The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Trial Summary dataset has become increasingly useful to reviewers. The Trial Summary (TS) dataset allows the sponsor to submit a high-level overview of the trial in a structured format. Each record in the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. For example, a Trial Summary dataset is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The Trial Summary dataset contains information about the planned and actual trial characteristics.
The TS dataset (ts.xpt) is required by FDA as of Dec 17, 2016 for NDA, BLA and ANDAs. It is required as of Dec 17, 2017 for commercial INDs (if study data are submitted).
Trial Summary dataset challenges
TS datasets can potentially cause challenges for programmers depending on the complexity of a study design. For example, in some trials, there will be multiple records in the TS dataset for a single parameter which can be addressed in the variable TSPARMCD (Trial Summary Parameter Short Name). For instance, a trial addressing both safety and efficacy could have two records with TSPARMCD = TTYPE: one with TSEVAL = ‘SAFETY’ and the other with TSEVAL = ‘EFFICACY’. See the FDA Study Data Technical Conformance Guide for more detailed information.
Trial Summary dataset requirements and rejections
Providing a complete picture of a study in TS involves fitting together the many pieces of data properly, much like a puzzle. Requirements for the TS dataset now include several guidances such as the SDTMIG, the FDA Study Data Technical Conformance Guide, NCI Controlled Terminology, SNOMED CT, and others. The creation of useful and consistent TS datasets across studies requires proper documentation by sponsors of implementation strategies based on the study design, as well as recording how to utilize the input resources that need to be referenced. The more robust the TS puzzle is, the more valuable the dataset becomes, which aids in accelerating FDA review of submissions.
To be more precise, FDA emphasizes adherence to strict guidelines of creating Trial Design Model (TDM), which includes Trial Arms, Trial Elements, Trial Visit, Trial Inclusion/Exclusion Criteria, Trial Summary and Trial Disease Assessment. FDA urges sponsors to submit TS datasets for legacy study, too.
Uniquely, keep in mind that the study start date (SSTDTC in TS. TSPARMCD) in the TS dataset will determine whether a given study needs to use a particular data standard as specified in FDA Data Standards Catalog. Even in SEND submission, all the Trial Design domains should be included as well.
A Trial Summary dataset is required for study reports in:
- CTD Module 4 (nonclinical study reports – sections 220.127.116.11; 18.104.22.168; and 22.214.171.124)
- CTD Module 5 (clinical study reports and related information in sections 126.96.36.199; 188.8.131.52; 184.108.40.206; 220.127.116.11; 18.104.22.168; 22.214.171.124; 5.3.4; 126.96.36.199; and 188.8.131.52.)
If a TS dataset is absent, eCTD submission validation criteria triggers a high severity error.
Submission rejection based on technical rejection criteria was added to the existing eCTD validation criteria. An enforcement deadline has not yet been announced. When announced, FDA will give the industry 30 days’ notice on the eCTD website prior to the criteria becoming effective. FDA can reject data after submission if data are not compliant with data standards after this cut-off date.
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