Where the SDTM provides a standard model for organizing and formatting data for human and animal studies, the SDTMIG is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets. It was developed to support data submitted to a regulatory authority, such as the US Food and Drug Administration (FDA), but is not restricted to use in regulated submissions. SDTM is one of the required standards that sponsors must use as specified in the FDA’s Data Standards Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions effective December 2016. For more information, please visit the Guidance on Standardized Data.
SDTMIG v3.2 Includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD. Re-designed as a PDF Portfolio instead of the traditional single PDF file**. Note: All previous annotations in SDTMIG 3.1.3, originally published in 2012, have been incorporated in SDTMIG v3.2.
CDISC has released the final version 1.0 of the MSG Package, which was originally released for public comment from 2010-05-14 to 2010-06-07. During that review period, over 570 comments were received, which needed to be resolved before this final package could be released. An appendix to SDTMIG v3.1.2 is included with the package to familiarize users with the SDTM submission components. Additionally, a sample electronic submission is included, which contains an annotated CRF, submission datasets compliant with the SDTMIG v3.1.2, a Define.xml file describing the structure and content of the submitted datasets, a stylesheet for visualizing the define.xml in a user-friendly way, and an optional reviewers’ guide.
SDTMIG-AP v1.0 describes how to represent collected data about persons other than the subject under study, who could be associated with the study itself, a particular study subject, or a device used in the study.
SDTMIG for Medical Devices v1.0 defines recommended standards for submitting data from clinical trials when medical devices are used. The document includes seven additional domains, developed by a team composed of medical device experts, CDISC specialists, and the FDA (CDRH and CBER).
SDTM v1.3 and SDTMIG v3.1.3 include:
The SDTMIG v3.2 details the structure and conventions for compliant SDTM domains. The majority of the SDTMIG v3.2 is published in a data definition table format, which allows the information to be used programmatically. Business and conformance rules (e.g., assumptions and examples), however, are expressed outside of the data definition tables, making them difficult to identify and program.
SDTMIG v3.2 Conformance Rules v1.0 aim to identify all conformance rules and case logic from the SDTM and SDTMIG, classifying and codifying them in a form that supports SDTM quality processes and tool development.
The Conformance Rules team has created a user guide that provides information on the structure of the rules and conventions for rules content.
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.
|SDTMIG v3.2 Conformance Rules v1.0||80.44 KB|
|SDTM Conformance Rules User Guide v1.0||321.95 KB|
|SDTMIG v3.2 Conformance Rules v1.0 Public Comments||64 KB|