Principal Investigator (PI) Training
Investigator Oversight and Accountability
For physicians taking on a trial: what a principal investigator is personally accountable for and cannot delegate — oversight and delegation, eligibility, consent, the medical care of participants, causality and expectedness judgement, unblinding, the data you endorse, and your own record at inspection. It assumes CRLN's GCP course rather than repeating it.
39 lessons, about 152 minutes. Free, in your language.
The Investigator's Accountability
Delegation and Supervision
Signatures and What They Attest
Eligibility and the Enrollment Decision
Consent as the Investigator's Duty
Medical Care of the Participant
Adverse Event Assessment
Safety Reporting and Unblinding
The Data You Sign For
Inspection, Findings and the Record
Recruitment, Enrollment and Retention
Investigational Product Decisions
The Business of Running a Site