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|
|Session Lead:||Peter Stokman|
|Location:||Online 12:00 – 13:00 UK Time|
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
|Price (Member)||£0 (+VAT)|
|Price (Non-Member)||£50 (+VAT)|
|Link for Booking:||click here|
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