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.

2017 CDISC Interchanges:

International Interchange

13 - 17 November

 

CDISC-PhUSE Virtual Roundtable Discussion 

Problem Statement:

Questionnaires, rating scales and other instruments may contain items that may be logically skipped or left unanswered. For example, an instrument may instruct the subject to skip to Question 5 when Question 1 is answered "no". Items that are logically skipped or left unanswered are typically not represented in SDTM. Regulatory agencies have been collaborating with CDISC to explore representing all items including those that have been logically skipped or left unanswered in SDTM. In order to maintain traceability, information about logically skipped items and/or items left unanswered would need to be collected in Electronic Data Capture (EDC) systems or Electronic Patient Reported Outcome (ePRO) devices. 

Request for Information Sharing:

CDISC asks members of the PhUSE community with experience in implementing questionnaires or other instruments in EDC or ePRO for their perspective on the following:

  • current industry practices configuring questionnaires or other instruments in EDC/ePRO systems.
  • practicality of configuring EDC/ePRO systems to collect information about logically skipped and/or unanswered items.
  • any changes to the site data entry burden to collect information about logically skipped and/or unanswered items.
  • any changes to data cleaning activities resulting from the collection of information about logically skipped and/or unanswered items.  

Meeting Logistics:

Session 1: August 28th, 10:00 am - 11:00am EDT 

Session 2: September 11th, 10:00am - 11:00am EDT 

Please respond to Dana Booth (dbooth.external@cdisc.org) and Scott Bahlavooni (scott.bahlavooni@phuse.eu) to be added to the meeting. 

 

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