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)

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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

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

6

SOP authors Anish

Bhattarai

BP Koirala Institute

of 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

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

Acknowledgements

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