Announcement: Policy Change Related to Deadline for Submitting Good Cause Extension Requests for Delayed Results Submission
Feb 10, 2022
“As of January 25, 2022, the PRS no longer permits responsible parties to submit good cause extension requests late (i.e., on or 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.
Clinical Research Support is happy to help with results reporting or delay requests. For help, contact [email protected].
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.
Clinical Research Support is happy to help with results reporting or delay requests. For help, contact [email protected].
Tags:
delay
results