CDISC updates this page with announcements from regulatory authorities (FDA, PMDA, EMA, etc.). We encourage readers to check for new announcements directly with the appropriate agency.
- Data Standards Catalog (September 2016) specifies using CDISC Controlled Terminology, SEND, SDTM, ADaM, and Define-XML standards.
- Study Data Technical Conformance Guide (March 2017) specifies rules for using CDISC standards on submissions to FDA CDER and CBER.
- Study Data Standards: What You Need to Know (June 2016)
- Section 5 of Prescription Drug User Fee Act (PDUFA) VI Proposed Commitment Letter addresses “Enhancing Capacity to Support Analysis Data Standards for Product Development and Review.”
- Guidance on Providing Regulatory Submissions in Electronic Format (December 2014) requires submissions in an electronic format specified by the agency beginning 24 months from the issuance of this document.
- FAQs in English on Electronic Study Data Submission (February 2017)
- Advanced Review with Electronic Data Promotion Group
- Notification on Practical Operations of Electronic Study Data (April 2015)
- Question and Answer Guide Regarding Notification on Practical Operations of Electronic Study Data Submissions (April 2015)
- Technical Conformance Guide on Electronic Study Data Submissions (April 2015)
- PMDA Data Standards Catalog (March 2017)
From China FDA (CFDA):
- CFDA has endorsed CDISC standards in their Clinical Trial Data Management Technology Guide (July 2016)