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 firstname.lastname@example.org.
Posted by Louise Crawley on
21 January 2019 at 9:00 AM