CDISC Implementation in an Academic Research Organization

Abstract

The FDA requirement for standardized data submissions has led us to use CDISC standards in clinical trials since January 2018. In our initial experience as an Academic Research Organization, we applied SDTM conversion to datasets after database lock. This presented challenges when trying to meet data standardization requirements not considered in our initial case report form design. In subsequent studies, we used predefined CDASH case report forms and developed original CDASH-compliant forms for disease- and study-specific data collection, easing the production of the final SDTM dataset. Continuing with this approach towards SDTM conversion has allowed us to leverage the Pinnacle 21 data checks to identify and resolve issues on an ongoing basis. This evolution of CDISC implementation enabled us to refine our standardization process to meet FDA requirements, streamlining data collection and overall efficiency of clinical trials. Looking towards the future, we hope to support collaborations to develop additional CDISC open-source educational resources and examples to improve the standardization process for all.