Panel Discussion: End of Study Quality and Archiving Inspection Findings

About this session

Part of Session 5, Track E: TMF Interoperability (Chair: Karen Roy, CDISC).

The FDA, EMA and MHRA all publish and share inspection findings.
In this panel session hosted by Arkivum's Chris Sigley, Blueprint Medicines' Curran Murphy and Abbvie's Ashley Avery will discuss common end of study inspection finding themes and what we can learn from them.
Pulling together an analysis of warning letters, inspection finding publications, freedom of information requests and first hand experience, the panel will discuss topics such as:
End of study quality checks and missing recordsGaps identified in end of study and retention related SOPs and processes (including their ongoing maintenance)TMF oversight and post trial data sprawlEnd of study TMF mismanagement including poor archiving processesAccess to closed study records and dataWe will also open out the panel for questions (and stories from the floor). This interactive session will share lessons learnt with the aim of helping improve future inspection outcomes.
Panelists:
Curran Murphy, Blueprint MedicinesAshley Avery, Abbvie

Speaker

• CS

  Chris Sigley

  Arkivum

  Moderator