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Hello:
I just start looking into implementing CDISC in SAS and my main resource is
http://support.sas.com/rnd/base/cdisc/index.html
My question is: Which of the 3 tools
1. SAS Clinical Standards Toolkit
2. SAS Clinical Data Integration
3. CDISC procedure
are necessary for CDISC implementation and which ones are optional?
Thanks,
Peter
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They are all optional. CDISC is a different organisation to SAS. CDISC provides models for data and guidance on how to populate those models along with code lists and such like. How you implement those models is up to the user. Personally I have looked at the Toolkit some time back and really wasn't impressed. Haven't used the other two.
What part are you doing, SDTM, ADaM, define etc. Generally speaking I would say best practice is to get your define.xml ready first, this is the spec part. That can then be used to process the data into SDTM - SAS could be used to do the manipulations, and I am sure a lot of users do this either based of define or some spreadsheet. The data from SDTM - currently still SAS datasets or XPT files but will at some point move to XML - can then be processed further into the ADaM model, again you could use SAS to do this. However that being said you could do the manipulations in pretty much any tool/language. I have seen XML manipulators, C# being usd to do conversions etc.
So, basically CDISC is the data model, how you arrive at the model is up to you (so long as it is robust, fully validated and replicabel of course )
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They are all optional. CDISC is a different organisation to SAS. CDISC provides models for data and guidance on how to populate those models along with code lists and such like. How you implement those models is up to the user. Personally I have looked at the Toolkit some time back and really wasn't impressed. Haven't used the other two.
What part are you doing, SDTM, ADaM, define etc. Generally speaking I would say best practice is to get your define.xml ready first, this is the spec part. That can then be used to process the data into SDTM - SAS could be used to do the manipulations, and I am sure a lot of users do this either based of define or some spreadsheet. The data from SDTM - currently still SAS datasets or XPT files but will at some point move to XML - can then be processed further into the ADaM model, again you could use SAS to do this. However that being said you could do the manipulations in pretty much any tool/language. I have seen XML manipulators, C# being usd to do conversions etc.
So, basically CDISC is the data model, how you arrive at the model is up to you (so long as it is robust, fully validated and replicabel of course )