CDISC Implementation in an Academic Research Organization

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 datasets after database lock. This presented challenges when trying meet standardization requirements not considered case report form design. subsequent studies, used predefined CDASH forms and developed original CDASH-compliant disease- study-specific collection, easing the production of final dataset. Continuing with this approach towards allowed leverage Pinnacle 21 checks identify resolve issues on ongoing basis. evolution implementation enabled refine process requirements, streamlining collection overall efficiency trials. Looking future, hope support collaborations develop additional open-source educational resources examples improve all.