BPDCI 07 Jul 2017 Meeting Minutes

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2017-07-07

Agenda

  • 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
  • Tina Lambert
  • Cathy Bezek
  • Lisa Houterloot
  • Jeannine Hughes
  • Charity Quick


Meeting Discussion

Disposition Discussion

  • Death

Jeannine commented that Death should only be an option on EOS when not able to report as an AE. (i.e. Death is linked to an AE and we need to avoid too much duplication). However, Cathy noted that the Study Data Technical Conformance Guide (v3.3. Mar 2017) states: DS Domain (Disposition) When there is more than one disposition event, the EPOCH or DSSCAT variable should be used to aid in distinguishing between them. This will allow identification of the EPOCH in which each event occurred or DSSCAT to differentiate if the disposition is for treatment or study. If a death of any type occurs, it should be the last record and should nclude its associated EPOCH. It is expected that EPOCH variable values will be determined based on the trial design and thus should be defined clearly and documented in the define.xml.

  • Recovery

Team felt this is rarely used / limited use

  • Protocol Deviation

Cathy noted that her company has SOP/Documentation on how to define. Jeannine noted that this should really track back to the protocol and should be a PD that directly affects safety or efficacy (even disapproved meds etc.). Action: Need clarity on this option.

  • Technical Problems

Jeannine noted that this could be valid option for a study heavily reliant on technology (eCOA heavy) or MRI only.

  • Physician Decision

Jeannine suggested the removal of this option. What would roll up to Physician decision that is not safety or efficacy related? Team agreed it is a valid point. Action: Todd to look at real world Biogen data and reach out to extended team for input.

  • Withdrawal by Subject

Team agrees with the sub-option approach. Jeannine suggested ordering sub-options by safety/eff first, however, the current order is based on real world occurrence (planning for preg is always a top reason).

Action Items

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