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. A Quick Guide to Standard Operating Procedures (SOPs)
  13. Emerald -Research learning zone with a list of HOW TO information.
  14. How to do Randomised Controlled Trials from Medecins Sans Frontieres.
  15. The CONSORT STATEMENT-Guidance for reporting of parallel group randomised clinical trials, updated 2010.
  16. Database Search Tips. How to search a database: Massachusetts Institute of Technology.
  17. Research reporting guidelines
  18. The PRISMA STATEMENT is a guideline for reporting systematic reviews and meta analyses.
  19. The STROBE checklists are guidelines for reporting on cohort, case-control and cross sectional (observational) studies.
  20. Conducting an Article Critique for a Quantitative Research Study: Perspectives for Doctoral Students and Other Novice Readers.  Dovepress.
  21. Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials
  22. Directive 2005/28/EC Guidelines for good clinical practice as regards investigational medicinal products for human use
  23. Volume 10: Clinical Trial Guidelines “The Rules Governing Medicinal Products in the European Community”
  24. Guidance for the Preparation of GCP Inspections
  25. Guidance for the Conduct of GCP Inspections
  26. Annex I to Guidance for the Conduct of GCP Inspections - Investigator Site
  27. Guidance for the Preparation of Good Clinical Practice Inspection Reports
  28. Recommendations on the Qualifications of Inspectors Verifying Compliance in Clinical Trials with the Provisions of Good Clinical Practice
  29. INS-GCP-2 Procedure for Preparing GCP Inspections Requested by the EMEA
  30. INS-GCP-3 Procedure for Conducting GCP Inspections Requested by the EMEA
  31. Annex I to Procedure for Conducting GCP Inspections Requested by the EMEA: Investigator Site
  32. INS-GCP-4 Procedure for Reporting of GCP Inspections Requested by the Committee for Medicinal Products for Human Use (CHMP)
  33. Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity and Age in Clinical Research
  34. 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
  35. Reviewing Clinical Trials: A Guide for the Ethics Committee
  36. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
  37. Department of Health and Human Services Subpart A: 45 CFR 46
  38. Food and Drug Administration Policy for the Protection of Human Subjects: 21 CFR 50
  39. Protecting Communities in Research: Current Guidelines and Limits of Extrapolation
  40. Effective Engagement: A Guide to Principles and Practice
  41. Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from an NHLBI Working Group
  42. International Ethical Guidelines for Epidemiological Studies
  43. Clinical Trial Compensation Guidelines
  44. The Rules Governing Medicinal products in the European Union Volume 10: Guidance Documents Applying to Clinical Trials: Questions and Answers
  45. Ethical Guidelines for Biomedical Research on Human Participants
  46. Ethical and Policy Issues in Research Involving Human Participants
  47. Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for research-Related Injury
  48. Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials 2011 (GPP)

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
  9. The National Institute for Health Research (UK)- Clinical Trials Toolkit.
  10. National Collaborating Centre for Methods and Tools

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
  4. SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials

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 2013 draft guidance to ‘Electronic Source Data 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
  4. What Makes Clinical Research Ethical?
  5. International Ethical Guidelines for Biomedical Research Involving Human Subjects
  6. Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach
  7. Placebo Orthodoxy in Clinical Research. II. Ethical, Legal and Regulatory Myths
  8. What Makes Palcebo-Controlled Trials Unethical?
  9. An Ethical framework for Biomedical Research
  10. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
  11. Standards and Operational Guidance for Ethics review of Health-Related Research with Human Participants. Genva, WHO 2011
  12. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London 2002
  13. Putting women first: Ethical and safety recommendations for research on domestic violence against women. Geneva, World Health Organization, 2001.
  14. WHO Ethical and safety recommendations for researching, documenting and monitoring sexual violence in emergencies. Geneva, World Health Organization, 2007
  15. WHO. Research Ethics in International Epidemic Response. Geneva, The World Health Organization (WHO), 2011.
  16. 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.
  17. Global Research Ethics Map (Harvard School of Public Health)

Microscopy:

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

Examples of large-scale international genomic research projects:

  1. MalariaGEN
  2. HAPMAP
  3. 1000 genomes
  4. H3 Africa
  5. International Cancer Genome Consortium
  6. A full list of genomic research references and resources

The science of genomics and genomic research: Further Reading

  1. Reflections on the first 10 years of genomic research
  2. What is Epigenetics article 1.?
  3. What is Epigenetics article 2.?
  4. Decoding the human genome and related open access articles
  5. Current and future initiatives in genomic research
  6. Links to a wide variety of genomic resources for researchers, healthcare providers and policy makers
  7. Resources for social scientists about genomic research
  8. A recent journal issue devoted to discussing issues related to reporting results of genomic research
  9. What is in our genomes?
  10. Press release on the function of DNA sequences that are not part of genes
  11. Article on the function of DNA sequences that are not part of genes

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  about Introductory Genetics, Non-Mendelian Inheritance, Introduction to Parametric Analysis, Introduction to Genetic Epidemiology, Association Studies and Linkage Disequilibrium