Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.
Sara Shaw GreenSung-Jae LeeSamantha ChahinMeardith Pooler-BurgessMonique Green-JonesSitaji GurungAngulique Y OutlawSylvie NaarPublished in: JMIR formative research (2024)
The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.
Keyphrases
- electronic health record
- clinical trial
- clinical decision support
- study protocol
- adverse drug
- transcription factor
- phase ii
- phase iii
- quality improvement
- antiretroviral therapy
- primary care
- young adults
- hiv infected
- mental health
- virtual reality
- hepatitis c virus
- hiv positive
- human immunodeficiency virus
- social media
- hiv testing
- open label
- randomized controlled trial
- machine learning
- south africa
- adipose tissue
- artificial intelligence
- deep learning
- big data
- placebo controlled