Therapeutic Area Standards

New Therapeutic Area User Guide for Chronic Hepatitis C Now Available for Public Review – Comments Due 28 January 2015



The CDISC Therapeutic Area Data Standards User Guide for Chronic Hepatitis C Virus Infection (TAUG-CHCV) Version 1.0 Draft is now available public comment.  The TAUG-CHCV describes the data endpoints for clinical studies focusing on phase 1 to 3 clinical trials of drugs to treat adults with Chronic HCV infection (CHC), covering genotypes 1-6 in the out-patient setting.

Please access the document package and provide comments through the CDISC Public Comment Tracker tool.  
You will need to login or register for a CDISC portal account to use the tool. Help is also available on the Public Comment Tracker page.
Instructions on using the Public Comment Tool

Alzheimer's | Asthma | Cardiovascular | Diabetes | Influenza | Multiple Sclerosis | Pain | Parkinson's Disease | Polycystic Kidney Disease | QT Studies | Tuberculosis | Virology

 

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.

Current CFAST Project Status (Click on a project name to view description)

 

CFAST Program Overview

 

 

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.

 

 

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 2014-2016

 

 

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

 

Standards Available for Use:

 

Alzheimer's | Asthma | Cardiovascular | Diabetes | Influenza | Multiple Sclerosis | Pain | Parkinson's Disease | Polycystic Kidney Disease | QT Studies | Tuberculosis | Virology

 

 


 

QT Studies Therapeutic Area Data Standard User Guide v1



Version 1.0 of the QT Studies Therapeutic Area Data Standard (TAUG-QT) is now available for provisional use (Released 2014-12- 8). This standard was developed under the CFAST program and the CDISC Standards Development Process. The TAUG-QT describes the most common research concepts relevant to QT Studies, and the necessary metadata to represent such data consistent with CDISC standards, including the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM).

** CDISC QT Studies Data Standard v1 Public Review Comments**


 

Alzheimer’s Therapeutic Area Data Standard User Guide v2

 

Version 2.0 of the Alzheimer’s Disease Therapeutic Area User Guide (TAUG-Alzheimer's) is now available (Released 2013-12-16). 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.

 

 

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

 

TAUG-Alzheimer's v1

 


 

Asthma Therapeutic Area Data Standard User Guide v1

 

The CFAST coalition is pleased to announce that the Version 1.0 of the Asthma Therapeutic Area User Guide is now available (Released 2013-11-26). 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.

 

Asthma standards package zip file (portfolio)

TAUG-Asthma v1 (single file)

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


 

 

Cardiovascular Studies Therapeutic Area Data Standard User Guide v1

 

The CFAST coalition is pleased to announce that Version 1.0 of the Cardiovascular Studies Therapeutic Area User Guide is now available for provisional use (Released 2014-10-17).  This standard was developed under the CFAST program and provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent cardiovascular data in regulatory submissions.  The focus of this version 1.0 (v1.0) of the TAUG-CV is on Acute Coronary Syndrome (ACS) and Cardiovascular Endpoints.  The Cardiovascular Endpoints are also referenced in the Standardized Definitions for Cardiovascular and Stroke Endpoint Events in Clinical Trials document.  A link to the ACC website for individual CV Endpoints Common Data Elements (CDEs) will also be added to the CDISC website when available.

 

 
 

 

Diabetes Therapeutic Area Data Standard User Guide v1

 

The CFAST coalition is pleased to announce that the Version 1.0 of the Diabetes Therapeutic Area User Guide is now available (Released 2014-09-11). This standard was developed under the CFAST program and provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent diabetes data in regulatory submissions. The TAUG-Diabetes describes the most common research concepts relevant to diabetes studies, and the necessary metadata to represent such data consistent with CDISC standards.

 

 

 

Influenza Therapeutic Area Data Standard User Guide v1



The CFAST coalition/CDISC is pleased to announce that the Version 1.0 of the Influenza Therapeutic Area Data Standard (TAUG-Influenza) is now available (Released 2014-11-25). This standard was developed under the CFAST program/CDISC Standards Development Process and provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent Influenza data in regulatory submissions. The Influenza Data Standard describes the most common research concepts relevant to influenza studies and the necessary metadata to represent such data consistent with CDISC standards.

** CDISC Influenza Data Standard v1 Public Review Comments**

 

 

Multiple Sclerosis Therapeutic Area Data Standard User Guide v1

 

The CFAST coalition is pleased to announce that Version 1.0 of the Multiple Sclerosis Therapeutic Area User Guide is now available. This is the third standard developed under the CFAST program and provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent multiple sclerosis data in regulatory submissions. The TAUG-Multiple Sclerosis v1.0 (Released 2014-05-02) describes the most common research concepts relevant to studies of multiple sclerosis, and the necessary metadata to represent such data consistent with CDISC standards.

 

**CDISC Multiple Sclerosis v1.0 Public Review Comments**

 

 


 

 

Polycystic Kidney Disease Therapeutic Area User Guide v1

 

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 (Released 2013-02-26) 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.

 


 

 

Parkinson’s Disease Therapeutic Area User Guide v1

 

 The National Institute for Neurological Disorders and Stroke (NINDS) and CDISC are pleased to announce that Version 1.0 (Released 2012-12-18) 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.

 


 

 

Virology (Viral Resistance) Therapeutic Area User Guide v1

 

The Virology Therapeutic Area Data Standards User Guide v. 1.0 (VR-UG) (Released 2012-12-06) 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.

 


 

 

Pain Therapeutic Area User Guide v1

 

CDISC, together with the Analgesic Clinical Trial Translations Innovations, Opportunities, and Networks (ACTTION) (http://www.acttion.org) group, has released v1.0 (Released 2012-08-07) 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 (TAUG-Pain)  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.

 


 

 

Tuberculosis Therapeutic Area User Guide v1

 

The Critical Path to TB Drug Regimens (CPTR) and the CDISC SDS team has released v1.0 (Released 2012-06-29) of the Tuberculosis Therapeutic Area (TAUG-Tuberculosis) 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.


 

SDTM Alzheimer's disease/Mild Cognitive Impairment User Guide v1

 

Version 1.0 (Released 2011-09-09) 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) describes how to implement  SDTM safety domains related Alzheimer's disease (AD) / Mild Cognitive Impairment (MCI) clinical trials.  The project was a collaboration between the Clinical Data Interchange Standards Consortium (CDISC) and the Coalition Against Major Diseases (CAMD) - a program of the Critical Path Institute. The Questionnaires relevant to Alzheimer's disease studies are posted along with other questionnaires on the CDISC Questionnaires and Functional Tests page, which also describes the status of copyright approval and controlled terminology for questionnaires.  The Questionnaires and Functional Tests page will be updated as new supplements for questionnaires and functional tests become available.

 

CDISC SDTM ALZHEIMER'S User Guide Public Review Comments

 



 

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