TS / TX validation rules?

Hi! Yes, I agree that

Hi!

Yes, I agree that expected Trial Summary parameters in the study data should be populated and the OpenCDISC validator needs to enforce those it.

Thank you, 

Sergiy Sirichenko

OpenCDISC

Two routes in one study?

Hi, Sergiy,

Thansk for the fast reply.

Some additional questions:

Let's say that for the same study we use 2 different routes (e.g. "Dermal" and "Gavage"). How to represent this into TS.xpt? 2 lines for TSPARMCD=ROUTE: first with TSPARM="Dermal" and TSSEQ=1, the next with TSPARM="Gavage" and TSSEQ=2?

Also, if we administer 2 different compounds, each with a different vehicle (C1 with V1 and C2 with V2), they should be linked via TSGRPID like below?

TSPARMCD="TRT", TSPARM="C1", TSGRPID=g1, TSSEQ=1

TSPARMCD="TRT", TSPARM="C2", TSGRPID=g2, TSSEQ=2

TSPARMCD="TRTV", TSPARM="V1", TSGRPID=g1, TSSEQ=1

TSPARMCD="TRTV", TSPARM="V2", TSGRPID=g2, TSSEQ=2

Note: validations for TSSEQ and TSGRPID should also be done in TS by the Validator.

 

 

 

Hi Amelia,  It should be

Hi Amelia, 

It should be one-to-one relationship between values of --PARM and --PARMCD variables. Therefore your TS may be something like this:

 

TS domain example data with selected columns
TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL
1	Treatment1	TRT	Investigational Therapy or Treatment	Compound 1
2	Treatment2	TRT	Investigational Therapy or Treatment	Compound 2
1		ROUTE	Route of Administration	Dermal
2		ROUTE	Route of Administration	Gavage
1	Treatment1	TRTV	Treatment Vehicle	V1
2	Treatment2	TRTV	Treatment Vehicle	V2

Regards,

Sergiy

One compound, two vehicles?

Hi all,

Another scenario similar to the previous one, but with just one compound and two vehicles - both vehicles are used for the same compound.

How can you relate the vehicles to the compound via TSGRPID? I assume you can't add the same compound (TRT) twice, each time with a new TSGRPID for vehicle1 and vehicle2. And you can't have 2 entries in TSGRPID for TRT...

Should I just just add 1 compound, 2 vehicles and no TSGRPID for none of them?

 

TS domain example data with selected columns TSSEQ TSGRPID TSPARMCD TSPARM TSVAL 1 ??
TRT Investigational Therapy or Treatment Compound
1   ROUTE Route of Administration Dermal 2   ROUTE Route of Administration Gavage 1 Treatment1 TRTV Treatment Vehicle V1 2 Treatment2 TRTV Treatment Vehicle V2

Hi!  Do you really need to

Hi! 

Do you really need to use TSGRPID in this case?

I think that if you listed one compound and two different drug vehicles, then it's quite straight forward what actual study treatments are.

Regards, 

Sergiy

I was just looking at the

I was just looking at the previous example: 2 compounds - each with its vehicle, linked via TSGRPID, and I was wondering if we can do something similar in my otrher case.

So... not sure if I really need TSGRPID here :)

I could ignore it also for the previous example (2 compounds - each with its vehicle); what do you think?

 

Same observation for the

Same observation for the expected Trial Sets parameters: ARMCD, SPGRPCD, GRPLBL, TRTDOS, TRTDOSU.

These should also be populated in tx.xpt and the Validator should be enhanced to perform these checks.

Yes, definitely it should be

Yes, definitely it should be a check similar to TS expected parameters.

Thank you for reminder!

Sergiy