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First Quarter 2017

CDISC Leadership

Happy Spring!

Welcome to the Q1 2017 edition of the CDISC Newsletter. As of 01 January, CDISC standards are required for submitting data in the United States (FDA) and Japan (PMDA); we want to continue to thank all our volunteers who made this monumental achievement possible. Clinical research data standards, what were once thought to be just a "good idea," are now a requirement for new drug development. Our standards that were once only available through PDF documents are now electronically accessible through the SHARE API.  What was once an all-volunteer, grassroots organization, has grown into a global leader in developing and supporting platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. 

Featured Articles

Traceability is an essential element of data quality and a regulatory requirement for studies submitted to the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Because a study’s strength hinges on the integrity of source data as well as the quality and reproducibility of the processes used to generate the results, traceability plays a crucial role in reinforcing clinical research analysis results.

CDISC hosted our Winter IntraChange in Silver Spring, MD on 22-24 March 2017. CDISC IntraChanges are an opportunity for those involved in our standards development teams to meet face-to-face to work collaboratively across teams to further standards development efforts, share knowledge and experience.

CDISC is the only organization that provides authorized and vendor-neutral standards training, globally. This year, we will deliver courses in ChinaDenmarkEnglandGermanyThe Netherlands, and Japan. We can accommodate private, in house training almost anywhere in the world.

Standard Updates

SHARE is CDISC’s metadata repository that delivers CDISC standards in machine-readable formats such as XML, RDF and JSON. Access to SHARE is a benefit of CDISC Membership. If you are an employee of a CDISC member organization, and have not taken advantage of the content produced by SHARE, you can do so from the Members Only Area of our web site. 

The CDISC Foundational Standards are the basis of the complete suite of harmonized CDISC standards, designed to enhance the quality, efficiency and cost effectiveness of clinical research processes from beginning to end.

SDTMIG v3.2 Conformance Rules v1.0 Now Available

In February, CDISC released the first Conformance Rules for the Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2.

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 25 indications.

Membership Update

We value our members and have added many new benefits to our Membership Benefits for 2017. Do remember ALL employees of CDISC Member organizations can create an account on our web site to download standards and access exclusive resources in the Members Only Area.

In the News

CDISC Alliances

The CDISC Team attended a variety of partner conferences to discuss with fellow stakeholders the importance of adopting standards.

HL7 Working Group

CDISC Leaders attended the HL7 Working Group in San Antonio in January, helping to organize the clinical research session of the FHIR Connectathon, and Working Groups (WGs) including the newly named Biomedical Research and Regulation (BR&R, formerly BRIDG & RCRIM) that centralizes research topics into a single WG, Clinical Genomics, and LOINC/SNOMED CT Workshops, Clinical Interoperability Council, Operations & Orders, and Imaging. CDISC remains active in many HL7 working groups and looks forward to continued collaboration in standards development.

CDISC Around the Globe

The E3C team held a two-day, face-to-face meeting in Berlin on 19-20 January to select the abstracts and create a draft program for the 2017 CDISC Europe Interchange, which will take place in London 24-28 April. The E3C team and CDISC were very pleased to receive an exceptionally high number of quality abstracts. 

CDISC Japan User Group (CJUG) Update

Yoshiteru Chiba, Head of CJUG

CJUG held its first webinar on 03 March 2017. During the webinar, Ayako Hara presented updates from the Japan PMDA, and Hidetoshi Misawa, J3C Chair, provided an update from the J3C. Following this were updates from the CJUG SDTM and ADaM teams.

Become a Committee Member of the AP3C  

The AP3C is currently accepting applications from CDISC members in the Asia-Pacific region to join the committee. The intent of the AP3C is primarily to provide an opportunity for Asia-Pacific Leaders/Countries to participate in a CDISC Coordinating Committee when there is not one in their country.

CDISC Education Opportunities

Happy New Year from CDISC Education

Read the LinkedIn article by Shannon Labout, VP, CDISC Education

 

Upcoming Events

Join CDISC at one or more of our annual global events!