SS P08 06March2018 Standard Scripts Project 08 Meeting

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Meeting Record


When: 06 March 2018
Place: PhUSE CSS ADW Breakout Session
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Vincent Guo, Mercy Navarro, Margo Cohen, Alan Shapiro, Jeff Flosino (spelling?), Nhi Beasley, Julie Shah, Nancy Bauer, Weizhi Shi, Sumeet Uppal, Terry Walsh, Eileen Navarro, others that may not have signed the sheet

Agenda
  1. Determined based on what the attendees wanted to discuss (a slide with potential topics was presented)

Minutes

  • Note: These minutes are just from the ADW breakout session
  • How to improve public review: expand reviewers list, create sign-up page to be a reviewer (as on CDISC home page), create "fan club" and meet often with them (ASA Safety Monitoring group has something similar)
  • Advertise white papers: Eileen Navarro mentioned ant upcoming meeting in June on medications, make 3-4 sentences on what's in it and summary of changes that the project team can use for an announcement
  • Clinical Review Template - Gather comments and give to our FDA representatives (high priority)
  • White papers participation - create kick-off meetings early
  • Counting patients versus events - guidance on when something is a new event should be addressed by the Data Collection Instructions project team
  • FMQs - FDA Medical Queries - FDA representatives gave an update on activities associated with this (Consolidated events it's a follow-up topic from the AE white paper). CV-related FMQ has been developed. Designed to work with MEAD. Not socialized yet. Once lists are final, we can determine next steps (share in repository? MedDRA? update white paper?)
    • Last revision by MaryNilsson,05/1/2018