CDISC Releases Therapeutic Area User Guide to Accelerate Development of Safer, More Effective Vaccines

05-Oct-2017 9:05 AM

AUSTIN, Texas--()--The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the release of a new Therapeutic Area Standard for Vaccines in the form of a User Guide for data managers, statisticians, programmers and study managers, which is freely available on the CDISC website. This Vaccines standard was developed and funded through BioVacSafe, Biomarkers for Enhanced Vaccines Safety, a project funded by the Innovative Medicines Initiative (IMI).


Since their discovery, vaccines have protected millions of people worldwide from a broad range of infectious diseases, making them one of the most effective public health interventions available. New and better vaccines are still urgently needed, yet their introduction is hampered by lengthy and expensive vaccine safety testing procedures. The goal of BioVacSafe is to develop cutting-edge tools to speed up and improve the testing and monitoring of vaccine safety, both before and after release to the market. By bringing together for the first time three of Europe's leading vaccine and manufacture companies as well as top experts from academic institutions and small and medium-sized enterprises (SMEs), the standard will ultimately accelerate the development and introduction of a new generation of safer, more effective vaccines.

“We are delighted to see this important new vaccines data standard published and are grateful to IMI for their generous support in achieving this goal,” remarked Stephen Pyke, Senior Vice President, GSK. “This will help to simplify and streamline the long journey for all new vaccines from idea to clinical use.”

CDISC Standards were originally developed to enhance the review of safety and efficacy data, and most recently have been extended in specific disease areas. The Therapeutic Area User Guide describes the most common biomedical concepts relevant to Vaccine studies, and the necessary metadata to represent such data consistently with CDISC Standards.

This CDISC Therapeutic Area Standard for Vaccines was developed through the Coalition For Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the U.S. NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), the U.S. Food and Drug Administration (FDA), TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA) and additional stakeholders. The goal of the CFAST initiative is to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health.

CDISC standards have been adopted and used in more than 90 countries, and are required for submissions to the U.S. FDA and Japan PMDA. To date, Therapeutic Area standards have been developed for over 30 disease areas.


CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures. CDISC standards are required for regulatory submissions to the U.S. FDA and Japan PMDA, are endorsed by the China CFDA, and are requested for use by the European Innovative Medicines Initiative (IMI). The suite of CDISC standards is freely available on the CDISC website.

CDISC is funded through the generous support of over 400 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC and get involved, please visit


Ann P. White, +1-512-363-5826


Topic: Health

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