ClinicalTrials.gov Tip of the Week: Required Record Updates
Sep 3, 2020
Required Record Updates
ClinicalTrials.gov records are required to be updated periodically, and when information in the record changes. If your IRB has approved a protocol amendment, be sure to check the information in your ClinicalTrials.gov record and update it with any relevant changes within 30 days of the amendment approval.
Even if nothing has changed, the regulations require that Record Owners must verify/update their records at least every 12 months until the study is “Completed”, “Terminated” or “Withdrawn”. If the record is out of date, the PRS system will flag the record with a “Not Recently Updated” error.
Refer to the table below for required record updates and deadlines specified by the Final Rule (42 CFR Part 11).
|
Data Element Changes |
Deadline for updating |
|
Record verification date |
Any time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time. |
|
Study Start Date |
30 calendar days after first subject is enrolled |
|
Availability of Expanded Access |
30 calendar days after expanded access becomes available |
|
Overall Recruitment Status |
30 days after a change in overall recruitment status |
|
Individual Site Status |
30 days after a change in status of any individual site |
|
IRB Review status |
30 days after a change in IRB status |
|
Primary Completion Date |
30 days after a clinical trial reaches its actual primary completion date |
|
Enrollment |
At the time the primary completion date is changed to “actual” the actual number of participants enrolled must be entered |
|
Study Completion Date |
30 calendar days after the clinical trial reaches its actual study completion date |
|
Responsible Party |
30 days after a change in the official title of the responsible party |
|
Responsible Party Contact Information |
30 days after a change in the contact information for the responsible party |