References

References
Reference
Web Address
Description
CDISC SDTM 3.1.1
http://www.cdisc.org/content1605
Provides access to CDISC SDTM Implementation Guide V3.1.1 Final and CDISC Study Data Tabulation Model Version 1.1 Final.
CDISC SDTM 3.1.2
http://www.cdisc.org/extranet/index.php?a=1209
Provides access to the Study Data Tabulation Model, Version 1.2 (SDTM v1.2) and the SDTM Implementation Guide for Human Clinical Trials (SDTMIG v.3.1.2).
CDISC CRT-DDS 1.0
http://www.cdisc.org/define-xml
Provides access to Case Report Tabulation Data Definition Specification (CRT-DDS, also called define.xml) Final Version 1.0.
CDISC ODM 1.3.0
http://www.cdisc.org/contentmgr/showdetails.php/id/2347
Provides access to ODMFinal Version 1.3.0 files and documentation.
CDISC Controlled Terminology
http://www.cancer.gov/cancertopics/terminologyresources/page6
Provides access to an FTP directory of supported CDISC terminology.
Note: The site http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ offers a current, cumulative set of terminology that supports CDISC SDTM.
CDISC ADaM 2.1
http://www.cdisc.org/extranet/index.php?a=1067
Provides access to the Analysis Data Model Version 2.1 and the Analysis Data Model Implementation Guide Version 1.0.
Download Form for Validation Checks Performed by WebSDM Version 2.6 on SDTM Version 3.1.1 Data Sets
https://www.phaseforward.com/resource/whitepapers/Validation%20Checks%202.6/default.aspx
WebSDM Version 2.6 validation checks.
Download Form for Validation Checks Performed by WebSDM Version 3.0 on SDTM Version 3.1.2 Data Sets
https://www.phaseforward.com/resource/whitepapers/Validation%20Checks%203.0/default.aspx
WebSDM Version 3.0 validation checks.
OpenCDISC SDTM Validation Rules
http://www.opencdisc.org/projects/validator/cdisc-validation-rules-repository
OpenCDISC CDISC validation rules repository.
Janus Operational Pilot
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327.htm
Provides information about operational pilots to date, including error checks.
ISO 8601:2004 Data Elements and Interchange Formats—Information Interchange—Representation of Dates and Times
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=40874
The official ISO 8601 standard.
SAS Knowledge Base for SAS Clinical Standards Toolkit
http://support.sas.com/rnd/base/cdisc/cst/index.html
Find current information and documentation about SAS Clinical Standards Toolkit.
SAS Clinical Standards Toolkit 1.3: User’s Guide
http://support.sas.com/documentation/onlinedoc/clinical/index.html
Link to this document.
SAS Knowledge Base for SAS Clinical Standards Toolkit Samples and SAS Notes
http://support.sas.com/notes/index.html
Provides access to SAS installation problems, usage problems, and SAS Notes that are associated with SAS Clinical Standards Toolkit.
(Enter “Clinical Standards Toolkit” in the search field.)
SAS and Clinical Trials Forum
http://support.sas.com/forums/forum.jspa?forumID=9
Primary public discussion forum for SAS Clinical Standards Toolkit.