ClinicalTrials.gov Announcement: Policy Change Related to Good Cause Extension Requests for Results
Feb 4, 2022
ClinicalTrials.gov Announcement: Policy Change Related to Good Cause Extension Requests for Results
“As of January 25, 2022, the PRS no longer permits the submission of good cause extension requests that are on our after the results information submission deadline for ACTs with a primary completion date on or after January 18, 2017. This change aligns the PRS's automated validation rules with the regulatory requirements in 42 CFR 11.44(e). Prior to January 25, 2022, a responsible party could have submitted a late good cause extension request.”
This means that if a study is very slow enrolling, or has to pause enrollment, then later is closed, the P.I. must make the decision to close the study and submit a delay request before the results would have been due, i.e., before 1 year after the Primary Completion Date.
The Primary Completion Date is the last date that a participant was examined or received an intervention for the purposes of data collection for the Primary Outcome Measure(s). Usually, it is the last participant's last study visit.
