"other specify " in ADaM

v Venkata

on March 3, 2013

Hello Friends -

I was strated working on questionarie ADaM adtasets and came acroos a problem in keeping "Other Specify" info @ ADaM dataset level. I completely gone through ADAM guidelines and could not able to find a element to include it ADaM level using BDS starcture. I greatly appreciate if you can help me out.

Forums: ADaM

s Sergiy

on March 3, 2013

Hi! It's very difficult to

Hi!

It's very difficult to answer, because it depends on many details.

The major question is "Do you use "Other Specify" info in your analysis or not?" If the answer is "No", then you do not need to store those information in analysis datasets.

If you use it for analysis, then what is the role? Is it analysis parameter, analysis grouping, traceability, etc.?

Do you need to keep the "Other Specify" value only or all additional "specified" values?

The knowledge of study protocol, study data structure and particular analysis is needed.

Regards,

Sergiy

v Venkata

on March 3, 2013

Required for listing

Thanks alot for the reply,

I need this info for Listing generation, its Questionarie dataset and we have specific questions if answear is "Yes" then we there is additional column in QS CRF "SPECIFY" - my clinical team wants to have it @ Listing this value to know why the answear is Yes and its importent information clinically to review.

here is one more limitation we have in our company - as per our internal guidelines we can only use ADaM adatsets for TLFs generation i can not go back and use SDTM element for Litsing.

I greatly appreciate if your help:)

Thnaks,

Venkata.

n Natalie

on April 3, 2013

CRF "SPECIFY"

HI Venkata,

the solution I often do, is to put the 'Other, specify' information into AVALC and use AVALCAT1 as 'Y' or 'N', in case you have BDS structure. For the tables you would then use AVALCAT1 and for listing AVALC.

Hope this helps