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Therapeutic Area Standards

 

 

CDISC is actively collaborating with a variety of partners, including the Critical Path Institute, FDA, National Cancer Institute, 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. Click on the image below to view the list of approved Therapeutic Area Standards Projects, then click on the links to view files.


 

Published Therapeutic Area Standards

 

Note: SDTM Oncology domain models for Tumor Identification (TU), Tumor Results (TR) and Disease Response (RS) are available in SDTMIG v3.1.3 and later versions.

 

**Some browsers may have difficulty viewing PDF portfolios, which require Adobe Flash. If you cannot view the portfolio, you can download this document as a single PDF here, though you will not be able to capitalize on the portfolio's advanced navigation features**

 


CFAST Therapeutic Area Standards Program

 

About CFAST

The Coalition for Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C-Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health. CFAST partners include TransCelerate BioPharma Inc. (TCB), the U.S. Food and Drug Administration (FDA), and the National Cancer Institute – Enterprise Vocabulary Service (NCI-EVS), with participation and input from many other organizations.

 

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.

 

CFAST List of Planned Therapeutic Area Projects

 

 

CFAST Governance

The CFAST program is governed by Therapeutic Area standards Program Steering Committee (TAPSC). For more information about CFAST governance see the CFAST Committee Charter (link below).

 

The steering committee meets every two weeks. Highlights and Decisions of CFAST Steering Committee Meetings are updated regularly to summarize meetings from the previous quarter.

 

CFAST Program Steering Committee Charter.

2012 CFAST Program Steering Committee Meeting Highlights and Decisions

2013 CFAST Program Steering Committee Meeting Highlights and Decisions

 

 

CFAST Participating Organizations

 

 

Announcements

 

Therapeutic Area Data Standards User Guide for Cardiovascular Disease v1.0 Now Available for Public Review – Comments Due 22 May 2014

 

The CFAST Cardiovascular Therapeutic Area project team is pleased to announce the availability of the Therapeutic Area User Guide package for Cardiovascular Disease (TAUG-CV) v1.0 Draft Data Standard for a 30-day public review.

 

The TAUG-CV v1.0 focuses on cardiovascular endpoints and acute coronary syndrome. Future versions of the TAUG-CV will include additional cardiovascular data elements such as Cardiovascular Imaging CDEs for transthoracic echocardiogram.

 

For Reviewers

 

The draft Therapeutic Area Data Standards User Guide for Cardiovascular Disease v1.0 contains approximately 110 consensus cardiovascular endpoint data elements that were developed by the Duke Clinical Research Institute (DCRI), American College of Cardiology (ACC)-American Heart Association (AHA) Data Standards, CDISC, FDA and other sources. The CDEs were developed within each cardiovascular endpoint definition: Death, Transient Ischemic Attack and Stroke, Myocardial Infarction, Percutaneous Coronary Intervention, Peripheral Vascular Intervention, Heart Failure Event, and Unstable Angina Hospitalization Event. These cardiovascular endpoints will be published in a joint ACC/AHA article.

 

The acute coronary syndrome (ACS) section includes data elements which were developed prior to the cardiovascular endpoints data elements. Several of the cardiovascular endpoints are relevant in ACS and were further developed as part of the cardiovascular endpoints project (for example, percutaneous coronary intervention and myocardial infarction). The package consists of the TAUG-CV and the draft CV domain for review and comment. The ACC CV Endpoint CDEs are also provided for your cross reference when reviewing the TAUG-CV. All three documents are included in a single PDF, rather than a PDF portfolio. The draft CV domain and the ACC CV Endpoint CDEs are bookmarked at the end of the TAUG under “Supplementary Material”. Please note that these ACC CDEs are provided for context and reference only when reviewing the TAUG-CV and are not part of this public review.

 

Please refer to Sections 3.2 Cardiovascular Endpoints, 3.2.1 Adjudication of Events and 3.2.2 SDTM Modeling Issues in the TAUG-CV for particular areas of interest. These include the proposal to add several variables to the SDTM for the Events Class, the use of Clinical Events versus Adverse Events for the Cardiovascular Endpoints, and additional information regarding biomarkers, modeling of CV lesions, and the use of Findings About to capture clinical judgments.

 

Please submit your comments using the CDISC Public Comment Tracker Tool located on the CDISC website located here.

 

Instructions on how to use the Public Comment Tool are located here.

 

 

New Diabetes Therapeutic Area User Guide v1.0 Now Available for Public Review – Comments Due 12 May 2014

 

The CFAST diabetes development team is pleased to announce the availability of the Diabetes Therapeutic Area User Guide (TAUG) v1.0 Draft Data Standard for a 30-day public review.

 

The Diabetes TAUG v1.0 describes the most common clinical concepts relevant to studies in diabetes, and shows examples of how these concepts are represented in SDTM. Representations of annotated CDASH-compliant example CRFs and associated metadata for some concepts are included. In addition, this document shows an example set of concept metadata displays as they may be represented in SHARE. Draft domains for Procedure Agents (AG) and Meal Data (ML), as well as a proposal for a disease milestones approach (SM and TM) are also included for review.

 

Please submit your comments using the CDISC Public Comment Tracker Tool located on the CDISC website located here.

 

Instructions on how to use the Public Comment Tool are located here.

 


Click here to download the Diabetes Therapeutic Area User Guide (TAUG).


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The Alzheimer’s Therapeutic Area Data Standard User Guide v 2.0 (TAUG-Alzheimer’s v2.0) - Now Available

 

The CFAST coalition is pleased to announce that Version 2.0 of the Alzheimer’s Therapeutic Area User Guide is now available. This is the second standard developed under the CFAST program and provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent Alzheimer’s data in regulatory submissions. The TAUG-Alzheimer’s v2.0 describes the most common research concepts relevant to studies of Alzheimer’s disease and mild cognitive impairment, and the necessary metadata to represent such data consistent with CDISC standards.

 

Follow this link to download the standards package as a PDF Portfolio file.

 


**Some browsers may have difficulty viewing PDF portfolios, which require Adobe Flash. If you cannot view the portfolio, you can download this document as a single PDF here, though you will not be able to capitalize on the portfolio's advanced navigation features** Click here to download the TAUG-Alzheimer v2.


**CDISC Alzheimer’s Disease v2.0 Public Review Comment**

 

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The Asthma Therapeutic Area Data Standard User Guide v 1.0 (TAUG-Asthma) - Now Available

 

The CFAST coalition is pleased to announce that the Version 1.0 of the Asthma Therapeutic Area User Guide is now available. This is the first standard developed under the CFAST program and provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent asthma data in regulatory submissions. The TAUG-Asthma describes the most common research concepts relevant to asthma studies, and the necessary metadata to represent such data consistent with CDISC standards.

 

Follow this link to download the standards package zip file.

 

**Some browsers may have difficulty viewing PDF portfolios, which require Adobe Flash. If you cannot view the portfolio, you can download this document as a single PDF here, though you will not be able to capitalize on the portfolio's advanced navigation features** Click here to download the TAUG-Asthma v1.

 

**CDISC Asthma v1.0 Public Review Comments**

 

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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.

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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.

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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.

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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.

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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.


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SDTM Alzheimer's disease/Mild Cognitive Impairment User Guide

 

The purpose of this project is to develop Alzheimer's disease (AD) / Mild Cognitive Impairment (MCI) clinical content data standards for regulated clinical research and clinical trials data.  This work was done in collaboration between the Clinical Data Interchange Standards Consortium (CDISC) and the Coalition Against Major Diseases (CAMD)--a program of the Critical Path Institute.

 

This document comprises version 1.0 of the Alzheimer's Disease--specific Therapeutic Area Supplement User Guide to the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMUG-ALZHEIMERS v1.0).  This guide describes the explicit implementation of a subset of the existing and new SDTM safety domains.  The Questionnaires selected for standardization in Alzheimer's disease studies have documentation located here.  The QS documentation is being stored in a separate location due to many Questionnaires that are utilized across many different therapeutic areas.  The CDISC Questionnaire Terminology Team in the process of assessing copyright issues and developing controlled terminology for questionnaires.  This site will be updated on a regular basis to inform you of their progress.

 

All permissible values sets and terms will be maintained for CDISC by National Cancer Institute Enterprise Vocabulary Services (NCI EVS) and published with other CDISC terminology sets.

 

This User Guide is aimed at the CDISC user community as an informative document for retrospective, current or future implementation of Alzheimer's Disease / Mild Cognitive Impairment studies with the CDISC SDTM domain models.  The UG describes the assumptions and rules for the SDTM domains, a data example of specific domains and a SDTM mapping strategy as necessary.

 

CDISC SDTM ALZHEIMER'S User Guide

 

CDISC SDTM ALZHEIMER'S User Guide Public Review Comments

 

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