Overcoming The Challenges Of Clinical Data Management In Low And Middle .
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 Discipline 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 Real time data validation Harmonisation?!? 2
ADMIT - Association for Data Management In the Tropics 3
ADMIT - History 2010 Workshop 1 Antwerp Challenges & Knowledge exchange 2011 2012 2013 2014 2015 2016 Infrastructure Internet and power Tools and solutions EDC, GIS Regulation and standards GCP, CFR21-11 Low profile Time constraints EDCTP Ethiopia & ECTMIH Barcelona Belgian Development Cooperation (DGD) “Switching the Poles Clinical Research Network” DGD 4
ADMIT - History 2010 Workshop 1 Antwerp Challenges & Knowledge exchange 2011 2012 EDCTP Ethiopia & ECTMIH Barcelona 2014 2015 2016 Workshop 3 Varanasi Workshop 2 Antwerp SOP 2013 Harmonisation Website admit.tghn.org DM Training Prince 2 Define future WP 800 subscribers SOP’s DM Plan Lifecycle Discussion Forum ASTMH New Orleans Belgian Development Cooperation (DGD) “Switching the Poles Clinical Research Network” DGD 5
SOP development DM processes Authorship Peer review Harmonisation Lifecycle DM plan 6
SOP authors Anish Bhattarai Yves Claeys Robert Meester Hercule Kalonji David Mwakazanga BP Koirala Institute of Health Sciences Institute of Tropical Medicine Amsterdam Medical Centre University of Kinshasa Tropical Diseases Research Centre Nepal Mary Thiongo Harry van Loen Arouna Woukeu Paritosh Malaviya Sun Sokleng International Centre for Reproductive Health Institute of Tropical Medicine Sayouba Ouedraogo IRSS/Centre Muraz Burkina Faso Hiwot Debalke Armauer Hansen Research Institute Ethiopia James Smedley Liverpool School of Tropical Medicine UK Martin Omello INTERACT Programme Uganda Sopheak Sok Sihanouk Hospital Centre of Hope Cambodia Belgium Netherlands D.R. Congo Zambia Kenya Belgium London School of Hygiene and UK Tropical Medicine Banaras Hindu University, India Varanasi The National Center for HIV/AIDS, Cambodja Dematology and STD 7
LIFECYCLE Data Management Project Stakeholders Site Staff Statistics Study Coordinator DATA MANAGEMENT PLAN REGULATIONS AND STANDARDS STUDY PROTOCOL 8
Benefits of the lifecycle approach Project Collaboration Data Sharing 9
ADMIT - Future 2010 Workshop 1 Antwerp Challenges & Knowledge exchange 2011 2012 EDCTP Ethiopia & ECTMIH Barcelona 2014 2015 Workshop 3 Varanasi Workshop 4 Antwerp Harmonisation Website admit.tghn.org DM Training Prince 2 Define future WP Work Packages 800 subscribers SOP’s DM Plan Lifecycle Workshop 2 Antwerp SOP 2013 Discussion Forum ADMIT revamp Restructure Work packages 2016 Grant Publications Training Organogram Data sharing, New website admitnetwork.org ASTMH New Orleans Belgian Development Cooperation (DGD) “Switching the Poles Clinical Research Network” DGD 10
Acknowledgements 11
Clinical Data Management in low and middle-income countries A context-adapted Data Management Plan and Lifecycle . (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 .
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Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. Crawford M., Marsh D. The driving force : food in human evolution and the future.
Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
