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.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.