Regulatory Issues in Utilization of Electronic Health Records for Multi-site Pragmatic Trials: Findings from the Adolescent Trials Network for HIV/AIDS Interventions Protocol 162b (Preprint)

UNSTRUCTURED Electronic health records are a cost-effective approach to providing necessary foundations for clinical trial research. The ability to utilize electronic health records in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings, however the regulatory components related to the utilization of electronic health records data, in multi-site clinical trials poses unique challenges. As part of the larger ATN162b study that evaluated clinic level outcomes of an HIV treatment and PrEP services intervention to improve retention within the emerging adult HIV population, the objective of this paper is to highlight the regulatory process and challenges in the implementation of a multi-site pragmatic trial utilizing electronic health records. As part of the larger ATN162b study that evaluated clinic level outcomes of an HIV treatment and PrEP services intervention to improve retention within the emerging adult HIV population, the objective of this paper is to highlight the regulatory process and challenges in the implementation of a multi-site pragmatic trial utilizing electronic health records. The process for engaging in multi-site clinical trial studies utilizing electronic health record data is a multi step, collaborative effort. Considerations surrounding the necessity of data use agreements, reliance agreements, external IRB review and engagement with clinical sites were a foremost consideration to ensure successful implementation and adherence to pragmatic trial timelines and outcomes. As part of the larger ATN162b study that evaluated clinic level outcomes of an HIV treatment and PrEP services intervention to improve retention within the emerging adult HIV population, the objective of this paper is to highlight the regulatory process and challenges in the implementation of a multi-site pragmatic trial utilizing electronic health records. The process for engaging in multi-site clinical trial studies utilizing electronic health record data is a multi step, collaborative effort. Considerations surrounding the necessity of data use agreements, reliance agreements, external IRB review and engagement with clinical sites were a foremost consideration to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.