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Study Data Technical Conformance Guide
Limited traceable path from ADaM to the Tables, Figures and the Clinical Study. Report (CSR). 8. Difficulty in understanding the source or derivation methods
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Guidance for Industry
6 Consistent with the FDARA mandate, this guidance discusses (1) broadening eligibility criteria and avoiding unnecessary exclusions for clinical trials; (2)
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E3 Structure and Content of Clinical Study Reports
C. Terminology (3) controlled clinical effectiveness studies. A3: Documentation needed to review the CSR should be included in the CSR appendices.
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