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Documents & Guidelines

  1. Declaration of Helsinki
  2. Global Health Trials' Glossary of Terms
  3. ICH Good Clinical Practice Guidelines
  4. NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 1
  5. WHO Handbook for Good Clinical Practice

 

Study Protocol Development:

  1. Free resources for conducting trials in developing countries
  2. WHO/TDR Guidance for Developing a Research Protocol
  3. WHO's International Clinical Trials Registry Platform

Data Management:

  1. Association for Clinical Data Managementdata management plan template
  2. CDSIC Study Data Tabulation Model
  3. Clinical Data Acquisition Standards Harmonization Draft CDASH guidance V1.0
  4. EpiHandy software
  5. Euroqol group’s EQ-5D which is a standardised instrument for use as a measure of health outcome
  6. European Clinical Research Infrastructures Network (ECRIN) 
  7. Food and Drug Administration (FDA). Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application 2003
  8. Food and Drug Administration (FDA). Guidance for Industry Computerized Systems Used in Clinical Investigations 2007
  9. International Conference on Harmonization Principles of Good Clinical Practice (ICH GCP) 1996 guidelines
  10. OpenClinica web-based electronic data capture data management system

Research Ethics:

  1. Tuskegee Study
  2. WHO's Research Ethics website

Malaria:

  1. Microscopy Quality Control Resources website
  2. Virtual Microscope
  3. WHO SEARO/WPRO’s Malaria Light Microscopy: Creating a culture of quality