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CDISC Collaborative Culture in Action - The CDISC Winter Intrachange

March 21, 2014 at 9:55 AM by cdisc

The 2014 CDISC Winter Intrachange was held February 25th – 27th in Silver Spring, Maryland. CDISC Intrachanges are informal CDISC cross-team meetings for CDISC standards development teams, as opposed to Interchanges, which are yearly conferences, focused on presentations and the sharing of implementation approaches and experience.

 

Katzenbach and Smith (2008) define a team as, “a small number of people with complementary skills who are committed to a common purpose, set of performance goals, and approaches for which they hold themselves mutually accountable.”

 

Photo by Rhonda Facile

 


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SHARE R1 is Done

February 13, 2014 at 4:41 PM by cdisc

SHARE is no longer merely a vision, idea, or plan. After nearly 6 months of implementation work SHARE R1, our first production library, has been completed. Woot woot! This is a major milestone. We've taken the first step on a long journey towards realizing the vision of transforming the CDISC standards into an end-to-end, interoperable set of metadata all available in a machine-readable format.

 

Both SDTM 1.2 (IG 3.1.2) and CDASH 1.1 have both been loaded into the production SHARE Library. Using SHARE R1 we will load SDTM 1.3 (IG 3.1.3) and SDTM 1.4 (IG 3.2) in the coming weeks. Although the CDISC Controlled Terminology development and governance processes will remain unchanged, we will continue to load each newly released terminology package into SHARE. BRIDG 3.2 and the ISO 20190 data types have also been loaded into the R1 library.


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FDA Guidance on Standardized Study Data for Electronic Submissions

February 6, 2014 at 6:00 PM by cdisc

 

Today, 6 February 2014, the U.S. Food and Drug Administration officially published several guidances for electronic regulatory submissions to the FDA. The documents, linked below, are a package for industry that include information on FDASIA, eStudy, a Conformance Guide and Standards Catalog, and have a 90-day window for public comment.

 

The Study Data Technical Conformance Guide was developed in an effort to combine the existing Common Issues, Study Data Specifications and Traceability Guidance documents, as well as Validation Rules, in order to offer one technical document that coordinates all these sources for the industry. The Standardized Study Data guidance provides requirements for a valid electronic submission of standardized study data to the FDA, including format specifications.

 

FDA-2014-D-0092 - Study Data Technical Conformance Guide and Data Standards Catalog

FDA-2012-D-0097 - Guidance on Electronic Submissions: Standardized Study Data

FDA-2014-D-0085 - Guidance on Submissions in Electronic Format--Submissions under the Federal Food, Drug, and Cosmetic Act


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World Cancer Day 2014

February 4, 2014 at 5:15 PM by cdisc

While the news on World Cancer Day has focused on the illusive cure to cancer, I would like to shed some light and bring necessary attention to one of the main ways that we as a global society of patients can actually work to ensure the faster development of therapies: the implementation and utilization of clinical research standards.

 

On this day, World Cancer Day 2014, we would like to pause to thank our volunteers, whose tireless efforts developing standards for clinical research are working toward real change to shorten the drug development timeline, bringing new and more effective therapies to patients more quickl


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Metadata Curator Wanted

December 18, 2013 at 12:16 PM by cdisc

Being a metadata curator means most won’t exactly understand what you do. You can certainly forget about explaining your job to your mom. Traditionally, curators have managed collections of old stuff, like what you might find in a museum. In today’s world of informatics and big data, however, metadata curators play an essential role in enabling metadata driven automation and semantic interoperability.

 

At CDISC we are implementing the SHARE metadata repository to manage the latest standards metadata, as well as the older stuff. The SHARE metadata curators will play a critical role in defining and administrating the processes and policies for governing the metadata that will become the CDISC standards. They will help to lead the CDISC community towards new ways of standards development. In this capacity, the metadata curator must be a passionate advocate for clinical research data standards, a strong communicator, as well as an energetic collaborator. Since SHARE represents a new approach to standards development, creative chops are a must.


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