SUMMARY
PRS Requires the Responsible Party to post summary results information, including all primary outcome measures, 12 months past the Primary Completion Date (or the Study Completion Date, if the Primary Completion Date has not been specified). If summary results are not complete at that time a certification or extension request can be submitted to delay the deadline for results information submission.
The steps outlined below detail how to submit the request for delay in Disclose, route for approval, and release to PRS.
Creating a Request for Delay
Navigate to the Study that you would like to request Delayed Posting.
Click on the Compliance left navigation link
Check out the Study
Select the CTGOV (USA) Compliance Authority to display the complete list of Compliance Events (* Note, CTgov may be the only one listed)
Click the Initial Results Disclosure Compliance Event
Select the option Request Delayed Posting from the Actions dropdown box. A message will be displayed indicating a request for delay has been created.
Check In the study
Click on the Back to Compliance button
You should see “Requested Delayed Results Posting for ClinicalTrials.gov” displayed below the “Initial Results Disclosure” CE. You will also see a Delayed Results Posting Compliance Event
Completing the Delayed Request Form
Navigate to Forms, then click on the Delayed Results Posting Form.
Click on the Check Out button Edit the DRPF
Select one of the options from the Delay Results Type Dropdown:
Certify Initial Approval
Certify New Use
Extension
Complete all remaining fields on the form. Click Save, then click Check In
Complete all tasks in the workflow including Edit, Create Delayed Posting Submission Record.
On the Create Submission Record task, Select the option “DRPF” for Results, choose the appropriate DRPF version, and provide your e-signature to complete the submission creation.
To upload the CTGOV submission, click "Upload to Registry". Select the reason for submission and be sure to select the "Auto-release submission on ClinicalTrials.gov" checkbox.
Complete Approval and Upload Delayed Posting Submission tasks in the workflow
Select the option “Record Submitted, Complete Workflow” on the task upon successful upload of task
The Initial Results Disclosure Compliance Event will be recalculated with a Compliance Due Date based on the Delay Request Type selected on the DRF Form.
Delay Results Type of Extension: The Initial Results Disclosure due date will reflect the Expected Results Date from PRS (which should be the same as the Delayed Results Extension Date entered on the form)
Delay Results Type of Certify Initial Approval: The Initial Results Disclosure due date will reflect the earlier of FDA Approval (for Product) + 30 Days or Delayed Results Submission upload date + 2 years
Delay Results Type of Certify Initial Use: The Initial Results Disclosure due date will reflect the earlier of FDA Approval (for Product) + 30 Days or Delayed Results Submission upload date + 2 years
Commonly Asked Questions.
What data conditions must be met for a study to request Delayed Results posting?
As per the PRS system: Delayed Results information can be entered only for trials that are applicable clinical trials (ACT) under FDAAA 801 or funded by NIH.
Study Type: Interventional
U.S. FDA-regulated Drug Product: Is "Yes" or U.S. FDA-regulated Device Product: Is "Yes"
Study Phase: Not Phase 1 or Primary Purpose: Not Device Feasibility
Primary Completion Date: On or after January 2008 or not specified, or
Study Completion Date: On or after January 2008, if Primary Completion Date not specified
Overall Recruitment Status: Not Withdrawn
Study Start Date: On or after January 18, 2017
Studies that are funded by the NIH can request a delay
Attempting to request a Delay for a study that is missing one of the criteria above will generate an exception message in Disclose. The user will need to address the problem data condition(s), check in the study and attempt to request again.
Can I delete the request for Delay if the sponsor has decided not to proceed with a delayed results submission?
The Delayed Results Request can be deleted in Disclose. Deleting the request will remove the Compliance Event and the Delayed Posting form.