Review Priorities

From PHUSE Wiki
Jump to: navigation, search


When: 09:00 EDT, 19Oct2018
Place: GoTo Meeting
Facilitator: Jared Slain and Wendy Dobson
Scribe: Jared Slain
Attendance: Wendy Dobson, Jared Slain, Mary Nillson, Mat Soukup, Hanming Tu
Agenda: Review Priorities

Updates

  • Mat: Hasn't heard back from DIA; will investigate educational videos based on the list below
  • Mary: Obtained approval to purchase DIA videos

Current FDA Internal Courses

  • FDA Clinical Trials
  • Statistical - Clinical Reviews
  • ICR
  • OCS Training on Data Standards
  • 3 courses on MEDRA
  • SDTM/ADaM
  • Tools - Review, Jump/Clinical

AE Whitepaper

  • Has typos
  • Mary will coordinate an update with Wendy

FDA Presentation

  • Uploaded to wiki
  • Now what happens?
  • Can we get more links from fda.gov? (Plan of action decided, Wendy will coordinate with Dave Epstein)

Review of Priorities

High priorities

  • Help other projects with communication around their final deliverables
  • Improve navigation from PhUSE home page (completed)
  • More presentations/posters at multiple conferences (perpetually ongoing)
  • Keep wiki up-to-date (perpetually ongoing)
  • Key educational video clips (define high vs medium)
  1. Expanded pooling
  2. Standard safety package for individual study
  • Links from FDA sites/documents/training (Wendy to speak with Dave Epstein)
  • Safety Analytics Workshop - record and post (likely with ASA/DIA)
  1. For CSS Workshop, need by end of Jan (90 minutes)
  2. Wendy to speak with Chris and Scott and raise at next Steering Committee

Medium priorities

  • Develop thorough/targeted communication plan (Initial plan done, but refinement is ongoing)
  • Improve index ranking (goes along with analytics site and additional linkage to deliverables)
  • Create a Safety Analytics site (likely with ASA/DIA)
  • Crowd-source educational library (FDA/sponsors share what they have?) (likely with ASA/DIA)
  1. Start asking around
  2. Home would be Safety Analytics site (Wendy to start team works site)
  • Additional education videos (define high vs medium)
  • Work with ADW project on any additional ideas to improve visibility, especially with Safety Analytics
  • Write a journal article (need to define focus)

Low priorities

  • Work with ADW project on improving review process
  1. Brought up at FDA meeting
  2. Need to get other regulatory agencies on board (e.g., Japan, China, Europe)
  3. Special topics whitepaper might get more interest
  • Write additional journal articles



Last revision by Jared s,11/2/2018