TS

TSPARMCD

Comment

General

Since there are quite a few oncology studies using 'Adaptive Design' approach, can we add a row for TSPARMCD='ADAPT'?.

Could the new proposed parameters be submitted to CDISC so they can be added to the Controlled Terminology for Trial Summary Parameters.

Are these listed TSPARAMCD/TSPARAM mandatory?.

INDIC

If the study team have a new parameter for e.g ‘Rare Tumor’ as per protocol. But this parameter does not exist in SNOMED. Can the study team add this parameter and document this in reviewers’ guide as a new parameter as per protocol.

INTMODEL

There are more under "Record with this Parameter", like "PARALLEL","SINGLE GROUP","FACTORIAL".

OBJEXP

Do we need to have this TSPARMCD? Per SDTM IG 3.3, A protocol may use multiple designations for objectives that are not primary (e.g., Secondary, Tertiary, and Exploratory), but all these non-primary objectives should be given as values of TSPARM = "OBJSEC".

PBJPRO

Typo?  Should that be OBJPRO.

PCLASATC

Would the WHO ATC only be available for approved drugs? Add method of identification to notes.

ROUTE
DOSE
DOSFRQ
DOSU

For combination therapy studies, how is the drug name identified if the intent is to populate these parameters for each drug?.

STRATFCT

TSPARM has typo, should be 'Stratification Factor'.

STUDYID

We would like to recommend not including STUDYID in the list of parameters as this is a required variable in the TS domain.

TPHASE

TSPARM should be "Trial Phase Classification".

TRT

Can we consider adding 'Unique Ingredient Identifier (UNII)' along with 'INN'/'USAN' for 'OCE/OOD Additional Information' column?.

TRT
COMPTRT

The notes specify to use INN, USAN, however per FDA Data Standards Catalog, TRT and COMPTRT should use UNII

TRTTSTR

Is this intended to be the required result of the diagnostic test for inclusion of a subject in a study?.

TRTUNII

Per CDISC SDTM standards the treatment should be submitted using the UNII vocabulary in the parameter TRT which would make the parameter TRTUNII redundant.