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Full-Text Articles in Medicine and Health Sciences
Regulatory Issues In Electronic Health Records For Adolescent Hiv Research: Strategies And Lessons Learned, Sara Ali Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y. Outlaw, Sylvie Naar
Regulatory Issues In Electronic Health Records For Adolescent Hiv Research: Strategies And Lessons Learned, Sara Ali Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y. Outlaw, Sylvie Naar
Publications and Research
Background: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs 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 use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.
Objective: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS …