The Department of Veterans Affairs (VA) is reinforcing its commitment to transparency and public access to clinical trial information by requiring all ORD-funded clinical trials to be registered and updated on ClinicalTrials.gov. This initiative ensures that Veterans, healthcare professionals, and the public have access to comprehensive information on VA research efforts. The policy mandates that Principal Investigators (PIs) of ORD-funded clinical trials register their studies, provide regular updates, and submit summary results to ClinicalTrials.gov as a condition of funding.
Registration and Update Process
VA investigators must register their clinical trial protocols through the ART Program, which facilitates data collection and submission to ClinicalTrials.gov. The ART Program emails PIs with instructions for accessing the ART intranet site and completing the data collection form. Protocol records must be updated or verified at least every twelve months, with more frequent updates required for specific data elements such as recruitment status and primary outcome measure completion date. Failure to provide timely updates may impact project funding.
Results Submission
ORD-funded clinical trials are required to submit summary results to ClinicalTrials.gov within one year of the study's Primary Completion Date, regardless of whether the trial meets the FDAAA 801 definition of an "Applicable Clinical Trial." The ART Program provides assistance to PIs throughout the results submission process, including granting permissions to edit trial records and offering guidance on data entry. ClinicalTrials.gov staff review submitted records for validity, consistency, and formatting before posting the information publicly. PIs are responsible for addressing any identified errors or deficiencies within 25 days to ensure timely dissemination of accurate results.
Impact and Enforcement
By mandating registration and results reporting on ClinicalTrials.gov, the VA aims to maximize the impact of its research and provide valuable information to Veterans and the broader healthcare community. This policy aligns with the VA's broader commitment to advancing knowledge and improving care for Veterans and the nation. Failure to report results in a timely manner will impact project funding and eligibility for future ORD funding. ORD provides multiple points of contact for investigators needing assistance with protocol registration, results reporting, or policy clarification.
