Partnerships & Collaborations
PhUSE has successfully built a relationship with the FDA (Food & Drug Administration) which has been further strengthened through the Computational Science Symposium in Maryland, USA. We have also established links with the EMA and PMDA through participation in the European Union clinical trials portal and database stakeholders meetings.
Additionally, PhUSE has helped in the transition to CDISC data submissions, by building on the PhUSE/CSS/FDA collaboration, and through the conversion of documents into Japanese. This has been with a view to creating a stand-alone stream or discussion group at future conferences.
PhUSE / CDISC MOU 2018-2019
2018 CDISC Interchanges:
23-27 April, Berlin Germany
PhUSE/CDISC Roundtable 2018
Are you interested in contributing at an upcoming roundtable discussion with PhUSE and CDISC? The details below provide an overview of the topics for discussion and meeting logistics information. PLEASE NOTE: The discussion will be limited to 50 seats. We will be limiting registration to ONE (1) seat per company.
1. Ambiguity exists regarding the tabulation of certain measurements as clinical classifications or physiological findings within a specific body system (e.g. cardiovascular, reproductive, etc.). The CDISC QRS team has developed a new rule clarifying the tabulation of these measurements. This new rule would require SDTM implementers to move/re-map the results for certain measurements (~12) from one domain to another.
The QRS team would like to vet this new rule with the implementation community, and gather feedback on moving/re-mapping results for existing measurements.
2. Standards developers and implementers use variable QSEVAL, Evaluator, to represent a variety of different concepts including instrument reporter, interviewer, health care professional, etc. As a result, data consumers struggle to understand the specific concept represented in QSEVAL for a given study. Further, these differences may impact pooled analyses. The QRS team proposes to remove QSEVAL/QSEVALID from SDTM and represent specific information about readers, responders, assessors, etc. as supplemental qualifiers.
The QRS team would feedback on this proposal. Please note, this proposal does not impact the FT and RS domains.
Request for Information Sharing:
CDISC asks members of the PhUSE community with experience representing measurements in SDTM for their perspective on the aforementioned proposals.
February 26th, 2018, 10:00 am - 11:00 am (EST), 15:00-16:00 (GMT) 16:00-17:00 (CET)
Please request to register by contacting Dana Booth (email@example.com) and Scott Bahlavooni (firstname.lastname@example.org). Again, registration will be limited to one seat per company.