Section 6 establishes Clinical Trial Protocol structure and content per E6 Section 6: title + background + objectives + design + selection + inclusion/exclusion + treatment + assessments + safety + statistics + quality control + ethics + data handling + monitoring + publication + supplementary; protocol amendments + versions + IRB/IEC re-approval. Section 7 Investigator Brochure (IB): compilation of clinical and non-clinical data + product overview + physicochemical + non-clinical (PK/PD/toxicology) + clinical (PK/PD/efficacy/safety in humans to date) + marketing experience + summary of risks; updated at least annually + after new safety information + sponsor obligation to distribute to investigators. Clinical Study Report (CSR) per ICH E3: structure + executive summary + objectives + methodology + results + safety + integrated discussion + conclusions + appendices; ICH E6(R3) emphasises lifecycle approach + integration with Common Technical Document (CTD) for marketing authorisation. R3 introduced harmonised reporting + plain language summary for participants (per EU CTR + FDA Plain Language Summary + WHO). Coordinates with ICH E3 (Structure and Content of Clinical Study Reports) + ICH E8 (General Considerations for Clinical Studies) + ICH E9 (Statistical Principles) + ICH M11 (Clinical Electronic Structured Harmonised Protocol CESHARP) + ClinicalTrials.gov + EudraCT + JREG + ChiCTR + ICTRP. ICH E6 + Protocol + IB + CSR + Reporting applies.
This control maps to 1 controls across 1 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 1 it maps to, and the evidence behind each claim, over MCP and REST.