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Global Regulatory Requirements

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.

Announcements

From FDA:

Section 4.1.1.3, sub-section “Trial 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 4.1.1.3 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”.

From PMDA: 

From China FDA (CFDA):