Index
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Worldwide
An useful document is the International Compilation of Human Research Standards. It contains an overview of laws, regulations and guidelines from more than 100 countries and organisations.
Internationaal
- Nuremberg Code
- Cochrane Collaboration
- Council for International Organizations of Medical Sciences (CIOMS)
- International Commission on Non-Ionizing Radiation Protection (ICNIRP)
- International Coalition of Medicines Regulatory Authorities (ICMRA)
- International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- International Organization for Standardization (ISO)
- ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice
- ISO 20387:2018 – Biotechnology — Biobanking — General requirements for biobanking
- ISO/TR 22758:2020 – Biotechnology — Biobanking — Implementation guide for ISO 20387
- ISO/TS 20658:2017 – Medical laboratories — Requirements for collection, transport, receipt, and handling of samples
- ISO 21709:2020 – Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
- ISO 21899:2020 – Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
- ISO 20916:2019 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
- Medical Dictionary for Regulatory Activities (MedDRA)
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
- Organisation for Economic Co-operation and Development (OECD)
- OECD Best Practice Guidelines for Biological Resource Centres (2007)
- OECD ‘Good Laboratory Practice (GLP)’
- OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
- OECD Guidelines on Human Biobanks and Genetic Research Databases 2009
- OECD report Best Practices for Ensuring Scientific Integrity and Preventing Misconduct, 2007
- Pan American Health Organization (PAHO)
- UNESCO/International Bioethics Committee
- Unicef
- United Nations
- United Nations Educational, Scientific, and Cultural Organization (UNESCO)
- Committees
- Code of Conduct and Ethical Guidelines for Social Science Research
- International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences (2003)
- Statement on COVID-19: ethical considerations from a global perspective
- Universal Declaration on Bioethics and Human Rights (2005)
- Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998 – 1999 (1997)
- World Health Organization (WHO)
- Development of the TDR global competency framework for clinical research
- Epidemic Intelligence from Open Sources (EIOS)
- International Clinical Trials Registry Platform (ICTRP)
- Nuremberg code turns 60. Bulletin of the World Health Organization, Volume 85, Number 8, August 2007, 569-648.
- REGTRAC: The WHO Database of Regulatory Information Tracking of Clinical Trials Registration & Ethics Committees
- Resolution WHA 58.34 (2005)
- The WHO Ethics Review Committee (ERC)
- COVID-19
- Country & Technical Guidance – Coronavirus disease (COVID-19)
- Coronavirus disease (COVID-19): Vaccines (Q&A).
- Coronavirus disease (COVID-19): Vaccine research and development (Q&A)
- Ethics and COVID-19: resource allocation and priority-setting (20 April 2020).
- Global research on coronavirus disease (COVID-19)
- R&D Blueprint and COVID-19. Coronavirus disease (COVID-2019).
- Guidance
- Ethics
- Ethical Standards for Research During Public Health Emergencies: Distilling Existing Guidance to Support COVID-19 R&D. 2020.
- Guidelines on Ethical Issues in Public Health Surveillance (2017)
- Ethical Considerations for Use of Unregistered Interventions for Ebola Viral Disease: Report of an Advisory Panel to WHO. 2014.
- Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
- Standards and Operational Guidance for Ethics Review of Health – Related Research with Human Participants (2011)
- Handbook for good clinical research practice (GCP) : guidance for implementation (2005)
- Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
- Laboratory tests, Biospecimens
- Laboratory testing for coronavirus disease (COVID-19) in suspected human cases: interim guidance (19 March 2020).
- Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim guidance (19 March 2020).
- Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus: interim guidance (2 March 2020)
- Laboratory testing of human suspected cases of novel coronavirus (nCoV) infection: interim guidance (10 January 2020)
- Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research (2003)
- Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997)
- Research
- Core Protocol for vaccines against COVID-19 (17 April 2020).
- Overview of the types/classes of candidate therapeutics (21 March 2020).
- COVID-19 Therapeutic Trial Synopsis (18 February 2020).
- Outline of trial designs for experimental therapeutics (27 January 2020).
- Outline of designs for experimental vaccines and therapeutics (20 January 2020).
- Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)
- Clinical management,Vaccination
- Guiding principles for immunization activities during the COVID-19 pandemic (24 April 2020).
- Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected, Interim guidance (13 March 2020).
- Vaccination in Acute Humanitarian Emergencies. A Framework for Decision Making. May 2017.
- Ethics
- World Medical Association (WMA)
- Human, D. & Fluss, S.S. (2001). The World Medical Association’s Declaration of Helsinki: Historical and Contemporary Perspectives.
- WMA Declaration of Geneva, amended by the 68th WMA General Assembly, Chicago, United States, October 2017
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 64th WMA General Assembly, Fortaleza, Oct 2013
- WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, revised by the 67th WMA General Assembly, Taipei, Taiwan, October 2016
- WMA Declaration on Medical Ethics and Advanced Medical Technology, revised by the 63rd WMA General Assembly, Bangkok, Thailand, October 2012
- WMA Statement on Animal Use in Biomedical Research, reaffirmed by the 203rd WMA Council Session, Buenos Aires, Argentina, April 2016
- WMA Statement on Embryonic Stem Cell Research, 60th WMA General Assembly, New Delhi, India, October 2009
Please use the “Contact” form to report broken links, outdated information and missing webpages.
Animal research
- European Consensus-Platform for Alternatives (ecopa)
- National Centre for the 3Rs (NC3Rs)
- Norway’s National Consensus Platform (Norecopa)
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Biobanking & genetics
- BBMRI
- Biobanken
- European Science Foundation (ESF)
- Human Genome Organisation
- Imagined Futures: Capturing the Benefits of Genome Sequencing for Society, December 2014
- International code of conduct for genomics and health-related data sharing, June 2014
- Statement on Benefit Sharing, April 2000
- Statement on Cloning, March 1999
- Statement on DNA Sampling: Control and Access (February 1998)
- Statement on Gene Therapy Research (April 2001)
- Statement on Human Genomic Databases (December 2002)
- Statement on Stem Cells, November 2004
- Statement on Supreme Court: Genes are not patentable, June 2013
- Statement on the Principled Conduct of Genetic Research (December 1995)
- The Human Genome Organisation: towards next generation ethics, April 2013
- Human Tissue Authority (UK)
- International Society for Biological and Environmental Repositories (ISBER)
- Public Population Project in Genomics (P3G) – research project of the Centre of Genomics and Policy (CGP) (McGill University)
- UKCRC Tissue Directory and Coordination Centre
- Vereniging Samenwerkende Ouder- en Patiëntenorganisaties (VSOP)
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Clinical Trial Registries
- Europa
- Verenigde Staten
- World Health Organization
- Overig
- Australian New Zealand Clinical Trials Registry (ANZCTR)
- Brazilian Clinical Trials Registry (ReBec)
- Chinese Clinical Trial Registry (ChiCTR)
- Clinical Research Information Service (CRiS), Republic of Korea
- Clinical Trials Registry – India (CTRI)
- Cuban Public Registry of Clinical Trials (RPCEC)
- Iranian Registry of Clinical Trials (IRCT)
- ISRCTN Register
- Japan Primary Registries Network (JPRN)
- Pan African Clinical Trial Registry (PACTR)
- PROSPERO – International database for prospective registration of systematic reviews
- Sri Lanka Clinical Trials Registry (SLCTR)
- Thai Clinical Trials Registry (TCTR)
- Commercieel/Industrie
- Bayer Clinical Trials
- Boehringer Ingelheim Ongoing & Completed Studies
- Eli Lilly and Company Clinical Trial Registry
- Genzyme Clinical Trials & Results
- GSK Clinical Study Register
- Novartis: Clinical trials
- Roche Clinical Trial Protocol Registry and Results Database
- Sanofi Pharma & Sanofi Pasteur Clinical study results
- Takeda Clinical Trials
- UCB Sponsored Clinical Studies
- ViiV Healthcare Clinical Study Register
- Pre-Clinical Trials
- Systematic reviews
Clinical trial trackers and viewers
- Artis Ventures:
- Bill & Melinda Gates Foundation, Cytel
- Clinical Trials Viewer – Search for clinical trials and FDA info
- HealthMatch COVID-19 Clinical Trials Tracker
- London School of Hygiene & Tropical Medicine
- Milken Institute
- Regulatory Focus
- STAT
- Trial Insights
- Trial Scope
- Other
Please use the “Contact” form to report broken links, outdated information and missing webpages.
Clinical trial results reporting
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Data Protection
- International Association of Privacy Professionals (IAPP)
- Tools
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Data Repositories
- Clinical study data
- Data repositories
- re3data.org – Registry of Research Data Repositories
- Dryad Digital Repository
- Dutch Dataverse Network
- EASY – online archiving system of Data Archiving and Networked Services (DANS)
- figshare
- Harvard Dataverse Network
- OpenfMRI
- OpenNeuro – A free and open platform for sharing MRI, MEG, EEG, iEEG, ECoG, and ASL data
- YODA Project (Yale University)
- Social sciences, psychology
- Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA) Openbare Databank
- Open Science
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(Investigational) Medicinal Products
- Drugs.com
- Good Manufacturing Practice (GMP)
- RQA – Good Manufacturing Practice (GMP) Committee
- University of Liverpool
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Medical Devices
- International Medical Device Regulators Forum (IMDRF)
- Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice ” (2015)
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Organisations
- Association of Clinical Research Organizations (ACRO)
- Association of Clinical Research Professionals (ACRP)
- Cancer Drug Development Forum (CDDF)
- Centre for Evidence-Based Medicine (CEBM)
- Center for Open Science
- Clinical Data Interchange Standards Consortium (CDISC)
- Standards
- Therapeutic Areas
- Standards
- Clinical Research Organisations
- Alimentiv
- COVANCE
- Delta Healthcare Consulting
- Covid-19 – Clinical Trial Rescue (16 March 2020). (‘visit subject at home‘)
- ICON
- IQVIA
- White paper – Rising to the challenge. Five key focus areas for Life Sciences during and after the COVID-19 pandemic (7 April 2020).
- COVID-19 Trial Matching Tool
Trial matching tool that includes all research projects seeking participants in the United States. - IQVIA launches new COVID-19 trial ‘matching service’ in U.S. (7 April 2020). Fierce Biotech.
- Julius Clinical
- Medidata
- Qserve CRO
- Clinical Trials Transformation Initiative (CTTI)
- Coalition for Epidemic Preparedness Innovation (CEPI)
- Cochrane
- Decentralized Trials and Research Alliance (DTRA)
- Drug Information Association (DIA)
- EATRIS – European infrastructure for translational medicine
- European Life Science Research Infrastructures
- European Network of Research Ethics and Research Integrity (ENERI)
- European Paediatric Translational Research Infrastructure
- Global Infectious Diseases and Epidemiology Network (GIDEON)
- Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)
- International Association of Privacy Professionals (IAPP)
- Internation Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
- International Pharmaceutical Federation (FIP)
- Nuffield Council on Bioethics
- Patient Focused Medicines Development (PFMD)
- Paediatric Clinical Research Infrastructure Network (PedCRIN)
- Research Data Alliance (RDA)
- Research Quality Association (RQA)
- RxISK – independent drug safety website
- Society for Clinical Data Management (SCDM)
- Society for Clinical Research Sites (SCRS)
- Society of Critical Care Medicine (SCCM)
- The Global Health Network
- COVID-19
- Clinical Characterisation Protocol (CCP)
- COVAX
- DAC Trials – The Bill & Melinda Gates Foundation and The Global Health Network launch DAC Trials Knowledge Hub (14 april 2021).
- EDCTP Knowledge Hub – Protocol development.
- Epidemic Ethics – Resources.
- International Health Regulations Strengthening Project (IHR-SP).
- Global Pharmacovigilance – Glossary of Drug Safety Terms
- UK-Public Health Rapid Support Team Knowledge Hub
- Kownledge Hub Coronavirus Outbreak
- Course: Research in global health emergencies: Ethical issues
- Research Resources
- Resource List: Social Science Research during the COVID-19 Pandemic (6 August 2020).
- Open Workshops.
- International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)
- COVID-19
- TransCelerate BioPharma Inc.
- TRANSVAC: European Vaccine Research and Development
- Wellcome Trust
- Sharing research data and findings relevant to the novel coronavirus (COVID-19) outbreak (31 January 2020).
- Ethics Working Group on ZIKV Research & Pregnancy. Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation. June 2017.
- Statement on data sharing in public health emergencies (1 February 2016).
- WIRB-Copernicus Group (WCG)
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Publications
- Committee on Publication Ethics (COPE)
- Elsevier
- International Committee of Medical Journal Editors (ICMJE)
- International DOI Foundation (IDF)
- Journals
- Open Access
- European Commission
- OECD
- UNESCO
- Publication of negative results
- Systematic reviews
- Tilburg University – Bronvermelding volgens de richtlijnen van de APA (.pdf)
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Quality of research
- Accreditation
- Bloedafnames, bloedsamples
- Compliance
- Consent
- Data Monitoring Committee (DMC)
- DAMOCLES studygroup. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. The Lancet , Volume 365 , Issue 9460 , 711 – 722. DOI: http://dx.doi.org/10.1016/S0140-6736(05)17965-3
- DAMOCLES template DSMB-charter
- Drazen, J. M., & Wood, A. J. J. (2010). Don’t Mess with the DSMB. New England Journal of Medicine, 363(5), 477–478.
- EMA Guideline on Data monitoring committees (CHMP/EWP/5872/03)
- FDA Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
- National Institute on Drug Abuse (NIDA) – Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board
- NCI Data and Safety Monitoring Guidelines – Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials Funded by the National Cancer Institute
- NIH – Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues
- NIH – Further NIH Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials (June 5, 2000)
- NIH Policy for Data and Safety Monitoring (June 10, 1998)
- NIH/NIDCR – Data and Safety Monitoring Board (DSMB) Guidelines
- WHO – Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards
- Endpoint Adjudication
- Endpoints, Outcomes
- Multi-Regional Clinical Trials (MRCT) Center Brigham and Women’s Hospital and Harvard University
- IDEAL: The IDEAL Collaboration – Idea, Development, Exploration, Assessment, Long-term follow-up
- SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
- Open Science, projectmanagement & data-sharing
- Process map
- Protocol violations, deviations
Please use the “Contact” form to report broken links, outdated information and missing webpages.
Reporting Guidelines
- EQUATOR Network – Enhancing the QUAlity and Transparency Of health Research (EQUATOR)
- The IDEAL Reporting Guidelines. A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation (January 2021). Annals of Surgery.
- TRIPOD
- Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): The TRIPOD Statement (6 januari 2015). Ann Intern Med.
- Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): Explanation and Elaboration (6 januari 2015). Ann Intern Med.
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Research Data Management
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Research Integrity
- SOPs4RI (Standard Operating Procedures for Research Integrity)
- The Hong Kong Principles for assessing researchers: Fostering research integrity. PLoS Biol. 2020 Jul 16;18(7):e3000737.
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Training, education and practical
- Books
- Catalogue of Bias. Centre for Evidence-Based Medicine.
- Consent for publication. A best practice guide for authors. BMJ.
- Courses and training
- Collaborative Institutional Training Initiative (CITI Program)
- Coursera
- COVID-19
- COVID-19: What You Need to Know
- DIA: Now In Focus: COVID-19
- Imperial College London & Coursera: Free COVID-19 online course re-launches to learners worldwide.
- JoVE: Coronavirus Free Access Resource Center
- London School of Hygiene & Tropical Medicine: Future Learn – COVID-19: Tackling the Novel Coronavirus
- Personal Health Train: Personal Health Train will help research on viral outbreaks (16 March 2020).
- GCP Central
- Elevate
- European Centre for Clinical Research Training (ECCTR)
- European Compliance Academy (ECA) – GMP/GDP
- Johns Hopkins University
- National Institutes of Health (NIH)
- Paul Janssen Futurelab Leiden
- Rianne Tooten,Clinical Research Professional / Academy of Rianne Tooten
- Stanford Online
- The Global Health Network
- Qserve
- Informative
- Practical toolbox
- EDGAR – Experimental Design Generator And Randomiser On-line software to randomise simple experimental designs.
- Free Statistics Calculators
- GPOWER: A general power analysis program
- JASP Statistics – open-source statistics program, easy-to-use GUI, JASP allows both classical and Bayesian analyses.
- On-line Statistical Power Calculator. – Java applets for power and sample size
- Same Stats, Different Graphs: Generating Datasets with Varied Appearance and Identical Statistics through Simulated Annealing. Autodesk.
- Simple Interactive Statistical Analysis – SISA allows you to do statistical analysis directly on the Internet
- SPSS
- StatTools
- The R Project for Statistical Computing
- UCLA Statistical Calculators
- Good Practice Cases
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Universities
- Johns Hopkins University
- University of California San Francisco
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