Tip of the Week Archive

Many funders require registration and/or results reporting to clinicaltrials.gov for studies that meet their definitions of a clinical trial, but the Patient-Centered Outcomes Research Institute (PCORI) is a little different, in that their policy also requires registration and results reporting for observational studies.

Registration:

• PCORI-funded studies, including observational comparative effectiveness studies as well as clinical trials, must be registered on ClinicalTrials.gov before enrollment of the first participant as part of their funding terms.

Results:

• If the PCORI-funded project is registered in ClinicalTrials.gov results must be submitted for that study (even observational studies).
• Results must be submitted as early as possible, but no less than 30 days prior to the draft final research report due date to PCORI. 
• If the study is also an Applicable Clinical Trial, results must be submitted before the FDAAA regulatory deadline, which is 12 months after the Primary Completion Date (usually, the last participant's last study visit). So, if both the PCORI and FDAAA deadlines apply, submit results by the earlier of the two.

For help registering your study or submitting results to ClinicalTrials.gov, contact clinicalresearchsupportcenter@ucdenver.edu.