CDISC and PhUSE Implementation Primer Project

CDISC and PhUSE Implementation Primer Project

Peter Van Reusel

Europe Liaison, CDISC

CDISC and PhUSE Implementation Primer Project 

The CDISC Implementation Primer project, sponsored by PhUSE and CDISC and  run by Scott Bahlavooni and Peter Van Reusel, kicked off during the 7th Annual PhUSE CSS meeting.  The goal of project is to develop a set of resources to guide industry newcomers and learners in using and implementing CDISC.   

Over the years, the volume of CDISC data standards and their implementation options have grown steadily. In addition, understanding the regulatory requirements, which mandate and specify the use of CDISC data standards can be quite daunting. 

Volunteers from FDA, PMDA, CDISC, Sponsors and CROs gathered to discuss the project scope.  Who are the newcomers?  What type of guide is needed and what are the topics on which help is needed?  It became clear that a guide is also needed to welcome people from outside the  PhUSE community, such as academia, researchers, medical device, nutritional, cosmetics, etc…

The working group will develop a questionnaire to better understand the learning needs of newcomers.  We also concluded that many resources already exist; there is no need to duplicate the CDISC website, the guidance documents and the best practice guides the PhUSE community has created over the years. However, these is a need to clarify where to find these resources and to simplify complex concepts by using visualizations.