Ts

layout: post title: Trial Summary Domain tags: [SDTM, Clinical Trial] —

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 Trial Summary dataset. Trial Summary domain presents high-level view and key information from protocol about the trial in a structured format. It provides a complete study picture containing 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 TSPARMCD.

TSPARMCD: Code limited to 8 letters for ease in programming

TSPARM: Term for Trial Summary parameter

TSVAL: Value of TSPARM (TSVAL1- TSVALn for additional comments)

*new variables: TSVALNF : iff TSVAL is null (mutually exclusive with TSVAL)

TSVALCD : code term in TSVAL

TSVCDREF: Referenc Terminology for TSVALCD ex: CDSIC, ISO8601

TSVCDVER: Version number of the Refence Terminology

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

https://www.fda.gov/drugs/news-events-human-drugs/fda-study-data-technical-rejection-criteria-trc-what-you-need-know-05212021-05272021?utm_medium=email&utm_source=govdelivery#event-information