adam_guidelines_v2_8-24-2006

1

2

Analysis Data Model: Version 2.0

Prepared by the

CDISC Analysis Dataset Modeling Team

(ADaM)

Notes to Readers

• This Model incorporates aspects of the previous General Considerations document version 1.0 and Subject Level Characteristics Model version 0.2, replacing these 2 documents. In order to avoid confusion with earlier documents, the version of this new document will begin with 2.0.

• A library of on-line satellite documents will be created as additional statistical analysis models are developed or other analysis topics and concepts are addressed. These documents will be developed using the concepts and standards presented here. A guide listing all of the documents and providing links to them will be maintained.

Revision History

Date Version Description

2/15/2006 v 2.0 Reformatted from General Considerations v1.0,

incorporating Subject-level model, emphasizing

requirements and naming and content rules and guidelines. 5/31/2006 V2.0 Incorporate comments from public review

document

8/11/2006 V2.0 Final

Note: Please see Appendix 8.8 for Representations and Warranties; Limitations of Liability, and Disclaimers.

Contents

1. Introduction / Purpose (4)

2. Background / Motivation (4)

3. Overview of Analysis Data Models (6)

3.1 Key

Principles (6)

3.2 Analysis Data Flow Diagram in Research Process (6)

Components (8)

3.3 Metadata

4. Analysis Datasets (8)

Considerations (8)

4.1 Practical

4.2 Analysis Dataset Variables (11)

4.2.1 Analysis Date Imputation Flag Example (19)

4.2.2 Comparison of Study Day Variable versus Analysis Study Day Variable (19)

4.2.3 Example of Numeric Code Variables (19)

4.2.4 Analysis Treatment Variables (20)

5. Analysis Dataset Documentation (20)

5.1 Analysis Dataset Metadata (20)

5.2 Analysis Dataset Creation Documentation (20)

5.3 Analysis Dataset Creation Programs (21)

5.4 Analysis Variable Metadata (21)

5.5 Analysis Variable Value-Level Metadata (21)

6. Analysis Results Metadata (22)

7. Subject-Level Analysis Data Model (23)

7.1 Example: Disposition and Baseline Summaries in a Hypothetical Clinical Trial (24)

7.2 Example Analysis Dataset for Subject-Level Model (24)

7.3 Example Analysis Dataset Metadata for Subject-Level Model (25)

7.4 Example Analysis Variable Metadata for Subject-Level Model (26)

7.5 Example Analysis Results Metadata for Subject-Level Model (29)

8. Appendices (30)

8.1 Links referenced in document (30)

8.2 Suggested Terminology to be used in “Reason” within Analysis Results Metadata (31)

8.3 Definitions (32)

Datasets (33)

8.4 Analysis-Ready

8.5 Further Information for Example of Subject-Level Model (36)