Section 4 establishes investigator responsibilities and qualifications. Investigator qualifications: education + training + experience + CV + current licence + GCP training + site-specific delegation log + delegation by name; site qualification + adequate facilities + adequate staff + adequate time + adequate resources; training records per study and ongoing. Communication: with IRB/IEC + Sponsor + Regulatory + Subjects + Site staff; protocol deviation reporting + Serious Adverse Event (SAE) reporting to Sponsor (within 24 hours initial + follow-up); Suspected Unexpected Serious Adverse Reaction (SUSAR) per ICH E2A + national requirements; Annual Safety Report + Development Safety Update Report (DSUR). Safety reporting: capture + assess + report adverse events + serious adverse events + SUSARs per protocol + GCP + national requirements; risk-based reporting in R3 (no longer mandatory 100 percent serious AE follow-up if not clinically significant). Source document verification (SDV): R3 risk-based SDV (no longer mandatory 100 percent) + critical data only + remote/centralised monitoring + statistical sampling + targeted; eSource where reliable. Subject privacy + confidentiality + GDPR + HIPAA. Investigator brochure review + updates + acknowledgments. Investigational product accountability + storage + dispensing + return + destruction. ICH E6 + Investigator + Qualifications + SAE + SDV + Source Documents 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.