BPDCI 02 Jun 2017 Meeting Minutes

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2017-06-02

Agenda

  • Clarify Scope of Project
  • Review Disposition example


Attendees

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


Meeting Discussion


Project Scope

  • We agreed to compile a 'use case' or example of what to collect as well as the corresponding completion guidelines that would support such a use case/example. We are looking to complement CDASH with a use case. We are taking CDASH to a greater level of granularity. Science tells you what to collect. CDASH has to be very generic. We want to be clear that we are not duplicating work done by CDASH or providing guidance that will contradict CDASH.
  • Before we can define completion instructions we need to define what to collect. Again, we'll create an example of what to collect and then the completion guidelines to support the collection.


Disposition Discussion Reviewed the following example:
File:Disposition eCRFs and Completion Instructions NVS.pptx

  • Aparna indicated that Novartis creates a disposition record at the end of each epoch.
  • End of Treatment record collected separately for cases where, per protocol, subject is able to discontinue treatment but stay on study. In such cases the DSCAT for the EOT record is set to 'Other Event' in order to avoid the current SDTM 3.2 limitation of having two disposition events in one epoch. NOTE: All signs indicate that this limitation will be removed in SDTM v3.3.
  • Some noted that this creates some confusion when looking across studies as some have an EOS and EOT record while some just have an EOS record. How to know? Charity, based on her experience, would prefer to always collect a separate EOT and EOS record. Todd notes that this has been Biogen's standard for many years (i.e. collect both on all studies).
  • Charity questioned the concept of 'completed study'. What defines the subject as having completed the study?
  • Tina explained that her company has come up with a framework for setting up the collection of disposition data based on SDTM CT. Each team starts with guidance, compiles collection CRFs, and then runs by Data Standards Governance for approval etc. Tina will share documentation at next meeting.


Action Items

  • [All] Verify/obtain authorization to discuss company specific details related to the collection of data.
  • [Todd] Reach out to CDISC/NCI CT team. Any plans to update/add completion reason submission values? Any plans to update description of existing values to include withdrawal of treatment? Right now the descriptions state withdrawal from study.
  • [All] Define/clarify when to collect 1 vs. 2 disposition events in an epoch.