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 (July 2016) specifies using CDISC Controlled Terminology, SEND, SDTM, ADaM, and Define-XML standards.
- Study Data Technical Conformance Guide (July 2016) specifies rules for using CDISC standards on submissions to FDA CDER and CBER.
- Important update from Study Data Technical Conformance Guide for SDTM and SEND regarding the use of the Trial Design Model (TDM) in regulatory submissions.
Section 126.96.36.199, sub-section “Trail Design Model (TDM)”, has been updated and emphasizes the importance of the TDM in all submissions, including the use of the TS dataset in legacy data submissions. The pertinent content from section 188.8.131.52 is provided below:
The SDTMIG TDM should be followed to define the treatment groups and planned visits and assessments that will be experienced by trial subjects. The TDM defines a standard structure for representing the planned sequence of events and the treatment plan for the trial. The TDM includes Trial Arms, Trial Elements, Trial Visit, Trial Inclusion/Exclusion Criteria, Trial Summary, and Trial Disease Assessment.
All TDM datasets should be included in SDTM submissions as a way to describe the planned conduct of a clinical trial. Specifically, the Trial Summary (TS) dataset will be used to determine the time of study start. The requirement to submit using a particular study data standard is dependent on its support by FDA as listed in the FDA Data Standards Catalog at the time of study start. TSPARMCD = SSTDTC will allow the determination of the study start date and should be included in all SDTM submissions.
As noted in section 1.1, the submission of standardized study data will be required according to the timetable specified in the eStudy Data guidance. FDA recognizes that during the transition period to required study data standards some study data submissions (i.e., legacy data) may not conform to the standards listed in the FDA Data Standards Catalog. During this transition period sponsors submitting legacy data should provide a TS dataset (ts.xpt), which includes the study start date in the form of SSTDTC (TSPARMCD = SSTDTC) and TSVAL= “yyyy-mm-dd”.
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.
- 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 Standard Catalog (July 2015)
From China FDA (CFDA):
- CFDA has endorsed CDISC standards in their Clinical Trial Data Management Technology Guide (July 2016)