CDISC Implementation Primer - Call for Volunteers

The PhUSE Working Group Project “CDISC Implementation Primer” are looking for new members.

The project will look to identify the needs of new CDISC implementers, with an additional focus on academia and technology providers to produce a CDISC Primer (e.g. Wiki, White Paper, Slide Deck, Guides). The Primer will seek to address the needs of the new CDISC implementers on their implementation journey.

Currently, both the FDA and PMDA require sponsors to provide study data in a CDISC format for certain types of regulatory submissions. The EMA and China FDA also endorse standardising clinical trial data in a CDISC format. Additionally, academic institutions are creating or interacting with CDISC datasets during their research activities. Therefore, this project would effectively help those wishing to submit to regulatory officials.

Essentially, by joining this project you will be helping to identify the needs of new CDISC implementers. The project will culminate in the development of the “CDISC Primer”, which will be made freely available to the public. The project will be co-sponsored and co-executed with CDISC.

If you would like to join this project, please email workinggroups@phuse.eu.

Posted by on

Tags: Partnerships and CollaborationsWorking Groups

Categories: PhUSE Blog

Related Blogs

Add Your Comments

Thinking of joining PhUSE?

Already a member but not sure how you can benefit?

PhUSE is an expanding, global society with a membership of more than 9,500 clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

Find Out More