BPDCI 19 May 2017 Meeting Minutes

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2017-05-19

Agenda

  • Introductions
  • Project Overview
  • Project Logistics


Attendees

  • Todd Bazin
  • Tina Lambert
  • Lisa Houterloot
  • Jeannine Hughes
  • Aparna Kulkarni
  • Charity Quick
  • Kit Howard


Meeting Discussion

Refer to the attached kick-off slides: File:PhUSE CSWG BestPracticesDataCollection Meeting 20170519.pptx

  • We spent a large portion of the meeting getting to know each other and providing a detailed background/overview of our current roles and experiences related to standards. We have a very experienced group who are extremely passionate about data standards.
  • Several questions came up around the scope of this project and what we will be focusing on.
    • Kit explained that science tells you what to collect and CDISC's CDASH tells you where to put the data. However, we need to focus on the business rules. Can this group target these business rules?
    • Aparna would like this group to focus on providing recommendations as to what to collect and how to collect the data to meet regulatory requirements (FDA, PMDA). Focus on instructions that are driven by regulators. Can we document what they want?
  • Todd clarified that our initial focus will be on establishing best practice instructions related the capture of Reason for End of Treatment and End of Study.
    • Several questions came up regarding multiple disposition events/epoch.
-Per Kit: I checked with the relevant parties about the multiple disposition events/epoch variable after the meeting today, and they indicated that the proposal was drafted, has been out for public review, and the team are just starting to address the 40 or so comments received. I don't know how significant the comments were, but it sounds as though it will be included in the SDTMIG v3.3 finalization package, to be out "soon". Probably within 3 months or so.
-Per CAC (CDISC Advisory Committee) meeting minutes from 15Mar2017 via Aparna: Q : SDTM, what is the multiple disposition events and epoch rule?
A : The current rule is one disposition event record per epoch. Often times there are separate dispositions for end of study treatment and end of study that occur in same epoch, so we are relaxing a restriction in the SDTMIG that specifies one disposition event per epoch to accommodate this scenario. Many companies have to create multiple disposition events within a single epoch due to study design.
-Per Mary Nilsson: From CDISC SDS sub-team - They identified the use of DSSCAT to hold the drug name for multiple drug dispositions. They also persuaded the FDA to allow for multiple disposition events per EPOCH (one for study and one for treatment).


Action Items

  • [All] Verify/obtain authorization to discuss company specific details related to the collection of data.
  • [Todd] Clarify scope of the project.