Module 12 2019

FDA Study Data Technical Conformance Guide (March 2019)

• General Considerations • Submit SEND dataset including define.xml (v2.0 preferred) and nSDRG • define.xml Sponsor studyid (cfr. eCTD folder) • define.xml Test Facility studyid (SEND dataset) • Use of VISITDY/--NOMDY (in case of grace days) • Domain Specifications • SUPPQUALS (SUPPMA, SUPPMI, and SUPPTF) • MI, CL, LB, PC • Custom Domains (not in final/draft SEND, nor SDTM) • Trial Design Model (TA, TX, TS) • Tumor Dataset • BG, CO

The Organisation for Professionals in Regulatory Affairs

2019 Europe Interchange | Amsterdam, Netherlands | 6-10 May 2019

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