CDISC is actively collaborating with a variety of partners, including the National Cancer Institute, Critical Path Institute, FDA, other National Institutes of Health and TransCelerate Biopharma Inc. on the development of Therapeutic Area Data Standards.

Please see below for details on current Therapeutic Area Standards available for comment or initial use. And see our monthly technical updates, eNewsletter, social media as well as our Press Releases for regular progress updates.

Click Here for a Summary Table of All Available Therapeutic Area Standards

CFAST Therapeutic Area Standards Program

CFAST List of Planned Therapeutic Area Projects

The CFAST Program Steering Committee has released a prioritized list of therapeutic area data standards projects planned for 2013. Detailed descriptions of each project will be described in project charters after the project scoping and planning is completed. This list will be updated periodically as individual project schedules change and new projects are identified and resourced.

The Coalition for the Advancement of Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute, has established a program to develop therapeutic area standards along with FDA and TransCelerate Biopharma, Inc. which is governed by a program steering committee.

CFAST Program Steering Committee Charter

The steering committee meets every two weeks. Highlights and Decisions of CFAST Steering Committee Meetings are updated quarterly to summarize meetings from the previous quarter. The current document represents the period September-December 2012.

CFAST Program Steering Committee Meeting Highlights and Decisions

CDISC Polycystic Kidney Disease Therapeutic Area User Guide v1.0 – Now Available

CDISC together with the Critical Path Institute’s Polycystic Kidney Disease (PKD) Consortium (http://www.c-path.org/PKD.cfm)  is pleased to announce Version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, a provisional standard that provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions. This user guide, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard PKD clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

A CDISC provisional release is defined as a proposed standard that has completed a public review within the CDISC user community and is available for initial use; but subject to modification for some component parts still in process. Any revisions to the draft or provisional domains and their publication status will be updated as needed in future versions of the PKD User Guide.

The PKD User Guide also describes how the PKD Common Data Elements align to existing SDTM standard, provisional and draft domains.  

Follow this link to download the zip file for the PKD v1.0 Standards package.

Parkinson’s Disease Therapeutic Area User Guide v1.0 – Now Available

The National Institute for Neurological Disorders and Stroke (NINDS) and CDISC are pleased to announce that Version 1.0 of the Parkinson’s Disease (PD) Therapeutic Area User Guide is now available as a provisional standard to provide guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent PD data in regulatory submissions. This user guide, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard PD clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

A CDISC provisional release is defined as a proposed standard that has completed a public review within the CDISC user community and is available for initial use; but subject to modification for some component parts (such as a new SDTM domain) that are still in process. Any revisions to the draft or provisional domains and their publication status will be updated as needed in future versions of the PD User Guide.

The PD User Guide provides background on the PD standards along with specific implementations for NINDS PD CRFs in existing SDTM standard, provisional and draft domains.

Follow the link to download the zip file for the PD v1.0 Standards package.

Virology Therapeutic Area Data Standards User Guide v.1.0 – Now Available

The Virology Therapeutic Area Data Standards User Guide v. 1.0 (VR-UG) is now available as a provisional standard to provide guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent virology data in regulatory submissions. Follow the link.

CDISC Pain Therapeutic Area Standards Now Available

CDISC, together with the Analgesic Clinical Trial Translations Innovations, Opportunities, and Networks (ACTTION) (http://www.acttion.org) group, is releasing v1.0 of the Pain Therapeutic Area Supplement to the Study Data Tabulation Model User Guide. This supplement, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard pain clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

The CDISC Pain Data Standards v1.0 package is being released for provisional use, since it depends on the approval of terminology submitted to the Controlled Terminology team and represents significant changes from the draft version posted for comment earlier this year. The package consists of a User Guide, 19 Questionnaire Supplements and 13 SDTM annotated CRFs. (CRFs are not included for 3 CRFs due to lack of permission from authors and 3 CRFs in the public domain.) The User Guide provides the background on the standards along with the specific Pain implementations of the Medical History domain, Questionnaire domain and Findings About domain.

Additionally, the package contains two documents that were generated as a result of the public comment period. The first is a high level summary of the major differences between the draft user guide and the final user guide. The second is a spreadsheet that contains all of the comments that were submitted during the review period with responses from the PAIN data modeling team. Controlled terminology relevant to this PAIN User Guide is being been prepared through the CDISC Terminology Team and will be released as part of terminology package 12.

Download a zip file containing the complete Pain Therapeutic Area Standards Package.

CDISC Tuberculosis Therapeutic Area User Guide Released

The Critical Path to TB Drug Regimens (CPTR) and the CDISC SDS team is releasing v1.0 of the Tuberculosis Therapeutic Area Supplement to the Study Data Tabulation Model User Guide. This supplement, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard tuberculosis clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

The TB package is being released for provisional use, since it also includes four separate SDTM draft domains that are important for tuberculosis including: Device in Use (DU), Morphology (MO), Microscopic Findings (MI), and Skin Response (SR). Draft Domains are proposed standards that have been circulated for discussion in the CDISC user community but have not yet been included in a formal release of the SDTMIG, and thus may undergo further changes before being finalized. These draft domains will be released for public comment separately by the SDS team and incorporated in a future release of the SDTMIG, and are included here to provide context for users. Additionally, the package contains two documents that were generated as a result of the public comment period. The first is a high level summary of the difference between the draft user guide and the final user guide. The second is a spreadsheet that contains all of the comments that were submitted during the review period with responses from the TB data modeling team. Controlled terminology relevant to this TB User Guide has also been prepared through the CDISC Terminology Team and will be released as part of terminology package 11.  Access the TB User Guide here.