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 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
 

Sample Spec:

Trial Visit

Variable

Label

Type

Length

Control of Format

Core

Role

Origin

STUDYID

Study Identifier

Char

200

 

Req

Identifier

Assigned

DOMAIN

Domain Abbreviation

Char

2

DOMAIN

Req

Identifier

Assigned

TSSEQ

Sequence Number

Num

8

 

Req

Identifier

Derived

TSPARMCD

Trial Summary Parameter Short Name

Char

8

TSPARMCD

Req

Topic

Assigned

TSPARM

Trial Summary Parameter

Char

40

 

Req

Synonym Qualifier

Assigned

TSVAL

Parameter Value

Char

200

TSVAL

Req

Result

Qualifier

Protocol

 

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

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

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