Before CDISC, every sponsor submitted trial data in its own format, forcing regulators to learn new schemas for each review. Founded in 1997, the Clinical Data Interchange Standards Consortium created unified standards now required by FDA, PMDA, and other agencies. Four core standards matter most: CDASH defines how data is collected on your case report forms, SDTM structures clinical trial data for submission, SEND handles nonclinical studies, and ADaM organizes analysis datasets. When sponsors adopt CDASH before designing eCRFs, data from your site arrives in a consistent format that maps directly to regulatory requirements. Teams that retrofit standards after database lock face months of remapping work and documentation gaps. FDA built its review tools around CDISC formats, meaning non-compliant submissions slow the entire process. For studies starting after December 2016, SDTM and ADaM are mandatory for NDAs, ANDAs, and certain BLAs. Japan and Denmark require them too. The practical lesson: if your sponsor designs CDASH-compliant forms from day one, your data entry work flows cleanly into downstream submissions without costly conversion.
CDISC Standards: What Site Staff Need to Know About…
CDISCRegulatory ComplianceData Standards
CDISC Standards: What Site Staff Need to Know About Clinical Data Requirements
How global data standards shape what you collect at the site level and why early adoption matters for sponsors and CROs.
Up to 60%
Resource Savings
Up to 80%
Start-Up Savings
December 2016
Compliance Date
Key Takeaway
CDISC standards are now mandatory for most FDA submissions. Sites benefit when sponsors adopt CDASH early, designing compliant eCRFs before study start rather than retrofitting data after database lock.