BPDCI 03 Nov 2017 Meeting Minutes

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2017-11-03

Attendees

  • Todd Bazin
  • Aparna Kulkarni
  • Jeannine Hughes
  • Charity Quick
  • Jane Lozano
  • Mary Nilsson
  • Sharon Weller
  • Tina Lambert


Agenda

1. Disposition Data Collection
a. Review Questions / Updates based on additional feedback.

2. Pregnancy Data Collection
a. Record as Adverse Event. Follow-up from Analysis and Code Sharing Group.

3. Adverse Events
a. Collecting all SAEs and AEs after signing ICF? b. Or collect all SAEs after signing ICF and only AEs after date/time of first study treatment (other events noted between ICF and first treatment recorded on MH)?

Per Aparna: No clear guidance. Need to decide on timing. Gain FDA support. Once gain FDA support then also look to align with EMA and PMDA (and other Reg Authorities).

4. Demography
a. Collection of Race / Ethnicity • Countries considered ‘restricted’? • How to operationalize?

Meeting Discussion

1. Disposition: Team discussed latest version and went through comments/questions. See attachment. File:PhUSE BPWG Disposition DRAFT v0.8.docx Key points: limit similar options (i.e. only collect Randomized by Mistake. Do not collection with or without treatment. This information can be obtained from other CRF/data sources.

Mary stressed that our job is to provide best practice recommendations AND be sure to include the WHY! Need clear rationale for our decisions.

Jeannine noted that future release of CT will include both protocol deviation and protocol violation. We'll need to review and decide on one to go with. Don't include both options. Too confusing to sites and will water down reporting. Based on draft guidance the definitions would favor moving to protocol violation as it's a serious deviation that would lead to termination.

Jane noted that this team needs to move on and start producing output. Todd agrees. Will work with Jane and Mary offline to kick off the white paper.

Action Items

Todd: Update Disposition draft based on team feedback. Todd: Start white paper.
Work with Mary and Jane to move forward.