TSSEQ rule in TS

p Pierre

on January 22, 2016

Hi,

I assigned by mistake a unique sequential value (1 to 47) for each line to variable TSSEQ in TS domain. The latest version of Pinnacle 21 didn't trigger any error nor warning even though this is somehow not in line with the SDTM IG 3.2 example.

On the other hand, I wonder if it's really an error for the IG says "TSSEQ has a different value for each record for the same parameter.", which is true in my case since all lines in TS domain have a unique TSSEQ value.

My question is the following: Is it something you have overlooked or do you agree that a unique TSSEQ value for each line in TS domain is not in contradiction with the IG specifications?

Thanks

Pierre

Forums: SDTM

j Jozef

on January 22, 2016

TSSEQ

Dear Pierre,

This isn't an error: there is no rule stating that you must start again at "1" for each new parameter.

I even thinks this also applies to xxSEQ in general. For example, if I have 9000 obervations for subject "SUB001" and give them a value of "1" to "9000" for xxSEQ, and then start with subject "SUB002", it is completely valid to assign a value of "9001" (or even "19001") to the first record of "SUB002".

The SDTM-IG is very confusing there (like in many other places :-( ). For example for LBSEQ it says "Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number".
I consider "sequence" and "any valid number" as a "contradictio in terminis".

So if you start with "18000" for the first record for subject "SUB001", and the second record gets "17996" and the third "17998", that would i.m.o. also perfectly OK. As long as xxSEQ is unique within the subject, you should be ok. But ... reviewers will probably not like it ...

Please also take into account that examples in the SDTM-IG are not anything more than ... "examples".

p Pierre

on January 22, 2016