36 - Tracking ClinicalTrials.gov Compliance

Background: Compliance with FDA regulations and NIH policies regarding ClinicalTrials.gov is a significant concern at institutions performing human subjects research. Acknowledging the complex registration and reporting requirements in ClinicalTrials.gov and the threat of federal sanctions, our institution put into place new processes to assist investigators in achieving and maintaining compliance.

Program

Description: A list of ClinicalTrials.gov records that are flagged with problems are downloaded daily from the PRS website to our IRB Protocol management system, which was modified to allow Regulatory reviewers and study teams to easily identify problem records: red icons for problem records and green icons for compliant ones. Our IRB system was adapted to send automatic email notifications to the Institutional PRS Administrator when certain IRB submissions are made to studies with ClinicalTrials.gov records, which triggers monitoring and greater efforts to correct outstanding problems. An enhanced communication plan, which includes successive levels of institutional leadership for support in correcting problems, has been implemented. This plan includes institutional consequences such as withholding approval of IRB submissions, and, with continued non-compliance, suspension, or termination of the associated IRB protocol. Lastly, a dedicated institutional PRS administrator now provides expanded assistance to study teams and continues development of monitoring plans.

Program

Assessment: The enhanced program has led to a decrease in problem records: in six months the number of problem records decreased by 56%, from 109 to 48. Increased monitoring uncovered discrepancies within records that were not flagged as problems by PRS; however, the increase in support and communication improved the accuracy of the records under our institutional account. Since implementation, we have received an increased number of questions from investigators, which clearly indicates the need for additional support, training, and education with respect to ClinicalTrials.gov requirements. This will be accomplished by revamping the institution’s website to include user-friendly information about ClinicalTrials.gov and by providing concise and topic-based material. Also planned is an IRB system-based tool designed to assist investigators in deciding whether registration is necessary. Finally, study and record closure processes need to be strengthened to ensure appropriate record resolution, particularly when investigators are departing the institution.

Limitations: The program has only been in effect for six months, so it is not yet clear whether improvements will persist. We plan periodic evaluations and modification in the processes as needed. Staffing limitations may slow the roll-out of website, education materials, and the development and implementation of the decision-making tool.

Discussion: Achieving compliance with ClinicalTrials.gov is necessary to meet legal requirements, avoid penalties and/or loss of study funding and to maintain institutional reputation. Our efforts have contributed to greater institutional compliance, increased record accuracy and improved communications, allowing investigators to better understand ClinicalTrials.gov requirements. The process of integrating problem record reports with our IRB system allows investigators to more easily visualize when there are problems. Our focus has been on maximizing visibility, information availability, and communication. Institutions in similar circumstances, with limited resources for monitoring compliance and system enhancements, may likewise benefit from this approach.