Clinical Standards Toolkit v1.5?

[SusanParker]

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!

[Bill_SAS]

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

[SusanParker]

Any news on releasing v1.5?

[Bill_SAS]

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

[SusanParker]

Thanks!