Module 12 Presentations

26/01/2024

• Mandatory for SDTM datasets • SDTM dataset related specifications should identify CRF page number • There are two related requirements: Domains and Visits • These can usually be created automatically from the datasets Required Documentation: Annotated Case Report Form (aCRF)

The Organisation for Professionals in Regulatory Affairs

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• It is mandatory for CDISC submissions to include program files for analysis datasets and any key efficacy and safety analyses • Identify the list early and obtain from Clin Programming • These are NOT executablecodes or files • Ensure programs are Readable • Add program information (eg list) intoADRG Required Documentation: Program Files

The Organisation for Professionals in Regulatory Affairs

40

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