Second Quarter 2017

BRIDG (ISO:14199) is an international standard biomedical research domain information model developed by stakeholders including CDISC, the National Cancer Institute, the Food and Drug Administration, Health Level 7 (HL7), and International Standards Organization (ISO).

CDISC, in collaboration with a variety of stakeholders, is developing Therapeutic Area (TA) standards through the Coalition for Accelerating Standards and Therapies (CFAST) initiative. TA Standards extend existing CDISC standard metadata to include disease-specific metadata, examples and guidance on implementing standards for a variety of uses, including global regulatory submissions. To date, CDISC has developed TA standards for over 30 indications.

We load the CDISC Controlled Terminology (CT) published by the NCI Enterprise Vocabulary Services (EVS) into the SHARE metadata repository (MDR). When we're through catching up with our backlog we'll have more CT in SHARE than any other type of metadata, and we'll publish the quarterly CT content to the SHARE Exports page on the CDISC web site. One of the main differences in how we load the CT is that we load only the incremental changes.

Nominations to the CDISC European Coordinating Committee

We are recruiting volunteers for 2017-2018 E3C. Send your CV to communications@cdisc.org to help guide CDISC activities in Europe. Nominations close 15 July.

The Japan CDISC Coordinating Committee (J3C) held another successful Interchange this June, attended by over 250 people, making it one of the largest Japan Interchanges in CDISC history. CDISC would like to thank the J3C for their incredible support of the Japan Interchange every year, assisting on the Program Committee, working on the site logistics, serving as session chairs, planning meetings, and much, much more. Additionally, we would like to thank the CDISC Japan User Group (CJUG), Pharmaceutical and Medical Devices Agency (PMDA) and Japan Agency for Medical Research and Development (AMED) for meeting with us the week of the Japan Interchange, and for their support of CDISC in Japan throughout the year.

CDISC standards courses are available for in-house delivery by our authorized instructors anywhere in the world*.

CDISC in-house training:

1.     Utilizes authoritative training materials developed by the standards teams

2.     Is delivered by an instructor qualified by the standards team

3.     Provides your staff with authorized CDISC training certificates

Join CDISC from our headquarters in Austin, Texas 13 - 17 NOV 2017

2017 CDISC International Interchange