TS: SDTM Trial Summary Domain
Background Story:
Recently my friend 77 told me they checked Trial Summary dataset for multiple rounds and fixed many miscellaneous issues. I wasn’t aware of the importance of the Trial Summary dataset until my colleague Jun told me FDA had a meeting emphasized on Trial Summary dataset on May.21.2021. So today we will go over the basics for the Trial Summary dataset. The Trial Summary domain presents a high-level view and key information from protocol about the trial in a structured format. It provides a complete study picture containing the trial phase, protocol title, trial objects, actual and planned arms, number of subjects, and study start/end dates. It works as a border or outline of a puzzle.
Key variables:
TSSEQ: sequence to ensure uniqueness within a dataset, allow multiple recors for the same TSPARMCDTSPARMCD: Code limited to 8 letters for ease in programmingTSPARM: Term for Trial Summary parameterTSVAL: Value of TSPARM
(TSVAL1- TSVALn for additional comments)*new variables:TSVALNF : iff TSVAL is null
(mutually exclusive with TSVAL)TSVALCD : code term in TSVALTSVCDREF: Referenc Terminology for TSVALCD
ex: CDSIC, ISO8601TSVCDVER: Version number of the Refence Terminology
Sample Spec:
Sample Output:
Note: this TS data is a sample, it does not make sense clinically or logically.
Ref:
Thanks Jun and 77 sharing their TS working experiences.
https://www.fda.gov/media/100743/download
https://www.lexjansen.com/pharmasug/2016/DS/PharmaSUG-2016-DS11.pdf