UW Research

How to Update a Clinical Trial Record

Contents

 

Basics

Visit How to Register a Clinical Trial for information about the system, the UW account, helpful tips, the workflow, and how to resolve problems.

To start

Log into the PRS system https://clinicaltrials.gov/ct2/manage-recs/register at ClinicalTrials.gov, using UWashington as the organization, your username and password. Select the trial record.

When you are done

  • Update the Record Verification Date in the Study Status module, to reflect the date you did the update.
  • Click on COMPLETED at the top of the form. This sends an email notice to the Responsible Party (PI) that the record is ready for the Approval and Release actions.

Deadlines for updates

The record must be assessed and updated once a year until final results are reported. However, some specific types of updates must occur earlier, within the regulatory deadlines listed below. All deadlines are in calendar days, not business days. For example: when a trial completes enrollment, that change must be reported within 30 days after the completion of enrollment.

  1. Correction of PRS-identified problems
    The PRS system will send the Responsible Party an email notification about incomplete, inconsistent, or deficient information.

    • Registration information problems: 15 days
    • Results information problems: 25 days
  2. Updates: Applicable clinical trials initiated before January 18, 2017
    • Overall recruitment status: 30 days
    • Primary completion date: 30 days
    • Record verification date: Must be refreshed at least once a year, no matter what.
  3. Updates: Applicable clinical trials initiated on or after January 18, 2017
    • Study start date: 30 days
    • Primary completion date: 30 days
    • Study completion date: 30 days
    • Record verification date: 30 days
    • Overall recruitment status: 30 days
    • Intervention name(s) (e.g., drug name): 30 days
    • Availability of expanded access: 30 days
    • Individual site status: 30 days
    • IRB review status: 30 days
    • Responsible Party official title: 30 days
    • Responsible Party contact info: 30 days
    • Device product approval/clearance: 15 days
    • Protocol description info: 30 days after IRB approval
    • All other record info: Once a year and when results are submitted
    • Results information: Once a year until final results are posted