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