Resource Center: Clinical Data Interchange Standards Consortium (CDISC)

CDISC Resources


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CDISC (Clinical Data Interchange Standards Consortium)
Visual Edge Consulting & Software is a member of CDISC, and actively participates in the Operational Data Model (ODM) Team where we have helped to shape CDISC standards.


“CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.”
http://www.cdisc.org


Articles, Presentations, and Webcasts

Articles
Below is a selection of archived articles that explain the CDISC standards and their use as well as some that provide perspective on how companies are utilizing CDISC standards.

All Articles  Search, filter and sort all articles.


Current CDISC news

More CDISC news at Yahoo! News.


News More news


Periodicals
The following periodicals frequently contain articles about CDISC.


Presentations


Webcasts
The links below lead to webcasts sponsored by Better Management.


User Groups
The following CDISC user networks are available in Yahoo! Groups.

Delaware Valley CDISC Users Network at Yahoo! Groups

NJ-NY-PA CDISC User Network at Yahoo! Groups

RTP Area CDISC User's Group at Yahoo! Groups

Seattle CDISC Network at Yahoo! Groups
CDISC PRG Tools and Technologies at Yahoo! Groups
CDISC SDS Oncology at Yahoo! Groups

Vendors
Below is a list of vendors that provide CDISC related tools and services.


Conferences
Below is a list of recurring CDISC and related conferences:


FDA Guidance and related documents
Following is a key subset of FDA guidance and related documents that related to the understanding and use of the CDISC SDTM and define.xml standards.

Federal Register: December 10, 2001 (Volume 66, Number 237) Patient Profile Viewer; Notice of Pilot Project
This provides a concise set of background regulatory information for electronic submissions.
http://www.fda.gov/OHRMS/DOCKETS/98fr/121001a.htm

Electronic Regulatory Submissions and Review
This link provides access all the documents on FDA's Electronic Regulatory Submissions and Review page.
http://www.fda.gov/cder/regulatory/ersr/default.htm

Providing Regulatory Submissions in Electronic Format — General Considerations
This document provides guidance for development...
http://www.fda.gov/cder/guidance/2867fnl.pdf

Providing Regulatory Submissions in Electronic Format - NDAs
This document provides guidance for development...
http://www.fda.gov/cder/guidance/2353fnl.pdf

Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
This document provides guidance for development...
http://www.fda.gov/CbER/gdlns/esubapp.pdf

Electronic Common Technical Document (eCTD)
More information on the Electronic Common Technical Document (eCTD) can be found here.
http://www.fda.gov/cder/regulatory/ersr/ectd.htm

Electronic Records and Electronic Signatures (21 CFR Part 11)
The following describe the FDA’s rule for implementing electronic records and electronic signatures and provide guidance for applying the rule known as 21 CFR Part 11.
http://www.fda.gov/ora/compliance_ref/part11/

Glossary of Computerized System and Software Development Terminology
This document is referenced in many of the FDA’s guidance documents.
http://www.fda.gov/ora/inspect_ref/igs/gloss.html

A list of all the FDA’s current guidance documents is available here.
http://www.fda.gov/cder/guidance/ 

FDA includes the CDISC Case Report Tabulation Data Definition Specification (define.xml), which is based on the CDISC Operational Data Model (ODM), as part of the eCTD Study Data Specifications for the eCTD for submissions using the Study Data Tabulation Model (SDTM).

Study Data Specifications
This document is referenced in the eCTD Specifications above. It discusses the use of the CDISC SDTM and define.xml in electronic submissions.
http://www.fda.gov/cder/regulatory/ersr/Studydata-v1.1.pdf

Portable Document Format Specifications
The following document provides the specifications for electronic submissions using the portable document format (PDF).
http://www.fda.gov/cder/regulatory/ersr/PDF_specification_v11.pdf

Specifications for CDISC datasets and documentation accepted by FDA are referenced below.

CDISC Study Data Tabulation Model / Submission Data Domain Models Version 3.1
http://www.cdisc.org/models/sds/v3.1/index.html

Case Report Tabulation Data Definition Specification (CRT-DDS, also called define.xml) Final Version 1.0
http://www.cdisc.org/models/def/v1.0/index.html

FDA and SAS Technology
The specification for the SAS Transport File Format is referenced below.
http://www.sas.com/govedu/fda/index.html


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