How to Update a Record or Report Results on ClinicalTrials.gov

How to Update a Record

All updates to study records occur in the CT.gov Protocol Registration and Results System (PRS). After initial registration, a record in PRS can be modified or updated at any time (except when the record is locked for PRS review). A list of all your records can be found on the Record List on the home page in PRS.

Steps to modify or update a record:

• Log into PRS, click ‘Open’ on the home page next to the record you want to enter results for.
• Click ‘Open’ next to the record you want to update. The Record Summary page will show all sections that can be edited by using the ‘Edit’ links for each section.
• The record status will automatically reset to ‘In Progress’ when the record is updated. ‘Entry Completed’, ‘Approve’, and ‘Release’ must be selected after updates have been made to advance the record for PRS review. The UW PI, as the Responsible Party, must complete these actions and cannot be delegated to the study team.

For more detailed instructions on updating and maintaining records, see section 7.1-Modifying a Record of the PRS User’s Guide.

Deadlines for Updating Records

For active study records in PRS, there are specific deadlines and requirements for updating study information and some data elements must be updated sooner than others. The key updates and deadlines are outlined below. All deadlines are in calendar days, not business days.

1. Annually: In general, the Responsible Party must review and update, as necessary, an active study record at least annually. Failure to do so will result in the record being identified by PRS as having a problem that needs to be addressed.
2. Correction of PRS-identified problems: The PRS system will send the Responsible Party an email notification about incomplete, inconsistent, or deficient information. The responsible party must ensure that any major comments are addressed within the following days of the date on which PRS staff sent the notification:
   • • Registration information problems: 15 days
     • Results information problems: 25 days

   Failure to respond within the expected timeframe can lead to restrictions and penalties (Consequences and Penalties for Late Registration/Results Reporting).

3. 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
4. Clinical trials initiated on or after January 18, 2017: Regulations require that some data elements be updated more frequently, such as when the first participant is enrolled and when enrollment status for the study changes. Pay special attention to recruitment statuses, location, and contact information, as the accuracy and timeliness of this information is important to maintain updated information on CT.gov website.
   See a detailed listing of the data elements and deadlines for updating the information at the CT.gov FAQ, When must I update clinical trial registration information?

Tip: Anytime a record is reviewed or changed, update the Record Verification date (in the ‘Protocol’ section, ‘Study Status’ module) to the current month and year before releasing it for review (see example below). This confirms that the record has been reviewed and when it was reviewed to ensure deadlines are met.

Change of PI, PI’s institution, or changes to the PRS Access List

If a UW PI leaves the UW for another institution (which may require transferring the clinical trial to that institution), or there is a change in PI for a clinical trial, or there is a change to the study’s PI Proxy or Primary Contact in Zipline, the study team should contact Regulatory Affairs team at hsdreprt@uw.edu as soon as possible. These changes affect who is responsible for maintaining the CT.gov record and ensuring compliance. Include ‘CT.gov’ in the subject line of your email to help triage your message efficiently.

How to Report Results

Results for ACTs and NIH-funded clinical trials are required to report results on ClinicalTrials.gov. Results are entered into the trial record in PRS and are due within one year of the primary completion date. Once data is entered into PRS, results are submitted to PRS staff for quality control review. Once accepted by quality control, the results are published on ClinicalTrials.gov.

Steps to enter results:

• Log into PRS, click ‘Open’ next to the record you want to enter results for.
• In the ‘Record Summary’ page click ‘Open’ next to the ‘Results Section’.
• In the Results Section page, you will be able to enter data into each of the results data modules.
• PRS quality control will review the results and will send the record back to you if corrections are needed (click ‘Review Comments’ on the ‘Record Summary’ page).
• Major issues must be addressed before PRS will accept the results.

TIP: Preparing data for the Results Section should involve individuals who are familiar with the study design and analysis (such as an investigator or statistician).

What results must be reported

Results are reported by completing topic-specific sections (called modules) in PRS which include: Participant Flow, Baseline Characteristics, Outcome Measures, Adverse Events, Limits and Caveats and more information. Almost all information must be entered in tabular format.

A copy of the protocol and statistical analysis plan (SAP), if not included in the protocol, is required to be submitted as part of clinical trial results information for ACTs with a Primary Completion Date on or after January 18, 2017 (see ClinicalTrials.gov FAQ). The responsible party may redact names, addresses, and other personally identifiable information, as well as any trade secret and/or confidential commercial information contained in the protocol or statistical analysis plan prior to submission. The protocol and SAP can be uploaded to the ‘Document Section’ in the ‘Record Summary’ page.

Note: Results cannot be reported by uploading publications.

Results reporting resources

• CT.gov PRS Guided Tutorials
  • Entering Initial Results and Uploading Study Documents tutorial
  • More detailed tutorials may be found under the Study Documents and Results sections
• CT.gov PRS User Guide
  • See section 7 Updating and Maintaining Records
• CT.gov FAQs for Results Information and Submission Deadlines
• PRS Help: Results Data Entry: under ‘Help’ when logged in to the PRS, includes links to:
  • PRS Results Data Element Definitions provides definitions for each of the results data elements and indicates whether each element is optional.
  • PRS Review Criteria for Results describes the criteria used by the PRS system to assess completeness and consistency of results.
  • Example results entries for various study designs.
  • Checklists and templates for each module. The templates are especially useful, because they assist researchers in identifying and organizing the information needed by the PRS system.

Deadlines for reporting results

Results should be posted no later than one year after the trial’s primary completion date. This requirement applies even if no participants were enrolled, or the study ended early or was terminated.

Possible exceptions:

• Trials involving FDA-regulated products and whose results will be used very soon for seeking FDA approval, licensure, or clearance can request a delay for up to two additional years. See “Late Results per FDAAA” in the table in section 8.1.2 of the PRS User’s Guide. This will rarely apply to anything except industry-initiated trials.
• Secondary outcome measures or additional adverse event information that is not collected by the primary completion date: Though the primary measures must still be reported by the one-year deadline, these additional measures may be reported as follows:
  • Secondary outcomes: One year after the date on which the final subject is examined or receives an intervention for the purposes of final collection of data for the secondary outcome measure
  • Adverse events: One year after the date of data collection for the additional adverse event information
• Extensions for good cause: The PI may request an extension of the deadline, prior to the date on which the results reporting would otherwise be due. See the following related guidance:
  • Good Cause Extension Request Process and Criteria
  • How does NIH determine whether to grant or deny a good cause extension request submitted under 42 CFR 11.44(e)?
• Waiver of results reporting for privacy or national security reasons: Waivers may be granted for national security or privacy reasons. The responsible party must submit a waiver request to CT.gov. Requests must include justification per 42 CFR §11.54(a)(2). See the CT.gov FAQ, Waiver of Results Information Submission Requirements section for further details.
• Trial was voluntarily registered and is not otherwise federally required to register and report results.

Resolving Problems

Section 8 of the PRS User’s Guide describes how to identify and resolve records with problems.

For specific questions related to updating your record or entering results, we recommend contacting register@clinicaltrials.gov for assistance.

For general questions, contact HSD at hsdreprt@uw.edu for assistance. Include ‘CT.gov’ in the subject line of your email to help triage your message efficiently.

For assistance with studies managed by the Cancer Consortium’s Clinical Research Support (CRS) Office, contact CRS at CTgov@fredhutch.org. More information can also be found on the CRS webpage.