When a P.I. leaves the institution, what happens to their ClinicalTrials.gov records?Jan 20, 2022
ClinicalTrials.gov records need to be resolved before a P.I. leaves their position at CU. If records are left unresolved, it puts the University at risk for noncompliance, and burdens other researchers and study team members with the tasks of tracking down the unreported data or contacting the P.I. at their new position.
If a P.I. is leaving, they can resolve their records in one of three ways:
- The P.I. can resolve and "close" any outstanding records for completed studies, by verifying that the study status and enrollment have been updated and that any required results have been submitted.
- The P.I. can ask that the record be transferred to a new P.I., if the study will continue at CU after they are gone.
- In certain situations, the P.I. can take the record with them to their new institution, if they will be continuing the study there.
Clinical Research Support is happy to help with all three options! For assistance, or to check if you have any study records with outstanding tasks, contact firstname.lastname@example.org.
Tags: clinicaltrials.gov offboarding PI records results