Module 5clinicalnda● High priority
5.3.7 — Case Report Forms and Patient Listings
Individual case report forms and patient data listings for pivotal and key studies
Requirements by Phase
Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required
Individual case report forms and patient data listings for pivotal and key studies
Requirements by Phase
NDA: required
Content Requirements
- Individual case report forms for key patients
- Patient data listings for pivotal and key studies
- Deaths, serious adverse events, discontinuations due to AEs
- Individual patient data for efficacy responder analyses
Expected Deliverables
- CRFs for deaths and serious AEs
- Patient data listings
ICH Guidelines: E3, M4E(R2)
Source: ICH E3
References
Related Sections
Up to5.3 — Clinical Study Reports5.3.1 — Reports of Biopharmaceutic Studies
5.3.1.1 — Bioavailability Study Reports
Reports of absolute and relative bioavailability studies
5.3.1.2 — Comparative BA/BE Study Reports
Reports of comparative bioavailability and bioequivalence studies
5.3.1.3 — In Vitro–In Vivo Correlation Reports
Reports correlating in vitro dissolution to in vivo bioavailability
5.3.1.4 — Bioanalytical and Analytical Methods
Validation reports for bioanalytical methods used in human studies
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