Section 8 establishes Essential Documents - the documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced; demonstrate compliance with GCP and applicable regulatory requirements. Essential Documents categorized by trial phase (before clinical phase commences + during clinical conduct + after completion or termination) and party (sponsor + investigator + IRB/IEC). Trial Master File (TMF): sponsor-side + investigator site file; essential documents collection + organisation + index + accessibility + integrity; ICH E6 + TMF Reference Model (DIA 2017 + updates) + EMA TMF Guidance + FDA. Electronic TMF (eTMF): increasing adoption + R3 supports + integrity + audit trail + access control + electronic signature; system validation per Annex 1; integration with EDC + safety + financial systems; metadata + workflow + version control. Archive + Retention: minimum 15 years post-marketing authorisation or per local regulation (longest); subject identification confidentiality preserved during retention; medium suitable for retention (paper + electronic); periodic integrity check; destruction after retention with sponsor approval; transfer in case of company merger + acquisition + divestment. FDA 21 CFR Part 312.62 (sponsor) + Part 312.62 (investigator) + Part 11 + EU CTR + Annex 19 (Reference Standards). Coordinates with DIA TMF Reference Model + EMA TMF Guidance. ICH E6 + Essential Documents + TMF + eTMF + Archive applies.
This control maps to 17 controls across 9 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 17 it maps to, and the evidence behind each claim, over MCP and REST.