RE:CDISC standards

deleted_user — Fri, 26 Mar 2010 20:39:30 GMT

I am very new to CDISC standards....i have a doubt on cdisc standards...can anyone clear my doubt plz...
after developing analysis datasets and tlf's are we going to map the clinical data wid cdisc standards ?or
bfore developing analysis datasets & tlf's we map the cdisc standatds wid clinical data.

and can u tell about SDTM,ADAM,Odm standards in cdisc... where we map this particular standards and significance of these standard in cdisc........

can anyone tell me the proper site to gothrough for this info as im not able to acess cdisc.org...as it is asking for membership

thanks..

Re: RE:CDISC standards

Cynthia_sas — Sat, 27 Mar 2010 15:16:46 GMT

Hi:

CDISC Standards are freely available and can be accessed here. The Standards are regularly updated and these updates are announced in the CDISC newsletter:
http://www.cdisc.org/standards

You can order the CDISC Primer here:
http://www.cdisc.org/primer

The Tufts CDISC study and findings are available here:
http://www.cdisc.org/content1114

You do not need to be a member to get the content on the above sites (although the Primer must be ordered).

Otherwise, for some perspective on the use of CDISC for clinical trial data and SAS, you should look at the archives of the PharmaSUG user group conference. Every year, there are many papers about SAS and CDISC presented at PharmaSUG. Almost all of the papers from this (and other) user groups are collected on this site:
http://www.lexjansen.com and the site has a search box, where you can enter search strings such as
CDISC SDTM
and see what papers have been presented, such as these:
http://www.lexjansen.com/pharmasug/2004/FDACompliance/FC02.pdf
http://support.sas.com/resources/papers/proceedings09/161-2009.pdf

cynthia

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RE:CDISC standards

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