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Hot Topic Discussions

Hot Topics from ACDM

About ACDM Hot Topics

These are held online as ‘discussions’ focussing on a topic in Data Management. They are free for ACDM members (small fee for Non-Members).

As they are ‘discussions’ they are different to webinars and no presentation slides are prepared.

A person is identified to lead each session, together with a Chair, they drive the discussion with those who join call. Sometimes the sessions are recorded and/or summarised and shared with ACDM members.

RBQM in CDM: An Inquiry into Queries and Quality

Date: January 29, 2021
Type: Hot Topic
Session Lead: Peter Stokman
Location: Online 12:00 – 13:00 UK Time
Learning Objectives:

With the implementation of EDC, the adequacy of CRF data acquisition improved dramatically. Nevertheless, the retrospective query-based data cleaning process essentially remained unchanged in the last decades. In a large-scale investigation, a team of 7 sponsors and 1 CRO pooled data of 20 Phase 3 studies. The efficacy of 2 million queries was analysed, zooming in on therapeutic area, automatic & manual queries, domains, and origin of the queries. The astonishing results prompt recommendations regarding the current process and a possible way forward – aligned with regulatory recommendations regarding a risk-based approach to quality management in CDM – to turn a generalized & wasteful process into a targeted approach that focuses on what matters most.

Who is this suitable for?

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management

Outline content
Price (Member)  £0 (+VAT)
Price (Non-Member)  £50 (+VAT)
Link for Booking:  click here

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