Standardizing Research Common Data Elements: Initiatives, Exchange Formats and Current Use by Patient-Level Trial Results Databases
Abstract: Sharing of de-identified patient level data from clinical trials is increasingly becoming a norm and this trend is increasing the importance of research Common Data Elements. CDEs have the potential to increase the value of trial data by making it easier to integrate data across multiple trials. CDEs can reduce study start-up costs, improve the quality of collected data, and facilitate cross study comparisons, data aggregation and meta-analyses. This panel will (1) describe current CDE initiatives, highlight several trial data sharing platforms (including their use of CDEs), and describe CDE informatics standards; (2) describe a case study a site using REDCap Electronic Data Capture system and their CDE experience; (3) describe a case study of a trial data sharing platform of the National Institute on Drug Abuse; and (4) showcase a multi-site observational study that first selected suitable CDEs and implemented collection of trial data directly within an Epic EHR.
Learning Objective 1: What are current major initiatives that define Common Data Elements for clinical research?
Learning Objective 2: What informatics standards can represent electronic Case Report Forms and what is the adoption of those standards by electronic data capture systems today?