Study Data Tabulation Model Implementation Guide (SDTMIG)
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.
Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2
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 Study Data Tabulation Model (SDTM) v1.4, Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 and Associated Persons Implementation Guide (SDTMIG-AP) v1.0 Final Documents
SDTM v1.3 and SDTMIG v3.1.3
SDTM v1.3 and SDTMIG v3.1.3 include:
- Additional variables to the general observation classes for clinical and non-clinical trials
- Content previously published in the SDTM Amendment 1
- Changes to the trial design section
- Document formatting updates
- TU/TR/RS Oncology domains developed as the Oncology Disease-specific Therapeutic Area Supplement.
Note: Amendment 1 to the SDTM v1.2 and SDTMIG v3.1.2, originally published in 2011, has been incorporated in SDTMIG v3.1.3. The original posted version of Amendment 1 can be accessed for reference purposes in the Members Only Area.
|SDTM v1.3 and SDTMIG v3.1.3||21.64 MB|
SDTM V1.2 & SDTMIG V3.1.2
|SDTM V1.2 & SDTMIG V3.1.2||4.95 MB|
SDTM V1.1 & SDTMIG V3.1.1
|SDTM V1.1 & SDTMIG V3.1.1||2.25 MB|
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-AP v1.0||462.58 KB|
SDTMIG for Medical Devices v1.0
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).
|SDTMIG for Medical Devices v1.0||2.01 MB|
Metadata Submission Guideline (MSG) for SDTMIG
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 SDTM 3.1.2 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 SDTM-IG 3.1.2, 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.
|MSG for SDTMIG||1.1 MB|