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Documents & Guidelines
- Declaration of Helsinki
- Global Health Trials' Glossary of Terms
- ICH Good Clinical Practice Guidelines
- NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 1
- WHO Handbook for Good Clinical Practice
Study Protocol Development:
- Free resources for conducting trials in developing countries
- WHO/TDR Guidance for Developing a Research Protocol
- WHO's International Clinical Trials Registry Platform
Data Management:
- Association for Clinical Data Managementdata management plan template
- CDSIC Study Data Tabulation Model
- Clinical Data Acquisition Standards Harmonization Draft CDASH guidance V1.0
- EpiHandy software (currently unavailable)
- Euroqol group’s EQ-5D which is a standardised instrument for use as a measure of health outcome
- European Clinical Research Infrastructures Network (ECRIN)
- Food and Drug Administration (FDA). Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application 2003
- Food and Drug Administration (FDA). Guidance for Industry Computerized Systems Used in Clinical Investigations 2007
- International Conference on Harmonization Principles of Good Clinical Practice (ICH GCP) 1996 guidelines
- OpenClinica web-based electronic data capture data management system