英文麻醉知情同意书

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医学知情同意书范文

医学知情同意书范文

医学知情同意书范文英文回答:Informed Consent Form for Medical Procedures.Title: Informed Consent for [Name of Medical Procedure]1. Introduction.Thank you for considering [Name of Medical Procedure]. Before proceeding, it is important that you understand the purpose, risks, benefits, and alternatives associated with this procedure. This informed consent form aims to provide you with the necessary information to make an informed decision.2. Explanation of Procedure.[Provide a detailed explanation of the medical procedure, including its purpose, how it is performed, andany potential risks or complications.]3. Risks and Complications.[Enumerate the potential risks and complications associated with the procedure. Discuss both common and rare risks, as well as any specific risks that may apply to the patient.]4. Benefits.[Outline the potential benefits of the procedure, including any expected improvements in the patient's condition or quality of life.]5. Alternatives.[Discuss any alternative treatment options available to the patient, including their risks, benefits, and success rates compared to the proposed procedure.]6. Questions and Clarifications.[Encourage the patient to ask any questions or seek clarification on any aspect of the procedure, risks, benefits, or alternatives.]By signing this form, you acknowledge that:You have received and understood the information provided in this informed consent form.You have had the opportunity to ask questions and have received satisfactory answers.You voluntarily consent to undergo [Name of Medical Procedure] after careful consideration of the risks, benefits, and alternatives.Patient's Signature: __________________________。

医学知情同意书范文

医学知情同意书范文

医学知情同意书范文英文回答:Informed Consent Form.Title: [Title of the Study]Principal Investigator: [Name of the Principal Investigator]Study Location: [Location of the Study]Introduction:Thank you for considering participating in this study. The purpose of this form is to provide you with information about the study, its objectives, procedures, potentialrisks and benefits, and your rights as a participant. Please read this form carefully and feel free to ask any questions before making a decision.Study Objective:The objective of this study is to [state the main objective of the study]. The study aims to [explain the purpose of the research and its potential impact].Study Procedures:During the study, you will be required to [describe the study procedures in detail]. These procedures may include [list the specific procedures involved]. The estimated duration of your participation will be [mention the duration].Potential Risks and Benefits:There are potential risks associated with participating in this study, including [list the potential risks]. However, every effort will be made to minimize these risks. Additionally, there may be benefits to participating inthis study, such as [list the potential benefits].Confidentiality:All information collected during the study will be kept strictly confidential. Your personal identity will be protected, and any data used for analysis or publication will be anonymized.Voluntary Participation and Withdrawal:Participation in this study is voluntary, and you have the right to withdraw at any time without penalty or loss of benefits. Your decision to participate or not will not affect your current or future medical care.Contact Information:If you have any questions or concerns regarding the study, please contact [provide contact information of the Principal Investigator or study coordinator].Consent:By signing below, you acknowledge that you have read and understood the information provided in this consent form. You have had the opportunity to ask questions and have received satisfactory answers. You voluntarily agree to participate in this study.Participant's Signature: ______________________。

知情同意书范文合集

知情同意书范文合集

知情同意书范文合集英文回答:Informed Consent Form Samples Collection.Informed consent forms are essential documents used in various fields to ensure that individuals have a clear understanding of the risks, benefits, and procedures involved in a particular activity or study. Here, I have compiled a collection of informed consent form samples for your reference. Please note that these are just examples, and it is important to tailor the content to your specific needs and requirements.1. Medical Research Study:Title: [Study Title]Purpose: The purpose of this study is to investigate the effectiveness of a new medication in treating [medicalcondition].Procedures: Participants will be required to attend regular check-ups, undergo medical tests, and take the medication as prescribed.Risks: Possible side effects of the medication include [list potential side effects]. There is also a minimal risk of discomfort during medical tests.Benefits: Participants may experience an improvement in their medical condition, and their contribution to this study may help advance medical knowledge.Confidentiality: All personal information collected during the study will be kept strictly confidential.Voluntary Participation: Participation in this study is entirely voluntary, and participants have the right to withdraw at any time without consequences.2. Psychological Counseling:Title: [Counseling Program Title]Purpose: The purpose of this counseling program is to provide support and guidance to individuals experiencing [specific issue].Procedures: Participants will attend counseling sessions, where they can openly discuss their concerns and work towards finding solutions.Risks: While counseling aims to provide emotional support, there may be instances where participants experience temporary emotional discomfort.Benefits: Participants may gain a better understanding of their situation, develop coping strategies, and experience improved emotional well-being.Confidentiality: All information discussed during counseling sessions will be kept confidential, except in cases where there is a risk of harm to self or others.Voluntary Participation: Participation in this counseling program is entirely voluntary, and participants have the right to discontinue at any time without consequences.中文回答:知情同意书范文合集。

麻醉风险知情同意书范文

麻醉风险知情同意书范文

麻醉风险知情同意书范文尊敬的患者:您好!在进行麻醉治疗前,我们需要您仔细阅读并签署本《麻醉风险知情同意书》,以确保您充分了解麻醉过程中的潜在风险和可能的并发症。

如您对麻醉治疗有任何疑问,请随时向我们咨询。

一、麻醉的目的和风险麻醉的目的是为了确保您在手术过程中没有疼痛感,并使您处于无痛状态。

然而,麻醉过程中可能会带来一定的风险和并发症,包括但不限于以下几个方面:1. 麻醉过程中可能出现的呼吸系统问题,例如:气道堵塞或气管插管困难等;2. 心血管系统问题,例如:血压升高或降低、心律失常等;3. 过敏反应,例如:对麻醉药物或其他药物过敏;4. 神经系统问题,例如:头痛、恶心、呕吐、麻木等;5. 麻醉过程中可能引发的感染、出血、肺栓塞等并发症。

二、麻醉风险同意书本人确认,在知晓麻醉治疗的目的和可能的风险后,自愿并同意接受麻醉治疗。

同时,本人明确同意医生在麻醉治疗中做出以下决策:1. 根据我的身体状况,选择合适的麻醉方法;2. 对我的身体进行全面的评估和检查,以确保麻醉治疗的安全性;3. 在麻醉过程中可能使用的各类药物;4. 在麻醉过程中可能使用的监测设备,如心电图仪、血氧仪等;5. 考虑可能的紧急情况,并采取适当的紧急处理措施。

本人确认,在签署本同意书前,已向医生详细了解了麻醉治疗的目的、风险和可能的并发症,而且医生已经回答了我所有的问题,并解释了可能的风险和并发症。

三、个人信息保护声明本医院对您的个人信息将予以保密。

这些个人信息仅用于麻醉治疗和相关医疗记录目的,并按照相关法律法规进行保护。

四、紧急联系人信息为了在紧急情况下与您的紧急联系人取得联系,请您提供以下信息:紧急联系人姓名:电话号码:与患者关系:五、法律责任和争议解决本同意书受中华人民共和国法律管辖。

如发生因麻醉治疗引起的纠纷、争议,双方应友好协商解决,协商不成的,应提交至合同约定的仲裁机构进行仲裁。

六、同意书的效力本《麻醉风险知情同意书》一经您签署即具有法律效力,并适用于麻醉治疗开始前的所有阶段。

口腔科知情同意书英文版

口腔科知情同意书英文版

口腔科知情同意书英文版Informed Consent for Dental TreatmentI, [Patient's Full Name], hereby give my voluntary and informed consent to undergo the following dental treatment, as proposed by my dentist, [Dentist's Full Name]:1. Treatment Description:Dental Procedure:______________________________________________________ ____Explanation:______________________________________________________ ________2. Risks and Benefits:I understand that there may be certain risks associated with the dental treatment, such as:- Post-treatment discomfort or pain- Swelling or bruising- Bleeding or infection- Allergic reactions to medications or anesthesia- Damage to adjacent teeth or tissuesI also acknowledge that there may be benefits to the treatment, including:- Improved oral health and hygiene- Relief of pain or discomfort- Restoration of tooth functionality and aesthetics3. Alternative Treatment:I understand that there may be alternative treatment options available for my condition. These alternatives have been explained to me, and I have been given the opportunity to ask any questions or seek additional information about them.4. Treatment Costs and Insurance Coverage:I acknowledge that the cost of the dental treatment will be my responsibility. I have been provided with an estimate of the treatment costs, which includes any applicable insurance coverage and out-of-pocket expenses. I agree to pay for the treatment as outlined in the financial agreement.5. Confidentiality:I understand that my dental records and personal information will be kept confidential and will only be disclosed with my consent, except as required by law.6. Voluntary Consent:I have read and understood the above information regarding my dental treatment and associated risks, benefits, alternatives, costs, and confidentiality. I hereby grant my voluntary consent for the proposed treatment.Patient's Signature: ________________________ Date:___________________(or Legal Guardian, if applicable)Dentist's Signature: ________________________ Date:___________________Witness Signature: _________________________ Date: ___________________。

英文麻醉知情同意书

英文麻醉知情同意书

Informed Consent for AnesthesiaName of patient: Gender: Age: Registry No: Diagnosis Prep-op:Name of the surgery procedures:Type of Anesthesia:Anesthesia mentioned above is necessary during the operation. But anesthesia may lead to certain degree injury and danger, even life-threatening consequences, from both known and unknown causes, and no warranty or guarantee has been made as to result or cure.The following complications, but not limited to, may occur during the anesthesia and operation:□Cardiologic complications, such as acute myocardial infarction, severe arrhythmia and cardiac arrest, etc.□Respiratory complications: Delayed breath recovery, dyspnea, aspiration pneumonia, hypoxia, apnea, or increased risk of pulmonary infection and tension pneumothorax, etc.□Complications of nerve system: Postoperative delayed awake, and headache.□Allergic reaction and local anesthesia-induced toxicity.□Complications of endotracheal intubation: Laryngeal edema, vacal cord impaired, pneumothorax.□Complications of intravertebral anesthesia: Nerves impaired and epidural space hematoma.□Complications of nerve plexus block: Nerves impaired, etc.□Complications caused by invasive clinical monitoring: Such as bleeding, shock, severe arrhythmia, embolism, pneumothorax caused by venipuncture for CVP or PAWP, and pseudoaneurysm or limb ischemia due to arteriopuncture for artery pressure monitoring.□Inhibited respiratory function and low blood pressure would occur postoperatively in some patients undergoing analgesia therapy.□Others:I have read and understood adequately the descriptions, which the doctor explained to me.I(signature) or relative/guardian (signature)(Relationship) , hereby consent to undergo the anesthesia procedure for the operation. And I am willing to undertake the risks of the anesthesia procedure.ID/passport No.DORTOR’S DECLARATION: I have fully explained the nature, risks and benefits of the anesthesia to the above patient/relative/guardian, and answered their questions. To the best of my knowledge, the patient/relative/guardian has been informed adequately and has consented. The medical staff will do their utmost to perform emergency management for the patient if any above stated description occurs.Doctor’s signature:Date: D M YIn the event of inconsistency or discrepancy between the Chinese version and the English version, the Chinese language version shall prevail.。

临床研究知情同意书范文

临床研究知情同意书范文

临床研究知情同意书范文英文回答:Informed Consent Form for Clinical Research.I understand that I am being asked to participate in a clinical research study. Before I make a decision, I would like to know more about the study and what it entails. The purpose of this form is to provide me with all the necessary information to make an informed decision.Firstly, it is important to understand the purpose of the study. What is the main objective? What are the researchers trying to achieve? For example, if the study is investigating the effectiveness of a new drug in treating a specific disease, the purpose would be to determine whether the drug is safe and effective in improving the condition of patients with that disease.Secondly, I would like to know the procedures involvedin the study. What will be done to me as a participant?Will I be required to undergo any tests, treatments, or interventions? How often will these procedures occur? It is important to have a clear understanding of what to expect during the study.Thirdly, I would like to know the potential risks and benefits of participating in the study. Are there any known side effects or complications associated with the procedures or interventions? On the other hand, what are the potential benefits that I may gain from participating in the study? It is important to weigh the risks against the benefits before making a decision.Furthermore, I would like to know about my rights as a participant in the study. What are my rights to privacy and confidentiality? Will my personal information be protected? Can I withdraw from the study at any time without any consequences? It is important to have a clear understanding of my rights and the protections in place.Additionally, I would like to know about thequalifications and experience of the researchers conducting the study. Are they qualified and experienced in conducting clinical research? Have they conducted similar studies in the past? It is important to have confidence in the researchers and their ability to conduct the study in a professional and ethical manner.Lastly, I would like to know about any financial considerations associated with participating in the study. Will there be any costs involved for me as a participant? Will I be compensated for my time and participation? It is important to have a clear understanding of any financial implications before making a decision.中文回答:临床研究知情同意书范文。

英文知情同意书范文

英文知情同意书范文

英文知情同意书范文英文回答:Informed Consent Form.I, [Your Name], am participating in [Name of the study or research project]. I have been provided with information about the purpose, procedures, and potential risks and benefits of this study. I understand that my participation is voluntary and that I have the right to withdraw at any time without penalty or loss of benefits.I understand that my personal information will be kept confidential and that my identity will be protected. Only the researchers involved in this study will have access to my data. Any information that is published or presentedwill be in anonymous form, and my identity will not be disclosed.I am aware that there may be potential risks associatedwith participating in this study. For example, there may be physical discomfort or psychological distress duringcertain procedures or discussions. However, I understand that the researchers will take all necessary precautions to minimize these risks and ensure my safety.I also understand that there may be potential benefits to participating in this study. For instance, I may gain new knowledge or insights about the topic being studied. Additionally, my participation may contribute to the advancement of scientific research and benefit society as a whole.I have had the opportunity to ask questions and have received satisfactory answers regarding this study. I understand that I can contact the researchers if I have any further questions or concerns. I have been given enough time to consider my participation and have made an informed decision to voluntarily participate.I understand that by signing this form, I am giving my consent to participate in this study.中文回答:知情同意书。

知情同意书格式 英文

知情同意书格式 英文

知情同意书格式英文Title: Format of Informed Consent FormIntroduction:Informed consent is an essential component of ethical research and medical practice. It ensures that individuals are fully informed about the purpose, procedures, potential risks, and benefits of a study or medical intervention before they decide to participate. This article aims to provide a comprehensive overview of the format of an informed consent form in English.I. Content of an Informed Consent Form:1. Background Information:1.1. Introduction to the study or medical intervention.1.2. Explanation of the purpose and objectives.2. Procedures and Duration:2.1. Detailed description of the procedures involved.2.2. Explanation of the duration of the study or medical intervention.2.3. Clarification of any follow-up visits or additional tests.3. Potential Risks and Benefits:3.1. Identification and explanation of potential risks and discomforts.3.2. Discussion of the potential benefits to the participant or society.3.3. Disclosure of any alternative treatments or interventions.4. Confidentiality and Data Handling:4.1. Assurance of participant confidentiality and privacy.4.2. Explanation of how data will be collected, stored, and analyzed.4.3. Clarification of any data sharing or publication plans.5. Voluntary Participation and Withdrawal:5.1. Emphasis on the voluntary nature of participation.5.2. Explanation of the participant's right to withdraw at any time.5.3. Discussion of any consequences or compensation for withdrawal.Summary:In conclusion, an informed consent form should provide a clear and comprehensive understanding of the study or medical intervention to the participant. It should include background information, details of procedures and duration, potential risks and benefits, confidentiality and data handling, as well as emphasize voluntary participation and withdrawal rights.The format of an informed consent form plays a crucial role in ensuring ethical research and medical practice. By following a structured approach and including the necessary information, researchers and healthcare professionals can obtain valid informed consent from participants, promoting transparency and respect for individual autonomy.。

医疗知情同意书汇编英文

医疗知情同意书汇编英文

医疗知情同意书汇编英文医疗知情同意书汇编英文版本可能因国家和地区而异,以下是一份示例:Informed Consent Form for Medical ProceduresThis form is to be completed by you, the patient, before undergoing any medical procedure. It is very important that you understand the information on this form and have an opportunity to discuss it with your doctor.1. General InformationName of the patient: __________________________Date of birth: __________________________Procedure to be performed: __________________________Date of the procedure: __________________________Name and contact information of the doctor performing the procedure: __________________________2. Risks and ComplicationsThe procedure involves risks and complications, including but not limited to: __________________________The risks and complications may be increased if you have certain conditions or if the procedure is performed in combination with other procedures. These additional risks and complications include: __________________________3. ConsentI, the patient, understand the risks and complications associated with the procedure.I have discussed the procedure and its risks and complications with my doctor.I consent to undergo the procedure.I understand that I may withdraw my consent to the procedure at any time prior to its performance.Signature of the patient: __________________________ Date:__________________________Signature of the doctor: __________________________ Date:__________________________请注意,这只是一个示例,具体的知情同意书应根据医疗程序和医疗机构的具体情况进行定制。

知情同意书的过程英语作文

知情同意书的过程英语作文

知情同意书的过程英语作文英文回答:Informed Consent Procedure.The informed consent procedure is an ethical and legal process that requires healthcare providers to obtain the voluntary and informed consent of patients before performing any medical or surgical procedures. The purpose of informed consent is to ensure that patients understand the risks and benefits of a proposed procedure, and to make autonomous decisions about their own healthcare.The informed consent procedure typically involves the following steps:1. Disclosure of information: The healthcare provider must provide the patient with sufficient information about the proposed procedure, including the risks, benefits, and alternatives. This information should be presented in aclear and understandable way, and should be tailored to the patient's individual circumstances.2. Comprehension assessment: The healthcare provider must assess the patient's understanding of the information that has been provided. This can be done through verbal or written questions, or through a discussion of the risks and benefits of the procedure.3. Voluntary decision-making: The patient must make the decision to consent or refuse the procedure voluntarily, without coercion or undue influence. The healthcare provider must respect the patient's decision, even if they do not agree with it.4. Documentation of consent: The healthcare provider must document the patient's consent in writing. This documentation should include a statement that the patient has been informed about the risks and benefits of the procedure, has understood this information, and has made a voluntary decision to consent to the procedure.The informed consent procedure is an important part of ethical healthcare practice. It helps to ensure that patients are making informed decisions about their own healthcare, and that they are treated with respect and autonomy.中文回答:知情同意书流程。

英文案例投稿患者知情同意书

英文案例投稿患者知情同意书

英文案例投稿患者知情同意书THE ANAESTHESIA AGREEMENT(To be signed by the patient himself or the responsible officer before operationName of patient: Age: yearsSex male/female ID number(if applicable):Nationality:Name of organization:Diagnosis: Operation:Anesthesia:The anaesthetist will take responsibility of the the patient will still be under the risks of anaesthesia complications and accident.1.Respiration/heartbeat suddenly stop induce death.2.Postoperative retention.3.Extradural haematoma spinal cord injury induce paraplegina.4. Transverse myelitis and cauda equine syndrome.5. Nausea/vomiting induce Respiratory depression.6.Hemorrhagic shock.7.Neurological complications(cognitive handicap).8. Cardiovascular complications induce of arrhythmias and hypertension,cardiac arrest.should be in charge of you.Patient's signature:Commander's signature Date其他一些常用说法:1. Investigators have to obtain informed consent before enrolling participants in clinical trials.2. Patients referred to a radiation oncology clinic for treatment of malignant neoplasms were tested for their immediate recall of information presented, recorded and signed on informed consent documents.3. Our analysis to 56 samples of ductal lavage fluid (obtained after informed consent) from women…..4.Written informed consent was obtained for each participant according to federal and institutional guidelines5. These patients were contacted by telephone to obtain verbal informed consent.6. All patients signed an informed consent approved by the institutional Review Board.7..…who were aged 18 years or more and who provided written informed consent, were eligible for this study.8.Twelve patients gave informed consent and agreed to participate in the study.9. Participants gave separate informed consents for eachphase were….10. The study was done after agreement from the local ethics committee and with the patients informed consent.11.Written informed consent was required for participation in the trial.12. Informed consent was obtained in all cases, and protocols were approved by the scientific ethical committee of Aarhus County.13.The patient was then asked to sign an informed consent statement for the consent study.14. After informed consent was obtained for the questionnaire study,………15. All patients gave written informed consent before participation in this study.16.Participants provided written informed consent before enrolment17.The study protocol and the comprehensive written informed consent used in this study protocol were reviewed.18.Our institution’s committee on human research gave approval for this study, and all participants gave informed consent.rmed consent for publication of photographs wasobtained from all subjects or their parents.。

签署知情同意书标准

签署知情同意书标准

签署知情同意书标准英文回答:Signing an informed consent form is a standard requirement in various fields, such as medical research, clinical trials, and legal agreements. The purpose of this document is to ensure that individuals fully understand the risks, benefits, and alternatives involved in a particular activity or procedure before giving their consent.In order to meet the standard requirements for an informed consent form, there are several key elements that need to be included. Firstly, the form should clearly state the purpose of the activity or procedure, as well as the potential risks and benefits associated with it. This information should be presented in a clear and concise manner, using language that is easily understandable to the average person.Additionally, the informed consent form should outlineany alternative options available to the individual, along with their respective risks and benefits. This allows the person to make an informed decision based on their own preferences and circumstances. It is important to provide examples or case studies that illustrate these alternatives, as it helps the individual better comprehend the options available to them.Furthermore, the form should clearly state that participation is voluntary and that the individual has the right to withdraw their consent at any time without facing any negative consequences. This ensures that individualsfeel empowered and have control over their own decision-making process.In terms of format, the informed consent form should be written in a language that is easily understandable to the target audience. It is important to avoid using technical jargon or complex terminology that may confuse orintimidate the reader. Instead, plain language should be used, along with visual aids or illustrations if necessary, to enhance comprehension.中文回答:签署知情同意书是在各个领域中的标准要求,例如医学研究、临床试验和法律协议等。

知情同意书豁免申请书

知情同意书豁免申请书

知情同意书豁免申请书英文回答:Informed Consent Waiver Application.I understand that you are requesting a response in both English and Chinese, so I will provide my answer in both languages separately.English Answer:Informed consent is an essential aspect of any research or medical procedure involving human subjects. It ensures that individuals are fully aware of the risks, benefits, and potential consequences of participating in a study or treatment.However, there are instances where obtaining informed consent may not be feasible or appropriate. In such cases, researchers or healthcare providers may apply for a waiverof informed consent. This waiver allows them to proceed with the study or treatment without obtaining explicit consent from the participants.There are several reasons why a waiver of informed consent may be sought. One example is in emergency situations where immediate medical intervention is required to save a person's life. In such cases, it may be impossible to obtain consent from the patient or their family members due to the urgency of the situation. By waiving the need for consent, healthcare providers can act swiftly and potentially prevent further harm or loss of life.Another example is in retrospective research studies where the data being analyzed is completely anonymized. In such cases, there is no direct involvement or impact on the individuals whose data is being studied. Obtaining informed consent from each participant would be impractical and unnecessary, as the research does not pose any risks or potential harm to the subjects.It is important to note that the decision to grant a waiver of informed consent is not taken lightly. Research ethics committees or institutional review boards carefully review each application to ensure that the proposed study or treatment meets specific criteria for waiving consent. These criteria often include considerations of thepotential benefits, risks, and alternatives, as well as the level of invasiveness or potential harm involved.In conclusion, a waiver of informed consent is a mechanism that allows researchers or healthcare providers to proceed with a study or treatment when obtainingexplicit consent is not feasible or appropriate. It is a decision that is made with careful consideration of the potential benefits and risks involved.中文回答:知情同意是涉及人体实验或医疗程序的重要方面。

(完整版)临床试验常见英文缩写

(完整版)临床试验常见英文缩写

临床试验常见英文缩写ADR(Adverse drug reaction) 不良反应AE(Adverse event)不良事件SAE(Serious Adverse Event) 严重不良事件CRF(Case report form/case record form)病例报告表CRO(Contract research organization)合同研究组织EC(Ethics Committee)伦理委员会GCP(Good clinical practice)药品临床试验管理规范EDC(Electronic data capture)电子数据采集IB(Investigator's Brochure) 研究者手册ND (Not Done) 未做NA (Not Applicable)不适用UK (Unknown)未知PI(Principal investigator )主要研究者Sub-I(Sub-investigator)助理研究者QA(Quality assurance)质量保证QC(Quality control)质量控制SDV(Source data verification)原始资料核对SD(Source data)原始数据SD(Source document ) 原始文件SFDA 国家食品药品监督管理局SOP(Standard operating procedure) 标准操作规程IRB 机构审查委员会ICF(Informed Consent Form) 知情同意书TMF(trial master file)研究管理文件夹临床试验常见英文单词A• Active control ,AC 阳性对照,活性对照阳性对照,活性对照• Adverse drug reaction ,ADR 药物不良反应药物不良反应• Adverse event ,AE 不良事件• Approval 批准• Assistant investigator 助理研究者• Audit 稽查• Audit report 稽查报告• Auditor 稽查员B• Bias 偏性,偏倚• Blank control 空白对照• Blinding/masking 盲法,设盲• Block 层C• Case history 病历• Case report form/case record form ,CRF 病例报告表,病例记录表• Clinical study 临床研究• Clinical trial 临床试验• Clinical trial application ,CTA 临床试验申请• Clinical trial exemption ,CTX 临床试验免责• Clinical trial protocol ,CTP 临床试验方案• Clinical trial/study report 临床试验报告• COA(药品检测报告)• Co-investigator 合作研究者• Comparison 对照• Compliance 依从性• Computer-assisted trial design ,CATD 计算机辅助试验设计• Contract research organization ,CRO 合同研究组织• Contract/agreement 协议/合同• Coordinating committee 协调委员会• Coordinating investigator 协调研究者• Cross—over study 交叉研究• Cure 痊愈• CTRB 临床试验文件夹D• Documentation 记录/文件• Dose—reaction relation 剂量-反应关系• Double blinding 双盲• Double dummy technique 双盲双模拟技术E• Electronic data capture ,EDC 电子数据采集系统• Electronic data processing ,EDP 电子数据处理系统• Endpoint criteria/measurement 终点指标• Essential documentation 必需文件• Excellent 显效• Exclusion criteria 排除标准F• Failure 无效,失败• Final report 总结报告• Final point 终点• Forced titration 强制滴定G&H• Global 全球• Generic drug 通用名药• Good clinical practice ,GCP 药物临床试验质量管理规定• Good manufacture practice ,GMP 药品生产质量管理规范• Good non-clinical laboratory practice ,GLP 药物非临床研究质量管理规范• Health economic evaluation ,HEV 健康经济学评价• Hypothesis testing 假设检验I• Improvement 好转• Inclusion criteria 入选标准• Independent ethics committee ,IEE 独立伦理委员会• Information gathering 信息收集• Informed consent form ,ICF 知情同意书• Informed consent ,IC 知情同意• Initial meeting 启动会议• Inspection 视察/检查• Institution inspection 机构检查• Institutional review board ,IBR 机构审查委员会• Intention to treat 意向治疗• Interactive voice response system ,IVRS 互动式语音应答系统• International Conference on Harmonization ,ICH 国际协调会议• Investigational new drug ,IND 新药临床研究• Investigational product 试验药物• Investigator 研究者• Investigator's brochure ,IB 研究者手册L• Local 局部M&N• Marketing approval/authorization 上市许可证• Matched pair 匹配配对• Monitor 监查员• Monitoring 监查• Monitoring report 监查报告• Multi—center trial 多中心试验• New chemical entity ,NCE 新化学实体• New drug application ,NDA 新药申请• Non—clinical study 非临床研究O• Obedience 依从性• Optional titration 随意滴定• Original medical record 原始医疗记录• Outcome 结果• Outcome assessment 结果指标评价• Outcome measurement 结果指标P• Patient file 病人指标• Patient history 病历• Placebo 安慰剂• Placebo control 安慰剂对照• Preclinical study 临床前研究• Principle investigator ,PI 主要研究者• Product license ,PL 产品许可证• Protocol 试验方案• Protocol amendment 方案补正Q&R(完整版)临床试验常见英文缩写• Quality assurance ,QA 质量保证• Quality assurance unit ,QAU 质量保证部门• Quality control ,QC 质量控制• Randomization 随机• Regulatory authorities ,RA 监督管理部门• Replication 可重复• Run in 准备期S• Sample size 样本量,样本大小• Serious adverse event ,SAE 严重不良事件• Serious adverse reaction ,SAR 严重不良反应• Seriousness 严重性• Severity 严重程度• Simple randomization 简单随机• Single blinding 单盲• Site audit 试验机构稽查• Source data ,SD 原始数据• Source data verification ,SDV 原始数据核准• Source document ,SD 原始文件• Sponsor 申办者• Sponsor-investigator 申办研究者• Standard operating procedure ,SOP 标准操作规程• Statistical analysis plan ,SAP 统计分析计划• Study audit 研究稽查• Subgroup 亚组• Sub—investigator 助理研究者• Subject 受试者• Subject diary 受试者日记• Subject enrollment 受试者入选• Subject enrollment log 受试者入选表• Subject identification code ,SIC 受试者识别代码• Subject recruitment 受试者招募• Subject screening log 受试者筛选表• System audit 系统稽查T&U• Trial error 试验误差• Trial master file 试验总档案• Trial objective 试验目的• Trial site 试验场所• Triple blinding 三盲• Unblinding 破盲• Unexpected adverse event ,UAE 预料外不良事件V&W• Variability 变异• Visual analogy scale 直观类比打分法• Vulnerable subject 弱势受试者• Wash—out 清洗期• Well—being 福利,健康EDC 系统常见英文缩写• 1.SCR (screening) 筛选• 2.DOV (date of visit) 访视第一天• 3。

英文知情同意书范文

英文知情同意书范文

英文知情同意书范文Signing an informed consent form is a crucial step in any medical or research procedure. It is incredibly important for participants to fully understand the risks and benefits associated with their involvement in the study. Knowing what they are consenting to can help individuals make informed decisions about their health and well-being. Therefore, it is essential for researchers and healthcare providers to provide detailed information in the informed consent document.参与者在接受任何医疗或研究程序时签署知情同意书是非常关键的一步。

对于参与者来说,充分了解他们参与研究的风险和好处是非常重要的。

知道他们正在同意的内容可以帮助个人做出对他们的健康和福祉做出明智的决定。

因此,研究人员和医疗服务提供者在知情同意书中提供详细信息是至关重要的。

Informed consent forms typically include information about the study objectives, procedures involved, potential risks and benefits, participant responsibilities, confidentiality measures, and contact information for questions or concerns. It is important for participantsto read the document thoroughly and ask any questions they may have before signing. This ensures that they are fully informed and aware of what they are agreeing to.知情同意书通常包括关于研究目的、涉及的程序、可能的风险和好处、参与者的责任、保密措施以及问题或疑虑联系信息。

手术申请麻醉签字请单流程

手术申请麻醉签字请单流程

手术申请麻醉签字请单流程英文回答:Process for Anesthesia Consent for Surgical Application.1. Patient Education: The patient should be thoroughly informed about the anesthetic procedure, including the risks, benefits, and alternatives. This education should be provided in a clear and understandable manner, and the patient should have the opportunity to ask questions and express any concerns.2. Patient Assessment: The anesthesiologist willconduct a thorough assessment of the patient's medical history, physical condition, and current medications. This assessment will help the anesthesiologist determine thebest anesthetic plan for the patient.3. Informed Consent: Once the patient has been educated and assessed, the anesthesiologist will obtain informedconsent from the patient. This consent must be voluntary, competent, and specific to the anesthetic procedure being performed. The patient must sign a consent form that outlines the risks and benefits of the procedure.4. Consent Witness: The consent form must be witnessed by a disinterested third party who can attest that the patient has understood the information provided and has given consent voluntarily.5. Documentation: The anesthesiologist will document the patient education, assessment, informed consent, and consent witness in the patient's medical record.中文回答:手术申请麻醉签字请单流程。

护理研究的知情同意书范文

护理研究的知情同意书范文

护理研究的知情同意书范文英文回答:Informed Consent Form for Nursing Research.Title of the Study: The Impact of Music Therapy on Pain Management in Postoperative Patients.Researcher: [Researcher's Name]Introduction:Thank you for considering participation in our nursing research study. The purpose of this study is to investigate the effects of music therapy on pain management in postoperative patients. Before deciding whether to participate, we kindly request you to read and understand the following information. If you have any questions or concerns, please feel free to ask.Study Procedures:If you agree to participate in this study, you will be randomly assigned to one of two groups: the music therapy group or the control group. Both groups will receive standard postoperative care, but the music therapy group will also receive sessions of music therapy. The sessions will involve listening to soothing music for a specified duration. Your pain levels will be assessed using a pain scale before and after each session.Benefits and Risks:Participating in this study may provide you with potential benefits such as reduced pain levels and improved relaxation. However, it is important to note that the effectiveness of music therapy may vary among individuals. There are no known risks associated with participating in this study, as the sessions involve listening to music and do not involve any invasive procedures.Confidentiality:Your privacy and confidentiality will be strictly maintained throughout the study. Your personal information will be kept confidential and will only be accessible to the research team. The data collected will be analyzed collectively and presented in a way that does not identify individual participants.Voluntary Participation:Participation in this study is entirely voluntary. You have the right to withdraw your consent at any time without providing a reason. Your decision to participate or notwill not have any impact on your current or future medical care.Contact Information:If you have any questions or concerns regarding this study, please feel free to contact the researcher, [Researcher's Name], at [Researcher's Contact Information]. Additionally, if you have any concerns about your rights asa research participant, you may contact the Institutional Review Board (IRB) at [IRB Contact Information].By signing below, you acknowledge that you have read and understood the information provided in this consent form and voluntarily agree to participate in this study.Participant's Signature: ______________________。

手术知情同意书-英文版

手术知情同意书-英文版

INFORMED CONSENT FOR OPERATION1.Your attending is: _ _; your doctor in charge is___ _________________________.2.The following information is provided to assist you make an informed decision regarding the proposedoperation/procedure. You may take as much time as you wish to make your decision before signing this consent.You have the right to ask questions regarding any proposed procedure before agreeing to have the operation/procedure performed.3.For known and unknown reasons, there are risks associated with any operation/procedure, including failing toachieve the desired effect, rare complications and unexpected injury that may result in death. Therefore, doctors CAN NOT guarantee perfect outcomes. You have the right to understand the purpose, potential risk, unexpected effects, and the potential influence of the proposed operation/procedure on the human body. Except for unusual conditions such as a life-threatening emergency, any operation/procedure can only be performed when you have read and signed this informed consent. You have the right to accept or refuse the operation/procedure at any time prior to the start of the operation/procedure.4.Your present diagnosis is :___Chronic Subdural Hematoma at Right Parietal ______________The Proposed operation/procedure is:_____________Drainage of Chronicles Subdural Hematoma_______________5.Doctors will explain the operation/procedure to you in general terms:5.1 Purpose and expected outcome of the operation/procedure:Evacuation of Chronic subdural hematoma5.2 Possible complications and risks:1)Possible accidents and risks during operation/procedure:□Anesthesia accident □Massive hemorrhage beyond control□Drugs allergy □Death or irreversible brain death□Respiratory and cardiac arrest in operation□Procedure interruption or change of proposed operation/procedure plan due to changed situation□Unavoidable injury to the nearby organ(s), blood vessel(s) or nerve(s) resulted in physical disability or dysfunction to the patient□Others: Neurological deteriorate, etc.2)Possible accidents and complications after operation/procedure:□Post-operation hemorrhage □Local or systemic infection□Incision dehiscence □Organ function failure□Disturbance of water-electrolyte □Post-operation airway obstruction□Respiratory and cardiac arrest □Aggravation of primary disease□Post-operation pathological report doesn’t agree with the intra-operation pathological diagnosis of fast frozen section(s)□Re-operation □Others5.3Measures to prevent the above situation are:As for kinds of intra-/post-operation complications, we are committed to use our best efforts to protect your safety as the patient and to complete the whole treatment following current evidence-based medical practice.1)Pre-operative evaluation:•Evaluate the patient carefully, and make the best operation/procedure plan•Complete required pre-operative diagnostic examinations such as PT, hepatic and renal function, immune function tests, ECG, CXR etc.2)Intra-operative care and monitoring:•Close monitoring and management of the patient’s vital signs,•Equipping the operating room with equipment capable of monitoring and assisting the physician and staff in identifying clinical changes or emergent problems during the operation.•Performance of a precise and professional operation/procedure.•Control of potential hemorrhage•Strict adherence to accepted sterile techniques3)Post-operative care:•close monitoring of patient’s vital signs and operative/procedure location•Appropriate use of anti-inflammatory and/or haemostatic drugs and other symptomatic treatments as needed4)Consultations from relative specialty department(s) ordered when necessary.5)Others.5.4Other alternative operation/procedure or treatment(s) available: Non.Your choice: _______________________________________________________________________________ 6.If in need of implants (osseous internal fixation, pacemaker etc.), your consented type and producer(s) are:7.Your authorized surgeon is: __Prof. Wang,yi-rong____; assistant(s) __Dr. Niu,Huan-jiang___; The surgical teamincludes the surgeon and assistant(s), anesthesiologist and operating room nurse(s); pathology or radiology doctors are available if necessary.8.The proposed anesthesia will be carried out under your authorization and consent. If during operation there areemergent or unpredicted conditions, doctors respond immediately and then contact the relatives of the patient in a reasonable amount of time and adjust the proposed operation/procedure according to the physician’s professional judgment and evaluation.9.If blood/blood products are needed during the operation/procedure, the doctor will inform you of the risks andbenefits of using blood/blood product, including possible contagion of hepatitis and HIV. You have the right to accept or refuse blood or blood products. You are free to consult the doctor(s) regarding any questions regarding blood or blood products.10.Signing this consent form gives consent to the pathologist to perform pathology studies on any tissue(s) ororgan(s) removed from the body during the operation/procedure11.Signing this consent allows students and other learners to observe and participate in your medical care includingthe taking of pictures of your surgical condition or treatment. Some pictures may be used in publications. Any pictures used will not reveal your identity and will be used for the purposes of teaching medical diagnosis or treatment or for other education or training programs conducted by the hospital.12.WE WISH TO INFORM YOU, NOT TO ALARM YOU. Please read this form carefully. Ask about anything thatyou do not understand. We will be pleased to explain.PATIENT STATEMENT1.In signing this Informed Consent, I am stating that I have read this Consent Form, that I understand theoperation/procedure risks, benefits, and other related information, as explained by my doctor.2.Although it is impossible for my doctor to inform me of every possible complication that may occur, the doctorhas answered all my questions to my satisfaction.3.I am unable to read, but this consent form has been read and explained to me by ____________________ (nameof reader). I understand the information stated above. I am willingly signing this Consent FormDO NOT SIGN THIS FORM UNTIL YOU HA VE READ AND UNDERSTOOD IT.SIGNA TURE_____________________________________ DATE ___________________________________ (patient/parent/guardian)NAME OF AUTHORIZED DOCTOR:SIGNA TURE____________________________________ DATE ___________________________________。

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I certify and acknowledge that I have read this form or had it read to me, that I understand the risks, alternatives and expected results of the anesthesia service and that I had ample time to ask questions and co consider my decision.
Date ond Time
Subs1iwte '.t Sig11ar1ut
Relutionship tu Patient
Oeve)Oped t>y tne Amencan A$SOC1a11on
of Nvrse AnestllebSIS · 1991
Pesia
Expected Result Total unconscious state, possible placement of a tube into the windpipe. Technique Drug injected into the bloodstream, breathed into the lungs, or by other routes. Risks Mouth or throat pain, hoarseness. injury to mouth or teeth, awareness under anesthesia, injury tO blood vessels, aspiration, pneumonia. 0 Spinal or Epidural Analgesia/ Expected Result Temporary decreased or loss of feeling and/or movement to lower part of the body. Drug injected through a ncedle/caLheter placed either directly into the spinal canal or Anesthesia Technique 0 With sedation immediately outside the spinal canal. 0 Without sedation Risks Headache, backache, buzzing in the ears, convulsions, infection, persistent weakness. numbness, residual pain, injury to blood vessels, "total spinal". 0 Major I Minor Nerve Block Expected Result Temporary loss of feeling and/or movement of a specific limb or area. 0 With sedation Technique Drug injected near nerves providing loss of sensation to the area of the operation. Infection, convulsions, weakness. persistent numbness, residual pain, injury to blood 0 Without sedation Risks vessels. 0 Intravenous Regional Anesthesia Expected Result Temporary loss of feeling and/or movement of a limb. Drug injected into veins of ann or leg while using a tourniquet. 0 With sedation Technique Infection, convulsions, persistent numbness, residual pain, injury to blood vessels. D Without sedation Risks 0 Monitored Anesthesia Care Expected Result Reduced anxiety and pain, partial or total amnesia. (with sedation) Technique Drug injected into the bloodstream, breathed into the lungs. or by other routes producing a semi-conscious state. An unconscious state, depressed breathing, injury to blood vessels. Risks Measurement of vital signs, availability of anesthesia provider for further intervention. 0 Monitored Anesthesia Care Expected Result (without sedation) Technique None. Risks Increased awareness, anxiety and/or discomfort.
CONSENT FOR ANESTHESIA SERVICES
I, , acknowledge that my doctor has explained to me that Twill have an operation, diagnostic or treatment procedure. My doctor has explained the risks of the procedure, advised me of alternative treatments and told me about the expected outcome and what could happen if my condition remains untreated. l also understand that anesthesia services are needed so that my doctor can perform the operation or procedure. It has been explained to me that all forms of anesthesia involve some risks and no guarantees or promises can be made concerning the results of my procedure or treatment. Although rare, unexpected severe complications with anesthesia can occur and include the remote possibility of infection, bleeding, drug reactions, blood clots, loss ofsensation, Loss of Limb function, paralysis, stroke, brain damage, heart attack or death. I understand that these risks apply to all forms of anesthesia and that additional or specific risks have been identified below as they may apply to a specific type of anesthesia. I understand that the rype(s) of anesthesia service checked below will be used for my procedure and that the anesthetic technique to be used is determined by many factors including my physical condition, the type of procedure my doctor is to do, his or her preference, as well as my own desire. It has been explained to me that sometimes an anesthesia technique which involves the use of local anesthetics, with or without sedation, may not succeed completely and therefore another technique may have to be used including general anesthesia.
I hereby consent to the anesthesia service checked above and authorize that it be administered by or his/her associates, all of whom are credentialed to provide anesthesia services at this health faci lity. I also consent to an alternative type of anesthesia, if necessary, as deemed appropriate by them. I expressly desire the following considerations be observed (or write "none"):
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