Last updated on: 27 May 2022
| This page is currently being updated
On this page, you’ll find websites and other resources related to human subject research and good research practices. The information on this page was previously available through the following subpages:
Please use the contact form to report broken links, outdated information and missing webpages. |
Deze pagina wordt momenteel vernieuwd
Op deze pagina vindt u verwijzingen naar websites en andere bronnen met betrekking tot medisch- en gedragswetenschappelijk onderzoek en goede onderzoekspraktijken. De informatie op deze pagina was voorheen beschikbaar via de volgende subpagina’s:
Gebroken verwijzingen en suggesties voor nieuwe verwijzingen kunt u aan mij doorgeven via het contactformulier. |
Index
Please use the contact form to report broken links, outdated information and missing webpages.
WorldwideAn 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. |
Please use the contact form to report broken links, outdated information and missing webpages.
Animal research
Authorities
- The Netherlands
Replacement, Reduction and Refinement
- European Consensus-Platform for Alternatives (ecopa) – “The primary aim of ecopa is to promote “the three Rs” (Replacement, Reduction and Refinement) in the use of animals in research, testing, education and training in Europe.”
- Norway’s National Consensus Platform (Norecopa) – “Norecopa is Norway’s National Consensus Platform for the advancement of “the 3 Rs” (Replacement, Reduction, Refinement) in connection with animal experiments.”
- United Kingdom: National Centre for the 3Rs (NC3Rs)
Organisations
- Dutch Association for Laboratory Animal Science (DALAS)
- European Animal Research Association
- Stichting Informatie Dierproeven (SID)
- Understanding Animal Research
World Medical Association (WMA)
Please use the contact form to report broken links, outdated information and missing webpages.
Alliances, Associations, Federations, Organizations & Research Infrastructures
Alliances
- Decentralized Trials and Research Alliance (DTRA)
- Good Clinical Practice Alliance (GCPA)
- Research Data Alliance (RDA)
Associations
- Association of Clinical Research Organizations (ACRO)
- Association of Clinical Research Professionals (ACRP)
- Belgian Association for Psychological Sciences (BAPS)
- Belgian association of Clinical Research Organizations (BeCRO)
- Belgian Association of Research Ethics Committees (BAREC)
- Belgian association of Pharmaceutical Medicine Professionals
- Drug Information Association (DIA)
- International Association of Privacy Professionals (IAPP)
- Research Quality Association (RQA)
Centre for Evidence-Based Medicine (CEBM)
Clinical Research Organisations
- 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 trial improvement
Cochrane
Federations
- Belgische Federatie van Psychologen (BFP)
- Belgian Federation for Chemistry and Life Sciences industries (essenscia)
- Internation Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
- International Pharmaceutical Federation (FIP)
Nuffield Council on Bioethics
Organisations
- All European Academies (ALLEA)
- BBMRI-ERIC (European research infrastructure for biobanking)
- Belgium
- Belgian Association for Psychological Sciences (BAPS)
- Belgian association of Clinical Research Organizations (BeCRO)
- Belgian Association of Research Ethics Committees (BAREC)
- Belgian association of Pharmaceutical Medicine Professionals
- Belgische Federatie van Psychologen (BFP)
- Belgian Federation for Chemistry and Life Sciences industries (essenscia)
- BioWin, the Health Cluster of Wallonia (Belgium).
- Flanders.bio
- Healixia
- Pharma.be
- Sciensano (Wetenschappelijk Instituut Volksgezondheid)
- Cancer Drug Development Forum (CDDF)
- Coalition for Epidemic Preparedness Innovation (CEPI)
- eClinical Forum (oa. eSource Readiness Assessment)
- European Bioinformatics Institute (EMBL-EBI)
- European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
- EUDAT Collaborative Data Infrastructure (EUDAT CDI)
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- European Forum for Good Clinical Practice (EFGCP)
- European Clinical Research Infrastructrure Network (ECRIN)
- ECRIN Tools Overview
- The CAMPUS Database – Online database including country-specific information on regulatory and ethical requirements in clinical research across Europe.
- COVID-19
- European Research Infrastructures against COVID-19
- COVID-19 Taskforce.
- COVID-19 Trials registries
- Regulatory – ethical considerations for ongoing trials during Pandemic
- Fast track procedure for COVID 19 Clinical trials.
- Clinical Research Metadata Repository
- COVID-19 Literature reviews
- Other COVID-19 resources
- PERsonalised Medicine Trials (PERMIT)
- European CRO Federation (EUCROF)
- European Life Science Research Infrastructures (LS RI)
- European Network for Health Technology Assessment (EUnetHTA)
- European Network of Research Ethics and Research Integrity (ENERI)
- European Network of Research Ethics Committees (EUREC)
- European Network of Research Integrity Offices (ENRIO)
- European Organisation for Research and Treatment of Cancer (EORTC)
- European Patients’ Academy on Therapeutic Innovation (EUPATI)
- European Strategy Forum on Research Infrastructures (ESFRI)
- European Quality Assurance Confederation (EQAC)
- Global Infectious Diseases and Epidemiology Network (GIDEON)
- Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)
- Netherlands
- Associatie van Contract Research Organisaties in Nederland (ACRON)
- COmmissie REgelgeving ONderzoek (COREON)
- Dutch Association of Research Quality Assurance (DARQA)
- Dutch Clinical Research Foundation (DCRF)
- Dutch Oncology Research Platform (DORP)
- Dutch Techcentre for Life Sciences (DTL)
- Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)
- Federa
- Federatie Medisch Specialisten
- Goedzo data-ethiek
- Health-RI
- Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG)
- Nederlands Huisartsen Genootschap (NHG)
- Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen (NKFK)
- Netherlands Research Integrity Network (NRIN)
- Nederlandse Vereniging voor Farmaceutische Geneeskunde (NVFG)
- Nederlandse Vereniging voor Medische Oncologie (NVMO)
- NVMETC
- Regulatory Science Network Netherlands (RSNN)
- Patient Focused Medicines Development (PFMD)
- TRANSVAC: European Vaccine Research and Development
- WIRB-Copernicus Group (WCG)
Research Infrastructures
- Association of European-level Research Infrastructure Facilities (ERF-AISBL)
- Conect4children – Collaborative Network for European Clinical Trials for Children
- EATRIS – European infrastructure for translational medicine
- European Life Science Research Infrastructures
- European Paediatric Translational Research Infrastructure
- Paediatric Clinical Research Infrastructure Network (PedCRIN)
Societies
- 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)
Wellcome Trust
- 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).
Please use the contact form to report broken links, outdated information and missing webpages.
Behavioral sciences, Psychology
- American Psychiatric Association
- Ethische Commissies Psychologie
- Open Universiteit – Commissie Ethische Toetsing Onderzoek (cETO)
- Rijksuniversiteit Groningen – Ethische Commissie Psychologie (ECP)
- Tilburg University Ethics Review Boards
- Universiteit Leiden – Commissie Ethiek Psychologie (CEP)
- Universiteit Maastricht – Ethics Review Committee Psychology and Neuroscience (ERCPN)
- Universiteit Twente – Ethics Committee BMS
- Universiteit Utrecht – Ethics Review Board of the Faculty of Social & Behavioural Science
- Universiteit van Amsterdam – Faculty Ethics Review Board (FMG-UvA)
- Vrije Universiteit Amsterdam – Vaste Commissie Wetenschap en Ethiek (VCWE)
- Nationaal Ethiek Overleg Sociale en Gedragswetenschappen
- Nederlands Instituut van Psychologen (NIP)
Please use the contact form to report broken links, outdated information and missing webpages.
Biobanking & Genetic research
Authorities
- Belgium: FAGG – Menselijk lichaamsmateriaal
- Netherlands
- United Kingdom: Human Tissue Authority (HTA)
Biobanken
- Biobank Sweden
- Biobank University College London
- Danish National Biobank
- Mayo Clinic Biobank
- Qatar Biobank
- UK Biobank
Organisations
Biobanking and BioMolecular resources Research Infrastructure (BBMRI)
- BBMRI.be
- BBMRI.de – German Biobank Node (GBN)
- BBMRI.it
- BBMRI.nl
- BBMRI-ERIC – European research infrastructure for biobanking
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
International Society for Biological and Environmental Repositories (ISBER)
Public Population Project in Genomics (P3G)
UKCRC Tissue Directory and Coordination Centre
Vereniging Samenwerkende Ouder- en Patiëntenorganisaties (VSOP)
Please use the contact form to report broken links, outdated information and missing webpages.
Clinical Trial Registries, Clinical trial results reporting, Clinical trial trackers and viewers
Clinical Trial Registries
World Health Organization |
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
Europe
- België
- Europese Unie
- Nederland
- Overige landen
Verenigde Staten
Pre-Clinical Trials
Systematic reviews
Other Clinical Trial Registries
- 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)
Clinical trial results reporting
Clinical trial trackers and viewers
Artis Ventures:
Bill & Melinda Gates Foundation, Cytel
London School of Hygiene & Tropical Medicine
Milken Institute
Regulatory Focus
STAT
Trial Insights
Trial Scope
Other
- A real-time dashboard of clinical trials for COVID-19 (24 April 2020). The Lancet.
- Clinical Trials Viewer – Search for clinical trials and FDA info
- HealthMatch COVID-19 Clinical Trials Tracker
Please use the contact form to report broken links, outdated information and missing webpages.
Communication
- Nederlands Huisartsen Genootschap (NHG)
- Siilo
- Signal, for messages and calls
Please use the contact form to report broken links, outdated information and missing webpages.
Data Protection
European Union (EU), General Data Protection Regulation (GDPR)
- Brexit
- Directives & Regulations
- European Data Protection Board (EDPB)
- GDPR: Guidelines, Recommendations, Best Practices
- Guidance
- Statements
- Other documents
- GDPR: Guidelines, Recommendations, Best Practices
- European Data Protection Supervisor (EDPS)
- Other informative documents
International Association of Privacy Professionals (IAPP)
- COVID-19
Netherlands
- Persoonsgegevens zijn niet altijd taboe in medisch onderzoek (11 mei 2021). NRC.
- Datasolidariteit voor gezondheid (3 december 2020). Rathenhau Instituut.
Ha Vincent, m.b.t. dit thema hebben we alles wat je moet weten uiteengezet in het Datasolidariteit-rapport (dec. 2020). Zie laatste bijlage voor beslisbomen! https://www.rathenau.nl/nl/maakbare-levens/datasolidariteit-voor-gezondheid
- Handreiking ontsluiten patiëntgegevens voor onderzoek: werken volgens de regels uit AVG, UAVG en WGBO (Juli 2019). Trimbos-instituut, MedLawconsult.
- KNMG
- Medisch beroepsgeheim
Tools
Please use the contact form to report broken links, outdated information and missing webpages.
Ethical Principles, Guidelines, Standards, Codes of Conduct
World Medical Association (WMA)
Nuremberg CodeThe Belmont ReportNational Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Council for International Organizations of Medical Sciences (CIOMS)
- International Ethical Guidelines for Epidemiological Studies, Council for International Organizations of Medical Sciences (CIOMS), 2009
- International Ethical Guidelines for Health-related Research involving Humans, Council for International Organizations of Medical Sciences (CIOMS), 2016.
Countries
- Belgium – Orde der artsen
- Code van geneeskundige plichtenleer (december 2016): Hoofdstuk VIII – Experimenten op mensen Art. 89-94
- Inleiding tot de medische deontologie 2017 – 2018 (16 november 2017)
- Belgisch Raadgevend Comité voor Bio-ethiek – Advies nr. 69 van 13 februari 2017 betreffende experimenten en ander wetenschappelijk onderzoek bij gedetineerden
- Advies ‘Raadplegen van medische dossiers met de bedoeling patiënten te rekruteren voor klinische studies’ (21 november 2015)
- Thema’s ‘Experimenten op mensen’
- Thema’s ‘Biopsie’
- Thema’s ‘Commissie voor medische ethiek’
- Thema’s ‘Epidemiologisch onderzoek’
- Thema’s ‘Geneesmiddelen’
- Thema’s ‘Wetenschappelijk onderzoek’
- Thema’s ‘Offlabel geneesmiddelen’
- Netherlands
- COmmissie REgelgeving ONderzoek (COREON)
- COREON publiceert statement over nader gebruik van patiëntgegevens bij spoedsituaties (7 April 2020). Nieuwsbrief voor Goede Onderzoekspraktijken, supplement Nieuwsflits.
- Statement delen van patiëntgegevens bij observationeel wetenschappelijk onderzoek in spoedsituaties (6 april 2020). COREON.
- Self-regulatory Codes of Conduct
- Gedragscode Verantwoord omgaan met lichaamsmateriaal ten behoeve van wetenschappelijk onderzoek ‘Code Goed Gebruik’
- Gedragscode Gezondheidsonderzoek ‘Code Goed Gedrag’
- Statement delen van patiëntgegevens bij observationeel wetenschappelijk onderzoek in spoedsituaties (6 april 2020). COREON.
- Koninklijke Nederlandse Akademie van Wetenschappen (KNAW)
- Code for the prevention of improper influence due to conflicts of interest. (January 2012)
- Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengelingen. (Januari 2012)
- Notitie Wetenschappelijke integriteit (2001)
- Wetenschap op bestelling. Over de omgang tussen wetenschappelijk onderzoekers en hun opdrachtgevers. (september 2005)
- Wetenschappelijk onderzoek: dilemma’s en verleidingen. (2005)
- Wetenschappelijke integriteit. (2010)
- Zorgvuldig en integer omgaan met wetenschappelijke onderzoeksgegevens. (September 2012)
- Responsible research data management and the prevention of scientific misconduct (april 2013)
- Landelijk Orgaan Wetenschappelijke Integriteit (LOWI)
- Nederlandse Federatie van Universitair Medische Centra (NFU)
- NFU Richtlijn Kwaliteitsborging Mensgebonden Onderzoek (update december 2020)
NFU Richtlijn Kwaliteitsborging Mensgebonden Onderzoek 2019 (Maart 2019)– [niet meer van toepassing, vervangen door update december 2020]NFU Kwaliteitsborging mensgebonden onderzoek 2.0 (Oktober 2012)– [niet meer van toepassing, vervangen door versie 2019]NFU Kwaliteitsborging van mensgebonden onderzoek. Juni 2010 (versie 1)– [niet meer van toepassing. vervangen door versie 2]
- Research integrity
- Stichting Code Geneesmiddelenreclame (CGR)
- Stichting Gedragscode Medische Hulpmiddelen (GMH)
- Vereniging Innovatieve Geneesmiddelen
- Vereniging van Universiteiten (VSNU)
- COmmissie REgelgeving ONderzoek (COREON)
European Committee for Standardization (CEN) – European Committee for Electrotechnical Standardization (CENELEC)
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
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)
United Nations (UN)
United Nations Educational, Scientific, and Cultural Organization (UNESCO)
- 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)
- 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
- Code of Conduct and Ethical Guidelines for Social Science Research
Committees
- International Bioethics Committee (IBC)
- World Commission on the Ethics of Scientific Knowledge and Technology (COMEST)
Unicef
- Ethical research for children
- Ethical research and children
- Discussion Paper: Ethical Considerations for Evidence Generation Involving Children on the COVID-19 Pandemic (April 2020). Unicef.
World Medical Association (WMA)
- 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
- Human, D. & Fluss, S.S. (2001). The World Medical Association’s Declaration of Helsinki: Historical and Contemporary Perspectives.
Please use the contact form to report broken links, outdated information and missing webpages.
Ethics Committees (EC), Research Ethics Committees (REC), Medical Research Ethics Committees (MREC)
Countries
Belgium – Ethische Comités met een volledig erkenning
Volgens artikel 10 van de Wet van 7 mei 2004 inzake experimenten op de menselijke persoon, mag een experiment slechts beginnen op voorwaarde dat de opdrachtgever en de onderzoeker in het bezit zijn van een gunstig advies van een volledig erkend ethisch comité.
Volgens het overzicht ‘Ethische Commissies‘ (versie 11 april 2018) van het Federaal agentschap voor geneesmiddelen en gezondheidsproducten (FAGG) telt België in totaal 25 Ethische Comités met een volledige erkenning. Op twee na zijn alle commissies op internet terug te vinden.
- Algemeen Ziekenhuis Delta (Roeselare)
- Algemeen Ziekenhuis Groeninge (Kortrijk)
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende (Brugge)
- AZ Maria Middelares (Gent)
- C.H.U. – UCL Mont-Godinne-Dinant (Mont-Godine) (informatie via FAGG)
- C.H.U. Bruxelles-Hopital Erasme (Anderlecht)
- Centre Hospitalier Chretien (Luik)
- Centre Hospitalier Universitaire Saint-Pierre Bruxelles (Brussel)
- Centre Hospitalier Universitaire Brugmann (Laken)
- Centre Hospitalier Universitaire de Liege (Luik)
- Cliniques Universitaires Saint-Luc (Woluwe-Saint-Lambert)
- Grand Hôpital de Charleroi (Charleroi)
- GZA Ziekenhuizen (Wilrijk)
- Imelda Ziekenhuis (Bonheiden)
- Institut Jules Bordet (Brussel)
- Jessa Ziekenhuis (Hasselt)
- Onze Lieve Vrouw Ziekenhuis (Aalst)
- UHasselt Comité voor Medische Ethiek
- Universitair Ziekenhuis Antwerpen
- Universitair Ziekenhuis Brussel (informatie via FAGG)
- Universitair Ziekenhuis Gent
- Universitair Ziekenhuizen K.U.L. (Leuven)
- VZW Emmaüs (Mechelen)
- Ziekenhuis Oost-Limburg (Genk)
- Ziekenhuisnetwerk Antwerpen
Netherlands
Erkende METC’s
Volgens het overzicht op de CCMO website telt Nederland 15 erkende METC’s.
- CCMO overview of Medical Research and Ethics Committees (MREC)/Medische ethische toetsingscommissies (METC)
- Medical Research Ethics Committees United (MEC-U)
- METC Academisch Medisch Centrum Amsterdam
- METC Academisch Ziekenhuis Maastricht / Universiteit Maastricht
- METC Brabant
- METC Erasmus Medisch Centrum Rotterdam
- METC Isala klinieken Zwolle
- METC Leiden Den Haag Delft
- METC Máxima Medisch Centrum
- METC Oost-Nederland*
- METC Universitair Medisch Centrum Groningen
- METC NedMec**
- METC VU medisch centrum
- METC Z
- Regionale Toetsingscommissie Patiëntgebonden Onderzoek (RTPO)
- Stichting Beoordeling Ethiek Biomedisch Onderzoek (BEBO)
* Voorheen CMO Regio Arnhem-Nijmegen. Toetst ook onderzoek van Wageningen University, Wageningen Research en Ziekenhuis Gelderse Vallei Ede. METC-WU opgeheven per 1 januari 2021.
** onstaat uit fusie METC AVL en METC Utrecht
Ethische Commissies Psychologie
- Open Universiteit – Commissie Ethische Toetsing Onderzoek (cETO)
- Rijksuniversiteit Groningen – Ethische Commissie Psychologie (ECP)
- Tilburg University Ethics Review Boards
- Universiteit Leiden – Commissie Ethiek Psychologie (CEP)
- Universiteit Maastricht – Ethics Review Committee Psychology and Neuroscience (ERCPN)
- Universiteit Twente – Ethics Committee BMS
- Universiteit Utrecht – Ethics Review Board of the Faculty of Social & Behavioural Science
- Universiteit van Amsterdam – Faculty Ethics Review Board (FMG-UvA)
- Vrije Universiteit Amsterdam – Vaste Commissie Wetenschap en Ethiek (VCWE)
Please use the contact form to report broken links, outdated information and missing webpages.
Funding
- Brexit
- European Research Council
- Innovative Medicines Initiative
- Marie Skłodowska-Curie Actions
- Netherlands
Please use the contact form to report broken links, outdated information and missing webpages.
Good Practices (GxP)
Good Clinical Data Management Practices (GCDMP)
Good Clinical Practice (GCP)
Investigational Medicinal Products
- EMA: Good Clinical Practice
- ICH E6 (R2) Good clinical practice
- WHO: Handbook for good clinical research practice (GCP) : guidance for implementation (2005)
Medical Devices & In Vitro Diagnostic Medical Devices
- ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice
- ISO 20916:2019 – In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
Good Laboratory Practice (GLP)
- OECD Good Laboratory Practice (GLP)
- OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring.
- European Commission – Good Laboratory Practice
Good Lay Summary Practice (GLSP)
- Good Lay Summary Practice Guidance (4 oktober 2021). Clinical Trials Expert Group, European Commission.
- Good Lay Summary Practice Roadmap Initiative. EFGCP & EFPIA.
- New guide to clinical trial lay summaries available for EU sponsors (5 oktober 2021). Regulatory Focus.
- Final report “Implementing “Good Lay Summary Practice” (GLSP Workshop, February 2022). EFPIA.
- Terugkijken: Good Lay Summary Practice Workshop Presentations (02-12-2021), EFPIA, EFGCP, EUPATI via YouTube.
Good Machine Learning Practice (GMLP)
- Guidance – Good Machine Learning Practice for Medical Device Development: Guiding Principles (27 oktober 2021). FDA, Health Canada, MHRA.
- UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software (27 oktober 2021). MHRA.
- Good Machine Learning Practice for Medical Device Development: Guiding Principles (27 oktober 2021). FDA.
- Regulators release 10 principles for good machine learning practice (27 oktober 2021). Regulatory Focus.
Good Manufacturing Practice (GMP)
- EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
- World Health Organization – Good Manufacturing Practices
- Nederlandse Vereniging van Ziekenhuisapothekers – GMP-Z Richtlijn
Please use the contact form to report broken links, outdated information and missing webpages.
History of Clinical Trials
- The evolution of clinical trials: Can we address the challenges of the future? (16-02-2018). Clinical Trials.
- Evolution of Clinical Trials throughout History (2017). Marshall Journal of Medicine: Vol. 3: Iss. 1, Article 9
- Chalmers I. The development of fair tests of treatments. Lancet. 2014 May 17;383(9930):1713-4. doi: 10.1016/s0140-6736(14)60821-7.
- Evolution of clinical research: A history before and beyond james lind. Perspect Clin Res [serial online] 2010 [cited 2022 May 22];1:6-10.
- The Evolution of Clinical Trials, Guarantors of Drug Safety (14-10-2021). OpenMind BBVA.
Please use the contact form to report broken links, outdated information and missing webpages.
Integrity
European Network of Research Ethics and Research Integrity (ENERI)
H2020 INTEGRITY Project
SOPs4RI (Standard Operating Procedures for Research Integrity)
Other
Please use the contact form to report broken links, outdated information and missing webpages.
Legal
- Blog
- Journal, tijdschriften
- Legal
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Legislation
- Belgium
- Wet van 7 mei 2004 (geconsolideerde versie) inzake experimenten op de menselijke persoon
- Wet van 7 mei 2017 betreffende klinische proeven met geneesmiddelen voor menselijk gebruik
- Wet van 19 december 2008 inzake het verkrijgen en het gebruik van menselijk lichaamsmateriaal met het oog op de geneeskundige toepassing op de mens of het wetenschappelijk onderzoek
- Nederland
- Beleidsregels gunstbetoon
- Beleidsregels gunstbetoon Geneesmiddelenwet 2018
- Beleidsregels gunstbetoon Wet medische hulpmiddelen
- IGJ
- Keuringsraad (KOAG KAG): Reclame voor geneesmiddelen, medische zelfzorg hulpmiddelen en gezondheidsproducten is toegestaan, maar vergt duidelijke regelgeving. De Keuringsraad ziet toe op naleving van die regels.
- Stichting Code Geneesmiddelenreclame (CGR)
- Stichting Gedragscode Medische Hulpmiddelen (GMH)
- Transparantieregister Zorg
- Embryowet
- Wet medische hulpmiddelen
- Verordening (EU) 2017/745 van het Europees Parlement en de Raad van 5 april 2017 betreffende medische hulpmiddelen, tot wijziging van Richtlijn 2001/83/EG, Verordening (EG) nr. 178/2002 en Verordening (EG) nr. 1223/2009, en tot intrekking van Richtlijnen 90/385/EEG en 93/42/EEG van de Raad
- Eerste Kamer
- Besluit van 24 april 2020, houdende regels met betrekking tot de herverwerking en het verder gebruik van hulpmiddelen voor eenmalig gebruik in de zin van artikel 17 van Verordening (EU) 2017/745 en nadere regels over het gebruik van medische hulpmiddelen (Besluit medische hulpmiddelen)
- Regeling medische hulpmiddelen
- IGJ
- Verordening (EU) 2017/745 van het Europees Parlement en de Raad van 5 april 2017 betreffende medische hulpmiddelen, tot wijziging van Richtlijn 2001/83/EG, Verordening (EG) nr. 178/2002 en Verordening (EG) nr. 1223/2009, en tot intrekking van Richtlijnen 90/385/EEG en 93/42/EEG van de Raad
- Wet medisch-wetenschappelijk onderzoek met mensen (WMO)
- niet-WMO plichtig onderzoek (vs. WMO plichtig onderzoek)
- Toetsingskader Niet-WMO plichtig onderzoek (in beheer DCRF)
- Definities
- Archief
- Ethische toetsing van niet-WMO-plichtig onderzoek: tijd en ruimte voor verbetering (6 juli 2020). COREON.
- Rapport “Naar een Toetsingskader voor niet-WMOplichtig onderzoek. De pilot resultaten”. Stuurgroep nWMO (oktober 2012).
- Nieuwsbrief Nr. 9/2014 “De Gedragscode per 2015” van de Stichting Code Geneesmiddelenreclame (CGR).
- Bosschaart-Castermans, R.M.M. & Hendriks A.C. (2010). De beoordeling van niet WMO-plichtig onderzoek door UMCs. Ervaringen van het Erasmus MC met de zorgvuldigheidstoets. NVMETC Forum nr. 2, 2010, p. 7-12.
- Van Veen, E & Janssen, I. (oktober 2008). ‘Toetsing op maat – een onderzoek naar de beoordeling van wetenschappelijk onderzoek op de grens van de Wet medisch-wetenschappelijk onderzoek met mensen’. In opdracht van de Federatie van Medisch Wetenschappelijke Verenigingen (FEDERA) en FEDERA/COREON.
- ZonMw
- niet-WMO plichtig onderzoek (vs. WMO plichtig onderzoek)
- Wet op het bevolkingsonderzoek (WBO)
- Wet op de geneeskundige behandelingsovereenkomst (WGBO)
- Wet zeggenschap lichaamsmateriaal (Wzl)
- Beleidsregels gunstbetoon
Please use the contact form to report broken links, outdated information and missing webpages.
Measurement instruments (questionnaires, surveys, rating scales, projective techniques, interview schedules, and tests)
- LUMC Walaeus Bibliotheek
- Meetinstrumenten in de zorg
Deze website geeft een overzicht van meer dan 400 vragenlijsten (PROMs), observatie- en performancetesten voor gebruik in de zorg.
Please use the contact form to report broken links, outdated information and missing webpages.
Medical Devices & In Vitro Diagnostic Medical Devices
Authorities
- Belgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
European Union (EU)
- Directives & Regulations
- Directives
- Regulations
- MDR: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- IVDR: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- Guidance documents
- Other information
International Medical Device Regulators Forum (IMDRF)
Please use the contact form to report broken links, outdated information and missing webpages.
(Investigational) Medicinal Products
Authorities
- Belgium
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
- COVID-19
- Guidance on the Management of Clinical Investigations during the COVID-19 (Coronavirus) pandemic.
- Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 2 (29 April 2020).
- Richtlijn voor rechtstreekse aflevering van geneesmiddel aan patiënt in klinisch proef (16 March 2020)
- Klinische proeven
- Leidraad voor niet-interventionele studies (mei 2008)
Sjablonen voor geïnformeerde toestemming
- COVID-19
- FOD Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu. CT-College (College Klinische Proeven).
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
- Netherlands – Compassionate use, off-label use, afleveren op artsenverklaring (NOT research!)
- Compassionate use
- Off-label use
- Afleveren op artsenverklaring
Drugs.com
ECA Academy
European Union (EU)
- Clinical Trials Directive (CTD)
- Clinical Trials Regulation (CTR)
- European Medicines Agency (EMA)
- EudraLex ‘The rules governing medicinal products in the European Union’
- EudraCT : European Clinical Trial Database (EU)
- EU PAS Register – ENCEPP Pharmacoepidemiological study register
COVID-19
- Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic.
- Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials.
- Guidance on remote GCP inspections during the COVID-19 pandemic (18 May 2020).
- COVID-19: What’s new
- Coronavirus disease (COVID-19).
- Paediatric investigation plans (PIP) + COVID-19
Genetically modified organism (GMO)
- European Union
- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance)
- Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration. | Current consolidated version: 27/03/2021.
- European Commission
- Belgium
- Netherlands
- Loket Gentherapie
- From 13 March 2020, submission of research dossiers for gene therapy and medicinal products containing GMOs takes place directly to the relevant authority (16 March 2020).
- Vanaf 13 maart 2020 indiening onderzoeksdossiers gentherapie en geneesmiddelen met GGO rechtstreeks bij betrokken instantie (13 March 2020).
- Ministerie IenW
- Loket Gentherapie
Good Manufacturing Practice (GMP)
Medical Dictionary for Regulatory Activities (MedDRA)
RxISK
University of Liverpool
Please use the contact form to report broken links, outdated information and missing webpages.
Pediatric research
Please use the contact form to report broken links, outdated information and missing webpages.
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
- Ethical GmbH
Endpoints, Outcomes
- COVID-19
- IDEAL: The IDEAL Collaboration – Idea, Development, Exploration, Assessment, Long-term follow-up
- SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
- What is the difference between an end-point and an outcome measure? (Kanchan Batra, 3 augustus 2016). Via ResearchGate.
Multi-Regional Clinical Trials (MRCT) Center Brigham and Women’s Hospital and Harvard University
Open Science, projectmanagement & data-sharing
Process map
Protocol violations, deviations
Research ethics
Please use the contact form to report broken links, outdated information and missing webpages.
Radiological Protection & Non-Ionizing Radiation Protection
International Commission on Non-Ionizing Radiation Protection (ICNIRP)
International Commission on Radiological Protection (ICRP)
- International Commission on Radiological Protection (ICRP)
- ICRP Publication 62 Radiological Protection in Biomedical Research
Please use the contact form to report broken links, outdated information and missing webpages.
Regulatory Authorities
European Union (EU)
- Council of Europe
- EU Science Hub
- European Centre for Disease Prevention and Control (ECDC)
- European Commission (EC)
- European Council
- European Directorate for the Quality of Medicines & HealthCare (EDQM).
- European network of paediatric research at the European Medicines Agency (Enpr-EMA)
- European Medicines Agency (EMA)
- Brexit: the United Kingdom’s withdrawal from the European Union
- Clinical Data Publication
- COVID-19
- Clinical Trial Regulation
- Conditional marketing authorisation
- Medical devices
- Paediatric investigation plans
- Q&A: Good clinical practice (GCP)
- European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- Heads of Medicines Agencies
- Clinical Trials Facilitation Group (CTFG)
- Link to National guidance on CT management during the COVID-19 pandemia
- Documents
- Brexit
- Clinical Trial Regulation EU 536/2014
- Clinical Trials Safety
- COVID-19
- Guidance
- National fees/information
- Voluntary Harmonisation Procedure (VHP)
- Conclusion of the Voluntary Harmonization Procedure project (January 2021).
- Results of the Voluntary Harmonisation Procedure 2009 – 2020 (February 2021).
- European Union Member States participation in VHP and VHP-related activities (October 2020).
- Guidance document for sponsors for a Voluntary Harmonised Procedure for the assessment of multinational Clinical Trial Applications (Version 5, October 2020).
International Coalition of Medicines Regulatory Authorities (ICMRA)
Other countries
Africa
- Kenia – Pharmacy and Poisons Board
- Nigeria – Association for Good Clinical Practice in Nigeria (AGCPN)
- Nigeria – National Health Research Ethics Committee (NHREC)
- South Africa
Asia
- Japan
- Singapore
Europe
- Austria
- Austrian Federal Ministry of Education, Science and Research (BMBWF)
- Austrian Federal Office for Safety in Health Care (BASG)
- Belgium – Go to section “Health & Medical Research in Belgium”
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
- COVID-19
- Guidance on the Management of Clinical Investigations during the COVID-19 (Coronavirus) pandemic.
- Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 2 (29 April 2020).
- Richtlijn voor rechtstreekse aflevering van geneesmiddel aan patiënt in klinisch proef (16 March 2020)
- COVID-19
- Federale overheidsdienst (FOD) Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu. CT-College (College Klinische Proeven).
- Federale commissie voor embryo’s
- Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
- Bulgaria – Bulgarian Drug Agency
- Czech Republic – State Institute for Drug Control (SÚKL)
- Croatia – Ministarstvo zdravstva Republike Hrvatske (Ministry of Health of the Republic of Croatia)
- Cypres – Ministry of Health
- Denmark – Lægemiddelstyrelsen
- Estonia – Agency of Medicines
- Finland – Finnish Medicines Agency (Fimea)
- France
- Authorities
- Organisations
- Germany
- Authorities
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
- Clinical Trials
- COVID-19
- Clinical Trials during the COVID-19 Pandemic – Information on the authorisation and conduct of clinical trials of medicinal products during the COVID-19 pandemic
- Supplementary recommendations to the document European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
- Klinische Prüfungen während der COVID-19 Pandemie – Hinweise zur Genehmigung und Durchführung klinischer Arzneimittelprüfungen während der COVID-19 Pandemie
- Ergänzende Empfehlungen zum Europäischen Dokument Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
- Bundesbeauftragte für den Datenschutz und die Informationsfreiheit (BfDI)
- Paul-Ehrlich-Institut (PEI)
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
- Organisations
- BBMRI.de – German Biobank Node (GBN)
- Covid-19: Gemeinsam gegen das Coronavirus
- Covid-19: Arbeiten mit SARS-CoV-2-Proben
- German Society for Good Research Practice – Deutsche Gesellschaft für Gute Forschungspraxis (DGGF)
- KKS-Netzwerk e. V. – Koordinierungszentren für Klinische Studien / association of academic coordinating centres for clinical studies in Germany
- Wet en regelgeving
- Authorities
- Greece – Εθνικός Οργανισμός Φαρμάκων (National Organization for Medicines)
- Hungary – Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) [EN]
- Ireland
- Italy
- Latvia – State Agency of Medicines
- Malta – Malta Medicines Authority
- Netherlands – Go to section “Health & Medical Research in the Netherlands”
- Centrale Commissie Mensgebonden Onderzoek (CCMO)
- COVID-19
- Model documenten/Standard research file
- Notities
- Onderzoek met medische hulpmiddelen vanaf 26 mei 2021
- Richtsnoeren/Leidraden
- College ter Beoordeling van Geneesmiddelen (CBG)
- Inspectie Gezondheidszorg en Jeugd (IGJ)
- COVID-19
- ‘Medische technologie’
- ‘Geneesmiddelen’
- Regels voor klinisch onderzoek
- Toestemmingsprocedure (Informed Consent)
- Het bewaren van essentiële studiedocumenten en inzage in de medische gegevens van de proefpersoon
- Geneesmiddelen voor onderzoek
- Ernstige inbreuken (serious breaches) bij geneesmiddelenonderzoek
- Nieuwe wetgeving: Verordening 536/2014 [via Wayback Machine]
- Wijzigingen WMO in 2021 en 2022
- Regels voor klinisch onderzoek
- ‘Geneesmiddelen voor geavanceerde therapie (ATMPs)’
- Rapport ‘Fase IV onderzoek als marketingonderzoek: beïnvloeding van voorschrijfgedrag door combinatie van elementen. Marketingdoeleinden bij onderzoek met geregistreerde geneesmiddelen’. Den Haag, april 2009.
- Handreiking inzake status van producten voor onderzoek. voedingsmiddel of geneesmiddel voor onderzoek? IGZ, 17 december 2009
- Nederlandse Voedsel- en Warenautoriteit (NVWA)
- Centrale Commissie Mensgebonden Onderzoek (CCMO)
- Norway – Statens legemiddelverk (NoMA) / Norwegian Medicines Agency
- Poland
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
- Naczelna Izba Lekarska (NIL)
- The Employers’ Union of Innovative Pharmaceutical Companies (INFARMA)
- Polish Association of Clinical Research Organizations (POLCRO)
- Polish Association of Good Clinical Practice (GCPpl)
- Portugal – Infarmed (English website)
- Romania – National Agency for Medicines and Medical Devices of Romania (NAMMD)
- Slovakia – Štátny ústav pre kontrolu liečiv (ŠÚKL) / State Institute for Drug Control
- Slovenia – Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) / Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
- Spain – Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) / (English website)
- Sweden
- Switzerland – Swissmedic
North America
- Canada
Middle East
- Jordan – Jordan Food & Drug Administration
- Turkey – Türkiye İlaç ve Tıbbi Cihaz Kurumu / Turkish Medicines and Medical Devices Agency
Oceania
- Australia
- New Zealand – Massey University – Research ethics
South America
- Argentina – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
- Brazil – Agência Nacional de Vigilância Sanitária (Anvisa)
- Colombia – Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
- Chile – Instituto de Salud Pública de Chile (ISPCH)
- Peru – Instituto Nacional de Salud (INS)
Please use the contact form to report broken links, outdated information and missing webpages.
Research Data Management
Clinical Data Interchange Standards Consortium (CDISC)
- Clinical Data Interchange Standards Consortium
- What’s New
- Standards
- Therapeutic Areas
(Clinical study) 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
Journals
Science Europe
Society for Clinical Data Management (SCDM)
Please use the contact form to report broken links, outdated information and missing webpages.
Research output, Publications
Committee on Publication Ethics (COPE)International Committee of Medical Journal Editors (ICMJE) |
Miscellaneous
- International DOI Foundation (IDF)
- Tilburg University – Bronvermelding volgens de richtlijnen van de APA (.pdf)
- The Source – Cabells gives academics and scholars tools to make smart decisions in journal evaluation.
Open Access & Open Science
Center for Open Science
European Commission
OECD
UNESCO
Publication of negative results
- Journal of Articles in Support of the Null Hypothesis (JASNH)
- Journal of Negative Results in BioMedicine (JNRBM)
- Journal of Pharmaceutical Negative Results
- Journal of Unsolved Questions (JUnQ)
- PeerJ (Biological and Medical sciences)
- The All Results Journals
Publishers
Reporting Guidelines
- EQUATOR Network
- EQUATOR Network – Enhancing the QUAlity and Transparency Of health Research (EQUATOR)
- Sex and Gender Equity in Research (SAGER) guidelines
- 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.
Salami Slicing
Systematic reviews
Please use the contact form to report broken links, outdated information and missing webpages.
Training, education and practical
Books & journals
- Applied Clinical Trials
- How to Read Numbers.
- On Being a Scientist: A Guide to Responsible Conduct in Research: Third Edition (2009)
- TIBCO Software Inc. (2020). Data Science Textbook.
- The Sourcebook for Clinical Research. A Practical Guide for Study Conduct (2018).
- Therapeutic Innovation & Regulatory Science
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
- Global Health Training Centre
- 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
- Catalogue of Bias. Centre for Evidence-Based Medicine.
- Consent for publication. A best practice guide for authors. BMJ.
- FDA Modernizes Clinical Trials with Master Protocols (26 februari 2019). [Basket Trial, Umbrella Trials]
- Good Practice Cases
- International Clinical Trials Day- 20th May (19-05-2022). Pullareddy M, via LinkedIn.
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
Please use the contact form to report broken links, outdated information and missing webpages.
United Kingdom (UK)
Autorities
- Human Tissue Authority (UK)
- Information Commissioner’s Office
- Medicines & Healthcare products Regulatory Agency (MHRA)
- Medicines, medical devices and blood regulation and safety: detailed information
- Clinical trials and investigations: detailed information
- COVID-19
- Manufacturing, wholesaling, importing and exporting medicines
- Vigilance, safety alerts and guidance: detailed information
- Medicines, medical devices and blood regulation and safety: detailed information
- National Institute for Health and Care Excellence (NICE)
- National Institute for Health Research (NIHR)
- NHS Health Research Authority (HRA)
- Public Health England
Funding
Organisations
Research Application System
Please use the contact form to report broken links, outdated information and missing webpages.
United States of America
Authorities & organisations
Centers for Disease Control and Prevention (CDC)
- Centers for Disease Control and Prevention (CDC)
National Academy of Sciences, Engineering, and Medicine
National Institutes of Health (NIH)
U.S. Department of Health & Human Services (HHS)
U.S. Food and Drug Administration (FDA)
- Clinical Trials Guidance Documents
- COVID-19
- FDA’s MyStudies Application (App)
- Guidance
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- COVID-19
- Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- Guidance for Industry on Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
- Guidance for Industry: Development and Licensure of Vaccines to Prevent COVID-19 (June 2020).
- Guidance for Industry – COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
- Guidance for Industry – Investigational COVID-19 Convalescent Plasma
- Recommendations for Investigational COVID-19 Convalescent Plasma.
- Guidance Documents (Including Information Sheets) and Notices
- Investigational New Drug (IND) Application (FDA)
- Regulatory Information: Search for FDA Guidance Documents
- Newly Added Guidance Documents
Regulations
Organizations and associations
- American Board of Radiology (ABR)
- American College of Physicians (ACP)
- American College of Radiology (ACR)
- American Lung Association
- American Medical Association (AMA)
- American Public Health Association (APHA)
- American Roentgen Ray Society (ARRS)
- American Society of Clinical Oncology (ASCO)
- American Society of Radiologic Technologists (ASRT)
- National Academy of Medicine
- National Academy of Sciences, Engineering, and Medicine
- Radiological Society of North America (RSNA)
Please use the contact form to report broken links, outdated information and missing webpages.
Universities
- Johns Hopkins University
- University of California San Francisco
Please use the contact form to report broken links, outdated information and missing webpages.
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
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics (20-06-2021).
- 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
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