topic Re: Clinical Standards Toolkit v1.5? in SAS Health and Life Sciences

Clinical Standards Toolkit v1.5?

SusanParker — Fri, 15 Mar 2013 18:11:29 GMT

Hi!

Will this have support (i.e. be able to create) for define 2.0?

If not, is there an ETA on v1.5 or an ETA on supporting define 2.0?

Thanks!

Re: Clinical Standards Toolkit v1.5?

Bill_SAS — Sat, 16 Mar 2013 13:34:07 GMT

Hi Susan,

SAS Clinical Standards Toolkit version 1.5 is scheduled for release on April 30. We have completed all new features for this version. This version does not include support for the new define 2.0 specification. Below you will find a list of the new items in this version. Thank you for your interest. We are working on the define 2.0 support for the product and will provide it as soon as possible while still maintaining the same high level of quality.

Best regards,

Bill Gibson

SAS Product Manager

Compatible with SAS Drug Development 4.2+
SDTM 3.1.1, 3.1.2, and 3.1.3
SEND 3.0 data structures only (no checks)
ADaM 2.1 with any additional data structures including ADAE
Full i18n multi-byte character support for data
Define.pdf generation
ODM 1.3 and 1.3.1
ODM form data into SAS data set
Macro to fold value-level metadata into define.xml
Internal validation checks to ensure SAS provided and user developed standards have consistent metadata definitons

Re: Clinical Standards Toolkit v1.5?

SusanParker — Mon, 18 Mar 2013 14:35:10 GMT

Thanks!

Re: Clinical Standards Toolkit v1.5?

SusanParker — Wed, 01 May 2013 14:29:50 GMT

Any news on releasing v1.5?

Re: Clinical Standards Toolkit v1.5?

Bill_SAS — Wed, 01 May 2013 18:16:45 GMT

Hi Susan,

SAS Clinical Standards Toolkit version 1.5 will be released next week on May 7. All of the major features I listed in my post back in March will be part of this release as planned. Thank you for taking an interest in the product!

Best regards,

Bill