Overcoming the challenges of Clinical Data Management in low and middle-income countries A context-adapted Data Management Plan and Lifecycle ASTMH conference, New Orleans, 5 th Nov 2014 Yves Claeys (Institute of Tropical Medicine, Belgium) James Smedley (Liverpool School of Tropical Medicine) 1
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Overcoming the challenges of Clinical Data Management
in low and middle-income countries
A context-adapted Data Management Plan and Lifecycle
ASTMH conference, New Orleans, 5th Nov 2014
Yves Claeys (Institute of Tropical Medicine, Belgium) James Smedley (Liverpool School of Tropical Medicine)
1
Introduction • Data Management has always been part of clinical research
• Activity
• Regulation and Standards • GCP, CFR21Part11 • Data integrity • Anonymous, Transparency • ‘In control’ over your data
• Advanced solutions • Electronic data capture (EDC) • Mobile devices • Complex edit checks • Central servers
• Young Discipline Isolation Harmonisation?!?
Real time data validation
Discipline
2
ADMIT - Association for Data Management In the Tropics
3
ADMIT - History
Workshop 1 Antwerp
Belgian Development Cooperation (DGD)
Challenges & Knowledge exchange
“Switching the Poles Clinical Research Network”
DGD
EDCTP Ethiopia & ECTMIH
Barcelona
• Infrastructure Internet and power
• Tools and solutions EDC, GIS
• Regulation and standards GCP, CFR21-11
• Low profile • Time constraints
4
2010 2011 2012 2013 2014 2015 2016
ADMIT - History 2010 2011 2012 2013 2014 2015 2016
Workshop 1 Antwerp
Belgian Development Cooperation (DGD)
Challenges & Knowledge exchange
“Switching the Poles Clinical Research Network”
Workshop 2 Antwerp
Workshop 3 Varanasi
DM Training Prince 2
Define future WP
SOP Harmonisation
Website admit.tghn.org
>800 subscribers
Discussion Forum
SOP’s DM Plan Lifecycle
ASTMH New Orleans
DGD
EDCTP Ethiopia & ECTMIH
Barcelona
5
SOP development
DM plan Lifecycle Harmonisation Peer review Authorship DM processes