BPDCI 04 Aug 2017 Meeting Minutes

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2017-08-04

Agenda

  • Continue to Review 'Reasons' for Disposition.


NOTE: We decided on the following which will frame future discussions on this topic.
Create a use case and define:

  1. Superset of Disposition reasons.
  2. Determine when a Disposition record should be captured (e.g. end of Screening epoch).
  3. Define disposition reasons to include in each disposition record (i.e. create a CRF for each) or at least guidance for which options to consider for each.
  4. Define the completion instructions that corresponds to each disposition reason.



Attendees

  • Todd Bazin
  • Jane Lozano
  • Charity Quick
  • Kit Howard
  • Aparna Kulkarni
  • Russell Newhouse
  • Jeannine Hughes
  • Sharon Weller
  • Cathy Bezek


Meeting Discussion

  • Issues with meeting logistics (Biogen Skype). Suggested to use FreeConferenceCAll.com.

Disposition Discussion
Aparna noted that there is a conflict/overlap between Withdrawal by Parent/Guardian and Withdrawal due to Caregiver Circumstances. Some trials it may be valid to have both options, however, some parents/guardians could also be the caregiver. How would we instruct the sites to respond? Further discussion needed with Lily team based on their experience with the option 'Withdrawal due to Caregiver Circumstances'.

  • NCI CT definition

Aparna noted that the definition for the NCI/SDTM CT codelist of 'Completion/Reason for Non-Completion' is only for 'study'. Can this be expanded to include 'treatment' or at least noted to be more flexible? Kit to follow-up with Erin M. at NCI. Also Kit to check with SDTM 3.3 team to fully understand Disposition recommendation and the ability to handle end of study and end of treatment records.

  • Protocol Deviation

Kit noted that the FDA is frustrated by the lack of information related to PDs. Much discussion centered around the collection of a PD identifier to explicitly link DS to DV domain (i.e. If subject discontinues due to Protocol Deviation then model a way to link that to the precise PD in the DV dataset. Overall, team likes the idea of a link. Kit volunteered to model a CDASH based form to link DS and DV

Team also noted that DS CT options of 'Protocol Deviation' and 'Non-compliance to Study Drug' overlap. Russ noted that 'Non-compliance ...' should take precedent over 'PD'.

Action Items

  • [Kit] Check with Erin M. at NCI to see if 'Completion/Reason for Non-Completion' definition can be refined to be more flexible (i.e. not limit to just 'study')
  • [Kit] Check with CDISC SDS team to fully understand Disposition rules in coming SDTM v3.3.
  • [Kit] Mock up CDASH representation linking DS and DV (i.e. if reason for not completing = Protocol Deviation then enable a link to the exact PD that led to discontinuation).