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Overcoming the challenges of Cli linical Data Management in in lo low and mid iddle-income countries A context-adapted Data Management Plan and Lifecycle ASTMH conference, New Orleans, 5 th Nov 2014 Yves Claeys (Institute of Tropical

  1. Overcoming the challenges of Cli linical Data Management in in lo low and mid iddle-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

  2. 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 Real time data validation • Complex edit checks • Central servers • Young Discipline Isolation Harmonisation?!? 2

  3. ADMIT - Association for Data Management In the Tropics 3

  4. ADMIT - History 2010 2011 2012 2013 2014 2015 2016 Workshop 1 • Infrastructure Antwerp  Internet and power • Tools and solutions Challenges &  EDC, GIS Knowledge • exchange Regulation and standards  GCP, CFR21-11 • Low profile • Time constraints EDCTP Ethiopia & ECTMIH Barcelona Belgian Development Cooperation (DGD) DGD 4 “ Switching the Poles Clinical Research Network”

  5. ADMIT - History 2010 2011 2012 2013 2014 2015 2016 Workshop 1 Workshop 2 Workshop 3 Antwerp Antwerp Varanasi Challenges & Harmonisation DM Training Knowledge SOP Website Prince 2 exchange admit.tghn.org Define future WP SOP’s >800 subscribers DM Plan Lifecycle EDCTP Ethiopia & Discussion ASTMH New ECTMIH Forum Orleans Barcelona Belgian Development Cooperation (DGD) DGD 5 “ Switching the Poles Clinical Research Network”

  6. SOP development DM processes Authorship Peer review Harmonisation Lifecycle DM plan 6

  7. SOP authors Anish BP Koirala Institute Nepal Mary International Centre for Kenya Bhattarai of Health Sciences Thiongo Reproductive Health Yves Institute of Tropical Belgium Harry Institute of Tropical Medicine Belgium Claeys Medicine van Loen Robert Amsterdam Medical Netherlands Arouna London School of Hygiene and UK Meester Centre Woukeu Tropical Medicine Hercule University of D.R. Congo Paritosh Banaras Hindu University, India Kalonji Kinshasa Malaviya Varanasi David Tropical Diseases Zambia Sun The National Center for HIV/AIDS, Cambodja Mwakazanga Research Centre Sokleng Dematology and STD Sayouba IRSS/Centre Muraz Burkina Faso Hiwot Armauer Hansen Research Ethiopia Ouedraogo Debalke Institute James Liverpool School of UK Martin INTERACT Programme Uganda Smedley Tropical Medicine Omello Sopheak Sok Sihanouk Hospital Cambodia Centre of Hope 7

  8. LIFECYCLE Data Management Site Staff Project Statistics Study Coordinator Stakeholders DATA MANAGEMENT PLAN REGULATIONS AND STANDARDS STUDY PROTOCOL 8

  9. Benefits of the lifecycle approach Project Collaboration Data Sharing 9

  10. ADMIT - Future 2010 2011 2012 2013 2014 2015 2016 Workshop 1 Workshop 2 Workshop 3 Workshop 4 Antwerp Antwerp Varanasi Antwerp Challenges & Harmonisation Grant DM Training Knowledge SOP Website Work Packages Prince 2 Publications ADMIT revamp exchange admit.tghn.org Training Define future WP Organogram SOP’s Data sharing,… Restructure >800 subscribers DM Plan New website Work packages Lifecycle admitnetwork.org EDCTP Ethiopia & Discussion ASTMH New ECTMIH Forum Orleans Barcelona Belgian Development Cooperation (DGD) DGD 10 “ Switching the Poles Clinical Research Network”

  11. Acknowledgements 11

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