Module 12 2019

CDISC Submission considerations

• Remember, CDISC requirements are stricter than legacy format • Must adhere to Technical Rejection Criteria • Greater focus on conformance checking CDISC SDTM and ADaM • Run validation checks • FDA require more detailed documentation for reproducibility • Define.XMLcontent • Use ADRG and cSDRG template for moredetails • Software programs are required • No FDA standard to follow, must be readable & interpretable • Beware, some FDA Reviewers may request executable code • PMDA (Japan) mandate and CDISC variations in issue categorization • Reject, Error, Warning.

The Organisation for Professionals in Regulatory Affairs

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