Cli linical Data Management in in lo low and mid iddle-income - - PowerPoint PPT Presentation

cli linical data management
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Cli linical Data Management in in lo low and mid iddle-income - - PowerPoint PPT Presentation

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


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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, 5th Nov 2014 Yves Claeys (Institute of Tropical Medicine, Belgium) James Smedley (Liverpool School of Tropical Medicine)

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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

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ADMIT - Association for Data Management In the Tropics

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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

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2010 2011 2012 2013 2014 2015 2016

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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

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SOP development

DM plan Lifecycle Harmonisation Peer review Authorship DM processes

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SOP authors

Anish Bhattarai BP Koirala Institute

  • f Health Sciences

Nepal Mary Thiongo International Centre for Reproductive Health Kenya Yves Claeys Institute of Tropical Medicine Belgium Harry van Loen Institute of Tropical Medicine Belgium Robert Meester Amsterdam Medical Centre Netherlands Arouna Woukeu London School of Hygiene and Tropical Medicine UK Hercule Kalonji University of Kinshasa D.R. Congo Paritosh Malaviya Banaras Hindu University, Varanasi India David Mwakazanga Tropical Diseases Research Centre Zambia Sun Sokleng The National Center for HIV/AIDS, Dematology and STD Cambodja 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

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Site Staff Statistics Study Coordinator Data Management Project Stakeholders

DATA MANAGEMENT PLAN

REGULATIONS AND STANDARDS STUDY PROTOCOL

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LIFECYCLE

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Benefits of the lifecycle approach

Project Collaboration Data Sharing

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ADMIT - Future

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

Work Packages >800 subscribers Discussion Forum Organogram Data sharing,…

New website

admitnetwork.org ADMIT revamp Restructure Work packages

Workshop 4 Antwerp

ASTMH New Orleans

DGD

EDCTP Ethiopia & ECTMIH Barcelona Grant Publications Training 10 DM Training Prince 2 Define future WP SOP Harmonisation Website admit.tghn.org SOP’s DM Plan Lifecycle

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Acknowledgements

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