When/How to Update a ClinicalTrials.gov Record When to Update a ClinicalTrials.gov Record? 1) Within 30 days of a change in: Locations Recruitment Status at any participating site (Opened, Suspended, Closed) Overall Recruitment Status (Opened, Suspended, Closed) Primary Completion Date The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. 2) Every 6 Months: Update the Record Verification Date (must be updated every 6 months) Review of Primary Completion Date and Study Completion Date: Update if necessary. o Email DFCIQACTClinicalTrialsGov@partners.org with updated dates Note: Only the Responsible Party typically Overall PI can update a record. How to Update a ClinicalTrials.gov record? 1. Login to ClinicalTrials.gov a. Go to ClinicalTrials.gov https://register.clinicaltrials.gov/prs/app/template/login.vm b. Enter Your Organization (DFCI, MassGH) c. Enter Username and Password For forgotten passwords, please contact DFCIQACTClinicalTrialsGov@partners.org
2. From the Main Record Page. 3. Locate the protocol of interest and Select [Open] (First Column). 4. Review each of the sections of the Clinicaltrials.gov record and make any necessary changes/updates. 5. To update the record, select [Edit] by the section that requires an update. Once updates have been made. 6. Click on Save at bottom of page. 7. The Study Status Section must be updated or verified at all required time points. 8. The following fields must be updated or verified at all required time points.: The Record Verification Date must be verified (with recorded timestamp) at least every 6 months, even if there were no other changes made to the record. Recruitment Status Or Overall Status -Require an update within 30 days of the change of status Study Completion Date (Anticipated)-Must be verified and updated (if changed). Please notify DFCIQACTClinicalTrialsGov@partners.org of any changes made to the Study Completion Date.
9. Study Status Section 10. Once section has been updated, click [Save] 11. Click on Record Summary (top of page) 12. Beside Next Step, Click [ Entry Complete ] 13. Beside Next Step, Click Approved
14. Beside Next Step, Click Released 15. Confirm that the Record Status = [Released] NOTE: The Record Status must say Released for any changes to be posted on clinicaltrials.gov. Final Step: ClinicalTrials.Gov Quality Assurance Process: 1) When the Protocol Record is Released by the Responsible Party, the record is sent to Clinicaltrials.gov staff for internal quality assurance review (PRS Review). i) If the record has no problems, then an email notification will be sent to the Responsible Party and confirming that the record has been made Public to the Clinicaltrials.gov website. This review process can take between 2 to 5 days. ii) If there are problems during the review process (such as missing information), ClinicalTrials.gov will send email notification to the Responsible Party and change the record status to In Progress. iii) If a record is In Progress, corrections MUST to be made to the record or the Protocol Registration will not be successful. To do this, please review the Review Comments
Section located at the top of the record. This section will outline the problems within the record. Please update the record according to the Comments Section and then repeat all steps in this document from # 2 on. When the trial has been Released again, the trial will be reviewed by ClinicalTrials.gov again. The process will repeat until all problems are resolved. The Record Status must say Released for any changes to be posted on ClinicalTrials.gov. Note: Results must be reported according to FDAA/ICMJE requirements. ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/manage-recs/fdaaa#whichtrialsmustberegistered ICMJE http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/ For more information on managing protocol records, please see the DF/HCC guidance onwhen /How to Submit Results to ClinicalTrials.gov.