To get a more accurate and complete answer, I'd suggest asking the SDS team at CDISC.   I will take a stab at answering, but my answer doesn't feel particularly fulfilling even to me. Unlike the --STDTC variables where the -- takes on the domain id, the DM domain's Subject Reference Start Date/Time uses RF and not DM as the prefix. I can't give you a justification over the difference, but there is one. Interestingly, in the 3.1.1 STDMIG the DM RFSTDTC variable was classified as Timing as were the other --STDTC patterned domain variables like CMSTDTC.   Best regards, Bill ... View more

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 ... View more

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 ... View more

Hello, Direct support for the functionality to convert ODM files to SDTM data sets is not available in Clinical Standards Toolkit 1.4. In SAS Clinical Standards Toolkit version 1.5, limited support of extraction of ODM data into SAS domain-based data sets is planned, however the planned functionality may not support the level of conversion ODM to SDTM data sets that you describe.  Mapping and transformation of patient data from one CDISC standard to another is generally managed through the use of SAS Clinical Data Integration. SAS Clinical Data Integration provides wizards for running the SAS Clinical Standards Toolkit macros, metadata-driven mapping via a graphical interface, metadata and data standards management, as well as an integration with Medidata Rave via web services and ODM. This integration provides a process similar to what you describe: Take incoming ODM metadata and data (either snapshot or transactional), transform the data into one or more SAS data sets, map that data into an existing data standard like CDISC SDTM, check the resulting tables against the data standard, and create the CRT-DDS documentation file (define.xml/define.pdf). If you would like to receive and evaluate a pre-production release of the SAS Clinical Standards Toolkit 1.5 ODM-extraction utility as part of our early adopter program, or if you wish to discuss related SAS Clinical Data Integration capabilities, please contact me, Bill Gibson (billj.gibson<at>sas.com). ... View more

Correction: the link picked up the trailing ). The corrected link is http://support.sas.com/rnd/base/cdisc/cst/index.html ... View more

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. ... View more

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. ... View more

Your work around of using shorter labels is the best we can offer right now. Like the Windows file explorer (large icon view) there is little that we can do to handle this well. There EG development team has heard this need, and we working on a solution to this problem. ... View more

The next version of the Add-In will support Office 2007. It will ship as part of the BI Server bundle along with SAS 9.2. I'm afraid I can't give you a specific date. ... View more

Hi Valesca, I am sorry that you are having problems after installing the hotfix. There is no easy way to uninstall the hoxfix, sorry. The hotfix install should not have caused connection problems. I suggest working with SAS Technical Support to get your newly hotfixed SAS Add-In back up and running. ... View more

From the Tools menu, choose the Options... menu item. Uncheck the "Open Generated data/results automatically" check box from the Results->Results General pane. It's an all or nothing arrangement to open data generated by a step in EG, but at least you have control. ... View more

The Add-in's online documentation is only available via the Add-in as online help. Given that, from the properties window on the main help page, I do see a URL: mk:@MSITStore:C:\Program%20Files\SAS\Add-In%20for%20Microsoft%20Office\SASAMOHelp.chm::/Results/Events.htm. ... View more