Clinical Standards Toolkit - Support for standard SDTM IG 3.1.2

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Clinical Standards Toolkit - Support for standard SDTM IG 3.1.2

Hi

I was wondering if anyone knows if / when the SDTMIG 3.1.2 standard will be available for the Clinical Standards Toolkit?

Thanks
SAS Employee
Posts: 33

Re: Clinical Standards Toolkit - Support for standard SDTM IG 3.1.2

We are working on both the plan and the SDTM 3.1.2 standard for SAS Clinical Standards Toolkit. I am not able to commit to a date yet, but I can assure you that it is coming.

It was just over a week ago that Phase Forward released the Janus 3.0 specification. We need a bit more time to review the changes, plan, implement, and test the new SDTM 3.1.2 package.
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Re: Clinical Standards Toolkit - Support for standard SDTM IG 3.1.2

Hi Bill,

The user guide illustrated sample reports and also mentioned the framework macro %cstutil_createreport can be used to create reports out of the results data set. But I am not able to find that macro from the downloaded package or in any of the installed macro libraries.

Could you please advise whether the reporting macro is actually included in the toolkit and, if not, whether I can get if from somewhere else? We are evaluating the toolkit and would like to make the best use of it. We appreciate the effort from SAS to develop such a useful toolkit and provide it to the industry for free.

Best regards,
Dan
SAS Employee
Posts: 33

Re: Clinical Standards Toolkit - Support for standard SDTM IG 3.1.2

The sample reporting package did not make it into the initial release. Both the reporting package and support for SDTM 3.1.2 will be available soon. The development team is hoping to have both packages posted in the new clinical focus area (it's not available yet but will be found from http://support.sas.com/rnd/). I will post an announcement to the forum when the focus area and the two packages are available.

Thank you for your interest,
Bill

Below, I've included some specifics about the two packages:



Sample Reporting Package [current proposed description]

This package contains a set of 3 sample reports supporting SAS® Clinical Standards Toolkit 1.2:

(1) A report applicable to most SAS® Clinical Standards Toolkit processes, itemizing records
written to the results data by the process. In the case of validation processes, this
report itemizes results data set records by validation check.
(2) A report specific to SAS® Clinical Standards Toolkit validation processes for standards
that have the concept of source data domains (for example, CDISC-SDTM and CDISC-ADaM).
Results are summarized by domain.
(3) A report specific to SAS® Clinical Standards Toolkit validation functionality that
summarizes all available metadata about validation checks for a supported standard.
This report offers a multi-panel or one-page-per-check presentation format.

These reports are templates or examples that illustrate the available metadata and process output files available within SAS® Clinical Standards Toolkit and how that information can be reported in a useful way. The report templates are PROC REPORT implementations that use ODS to generate report output in a variety of ODS-supported formats.


Documentation
Preliminary documentation of these reports will be available in the clinical focus area.

This documentation supersedes Chapter 6 of the SAS® Clinical Standards Toolkit 1.2 User’s Guide (http://support.sas.com/documentation/onlinedoc/clinical/) that provided draft documentation on an earlier version of this reporting functionality.


Availability
These reports may be deployed and used on all versions of SAS software and all operating systems on which SAS® Clinical Standards Toolkit is available.


CDISC-SDTM 3.1.2 Domain and Metadata Templates

As noted in Chapter 3 of the SAS® Clinical Standards Toolkit User's Guide, 'Part of the definition of each standard is the itemization of the data tables that define the SAS representation of that standard (and version)." In anticipation of the release of the full SAS representation of the CDISC-SDTM 3.1.2 standard with SAS® Clinicall Standards Toolkit 1.3, the following metadata files and domain descriptions are made available to the user community with this package:

1) the reference_tables data set, which captures table-level metadata about each reference standard data set

2) the reference_columns data set, which captures column-level metadata about each reference standard column

3) descriptions of each of the 32 CDISC-SDTM 3.1.2 domains, provided in the form of SAS data step code that derives 0-observation data set representations of those domains.
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Re: Clinical Standards Toolkit - Support for standard SDTM IG 3.1.2

Thanks for the update Bill.
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