Resources Library
Find an extensive range of resources below
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Documents & Guidelines
- Belmont Report
- CIOMS 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
- NBAC Ethical & Policy Issues in International Research: Clinical Trials in Developing Countries Volume 2
- Nuremberg Code
- US Code of Federal Regulations ‘Common Rule’
- US Code of Federal Regulations ‘Title 21‘
- WHO Handbook for Good Clinical Practice
- Emerald -Research learning zone with a list of HOW TO information.
- How to do Randomised Controlled Trials from Medecins Sans Frontieres.
- The CONSORT STATEMENT-Guidance for reporting of parallel group randomised clinical trials, updated 2010.
- Database Search Tips. How to search a database: Massachusetts Institute of Technology.
- Research reporting guidelines
- The PRISMA STATEMENT is a guideline for reporting systematic reviews and meta analyses.
- The STROBE checklists are guidelines for reporting on cohort, case-control and cross sectional (observational) studies.
- Conducting an Article Critique for a Quantitative Research Study: Perspectives for Doctoral Students and Other Novice Readers. Dovepress.
- Directive 2005/28/EC Guidelines for good clinical practice as regards investigational medicinal products for human use
- Guidance for the Preparation of GCP Inspections
- Guidance for the Conduct of GCP Inspections
- Annex I to Guidance for the Conduct of GCP Inspections - Investigator Site
- Guidance for the Preparation of Good Clinical Practice Inspection Reports
- Recommendations on the Qualifications of Inspectors Verifying Compliance in Clinical Trials with the Provisions of Good Clinical Practice
- INS-GCP-2 Procedure for Preparing GCP Inspections Requested by the EMEA
- INS-GCP-3 Procedure for Conducting GCP Inspections Requested by the EMEA
- Annex I to Procedure for Conducting GCP Inspections Requested by the EMEA: Investigator Site
- INS-GCP-4 Procedure for Reporting of GCP Inspections Requested by the Committee for Medicinal Products for Human Use (CHMP)
- Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity and Age in Clinical Research
- 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
- Reviewing Clinical Trials: A Guide for the Ethics Committee
- Food and Drug Administration Policy for the Protection of Human Subjects: 21 CFR 50
- Protecting Communities in Research: Current Guidelines and Limits of Extrapolation
- Effective Engagement: A Guide to Principles and Practice
- Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from an NHLBI Working Group
- International Ethical Guidelines for Epidemiological Studies
- Clinical Trial Compensation Guidelines
- The Rules Governing Medicinal products in the European Union Volume 10: Guidance Documents Applying to Clinical Trials: Questions and Answers
- Ethical Guidelines for Biomedical Research on Human Participants
- Ethical and Policy Issues in Research Involving Human Participants
- Assessment of Medical School Institutional Review Board Policies Regarding Compensation of Subjects for research-Related Injury
- Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials 2011 (GPP)
Templates &Tools
- Adverse Events Form (MRC example)
- Common terms encountered in clinical research
- Consent form templates examples
- Protocol Guide (MRC)
- Protocol Template (MRC example)
- Retrogenecity Rorm (MRC example)
- Trial Protocol Tool
- Zotero reference and bibliography tool
- The National Institute for Health Research (UK)- Clinical Trials Toolkit.
- National Collaborating Centre for Methods and Tools
Study Protocol Development
- WHO's International Clinical Trials Registry Platform
- SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials
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
- 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
- US Food and Drug Administration 2013 draft guidance to ‘Electronic Source Data in Clinical Investigations’
Adverse Event Reporting
- Consort Statement (revised) 2001
- Division of Acquired Immunodeficiency Syndrome (DAIDS) adverse events grading scales
- FDA Toxicity Grading Scale 2007
- 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
- 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
- WHO Draft Guidelines for Adverse Event Reporting and Learning Systems
Research Ethics
- Nazi experiments on WWII concentration camp prisoners
- Tuskegee Study
- WHO's Research Ethics website
- What Makes Clinical Research Ethical?
- International Ethical Guidelines for Biomedical Research Involving Human Subjects
- Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach
- Placebo Orthodoxy in Clinical Research. II. Ethical, Legal and Regulatory Myths
- What Makes Placebo-Controlled Trials Unethical?
- An Ethical framework for Biomedical Research
- What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
- Standards and Operational Guidance for Ethics review of Health-Related Research with Human Participants. Genva, WHO 2011
- Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London 2002
- Putting women first: Ethical and safety recommendations for research on domestic violence against women. Geneva, World Health Organization, 2001.
- WHO Ethical and safety recommendations for researching, documenting and monitoring sexual violence in emergencies. Geneva, World Health Organization, 2007
- 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.
- Global Research Ethics Map (Harvard School of Public Health)
Microscopy
- Microscopy Quality Control Resources website
- Virtual Microscope
- WHO SEARO/WPRO’s Malaria Light Microscopy: Creating a culture of quality
- Swiss Tropical and Public Health Institutes Introduction to Diagnostic Medical Parasitology complete with virtual microscope
Examples of large-scale international genomic research projects
- MalariaGEN
- HAPMAP
- 1000 genomes
- H3 Africa
- International Cancer Genome Consortium
- A full list of genomic research references and resources
The science of genomics and genomic research: Further Reading
- What is Epigenetics
- Decoding the human genome and related open access articles
- Current and future initiatives in genomic research
- Links to a wide variety of genomic resources for researchers, healthcare providers and policy makers
- Core competencies in genetics
- A recent journal issue devoted to discussing issues related to reporting results of genomic research
- Article on the function of DNA sequences that are not part of genes