Find an extensive range of resources below


Documents & Guidelines


Templates & Tools


Study Protocol Development


Data Management


Adverse Event Reporting


Research Ethics


Microscopy


Large-scale IG research projects


The science of genomics and
genomic research: Further Reading


Courses about the science of
genetic and genomic research

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
  12. Database Search Tips. How to search a database: Massachusetts Institute of Technology.
  13. The PRISMA STATEMENT is a guideline for reporting systematic reviews and meta analyses.
  14. Conducting an Article Critique for a Quantitative Research Study: Perspectives for Doctoral Students and Other Novice Readers.  Dovepress.
  15. Directive 2005/28/EC Guidelines for good clinical practice as regards investigational medicinal products for human use
  16. Guidance for the Preparation of GCP Inspections
  17. Guidance for the Conduct of GCP Inspections
  18. Annex I to Guidance for the Conduct of GCP Inspections - Investigator Site
  19. Guidance for the Preparation of Good Clinical Practice Inspection Reports
  20. Recommendations on the Qualifications of Inspectors Verifying Compliance in Clinical Trials with the Provisions of Good Clinical Practice
  21. INS-GCP-2 Procedure for Preparing GCP Inspections Requested by the EMEA
  22. INS-GCP-3 Procedure for Conducting GCP Inspections Requested by the EMEA
  23. Annex I to Procedure for Conducting GCP Inspections Requested by the EMEA: Investigator Site
  24. INS-GCP-4 Procedure for Reporting of GCP Inspections Requested by the Committee for Medicinal Products for Human Use (CHMP)
  25. Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity and Age in Clinical Research
  26. Food and Drug Administration Policy for the Protection of Human Subjects: 21 CFR 50, 56 FR 28025 Informed Consent; Standards for Institutional Review Boards for Clinical Investigations
  27. Protecting Communities in Research: Current Guidelines and Limits of Extrapolation
  28. Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from an NHLBI Working Group
  29. International Ethical Guidelines for Epidemiological Studies
  30. The Rules Governing Medicinal products in the European Union Volume 10: Guidance Documents Applying to Clinical Trials: Questions and Answers
  31. Ethical Guidelines for Biomedical Research on Human Participants
  32. Ethical and Policy Issues in Research Involving Human Participants
  33. Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for research-Related Injury
  34. Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials 2011 (GPP)

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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. The National Institute for Health Research Clinical Trials Toolkit.

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Study Protocol Development

  1. WHO/TDR Guidance for Developing a Research Protocol
  2. WHO's International Clinical Trials Registry Platform

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Data Management

  1. Association for Clinical Data Management
  2. CDSIC Study Data Tabulation Model
  3. Clinical Data Acquisition Standards Harmonization Draft CDASH guidance V1.0
  4. Food and Drug Administration (FDA). Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application 2003
  5. Food and Drug Administration (FDA). Guidance for Industry Computerized Systems Used in Clinical Investigations 2007
  6. US Food and Drug Administration 2013 draft guidance to ‘Electronic Source Data in Clinical Investigations’

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Adverse Event Reporting

  1. Consort Statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
  2. Division of Acquired Immunodeficiency Syndrome (DAIDS) adverse events grading scales
  3. WHO Draft Guidelines for Adverse Event Reporting and Learning Systems

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Research Ethics

  1. Nazi experiments on WWII concentration camp prisoners
  2. Tuskegee Study
  3. What Makes Clinical Research Ethical?
  4. Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach
  5. What Makes Placebo-Controlled Trials Unethical?
  6. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
  7. Standards and Operational Guidance for Ethics review of Health-Related Research with Human Participants. Genva, WHO 2011
  8. Putting women first: Ethical and safety recommendations for research on domestic violence against women. Geneva, World Health Organization, 2001.
  9. WHO Ethical and safety recommendations for researching, documenting and monitoring sexual violence in emergencies. Geneva, World Health Organization, 2007
  10. WHO. Research Ethics in International Epidemic Response. Geneva, The World Health Organization (WHO), 2011.
  11. UNAIDS/WHO. Ethical Considerations in Biomedical HIV Prevention Trials. UNAIDS/WHO guidance document. Geneva, Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization, 2007.
  12. Global Research Ethics Map (Harvard School of Public Health)

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Microscopy

  1. Microscopy Quality Control Resources website
  2. WHO SEARO/WPRO’s Malaria Light Microscopy: Creating a culture of quality
  3. Swiss Tropical and Public Health Institutes Introduction to Diagnostic Medical Parasitology complete with virtual microscope

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Examples of large-scale international genomic research projects

  1. MalariaGEN
  2. HAPMAP
  3. 1000 genomes
  4. H3 Africa
  5. International Cancer Genome Consortium
  6. eLearning: Introduction to reviewing genomic research

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The science of genomics and genomic research: Further Reading

  1. What is Epigenetics
  2. Decoding the human genome and related open access articles
  3. CDC List of Genomic Resources
  4. Core competencies in genetics
  5. Article on the function of DNA sequences that are not part of genes

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Courses about the science of genetic and genomic research

  1. Free online courses on genetics, genomics and related research, including from DNA to protein, and heredity and traits
  2. Free online courses at the Center for Genomic Education & Outreach

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