG13) on Intermediate Energy Nuclear Data was formed by the NEA Nuclear Science Committee in 1994 to solve common problems of intermediate energy nuclear data for nuclear applications. The first meeting was chaired by the monitor, the late Dr. Kikuchi of JAERI, during the Gatlinburg conference on Nuclear Data for Science and Technology in 1994. The enormous interest in accelerator-driven systems that has emerged in the past decade has resulted in the associated interest, and importance, of intermediate energy nuclear data. Of course, this topic itself covers many aspects, from basic nuclear model calculations and microscopic experiments to applied transport calculations. The main scope of SG13 has always been to focus the present expertise in the various branches of research, thereby primarily using transmutation of waste as the objective.The general nature of SG13, combined with the aforementioned boost in accelerator-driven system research, has entailed that the range of SG13 has become very wide. With various national and international activities on intermediate energy nuclear data now well underway, it may be the right moment to finalise this subgroup and to discuss possible new subgroups that handle the most crucial subtopics of intermediate energy nuclear data, i.e. subgroups that are entirely devoted to more strictly defined tasks.In this final report, we give an overview of the present status of the various activities of SG13. First, we go in some detail. At the end we give a summarised list. We also provide a list of recommendations for follow-up actions.We mention that most reports related to SG13 can be obtained electronically from the NEA Data Bank. In particular the following WWW-pages contain relevant documents:• http://www.nea.fr/html/science/pt/iend.html• http://www.nea.fr/html/trw/nucdat/high.html• http://www.nea.fr/html/trw/nucdat/iend/iend.html72.General scopeMany applications, such as accelerator-based transmutation of waste, energy amplification, medical research, astrophysical applications and also fusion research, require nuclear data that go beyond the traditional evaluation limit of 20 MeV. Whereas low-energy neutron-induced reactions already have been extensively evaluated, mainly for conventional reactor purposes, the situation for protons and neutrons above 20 MeV is less clear. The purpose of SG13 was to investigate the nuclear data needs for applications and to provide the link with nuclear reaction physics. Important topics that have been, and are still, considered are:• Investigation of nuclear data needs from the point of view of applications. Which nuclear data have the highest priority?• Recommendations for experiments.• Compilation of existing experimental data into computational format (EXFOR; NEA Data Bank).• Assessment of the current status of nuclear models and associated codes (and comparison of such codes in a benchmark).• Recommendation and organisation of specialists meetings on topics that are crucial for improving the quality of intermediate energy nucleardata.• Discussion of ENDF-format aspects for evaluated nuclear files (i.e. Can we create nuclear data libraries in analogy with low-energyapplications?) and organisation of pilot evaluations.• Application of basic nuclear data in transport calculations.A more schematic outline is presented in Figure 1 which at one point defined all the task forces of SG13. Some of the task forces have received more attention than others and we will use this scheme as a guideline to enumerate the accomplishments of SG13.8Figure 1. Task forces of SG1393.Activities and their status3.1Data needsAn important task was to investigate the nuclear data requirements from the point of view of applications. As follow-up of the study made in Ref. [1], Kikuchi and Fukahori [2] have made a systematic inquiry on the type of incident particle, target nuclei and physical quantities. This study is not only aimed at nuclear energy applications, but also serves medical and astrophysical purposes. For accelerator-driven systems, the requested data comprise transport libraries, activation and damage cross-sections of accelerator components, double-differential light-particle cross-sections and spallation product yields for a whole spectrum of nuclides and recoils. To meet these requests, the subgroup has defined a high priority request list which may serve as a guideline for necessary measurements for accelerator-driven system research. This is a separate activity which is presented in the next subsection.3.2High-Priority Nuclear Data Request List for Intermediate EnergiesThe present High-Priority Request List (HPRL) for Intermediate Energy Nuclear Data (IEND) deviates considerably from the first, preliminary versions. The initiative for maintaining this HPRL was taken in 1994, as a guideline for necessary measurements for accelerator-based transmutation research.As expected, the most difficult aspect of maintaining a HPRL turned out to be keeping it within bounds; several suggestions from both the applied and fundamental community were added to the list until at some point the list provided enough experimental work for the next millennium. Clearly, the adjective “high-priority” was no longer appropriate. On the other hand, several conferences in the field and personal communications between scientists have arguably led to more consensus on the required data. Accordingly, a new HPRL has been created by means of a threefold reduction:− fewer nuclides;− a smaller energy region (for evaluated data files only: E < 200 MeV);− fewer types of cross-sections to be measured.As usual, scientists are still invited to criticise this choice and to argue that other nuclides or reactions are more, or at least equally, important. Keep in10mind however that this should remain a HIGH-PRIORITY list. If it gets too big by new additions, other nuclides/cross-sections should be left out to keep this project focused.3.2.1NuclidesThe proposal is to include 10 nuclides in this list, which cover both the periodic table and various applications. They are the most abundant (apart from 100Mo) isotopes of:− one material for medical purposes: O;− three structural materials: Al, Fe and Ni;− one fission product: Mo;− one “nuclear model” material: Zr;− two target materials: W and Pb;− two actinides: Th and U.Table 1 may be referred to for a more detailed list.3.2.2EnergiesThe highest energy in the HPRL is now 200 MeV. Not only does this coincide with the new upper limit of intermediate energy evaluated data files (Los Alamos has chosen 150 MeV), it is also near the maximum energy of some of the remaining experimental facilities (AGOR-KVI, Groningen, Holland; Svedberg Lab., Uppsala, Sweden; Louvain-la-Neuve, Belgium and NAC, Faure, South Africa are examples of such laboratories). The proposed energy grid for neutron and proton production cross-sections has been chosen so that it may overlap with existing measured cross-sections for other nuclides or incident particles.3.2.3Cross-sectionsAnother reason to keep the number of isotopes limited is that we may eventually obtain “complete” sets of experimental nuclear data. This is of critical importance to nuclear model calculations. If elastic and total (reaction)11Table 1. High-Priority Nuclear Data Request List for Intermediate Energies Nuclide Cross-section Energy (MeV)Purpose16O(p,reac)(n,xn)10,15,20,30,40,60,80,100,150,20027,41,61,70O,M,AM,A,N27Al(p,p),(p,p’),Ay,(p,reac)(n,n),(n,n’),Ay,(n,reac)(n,xn)20,30,40,50,60,80,100,150,20040,50,60,70,80,10025,45,80O,A,FO,A,FA,F,N56Fe(p,reac)(n,xn),(n,xp)10,15,20,30,40,60,80,100,150,20025((n,xp)only),45,80O,A,FA,F,N58Ni(p,xn)(p,xp)(n,xn),(n,xp)80,16025,4525,45((n,xn) only),80A,F,NA,F,NA,F,N90Zr(n,xn),(n,xp)(p,xp)25,45,8025,45N,A,FN,A,F100Mo(p,p),(p,p’),Ay,(p,reac)(n,n),(n,n’),Ay,(n,reac)(n,xn),(n,xp)(p,xn)20,30,40,50,60,80,100,150,20020,30,40,50,60,70,80,10025,45,8025,45,60,80,160O,M,AO,M,AM,A,NM,A,N184W(p,p),(p,p’),Ay,(p,reac)(n,n),(n,n’),Ay,(n,reac)(n,xn),(n,xp)(p,xn)(p,xp)(p,f),(n,f)20,30,40,50,60,80,100,150,20015,20,30,40,50,60,70,80,10025((n,xp) only),45,8025,45,80,113,16025,45,80,16050,100,150,200O,AO,AN,AN,AN,AA,N208Pb(p,reac)(n,n),Ay(n,xn),(n,xp)(p,xp)(p,f),(n,f)40,60,80,100,150,20060,70,80,10025,45,8025,45,16050,100,150,200O,A,MO,A,MA,M,NA,M,NA,M,N232Th(p,p),(p,p’),Ay,(p,reac)(n,n),(n,n’),Ay,(n,reac)(n,xn),(n,xp)(p,f),(n,f)20,30,40,50,60,80,100,150,2006,8,10,15,20,30,40,50,60,70,80,10025,45,8050,100,150,200O,AO,AA,NA,N238U(p,p),(p,p’),Ay,(p,reac)(n,n),(n,n’), Ay,(n,reac)(n,xn),(n,xp)(p,f),(n,f)20,30,40,50,60,80,100,150,2006,8,10,15,20,30,40,50,60,70,80,10025,45,8050,100,150,200O,A,MO,A,MA,N,MA,N,MA: Accelerator-Driven Systems, F: Fusion (En< 50 MeV), M: Medical, N: Nuclear reaction models, O: Optical models, Ay: Analysing power12cross-sections for both neutrons and protons (to construct a 0-200 MeV optical model) as well as a complete set of (p,xn),(p,xp),(n,xn) and (n,xp) cross-sections are available, code developers can narrow down the uncertainties in their calculations, which has an immediate, positive impact on predictions for other nuclides where no experimental data exist. Of the whole periodic table, 90Zr is the closest to this ideal situation. Therefore, the remaining measurements for this nuclide are included in the list.There are two important quantities not on the list, which are however equally important. They are not yet included in the main table since the database of these cross-sections has not yet been investigated to designate the top-priority nuclei and energies.− Residual production cross-sections. A lot of these requirements have been or will be met by the experimental group of Dr. Michel,Hannover. Since the total collection of measured data is so large, it isdifficult to see on short notice where particular shortcomings exist forthe ten selected nuclei.− Deuteron up to alpha production cross-sections. Although these cross-sections are much smaller than the neutron and proton productioncross-sections (for heavier targets at least), they are still important fore.g. damage, heating and gas production. Since the measurements arevery scarce, both for incident neutrons and protons, the requirementsfor these quantities apply to almost every nuclide.The last column of Table 1 gives the possible applications of the measured cross-sections, thereby attempting to give a priority order as well. Optical model and nuclear reaction model requirements have an indirect character: the quality of these data determines the quality of the whole evaluated data file.3.2.4FutureThis is a request list for experiments and indirectly for evaluations. At present, there is a 100% overlap between experiment and evaluated data requirements. High-energy evaluations completely consist of results from nuclear model calculations that have been tuned to experimental data. An exception to this may be residual production cross-sections. These are so difficult to predict (see the NEA benchmark by Michel and Nagel – a factor of two on average is considered good!) that it may be more appropriate to directly include experimental data in activation data files. This however, needs further13discussion. In sum, the HPRL for IEND is now much shorter than it was before, though still quite substantial. Therefore, results of sensitivity calculations are needed to narrow down the HPRL.Finally, we mention that some experimental groups are already taking items of this list into account in their programme, e.g. IPN in Louvain-la-Neuve where (n,xp) cross-sections for various isotopes in the 25-65 MeV region are being measured. Accordingly, a revised request list is expected before long.3.3Compilation of experimental dataComputational documentation of experimental nuclear reaction data is extremely important. It will assist nuclear scientists in choosing new experiments and benchmarking model codes. At the NEA Data Bank, the collection of intermediate-energy experimental data has been significantly extended in the past years. At the moment, the total charged-particle EXFOR database contains about 20 Mb of relevant data. Updating EXFOR with charged-particle induced data is a relatively new activity and consequently there is still a considerable gap between the data measured in the past and the data actually stored in EXFOR [1]. As a probably redundant statement, we strongly recommend continuation of updating the EXFOR database1. Accelerator-driven system research requires a charged-particle database that is as comprehensive as the neutron database that has been maintained by the National Nuclear Data Centres over the years.3.4Nuclear modelsIt is obvious that the evaluation of high-energy data is mainly provided by nuclear model codes, which are benchmarked against crucial experiments. Initially, nuclear model codes with application above 20 MeV were part of SG13 too. This has however been transferred to SG12 (nuclear model validation). Nuclear models and codes do however come into play in the various benchmarks that were initiated by SG13. They are discussed in the next subsection.1The cost of a single update in EXFOR is negligible compared to the total cost of the associated experiment, while general availability and easy retrieval of the data is, next to the actual scientific publication, the most important manifestation of any experiment!143.5Specialist meetings and benchmarksWith the increasing interest in intermediate-energy applications, various low-energy directed model codes have been extended to higher energies to meet the data requirements. These codes, together with intranuclear cascade programs that were already suitable for high energies, have been compared with each other and with experimental neutron and proton reaction cross-sections and spectra in the NEA Code Comparison Meeting [3]. Rather large predicted differences were observed which, not surprisingly, have led to further research recommendations. To discuss and solve these problems, SG13 has initiated the following activities:3.5.1NEA Specialist Meeting on the Nucleon-Nucleus Optical Model up to200 MeVThis [4] was held in November 1996, at CEA Bruyères-le-Chatel, France. Perhaps the most conspicuous problem that was revealed in the NEA Code Comparison Meeting was an unacceptable spreading (up to 50%) of the predicted proton reaction cross-sections. One of the conclusions of the Optical Model Meeting was that old, global optical models were no longer suitable to satisfy intermediate energy nuclear data needs. Improved parametrisations are required.3.5.2International codes and model comparison for intermediate energyactivation yieldsA benchmark of codes for residual production cross-sections [5] was organised by the NEA, co-ordinated by R. Michel (University of Hannover) and P. Nagel (NEA, Paris). These quantities turned out to be among the most difficult to predict in nuclear reaction physics. Codes that predict the data, on average, within a factor of two of the experimental data are considered good. The precise reason for this large discrepancy is not yet known, although it is clear that the effects of different optical models, level densities and mechanisms like high-energy fission and multiple pre-equilibrium emission have a drastic influence on the predictions. It seems that a sensitivity study on this topic would be very useful. Another SG13 report that addresses these problems is written by Mashnik et al. [6].153.5.3Thick target benchmarkA thick target benchmark [7] was organised at the NEA. Participants were asked to predict the neutron yields per proton and the mass distribution of spallation products for a cylindrical tungsten target bombarded by 800 MeV protons. Conclusions are given by Sobolevsky [8]. The general conclusion is that the neutron yield and leakage are well predicted but that product yields prediction gives problems (up to an order of magnitude difference).3.6Data formats and evaluated data libraries3.6.1ENDF format for high energiesSeveral format proposals for high-energy evaluated data files have been considered [9,10], all based on ENDF6 rules [11], and there is now reasonably good agreement on the format from the evaluators’ point of view. For the construction of a high energy data file, procedures different from those used in the low energy files have to be employed, since it is no longer possible to store all reactions that describe different sequential particle emissions in separate MT-numbers. On the other hand, detailed low energy neutron data remain as important as in normal reactor calculations. Therefore, as a general rule, the detailed representation of cross-sections below 20 MeV should be left untouched as much as possible. For energies above 20 MeV, the detailed information concerning each individual excited state of the target nucleus and each particular sequential reaction chain are somewhat less important. Therefore, almost all reaction information should be lumped in MT5, which comprises all non-elastic processes that are not explicitly considered in other MT-numbers (such as fission). The particle and product yields and the outgoing energy-angle distributions can then be stored in MF6/MT5.Besides consisting of reliable cross-sections, the quality criterion for a nuclear data file is a successful check by the standard ENDF-utility codes CHECKR, FIZCON and PSYCHE [12] and successful processing by the code NJOY [13] into both multi-group format for deterministic codes and a continuous-energy MCNP-library. In another recent SG13 document [14], a set of special rules and recommendations for an evaluated nuclear data file are given, such that the NJOY-processing conditions are obeyed. In general, the procedure follows the method that is used in Los Alamos to create 150 MeV libraries.163.6.2High-energy transport files: Status in May 1998The collection of transport data files that exceed 20 MeV and have proven to be applicable in transport calculations is [15,16,17,18,19]:• Los Alamos National Laboratory: Neutrons and protons 0-150 MeV − 1,2H, 12C, 14N, 16O, 27Al, 28,29,30Si, 31P, 40Ca, 50,52,53,54Cr, 54,56,57,58Fe, 58,60,61,62,64Ni, 63,65Cu, 93Nb, 182,183,184,186W, 204,206,207,208Pb• ECN Petten/CEA Bruyères-le-Chatel: Neutrons and protons 0-150 MeV− 54,56Fe, 58,60Ni• ECN Petten/EC (IABAT project): Neutrons and protons 0-150 MeV − 204,206,207,208Pb (under development)• FZK Karlsruhe/INPE Obninsk: Neutrons: 0-50 MeV− 12C, 16O, 23Na, 28Si, 39K, 51V, 52Cr, 56Fe, 208Pb, 232Th, 233Pa, 233,238U, 239Pu • JAERI: JENDL high-energy file up to 50 MeV3.6.3MENDL and WIND activation/transmutation librariesThe Medium Energy Nuclear Data Library, MENDL [20], contains residual production cross-sections for neutrons with energies up to 100 MeV incident on stable and unstable nuclei. In total, 57,000 threshold reactions are included for elements ranging from Aluminium to Polonium. MENDL has been created by Shubin, Lunev, Konobeyev and Dityuk. The Waste Incineration Nuclear Data Library, WIND [21], contains fission and residual production cross-sections for neutrons up to 100 MeV for uranium, neptunium and plutonium isotopes. WIND is made by Konobeyev, Korovin, Preslavtsev, Plyaskin and Stankovsky.A drawback of the original form of these libraries was that they were not processable due to an alternative method to store the residual production cross-sections. It was a SG13 task to transform MENDL and WIND to the ENDF6-format [22]. The same methods are now used to extend well tested low-energy activation libraries, such as EAF-97, to higher energies.174.Final status: SummaryWe summarise some of the important accomplishments of SG13:• The data needs as required by the applied community are categorised (see however, the next section on recommendations).• The most significant deficits of our nuclear modelling capability have been diagnosed. Accordingly, relevant meetings and benchmarks havebeen suggested, organised and reviewed:− International code comparison for intermediate energy nuclear data: the thick target benchmark.− International codes and model comparison for intermediate energy activation yields.− NEA Specialists Meeting on the Nucleon-Nucleus Optical Model up to 200 MeV.• A high-priority request list for experiments has been set up and maintained.• The experimental database EXFOR has been extended with charged-particle induced data. SG13 has initiated both therecommendations for data to be included and the actual compilationof the data.• The procedures for high-energy files in ENDF6-format have been defined in a unique way that guarantees NJOY-processibility.• The MENDL and WIND activation/transmutation libraries have been documented, stored and transformed into ENDF6-format.• A book-keeping of all available E > 20 MeV data files is maintained at the NEA.5.RecommendationsAs stated in the introduction, in the four years of existence of SG13 it became clear how many different aspects come into play when considering intermediate energy data. To do a serious job, one should treat nuclear reaction18。
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Co-operative Evaluation of a DesktopVirtual Reality SystemTim Marsh and Peter WrightHCI GroupDepartment of Computer ScienceUniversity of YorkYO10 5DD{tmarsh, pcw}@AbstractA summative usability evaluation of a desktop virtual reality (VR) system wasdeveloped and a preliminary study then conducted. The purpose of the study was twofold. Firstly, to test whether the traditional evaluation technique, co-operative evaluation, is effective in the evaluation of desktop VR systems. Co-operative evaluation is a variation on a ‘think-aloud’ verbal protocol, whereby, in addition to concurrently 'thinking-aloud', users are encouraged to ask any questions about an evaluation, relating to the computer-based system, the application, or the tasks that they are required to perform during the evaluation. As well as this, the evaluator may ask questions of the user at any time during the evaluation. Results from the study indicate that this additional probing technique enables an evaluator to elicit further usability problems that may not have otherwise been exteriorized by the user. Additionally, a method is developed which attempts to turn round the qualitative 'think-aloud' type data into quantitative data. This provides a way of evaluating empirical 'think-aloud' evaluation methods and will be useful for comparing their effectiveness to evaluate 3D virtual reality systems. Secondly, attempts were made to capture a user’s awareness of the spatial layout of virtual environment (VE) and the objects and their positions within the VE. However, problems with the methods that were employed in the evaluation are identified, and suggestions that may inform future evaluations are made in an attempt to capture more directly a user's awareness of the spatial layout of a VE.1 The StudyA preliminary study was conducted with 4 users employed in a summative evaluation of a desktop VR system. The following are the research questions that the study attempts to answer:i.how effective is co-operative evaluation in evaluating the usability of desktopVR?ii.is co-operative evaluation an appropriate technique for capturing the spatial features or qualities of a 3D virtual reality system?The 4 users volunteered to participate in the study. They consisted of 2 males and 2 females. All used computers in their daily work and two users had home computers.Their daily computer usage ranged from approximately 1 hour to 9 hours per day. Only one user had experience of VR for entertainment purposes.2 Desktop VRThe test environment for the study was a desktop VR system called the Virtual Production Planner © [VPP97]. Virtual Production Planner is a desktop VR based training system. End users are intended to be student and professional television camera operators, producers, set designers and directors. Its purpose is to provide a teaching and development environment for a range of studio television production techniques from, storyboarding, camera operation and planning, development and creation of virtual productions, to set design and layout, and directing virtual productions. The sets provided are 3D computer generated graphical representations of two British Broadcasting Corporation (BBC) television programmes, the soap opera EastEnders™, and the news and current affairs programme, Newsnight TM The range of features and functions that can be performed in the Newsnight TM set are representative of that provided in the Virtual Production Planner system and therefore, this was used in the evaluation study.3 MethodThree standard tasks were devised to test the usability, functionality and effectiveness of the Virtual Production Planner:Task 1. Identify / Operate Cameras:Users are asked to identify the 5 cameras in the studio. 4 conventional studio cameras that move around the floor of the studio, and 1 free or flying camera, and perform the following: Select cameras, Move cameras, Control the camera views.Task 2. Orientation / Familiarization:The second task consisted of 3 phases. Firstly, by viewing through camera 1, navigate around the Newsnight studio, and draw a plan view of the studio. Secondly, using the flying / free camera navigate around Newsnight studio and again draw a plan view of the studio. Finally, users were shown how to obtain the plan view mode of the studio and asked to move the cameras around the studio from the plan view. Following task 2, subjects were then asked to complete a questionnaire.Task 3. Set-Up / Line-up Cameras: Without using the plan view, subjects were asked to position camera 1 to show a close-up of the presenter, and position camera 2 to show a shot of the presenter over the guest’s left shoulder. Using the plan view, subjects were asked to position camera 3 to show a straight-on shot of the desk, with the presenter and guest seated at either end and the monitor over the desk, and finally, position camera 4 to show a close-up of the guest with the studio monitor displaying the BBC logo to the left of the screen.©BBC/Colt Virtual Reality Ltd. 1997.™EastEnders and Newsnight are trademarks of the British Broadcasting Corporation (BBC).To obtain information about how well VPP supports the tasks, users were asked to adopt a concurrent ‘think-aloud’ verbal protocol. Additionally, users were encouraged to ask the evaluator any questions about the desktop VR system and the tasks that they were required to perform, and they were informed that the evaluator may ask questions of the user at any time during the evaluation. This method of evaluation is co-operative evaluation, as previously described. For an in-depth treatment of co-operative evaluation the reader is referred to Wright and Monk (1989, 1992), and Monk, Wright, Haber, and Davenport (1993). To provide a way to assess the co-operative evaluation technique, a method is developed which attempts to turn round the qualitative 'think-aloud' type data into quantitative data. Based on a similar technique proposed by Hackman and Beirs (1992), empirical evaluations are assessed according to their quantity and quality of the users' 'think-aloud' verbalizations. The quantity is attained by counting all verbalizations; scoring a single utterance, statement, or sentence, or group of these relating to the same issue, as one. The quality of each of these is then judged as low or high, by two evaluators: the study evaluator and an independent evaluator. The criteria by which this will be judged is as follows: Low Quality usability problems are judged to be of low importance or low quality to designers of virtual environments, are more than likely to be user errors in operation, and users will have no problems overcoming these with more usage and time with the virtual environment. High Quality usability problems are judged to be of high importance or high quality to designers of virtual environments, they are not the criteria for low quality usability problems, they did occur frequently, or usability problems that may not likely be overcome with more usage and time, and may possibly shock or startle a user, for example, moving through or colliding with objects. Essentially, this provides a method of evaluating the evaluation technique. Finally, as suggested in task 2, a user's awareness of the layout of the studio and the objects and their positions within the studio is tested. This is carried out by getting the users to draw plan views (birds eye view) of the studio layout and the positions of objects on grid paper. Two plan drawings will be made. One using the conventional studio floor camera (moving along the floor of the studio) and the other using the flying camera (flying through the space of the studio) to navigate around the studio. During each navigation, users are asked to draw a plan view of the studio layout.4 ResultsUsers’ times to complete the study ranged from 15 to 43 minutes (26.5 minutes average). Refer to table 1. The evaluation produced a total of 130 verbalizations. Of these, 30 were usability-related verbalizations. A full list of usability-related verbalizations exteriorized during the evaluation study is given in the Appendix. 10 of these (33%) were exteriorized following evaluator questions to the user.User:1234Total‘think-aloud’ verbalizations (in-total) (average time for each verbalization)14(184s)66(28s)31(36s)19(47s)130Usability-related verbalizations (quantity in total) (percentage of total verbalizations)9(64%)12(18%)3(9%)6(32%)30Evaluator questions to user24146347Prompting usability-related verbalizations (Percentage of usability-related verbalizations)5(55%)3(25%)1(33%)1(17%)10User questions to evaluator823518 Reminded to talk-aloud70018 Study time (minutes)43311915Table 1. ‘Think-aloud’ verbalization made during the evaluation of a desktop VR systemEvaluator 1LOW HIGH TOTALLOW10515 Evaluator 2HIGH01515TOTAL102030Table 2. Confusion MatrixThe usability problems were judged to be of low or high quality to designers of VEs by the two evaluators (see Appendix). A confusion matrix to show the level of confidence and not chance judgements of low or high quality usability problems, is shown below in table 2. From the confusion matrix, we have a coding schedule of 2 different categories (LOW,HIGH) and there are 30 occasions when coding has taken place. With two observers, an agreement takes place when they both use the same code for the occasion. If they use different codes then that is in disagreement. The pattern of agreements and disagreements is shown in the 2 dimensional matrix in table 2. The diagonal from top left to bottom right, indicate agreement between the two observers; scores off this diagonal indicate their disagreement. The evaluators were in agreement 25 times, and of these, 15 of the usability problems were judged to be high quality and 10 low quality. The remaining 5 were judged to be both high and low. Using Cohen’s Kappa (K), the results of the confusion matrix provide a significance rating of 83%, which according to this formula gives an ‘excellent’ degree of confidence for the result [Robson95]. Therefore, of the 30 usability-related problems, 15 were judged in agreement to be of high quality and, of these, 7 (~50%) were exteriorised following a question from the evaluator to the user. On analysis, the users’ 30 usability-related verbalisations were reduced to 11 related, similar or duplicate usability problems. Refer to table 3 below. Down the left hand column are the 11 overall usability problems by users, along the top row. Indicated in each segment is the number of times each usability problem was verbalised by each user, and whether this was judged to be of low (L) or high (H) value to designers of desktop VR virtual environments. Entries with just one letter, either 'L' or 'H', indicate that each evaluator was in agreement. Two entries, 'L' and 'H', indicate that the evaluators were in disagreement, and 'E' indicates that the usability problem was exteriorised following a question from the Evaluator to the user.Usability Problem User1User2User3User4No of TimesUsabilityProblemVerbalisedNo. of UsersVerbalisingUsabilityProblemCollision with objects within studio (HE)(HE)(L/HE)(L/H)(L/H)(L/H)(L/H)7(2 HE,4 L/H,1 L/HE)4Initialinteractionwith on-screencameras(H)(H)(H)(H)4H4Moving through objects Disorientation (HE)(HE)(H)3H(2HE)3Confusion with camera control on-screen icons (L)(HE)(HE)3(2HE,1L)3Confusion with other on-screen icons (LE)(L)(LE)(L)4L(2L,2LE)3No represent-ation of free/flying Camera (H)(H)2 H1System shouldshow where useris, and what’shappening(HE) 1 HE1Confusion withmain and miniviews(L)(L)2L2Confusion about camera movements (L)(L)2L1Feedbackselecting camerain plan view(H)1H1Problems withspecialisedterminology(L)1L1Total9123630Table 3. Reduction of ‘think-aloud’ usability verbalizations to similar usability problems (L = Low quality; H = High quality; E = exteriorized following Evaluator’s question) Finally, an attempt to capture the users’ awareness of the layout of the studio and objects was made. Essentially, the plan views drawn by all users, for both the conventional and the flying camera were very similar. The greatest difference between them was in the increased level of detail, including, the layout of the studio and the number of objects in the studio that were contained in the flying camera’s plan view. Refer to table 4 below. The percentage of the total number of objects and their correct location that were drawnin the plan view using the free or flying camera to navigate around the studio, was 92.5%. This is in contrast to 72.5% of the total number of objects and correct locations drawn in the plan view using the conventional floor camera 1. However, the plan view using the flying camera was drawn after the users had already navigated around the studio using camera 1, drawing a plan view as they went, and therefore, a cumulative effect may well have had an influence on these results.Camera 1: Plan View Free Camera: Plan ViewUser:12341234 Studio Objects:PresenterGuesttable (main)table (far end)Monitor (TV)Audio speakergaps in studio wallsCamera 2Camera 3Camera 4Table 4. Studio objects drawn on the plan views using camera 1 and the free camera5 DiscussionThe quantity of ‘think-aloud’ verbalizations made during the study was 130. 30 of the verbalizations were usability-related, and of these, 15 were judged in agreement to be high quality to designers of future versions of the desktop VE used in the study. Out of the total number of usability-related verbalizations, 10 (33%) were solicited using the questioning technique of co-operative evaluation. Of these, 7 were judged to be high quality usability related verbalizations, that is, almost 50% of the total high quality verbalizations were exteriorized following questions to users. Many of these however, may possibly have not been exteriorized without this additional probing technique. For instance, questioning the user during the study permitted the evaluator to immediately clarify certain issues or concerns raised during the study, or hesitations made in response to a user’s performance with tasks. This additional probing technique proved to be quite an effective way to pursue further lines of inquiries, whilst the thoughts relating to these were still in the users’ mind. In some cases, additional usability problems were identified that may have not been exteriorized otherwise. Although quizzing the user may provide the evaluator with a means to extract more information, the process of questioning the user whilst performing a task may however, introduce further problems. In effect, asking questions of the user is momentarily stopping the evaluation and users may view the questioning as intrusive to a task. For instance, users responding to questions may lose their trail of thought, and possibly the contents of short-term memory may be altered or worst still, lost forever. Hence, it may take users some time to resume their current task following a question. However, during the evaluation of the desktop VR system, there did not seem to be any noticeable addition in time for users to resume their task following a question. Three out of four users said during the debriefing that they had “no problems”with the questioning technique, the remaining user said however, “asking questionsbothered me while doing the task”. One possible solution to this might be to postpone the questioning until the task is complete. Although, this is effectively now conducting a retrospective evaluation and may introduce associated problems, such as, users forgetting and even worse, inventing things.Three out of four users experienced no difficulties talking aloud and one of these added that it helps when learning new skills. Only one user had difficulties with talking aloud and had to be constantly reminded to talk aloud during the evaluation. In the debriefing, the user suggested that this was because of their shy personality. The same user also had difficulties answering questions during the study (see above). This does seem to suggest avoiding the use of users in ‘think-aloud’ evaluations, and especially, using co-operative evaluation, with a shy or introvert disposition. However, whilst the user did have to be constantly reminded to talk aloud, was asked the most questions from the evaluator, and stated that asking questions was bothersome during the study, the same user highlighted the second most usability-related verbalizations and gave the greatest number of high quality verbalizations.The method used in an attempt to capture a user’s awareness of the spatial layout of the studio and objects, and their positions within the studio failed for two main reasons. Firstly, the plan view using the flying camera was drawn after the users had already navigated around the studio using camera 1. A cumulative effect may well have had an influence on these results, and so any comparisons that are made between the two are irrelevant. Secondly, users drew the map whilst they moved around the studio and therefore, this may not allow the user to fix in their minds or commit to memory the studio layout or objects' positions. The lessons learned from this study have been used to inform evaluation methods in an attempt to capture a user’s awareness of the spatial layout of a HMD stereoscopic VR system. Whereby, a user explores a virtual environment for a predetermined period of time (unknown to the user). After this time has elapsed, the display screen is blanked (HMD removed) and immediately following this, the user is asked to draw the layout of the VE and the objects and their positions within the VE from memory. A user's awareness of the spatial layout of the VE is then proportion to the accuracy of their plan view and number of objects and objects' positions. This is similar to a technique (SAGAT) proposed by Endsley (1989) to measure pilots’ situation awareness. In addition to this, a study was carried out to test the effectiveness and appropriateness of the co-operative evaluation technique to evaluate the usability of the stereoscopic Head Mounted Display (HMD) VR system. The results from this recent study are currently being analysed and will be available soon.6 AcknowledgementsThanks to Shamus Smith for his help with the evaluations. This work was supported in part by the UK EPSRC INQUISITIVE project, Grant GR/L53199.References[Endsley89]Endsley M. R., “Situation Awareness Global Assessment Technique (SAGAT)”, Proceedings of the National Aerospace and Electronics Conference (NAECON), May,1988.[Hackman92]Hackman G. and D. Biers, Team Usability Testing: Are Two Heads Better than One? In Proceedings of 36th Annual Human Factors Society Meeting, 1992.[Monk93]Monk A., Wright P., Haber J. and Davenport L., Improving You Human-Computer Interface, Prentice Hall, London, 1993.[Robson95]Robson C., Real World Research: A Resource for Social Scientists and Practitioners-Researchers, Blackwell, Oxford, 1995.[VPP97]Virtual Production Planner (VPP), COLT Virtual Reality Ltd., 1997.[Wright89]Wright P. C. and A. F. Monk, A cost-effective evaluation method for use by designers, International Journal of Man-Machine Studies, 35, 1989.[Wright92]Wright P. and A. Monk, Co-operative Evaluation: The York Manual, CHI92 Tutorial, CHI 1992.AppendixUser Task:Verbalisations: Usability ConcernsEvaluator 1Evaluator 2Low High Low High 1Task 1 1. User clicks on graphical representation of camera 1;nothing happens.2. Evaluator question to user: “have you any idea why thereare two sets of numbers?User reply: “NO”3. Evaluator question to user: “have you any idea whythere are two views?”User reply: “NO”Task 2 i 4. User cannot find free/flying camera icon.ii 5. User goes through the roof/ceiling of the studio. Theentire display screen is grey.Evaluator question to user: “have you any idea where youare or what is happening?”User reply “NO”.6. User: “I think its not very friendly”Evaluator: “why don’t you think it is very friendly”User: “the system should show what happens, where I am,and what you need to do to get out of this”iii7. In plan view, user tries selecting a camera with themouse, by clicking and dragging. The camera doesn’tappear to be selected.User: “the colour should be changing to let you know thatyou’ve clicked it”Task 3 i8. User bumps into studio set.Evaluator: “do you know what’s happening”User: ”its moving”Evaluator: “is the camera moving as you expect it to”User: “NO”ii9. User bumps into studio.Evaluator: “what do you think is happening”User: “it’s going forward whenever I try to go backward”Evaluator: “why do you think the camera moves like that”User: “I don’t know, it shouldn’t behave like that”Evaluator 1Evaluator 2 User Task:Verbalizations: Usability ConcernsLow High Low High 2Task 1 1. User clicks on graphical representation of camera 1;nothing happens.2. User: “I don’t know where the free camera is, I can’t seeit”3. Evaluator: “have you any idea why there are two views”;referring to the main and the mini views.User: “I found it confusing at first” Evaluator and userdiscuss the reason for the mini view. User is eventually toldwhat its purpose is.Task 2 4. User appears confused about camera movement.User: “I would have thought that the camera rotates on itsbase, rather, or maybe its moving on a large circle" User:“all the figures have stopped moving”User is referring to the camera co-ordinates along thebottom of the screen.5. User bumps into set.User: “its moving left and I’m pulling it backwards”Evaluator explains that the camera is colliding with objectsor the studio set.6. User thought that the icons directly above each camera,controlled the movement of each camera, and therefore, didnot use all the camera movement icons until the evaluatorsuggested using all controls for more precise movements.7. Flying camera goes through the wall of the studio. Theentire display turns grey. User looks puzzled.Evaluator: “have you any idea what the grey is”User: “run out of the scope of the programme”8. User: “ the camera went in the direction the head waspointing. I would have thought it would move in thedirection of the camera base”9. The user selects the plan view.User : “I don’t know what the representation of the flyingcamera that they use”Task 3 i10. User bumps into wall and camera moves left instead ofahead. User: “I don’t want to go that way I want o gostraight ahead”11. Evaluator: ”have you any idea why the camera moves inthat way in response to your camera movement selection.User: “maybe it’s on a lead or cable and I’ve got to the endof the cable”.ii12. User: “I would expect one icon to move the wheels andone icon to control the movement of the head. But thecamera moves in the direction the head is pointing in”Evaluator 1Evaluator 2 User Task:Verbalizations: Usability ConcernsLow High Low High 3Task 1 1. User: “Now, the obvious method is to click on thecamera itself"User clicks on graphical representation of camera 1;nothing happens.User: “But we get no reaction, no feedback”.Task 2 i 2. User is moving around the outside of studio set, bumpsinto studio one wall, then bumps into another wall.User: “I’m struggling”.User appears to lose co-ordination and control.3. User fails to use zoom in/out.Evaluator: "is there any particular reason why you didn’tuse those buttons”Evaluator points to zoom.User: “In actual fact, I thought that I could achieve the sameeffect with the other buttons, referring to track and pan"Evaluator 1Evaluator 2 User Task:Verbalizations: Usability ConcernsLow High Low High 4Task 1 1. User clicks on graphical representation of camera 1;nothing happens.User: “ trying to click on actual camera, but that doesn’twork”2. User experiments with zoom and track icons. Thereappears to be some confusion between the zoom and trackicons.Evaluator: “do you know the difference between, or thefunction of these two icons”Evaluator points to zoom and track.User: “No, they appear to do the same thing”Task 2ii er: “what is a plan view”Evaluator explains that a plan view is a bird's eye view.Task 3 i 4. User: “how come when I select camera 2 there ”User points to main view camera 2 icon.User: “it doesn’t highlight 2 there?”User points to mini view camera 2 icon.Evaluator: “have you any idea”User: “No”Evaluator: “try clicking on the buttons”User experiments, becoming familiar with the functions.User: “I suppose this is for previewing and this is what theviewers see”.ii 4. User zooms through the ceiling and the whole screen goes grey for a few seconds.User: “Oh, what happened, disappeared”.er moves camera very close to studio set, and appearsdisoriented.User: “I’m entirely lost”.Task is abandoned。