Published May 5, 2020
Requirements in Section 801 of FDAAA and 42 CFR 11.64 state that a record must be updated at least once every 12 months. This update should be made within 30 days of a change.
Certain studies listed on ClinicalTrials.gov that have paused recruitment due to the COVID-19 pandemic should have their recruitment status reviewed and changed to one of the following depending on the status of your trial:
1) If your ct.gov study record status was “Recruiting” or “Enrolling by Invitation” and recruitment has been paused due to the COVID-19 Pandemic please change your “Overall Status” in your record. Please update your record to one of the following that reflects current status:
- Active, not recruiting: Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. This could be selected if you are making follow up phone calls, study visits are being conducted via a remote visit; or data is still being collected over time although visits are delayed
OR
- Suspended: Study halted prematurely but potentially will resume. If the study is considered to be temporarily halted due to COVID-19.
- Why Study Stopped? (text box – character max: 160)
- This data element appears if the Overall Recruitment Status is Suspended, Terminated, or Withdrawn
- Sample reason for Suspended due to COVID-19 (modify as appropriate):
- Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval.
- Similar reasons can be given if a study is Terminated or Withdrawn due to COVID-19.
- “COVID-19” entered here is not captured in search results for the term on the ClinicalTrials.gov public site.
2) In addition, it may be likely that the “Primary Completion Date” and the “Study Completion Date” will have to be extended for paused studies, so please review and update accordingly.
To Update a Record
- Go to – https://register.clinicaltrials.gov
- Organization – WashingtonU
- Log in to your account
- Click “Open” next to “Protocol Section”
- Click “Edit” next to “Study Status”
- Update “Record Verification Date”
- Edit “Overall Recruitment Status” to reflect current status
- Click “Save” at the bottom
- Click the Green “Entry Complete” button on the main page of your record
For questions or assistance, please contact Michelle Jenkerson, WashU PRS Administrator at jenkerson_m@wustl.edu.