Enhancing Clinical Research Data Interoperability, Submission, and Sharing with Embedded Electronic Case Report Form Standards Mapping

Vanderbilt University Medical Center, Nashville TN

Investigators

Abstract

Project Summary Within the clinical research arena, investigators are increasingly expected to share their research data. Enhanced data sharing can enable collaboration and reuse to achieve more scientific goals from the same or decreased funding. Harmonizing disparate datasets can be a challenging and time-consuming process for investigators. Therefore, applying a common data standard as part of the data sharing process can have downstream benefits and efficiency gains. Additionally, investigators conducting regulatory clinical trials must submit study data to the Food and Drug Administration (FDA) following the Study Data Tabulation Model (SDTM) data standard developed by the Clinical Data Interchange Standards Consortium (CDISC). Transforming data from case report forms into a common data standard, such as SDTM, is a resource- intensive process. Up until recently, SDTM dataset preparation has been performed mostly by industry sponsors and clinical research organizations who have sufficient resources to be able to handle this work. However, a growing number of investigator-led studies have FDA submission or National Institutes of Health Data Sharing Policy requirements. Researchers at academic medical centers are finding themselves in a position where they have neither the expertise, nor the resources to prepare SDTM datasets. REDCap is an electronic data capture system that is available at no cost to academic and non-profit institutions and is in use at over 7600 organizations around the world. Since REDCap is already used by academic researchers for data collection and dataset preparation, we hypothesize that a method to map REDCap case report form fields to SDTM data elements will increase the accessibility and uptake of SDTM among academic research organizations by greatly reducing the associated burden. Through the REDCap Standards Mapper (REDSTAMP) project, we aim to 1) develop a coding structure and user interface for researchers to associate REDCap fields to SDTM, and 2) apply the REDSTAMP method to existing International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) studies and CDISC foundational case report forms. We will demonstrate the effectiveness of this method by comparing the SDTM datasets generated by REDSTAMP with those originally produced for those studies by traditional methods. Both the REDSTAMP software and the case report forms with embedded SDTM mapping will be published and shared through REDCap Consortium platforms where researchers can import both directly into their projects. By developing a method where researchers are guided through preparation of a SDTM dataset and can share the mapping with other researchers, this project can promote awareness and expertise for clinical trials data standards. The collective ability to map data to standards will improve the efficiency of regulatory submission and the interoperability and reuse of shared clinical trials data.