How to Report Clinical Trial Results

 

Basics

Read 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 reporting results

No later than one year after the trial’s primary completion date. 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. 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.
• Waiver of results reporting for privacy or national security reasons

What must be reported

Results are reported by completing four topic-specific modules. Almost all information must be entered in tabular format. Results cannot be reported by uploading publications. The PRS system provides numerous helpful documents and templates for each of the four results modules. The templates are especially useful, because they assist researchers in identifying and organizing the information needed by the PRS system.

General documents and links

• PRS Help: Results Modules. For each of the four modules, this PRS document provides a description, resources, data elements, examples, and data entry tips.
• PRS Results Data Element Definitions. This PRS documents 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.

Checklists and templates for each module
1 – Participant flow

• Participant Flow Checklist
• Participant Flow Template

2 – Baseline characteristics

• Baseline Characteristics Checklist
• Baseline Characteristics – Age Template
• Baseline Characteristics – Gender Template
• Baseline Characteristics – Race, Ethnicity, Region Template
• Baseline Characteristics – Study Specific Measures Template

3 – Outcome measures and statistical analysis

• Outcome Measures and Statistical Analysis Checklist
• Outcome Measures Template
• Outcome Measures Template Examples

4 – Adverse events

• Adverse Events Checklist
• Serious Adverse Events Template
• Other Adverse Events Template