Contains Nonbinding Recommendations 2017 03 Technical Conformance Guide V3.3
User Manual: Pdf
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Page Count: 45
- 1. Introduction
- 2. Planning and Providing Standardized Study Data
- 3. Exchange Format – Electronic Submissions
- 4. Study Data Submission Format – Clinical and Nonclinical
- 5. Therapeutic Area Standards
- 6. Terminology
- 7. Electronic Submission Format
- 8. Study Data Validation and Traceability
- Appendix: Data Standards and Interoperable Data Exchange
- Glossary