CDISC Study Data Tabulation
Model
Release of SDTM V1.2 & SDTM IG V3.1.2
CDISC is pleased to announce the posting of 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). As most of you will be aware the FDA are not able to immediately accept this new version. The FDA has stated that "we intend to move to 3.1.2 and that the timing on that will be determined by the availability of updated software". CDISC expects this to be around the middle of 2009 but it is for FDA to make further statements on this. In the interim users are advised to discuss potential use of V3.1.2 with the FDA as part of their normal discussions surrounding a regulatory submission.
SDTM V1.2 & SDTM IG V3.1.2
Metadata
Submission Guidelines, Appendix to the Study
Data Tabulation Model Implementation Guide 3.1.1
The CDISC Submission Data Standards (SDS) Metadata Team has released a draft version of the Metadata Submission Guidelines, Appendix to the Study Data Tabulation Model Implementation Guide 3.1.1 for review. Included with the IG Appendix is a sample electronic submission that contains examples of CRF annotations, metadata associated with the submission domains, SDTM domains, and an example of a define.xml. The Appendix describes the sample submission and the steps that need to be taken to prepare the data for submission.
Please note that this Appendix refers to the SDTMIG version 3.1.1. The Appendix will be published as final and updated to incorporate the review comments and reflect the features of the SDTMIG 3.1.2 after the comment period for both documents.
- Metadata Submission Guidelines, Appendix to the SDTM IG V3.1.1 (zip)
Status of Study Design
CDISC work on Study Design began as part of the SDS team, and resulted in the Trial Design datasets first introduced in SDTM V1.0 and SDTMIG 3.0. Study Design has also been in the scope of the Protocol Representation Group since its inception. The TDM (Trial Design Model) team continues to develop concepts in this area, and coordinates study design work occuring in several CDISC and CDISC-HL7 teams.
In October 2005, a proposal for TDM Part 2 was published for public comment. It included proposals for several SDTM-style datasets which would be used to represent the schedule of activities (planned assessments, interventions, administrative activities, and encounters). Consideration of the comments received and further thought about the challenges presented by complex scheduling examples led the team to abandon this approach and to concentrate on creating a UML model for study design. That model was harmonized with BRIDG, and study design concepts were included in BRIDG Release 1.1.
Two xml implementations of study design are currently under development, an extension to ODM, and an HL7 message. The first builds on the representation of study data collection already in ODM, adding information on the timing and conditions for data collection, as well as study summary and high-level experimental design information. The HL7 Study Design message builds on existing HL7 messages and methodolgy for describing workflow, while adding representation of experimental design.
Work on study design within the SDTM framework has been incorporated into SDTM 1.2 and SDTM 3.1.2. The SEND pilot is utilizing a proposed Trial Sets dataset, and the TDM team is working on generalizing the Trial Visits dataset to other kinds of encounters (e.g., telephone contacts, diary entries) and developing datasets to describe planned timepoints.
See BRIDG Study Design diagram.
CDISC SDTM Implementation
Guide V3.1.1 Final
Version 3.1.1 (V3.1.1)
of the CDISC Study Data Tabulation Model Implementation
Guide: Human Clinical Trials has been released
by the CDISC Submission Data Standards (SDS) Team.
V3.1.1 is based upon Version 1.1 of the SDTM,
which was posted in May, 2005. This newest version
includes new features, corrections, clarifications,
and examples, all of which are described in detail
in Section 10.6 of the document. V3.1.1 also includes
a new domain model for Protocol Deviations, which
is posted separately. Although V3.1.1 represents
the most current, approved version of the SDTMIG,
the SDS Team will continue to work on providing
additional examples to represent more complex
data domains such as signs and symptoms, pharmacokinetic
concentrations and parameters, and microbiology.
In addition, the team plans to continue work on
developing additional models and examples for
intervention and event data that include both
spontaneous and pre-specified treatments and terms.
Comments on this released version can be posted
through the CDISC Discussion Board at http://www.cdisc.org/discussions/discussions.html.
For a list of validation checks currently installed at FDA for verifying SDTM V3.1.1 compliance, click here.
CDISC Study Data Tabulation Model Version 1.1
Final
Version 1.1 (Final) of the CDISC Study Data
Tabulation Model (SDTM), prepared by the CDISC
Submission Data Standards (SDS) Group, is now
available for use. Version 1.1 includes seven
new variables that have been included for non-clinical
and clinical data applications and the new Trial
Summary dataset (that is part of the Trial Design
Model). This final version includes several
minor corrections and clarifications (listed
in Section 6.3) to address issues raised during
the comment period, but no major changes. Sponsors
who wish to contribute comments for consideration
for future versions of the SDTM may do so through
the CDISC
Discussion Board.
- Study Data Tabulation Model (SDTM) Implementation
Guide Final Version 3.1.1, September 8, 2005
- Protocol Deviations (DV) Domain Final Version,
October 20, 2005
- Study Data Tabulation Model (SDTM) Final
Version 1.1, May 4, 2005
- SDTM V1.1 Review Comments and Responses,
May 4, 2005
Click
here to register and download a zip file of
these 4 documents.
Go
to CDISC Public Discussion Forums |
