Documents & Guidelines

  1. Belmont Report
  2. CIOMS Guidelines
  3. Declaration of Helsinki
  4. Global Health Trials' Glossary of Terms
  5. ICH Good Clinical Practice Guidelines
  6. NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 1
  7. NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 2
  8. Nuremberg Code
  9. US Code of Federal Regulations ‘Common Rule’
  10. US Code of Federal Regulations ‘Title 21‘
  11. WHO Handbook for Good Clinical Practice

Templates & Tools:

  1. Adverse Events Form (MRC example)
  2. Common terms encountered in clinical research
  3. Consent form templates examples
  4. Protocol Guide (MRC)
  5. Protocol Template (MRC example)
  6. Retrogenecity Rorm (MRC example)
  7. Trial Protocol Tool
  8. Zotero reference and bibliography tool

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
  11. US Food and Drug Administration 2010 draft guidance to ‘Electronic Source Documentation in Clinical Investigations’

Adverse Event Reporting:

  1. Consort Statement (revised) 2001
  2. Division of Acquired Immunodeficiency Syndrome (DAIDS) adverse events grading scales
  3. FDA Toxicity Grading Scale 2007
  4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) 1996
  5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Harmonised Tripartite Guideline on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, E2A 1994
  6. WHO 2005 Draft Guidelines for Adverse Event Reporting and Learning Systems

Research Ethics:

  1. Nazi experiments on WWII concentration camp prisoners
  2. Tuskegee Study
  3. 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