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TS domain labels vs SDTM IG V 3.2
SergiyHi Steve, I'm confused…
Hi Steve,
I'm confused. You refer to warnings about labels, but show an example of variable values.
What is rule ID?
Thanks,
Sergiy
TS domain labels vs SDTM IG V 3.2
Well, I think Steve is referring to that in principle, every TS parameter pair is essentially describing a variable (after transposal).
SDTM uses a hypervertical structure, so every PARAMCD/PARAM pair represents a column with a name and a label (after transposal).
@Steve: what are the warning codes you get? Otherwise it is pretty hard to find out what happened.
SergiyHi Steve, You need to use…
Hi Steve,
You need to use CDISC SDTM Controlled Terminology for standard terms of Trial Summary Parameters.
It's a shame that CDISC standards are not consistent with each other.
Kind Regards,
Sergiy
TS domain labels vs SDTM IG V 3.2
Here are the correct pairs according to the latest (2019-06-28) SDTM controlled terminology which you can get from: https://evs.nci.nih.gov/ftp1/CDISC/SDTM/
LENGTH - Trial Length
TINDTP - Trial Intent Type
INDIC - Trial Disease/Condition Indication
PCLAS - Pharmacologic Class
FCNTRY - Planned Country of Investigational Sites
As Sergiy said, there are indeed inconsistencies between the (examples in the) SDTM-IG and the CDISC controlled terminology files.
You can also start using the CDISC Library API (https://www.cdisc.org/cdisc-library/api-documentation) which has RESTful web services available, which you can use to auto-generate a prototype TS dataset.
There are also tools available that generate TS prototype datasets starting from a file with controlled terminology. You can contact me for more information.
Thank you both for the…
Thank you both for the clarification, so now I assume that the use of CT values for these labels takes a higher priority then using the IG values.
Wonderful. I'm so glad this forum is available.
Steve
Hello,
I kept getting label warnings on a number of variables in the TS domain which I believe were correct per the SDTM IG v 3.2. I may be missing something but these are the ones I had issues with that I've solved - modified the labels to what P21 suggested, but feel a little queesy about changing my labels from the IG just to make the warnings go away.
TSPARMCD LENGTH TSPARM: Trial Length 3.2 IG: Planned Trial Length
TSPARMCD TINDTP TSPARM: Trial Intent Type 3.2 IG: Trial Indication Type
TSPARMCD INDIC TSPARM: Trial Disease/Condition Indication 3.2 IG: Trial Indication
TSPARMCD PCLAS TSPARM: Pharmacologic Class 3.2 IG: Pharmacological Class of Investigational Therapy
TSPARMCD FCNTRY TSPARM: Planned Country of Investigational Sites 3.2 IG: Planned Country of Investigational Site(s)
Am I better off just explaining the warnings or changing my labels to remove the warning? and why the difference in labels?