Table 2.

Principal investigator responsibilities

No.ResponsibilityComponents
1Use good clinical judgment• Do no harm
• Review abnormal results
• Decide if early study termination is needed
2Confirm eligibility• Review inclusion and exclusion criteria
3Confirm informed consent• Use an IRB-approved informed consent form
• Conduct and/or supervise consent process
4Adhere to protocol• Address subject and staff compliance
5Document adequately• Compile key data to medical records
6Manage data• Ensure CRFs match medical records
7Account for study product• Maintain accurate, complete documentation of study product shipment, storage, dispensation, and administration
8Manage documents• Organize records to ease document retrieval
9Manage staff• Delegate responsibility where appropriate
• Supervise
10Communicate with IRB• Obtain approval for study
• Obtain approval of informed consent
• Notify of serious adverse events
• Notify of significant news, e.g., study hold
11Maintain credentials• Keep accurate, up-to-date, information-rich Curriculum vitae for each research clinician

NOTE: Adapted from Mackintosh et al. (20).