Developing a Data Management Plan for Electronic Medical Records Abstraction within Clinical Trials: A Report from NIDA CTN Studies

Publication Type
Conference Paper
Year of Publication
Hoehn, A; Yesko, L; Case, A
Society for Clinical Trials (SCT) 37th Annual Meeting
Date Published
Data Management; electronic medical record; EMR; Medical Record Abstraction
The use of electronic management systems for medical records has substantially increased in the last decade and the collection of research data from medical record abstraction has become an increasingly common practice in clinical trials. While the use of electronic medical records (EMRs) can improve efficiency, abstracting data from these records for research purposes introduces new challenges to clinical trial design and data collection, and impacts all aspects of the trial including case report form (CRF) development, query generation, site training, and site monitoring. As more clinical research studies utilize EMRs for data collection, clinical data management plans must evolve to accommodate the unique challenges inherent in EMR data collection. Since study staff may not be well versed in medical records, the data elements to be collected and the time points for data collection must be unambiguous to prevent individual interpretation of questions and to ensure good data quality. Appropriate data queries must be developed for medical record abstraction forms and the best deployment strategies for these queries must be considered. Thorough site training must address potential areas of confusion to ensure data collection is consistent across all clinical sites. These considerations and strategies devised to effectively address these complexities will be discussed within the context of recent National Institute on Drug Abuse (NIDA) Clinical Trial Network (CTN) studies.