Documenting PI Oversight Responsibilities
Documenting PI Oversight Responsibilities How to Document Principal Investigator Oversight Responsibilities in Clinical Trials Introduction: Why PI Oversight Documentation is Critical The Principal Investigator (PI) is ultimately responsible for the conduct of a clinical trial at the site level. Regulatory guidelines, particularly ICH-GCP E6(R2), FDA 21 CFR Part 312, and EMA GCP directives, mandate that…