Module 12 Presentations

26/01/2024

Study Data Technical Conformance Guide (Dec 2023)

For clinical and nonclinical studies, sponsors should include a plan describing the submission of standardized study data to FDA.

The Study Data Standardization Plan (SDSP) may also initiate discussions at the pre-IND stage (relevant for SEND); should be provided with pre-NDA meeting package for CDER and for CBER should be provided no later than the End-of Phase 2 (EOP2) meeting..

Details the Support and Requirements: Begins for the CDISC SDTM Version 2.0, SDTMIG V3.4, and SENDIG-Genetox V1.0; Ends for the CDISC SDTMIG V3.2

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Contents of SDTCG

APPENDIX A: DATA STANDARDS AND INTEROPERABLE DATA EXCHANGE

APPENDIX B: TRIAL SUMMARY (TS) PARAMETERS FOR SUBMISSION – CLINICAL

APPENDIX C: TRIAL SUMMARY (TS) PARAMETERS FOR SUBMISSION – NONCLINICAL APPENDIX D: ADDITIONAL DOCUMENTS EVALUATED BY FDA APPENDIX E: EXAMPLE STUDY DATA FOLDER STRUCTURE APPENDIX F: TECHNICAL REJECTION CRITERIA FOR STUDY DATA VALIDATION IMPORTANT INFORMATION

APPENDIX G: EXAMPLES OF TS.XPT DATASETS

APPENDIX H: HHS DECLARED PUBLIC HEALTH EMERGENCIES AND MODIFICATIONS TO DATA STANDARDS REQUIREMENTS

GLOSSARY

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