Study Data Technical Conformance Guide 2017 10 V4.0

• 1. Introduction
  • 1.1 Background
  • 1.2 Purpose
  • 1.3 Document Revision and Control
  • 1.4 Organization and Summary of the Guide
  • 1.5 Relationship to Other Documents
• 2. Planning and Providing Standardized Study Data
  • 2.1 Study Data Standardization Plan
  • 2.2 Study Data Reviewer’s Guides
    • 2.2.1 SDRG for Clinical Data
    • 2.2.2 SDRG for Nonclinical Data
  • 2.3 Analysis Data Reviewer’s Guide
• 3. Exchange Format – Electronic Submissions
  • 3.1 Extensible Mark-up Language
  • 3.2 Portable Document Format
  • 3.3 File Transport Format
    • 3.3.1 SAS Transport Format
    • 3.3.2 Dataset Size
    • 3.3.3 Dataset Column Length
    • 3.3.4 Variable and Dataset Descriptor Length
    • 3.3.5 Special Characters: Variables and Datasets
    • 3.3.6 Variable and Dataset Names
    • 3.3.7 Variable and Dataset Labels
• 4. Study Data Submission Format – Clinical and Nonclinical
  • 4.1 Clinical Data Interchange Standards Consortium
    • 4.1.1 Study Data Tabulation Model
      • 4.1.1.1 Definition
      • 4.1.1.2 SDTM General Considerations
      • 4.1.1.3 SDTM Domain Specifications
    • 4.1.2 Analysis Data Model
      • 4.1.2.1 Definition
      • 4.1.2.2 General Considerations
      • 4.1.2.3 Dataset Labels
      • 4.1.2.4 Subject Level Analysis Data
      • 4.1.2.5 Core Variables
      • 4.1.2.6 Key Efficacy and Safety Variables
      • 4.1.2.7 Timing Variables
      • 4.1.2.8 Numeric Date Variables
      • 4.1.2.9 Imputed Data
      • 4.1.2.10 Software Programs
    • 4.1.3 Standard for Exchange of Nonclinical Data
      • 4.1.3.1 Definition
      • 4.1.3.2 General Considerations
      • 4.1.3.3 SEND Domain Specification
    • 4.1.4 General Considerations: SDTM, SEND, and/or ADaM
      • 4.1.4.1 Variables in SDTM and SEND: Required, Expected, and Permissible
      • 4.1.4.2 Dates in SDTM and SEND
      • 4.1.4.3 Naming Conventions in SDTM and SEND
      • 4.1.4.4 SDTM and SEND Versions
      • 4.1.4.5 Data Definition Files for SDTM, SEND, and ADaM
      • 4.1.4.6 Annotated Case Report Form (aCRF) for SDTM
• 5. Therapeutic Area Standards
  • 5.1 General
  • 5.2 Supported Therapeutic Areas
    • 5.2.1 Chronic Hepatitis C
    • 5.2.2 Dyslipidemia
    • 5.2.3 Diabetes
    • 5.2.4 Diabetic Kidney Disease
    • 5.2.5 Ebola
    • 5.2.6 Influenza
    • 5.2.7 Kidney Transplant
    • 5.2.8 Malaria
    • 5.2.9 QT Studies
    • 5.2.10 Rheumatoid Arthritis
    • 5.2.11 Tuberculosis
    • 5.2.12 Virology
• 6. Terminology
  • 6.1 General
    • 6.1.1 Controlled Terminologies
    • 6.1.2 Use of Controlled Terminologies
    • FDA recognizes that studies are conducted over many years, during which time versions of a terminology may change. Sponsors should use the most recent version of the dictionary at the start of a clinical or nonclinical study. It is common to have dif...
    • Regardless of the specific versions used for individual studies, pooled analyses of coded terms across multiple studies (e.g., for an integrated summary of safety) should be conducted using a single version of a terminology. This will ensure a consis...
      • 6.1.2.1 Use of the specific controlled term “OTHER”
    • 6.1.3 Maintenance of Controlled Terminologies
  • 6.2 CDISC Controlled Terminology
  • 6.3 Adverse Events
    • 6.3.1 MedDRA
      • 6.3.1.1 General Considerations
  • 6.4 Medications
    • 6.4.1 FDA Unique Ingredient Identifier
      • 6.4.1.1 General Considerations
    • 6.4.2 WHODrug Global
      • 6.4.2.1 General Considerations
  • 6.5 Pharmacologic Class
    • 6.5.1 National Drug File -- Reference Terminology
      • 6.5.1.1 General Considerations
  • 6.6 Indication
    • 6.6.1 SNOMED CT
      • 6.6.1.1 General Considerations
  • 6.7 Laboratory Tests
    • 6.7.1 LOINC
      • 6.7.1.1 General Considerations
• 7. Electronic Submission Format
  • 7.1 eCTD Specifications
  • 7.2 eCTD Sample Submission
• 8. Study Data Validation and Traceability
  • 8.1 Definition of Study Data Validation
  • 8.2 Types of Study Data Validation Rules
    • 8.2.1 FDA Business and Validator Rules
    • 8.2.2 Support on Data Validation Rules
  • 8.3 Study Data Traceability
    • 8.3.1 Overview
    • 8.3.2 Legacy Study Data Conversion to Standardized Study Data
      • 8.3.2.1 Traceability Issues with Legacy Data Conversion
      • 8.3.2.2 Legacy Data Conversion Plan and Report
• Appendix: Data Standards and Interoperable Data Exchange
• Glossary