Biomedical Research

Last updated on: 11 December 2022

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: International Laws, regulations, and guidelines – by country Research in the Netherlands Research in Belgium Please use the contact form to report broken links, outdated information and missing webpages.

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: International Laws, regulations, and guidelines – by country Research in the Netherlands Research in Belgium Gebroken verwijzingen en suggesties voor nieuwe verwijzingen kunt u aan mij doorgeven via het contactformulier.

 

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Index

Animal research Alliances, Associations, Federations, Organizations & Research Infrastructures Behavioral sciences, Psychology Biobanking & Genetic research Clinical Trial Registries, Clinical trial results reporting, Clinical trial trackers and viewers Communication Data Protection Ethical Principles, Guidelines, Standards, Codes of Conduct Ethics Committees (EC), Research Ethics Committees (REC), Medical Research Ethics Committees (MREC) Funding Good Practices (GxP) History of Clinical Trials Integrity Legal Legislation

Measurement instruments (questionnaires, surveys, rating scales, interview schedules, and tests) Medical Devices & In Vitro Diagnostic Medical Devices (Investigational) Medicinal Products Pediatric research Quality of research Radiological Protection & Non-Ionizing Radiation Protection Regulatory Authorities Research Data Management Research output, Publications Training, education and practical United Kingdom (UK) United States of America Universities World Health Organization (WHO)

Please use the contact form to report broken links, outdated information and missing webpages.

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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. International Compilation of Human Research Standards, Office for Human Research Protections, U.S. Department of Health and Human Services.

Please use the contact form to report broken links, outdated information and missing webpages.

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Animal research

Authorities

• The Netherlands
  • Centrale Commissie Dierproeven (CCD)
  • Nationaal Comité advies dierproevenbeleid (NCad)
    • Codes of Practices, actuele ‘beste praktijken’ in het proefdierveld
  • NVWA: Dierproeven en toezicht

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.”
  • Norecopa: News
• 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)

• WMA Statement on Animal Use in Biomedical Research, reaffirmed by the 203rd WMA Council Session, Buenos Aires, Argentina, April 2016

Please use the contact form to report broken links, outdated information and missing webpages.

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Alliances, Associations, Federations, Organizations & Research Infrastructures

Alliances

• Decentralized Trials and Research Alliance (DTRA)
• Good Clinical Practice Alliance (GCPA)
• Research Data Alliance (RDA)
  • RDA-COVID19

Associations

• Association of Clinical Research Organizations (ACRO)
  • COVID-19
    • ACRO’s Recommendations in order to Support Clinical Trial Monitoring Oversight During COVID-19
      • Considerations to Support Clinical Trial Monitoring Oversight During COVID-19 (13 March 2020).
    • ACRO Feedback on Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 2 (27/03/2020).
    • COVID-19 Resource Center
    • COVID-19 Member Corner
• Association of Clinical Research Professionals (ACRP)
  • COVID-19 News & Resource Center
• 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)
  • DIA Now In Focus: COVID-19
• International Association of Privacy Professionals (IAPP)
• Research Quality Association (RQA)
  • Discussion Forums: COVID-19

Centre for Evidence-Based Medicine (CEBM)

• Centre for Evidence-Based Medicine (CEBM)
  • Covid-19 TrialsTracker
  • Oxford COVID-19 Evidence Service
  • COVID-19 Registered Trials – and analysis (17 March 2020).

Clinical Research Organisations

• COVANCE
  • Coronavirus (COVID-19) Update
• Delta Healthcare Consulting
  • Covid-19 – Clinical Trial Rescue (16 March 2020). (‘visit subject at home‘)
• ICON
  • COVID-19 CEO Letter
  • Coronavirus Observatory
• 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
  • COVID-19 Regulatory Developments Impacting Technology Use in Clinical Trials (23 March 2020).
  • COVID 19 and Clinical Trials: The Medidata Perspective (23 March 2020).
• Qserve CRO

Clinical trial improvement

• Clinical Trials Transformation Initiative (CTTI)
  • A Case Study Exchange
  • COVID-19
    • Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet (18 May 2020).
  • Webinars
    • Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials (19 June 2020).
• TransCelerate BioPharma Inc.

Cochrane

• Cochrane
  • Cochrane Handbook for Systematic Reviews of Interventions
  • COVID-19
    • An update on Cochrane’s COVID-19 response.
    • Cochrane’s COVID-19 Study Register
    • Coronavirus (COVID-19) – Cochrane resources and news

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)
  • FIP Covid-19 Information Hub
  • Publications: Policies/ Professional standards/ Guidance/ Statements

Nuffield Council on Bioethics

• Nuffield Council on Bioethics
  • Topics – Health and Society: COVID-19
  • Health and society: COVID-19
  • Liberty, solidarity and the biopolitics of COVID-19 (1 April 2020).
  • Nuffield Council on Bioethics. Research in Global Health Emergencies. January, 2020.
  • Research ethics: Research in global health emergencies

Organisations

• All European Academies (ALLEA)
  • The European Code of Conduct for Research Integrity
• BBMRI-ERIC (European research infrastructure for biobanking)
  • BBMRI-ERIC Directory (biobank explorer)
• 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)
  • Calls for proposals.
  • CEPI publishes analysis of COVID-19 vaccine development landscape (9 April 2020).
• eClinical Forum (oa. eSource Readiness Assessment)
• European Bioinformatics Institute (EMBL-EBI)
• European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
  • COVID-19 Corona Virus updates
• 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
    • COVID-19 Taskforce
    • 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)
  • EUCROF CRO Platform
  • Legislations & Regulations
  • COVID-19 Pandemic: Information & Guidance
• 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)
  • Newsletter
• 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)
• France
  • Association Française de Pharmacologie Translationnelle (AFPT) – Le Club Phase I
• Germany
  • Arbeitsgemeinschaft für Angewandte Humanpharmakologie e.V. (AGAH) – Association for Applied Human Pharmacology
  • Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland (AKEK) – Association of Medical Ethics Committees (AKEK)
  • Bundesverband der Arzneimittel-Hersteller e.V. (BAH)
  • Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA) – Federal Association of Contract Research Organisations
  • Bundesverband der Pharmazeutischen Industrie e.V. (BPI)
  • Deutsche Hochschulmedizin e.V.
  • Verband Forschender Arzneimittelhersteller e.V. (vfa) – English
• 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)
    • 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.
  • Dutch Association of Research Quality Assurance (DARQA)
  • Dutch Clinical Research Foundation (DCRF)
    • COVID-19
      • DCRF enquête impact COVID-19 resultaten (management samenvatting), versie 1.2, d.d. 11 mei 2020.
    • Nieuwsbrief
  • Dutch Oncology Research Platform (DORP)
    • Clinical Trial Roadmap overview
    • Kennisbank – Documenten, tools, webinars
    • Toolkit Cohort studies
    • Handleiding Lekensamenvatting onderzoeksresultaten. Praktische handleiding voor het maken van een lekensamenvatting van de resultaten van (klinisch) wetenschappelijke studies, versie 2.0 d.d. 24-02-2021.
  • Dutch Techcentre for Life Sciences (DTL)
    • Nieuwsbrief
  • Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)
  • Commissie Regelgeving Onderzoek (COREON)
  • Federatie Medisch Specialisten
    • Overzichtspagina COVID-19
    • Richtlijnen, handreikingen, leidraden
    • Richtlijnendatabase
  • Goedzo data-ethiek
    • Dataethiek.info
  • Health-RI
    • COVID-19
      • Dutch Covid-19 Data Support Programme
      • COVID-19 related data initiatives
    • ELSI Servicedesk
    • Podium : Providing access to data
    • Personal Health Train: Making data interoperable
    • XNAT: Sharing Radiology images
  • Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG)
    • KNMG (juni 2004). Van wet naar praktijk. Implementatie van de WGBO. Deel 2 Informatie en toestemming. J.M.Witmer en R.P. de Roode (red.) (.PDF)
    • KNMG. Meerderjarige wilsonbekwamen
    • KNMG. Van wet naar praktijk: implementatie van de WGBO Deel 2. Informatie en toestemming (2004)
  • Nederlands Huisartsen Genootschap (NHG)
    • Dossier Coronavirus (COVID-19)
  • Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen (NKFK)
  • Netherlands Research Integrity Network (NRIN)
  • Nederlandse Vereniging voor Farmaceutische Geneeskunde (NVFG)
  • Nederlandse Vereniging voor Medische Oncologie (NVMO)
    • Dossier COVID-19
  • NVMETC
  • Regulatory Science Network Netherlands (RSNN)
    • Covid-19: Regulatory response to the public health crisis (31 March 2020).
• Patient Focused Medicines Development (PFMD)
  • Book of Good Practices 3rd edition
  • Coronavirus Resource Hub
  • Patient Engagement Management Suite
• TRANSVAC: European Vaccine Research and Development
• WIRB-Copernicus Group (WCG)
  • COVID-19 and Clinical Trial Operations

Research Infrastructures

• Association of European-level Research Infrastructure Facilities (ERF-AISBL)
  • Research Infrastructures and COVID-19 Research
• Conect4children – Collaborative Network for European Clinical Trials for Children
  • conect4children’s Podcast
• EATRIS – European infrastructure for translational medicine
  • COVID-19
    • Services to COVID-19 vaccine developers
• European Life Science Research Infrastructures
  • LS RIs Respond to COVID-19
• European Paediatric Translational Research Infrastructure
• Paediatric Clinical Research Infrastructure Network (PedCRIN)

Societies

• Society for Clinical Data Management (SCDM)
• Society for Clinical Research Sites (SCRS)
  • SCRS COVID-19 Resource Center
• Society of Critical Care Medicine (SCCM)
  • COVID-19
    • Critical Care for the Non-ICU Clinicians – Free Training for Non-ICU Clinicians
    • SCCM COVID-19 Journal Articles
    • Webcast series addresses clinical issues and questions related to the pandemic.

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).
  • 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.

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Behavioral sciences, Psychology

• American Psychiatric Association
  • American Psychiatric Association. Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry. 2013 Edition
  • APA Ethical Principles of Psychologists and Code of Conduct – (Effective date June 1, 2003 with amendments effective June 1, 2010 and January 1, 2017)
• 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
  • Code of Ethics for Research in the Social and Behavioral Sciences involving Human Participants
• Nederlands Instituut van Psychologen (NIP)
  • NIP – Algemene Standaard Testgebruik (AST-NIP 2017)
  • NIP – Beroepscode
  • NIP – Code of Ethics for Psychologists, 1 April 2007
  • NIP – Commissie Testaangelegenheden Nederland (COTAN)
  • NIP – COTAN Beoordelingssysteem voor de kwaliteit van tests, mei 2010
  • NIP – Onderzoek bij testkandidaten

Please use the contact form to report broken links, outdated information and missing webpages.

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Biobanking & Genetic research

Please use the contact form to report broken links, outdated information and missing webpages.

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Clinical Trial Registries, Clinical trial results reporting, Clinical trial trackers and viewers

Clinical Trial Registries

World Health Organization WHO ICTRP Clinical Trials Search Portal

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
  • FAMHP Clinical trials database (Belgium)
• Europese Unie
  • European Union Clinical Trials Register (EU-CTR)
  • EU PAS Register/ENCePP E-Register of Studies
• Nederland
  • CCMO-register
  • Netherlands National Trial Register (NTR)
• Overige landen
  • German Clinical Trials Register (DRKS)

Verenigde Staten

• ClinicalTrials.gov

Pre-Clinical Trials

• Preclinicaltrials.eu

Systematic reviews

• PROSPERO – International prospective register of 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

• All Trials Registered (AllTrials)
• Restoring Invisible & Abandoned Trials (RIAT)

Clinical trial trackers and viewers

Artis Ventures:

• Fight the Pandemic
• Diagnostics in development
• Treatments in development
• Vaccines in development

London School of Hygiene & Tropical Medicine

• COVID-19 vaccine development pipeline

Regulatory Focus

• COVID-19 Therapeutics Tracker
• COVID-19 Vaccine Tracker

STAT

• STAT’s Covid-19 Drugs and Vaccines Tracker.

Trial Insights

• Portfolio Summary: Covid-19 OR Coronavirus
• Trial Insights Data Sources

Trial Scope

• Coronavirus Clinical Trials

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.

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Communication

• Nederlands Huisartsen Genootschap (NHG)
  • Corona – inzet van digitale communicatiemiddelen en applicaties
•  Siilo
  • How Users are Working with Siilo to Address Covid-19
• Signal, for messages and calls

Please use the contact form to report broken links, outdated information and missing webpages.

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Data Protection

European Union (EU), General Data Protection Regulation (GDPR)

•  Brexit
  • Decision on the adequate protection of personal data by the United Kingdom (28 juni 2021).
• Directives & Regulations
  • GDPR: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC
• European Data Protection Board (EDPB)
  • GDPR: Guidelines, Recommendations, Best Practices
    • Guidance
      • Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak (21 April 2020).
    • Statements
      • Statement on the processing of personal data in the context of the COVID-19 outbreak (20 March 2020).
      • Statement of the EDPB Chair on the processing of personal data in the context of the COVID-19 outbreak (16 March 2020).
  • Other documents
• European Data Protection Supervisor (EDPS)
• Other informative documents
  • Marlon Domingus. (2021). Passende waarborgen (AVG) in wetenschappelijk onderzoek (Version 1). Zenodo.

International Association of Privacy Professionals (IAPP)

• COVID-19
  • COVID-19 Guidance and Resources
  • DPA guidance on COVID-19.
  • Infographic: IAPP Resources for COVID-19.
  • How is COVID-19 affecting privacy programs? A call for research action (10 April 2020).

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

— Joost Gerritsen (@JBAGerritsen) May 14, 2021

• Handreiking ontsluiten patiëntgegevens voor onderzoek: werken volgens de regels uit AVG, UAVG en WGBO (Juli 2019). Trimbos-instituut, MedLawconsult.
• KNMG
  • KNMG-richtlijn Omgaan met medische gegevens
• Medisch beroepsgeheim
  • Basisprincipes medisch beroepsgeheim (15 juni 2016). Ministerie van Volksgezondheid, Welzijn en Sport.

Tools

• DICOM Anonymizer – Drag ‘n Drop batch anonymization of DICOM data – for free.

Please use the contact form to report broken links, outdated information and missing webpages.

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Ethical Principles, Guidelines, Standards, Codes of Conduct

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 Nuremberg Code Nuremberg Code United States Holocaust Memorial Museum. “The Nuremberg Code” Holocaust Encyclopedia. https://encyclopedia.ushmm.org/content/en/article/introduction-to-the-holocaust. Accessed on [date]. The Belmont Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research The Belmont Report The Belmont Report, Appendix Volume I The Belmont Report, Appendix Volume II

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)
    • Notitie wetenschappelijke integriteit, 2001
  • 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
    • Netherlands Code of Conduct for Research Integrity (2018).
  • Stichting Code Geneesmiddelenreclame (CGR)
    • Gedragscode Geneesmiddelenreclame, Stichting Code Geneesmiddelenreclame (CGR)
    • Toetsing niet-WMO-plichtig onderzoek
  • Stichting Gedragscode Medische Hulpmiddelen (GMH)
    • Gedragscode Medische hulpmiddelen
  • Vereniging Innovatieve Geneesmiddelen
    • Code Vereniging Innovatieve Geneesmiddelen
    • Nieuwsbrief
  • Vereniging van Universiteiten (VSNU)
    • VSNU Nederlandse Gedragscode Wetenschapsbeoefening (2004, herziening 2012 en 2014)
    • VSNU The Netherlands Code of Conduct for Scientific Practice 2012

European Committee for Standardization (CEN) – European Committee for Electrotechnical Standardization (CENELEC)

• CEN CENELEC
  • CEN and CENELEC make European standards available to help prevent the COVID-19 contagion (20 March 2020).

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

• International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • ICH Guidelines

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)

• Pan American Health Organization (PAHO)
  • Documents
  • Publications

United Nations (UN)

• Universal Declaration of Human Rights (UDHR)
• “Universele Verklaring van de Rechten van de Mens”

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)
  • Digital Library
• World Commission on the Ethics of Scientific Knowledge and Technology (COMEST)
  • Digital Library

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.

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Funding

• Brexit
  • Q&A on the UK’s participation in Horizon Europe
• European Research Council
• Innovative Medicines Initiative
  • Apply for funding
• Marie Skłodowska-Curie Actions
• Netherlands
  • Health~Holland
  • Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO)
  • ZonMw
    • Coronavirus
    • Belangrijkste maatregelen.
    • Onderzoek naar corona en COVID-19
    • Wikipedia: ZonMw

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Good Practices (GxP)

Good Clinical Data Management Practices (GCDMP)

• SCDM: Good Clinical Data Management Practices (GCDMP©)

Good Clinical Practice (GCP)

Investigational Medicinal Products

• EMA: Good Clinical Practice
• ICH E6 (R2) Good clinical practice
• WHO
  • Workshop on good clinical practices in clinical trials and post-marketing surveillance (2007). WHO Regional Office for South-East Asia.
  • Handbook for good clinical research practice (‎GCP)‎ : guidance for implementation (2005). World Health Organization.
  • WHO guidelines on good clinical practice reviewed : current topics. WHO drug information 2001 ; 15(‎2)‎ : 71.
  • Proposed WHO guidelines for good clinical practice (‎GCP for trials on pharmaceutical products. WHO drug information 1992 ; 6(‎4)‎ : 170-188.

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 Clinical Laboratory Practice (‎GCLP)‎

• Ezzelle, J., Rodriguez-Chavez, I. R., Darden, J. M., Stirewalt, M., Kunwar, N., Hitchcock, R., Walter, T., & D’Souza, M. P. (2008). Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. Journal of pharmaceutical and biomedical analysis, 46(1), 18–29.
• The Global Health Network
  • Global Health Laboratories
    • Understanding the principles of Good Clinical Laboratory Practices (GCLP) – Training presentations (01-08-2014). Global Health Laboratories.
  • Course(s)
    • Good Clinical Laboratory Practice
      • Introduction to Good Clinical Laboratory Practice
• United Kingdom
  • Good Clinical Laboratory Practice (GCLP) (01-01-2009).
• WHO
  • UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. (‎2009)‎. Good clinical laboratory practice (‎GCLP)‎. World Health Organization.
• Wikipedia – Good clinical laboratory 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

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History of Clinical Trials

• The James Lind Library
• 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.

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Integrity

European Network of Research Ethics and Research Integrity (ENERI)

• European Network of Research Ethics and Research Integrity (ENERI)
  • COVID-19
    • The importance of research ethics and research integrity standards during the pandemic.

H2020 INTEGRITY Project

• H2020 INTEGRITY Project

SOPs4RI (Standard Operating Procedures for Research Integrity)

• SOPs4RI (Standard Operating Procedures for Research Integrity)
  • Research Integrity tools for RPOs
  • SOPs4RI Toolbox

Other

• The Hong Kong Principles for assessing researchers: Fostering research integrity. PLoS Biol. 2020 Jul 16;18(7):e3000737.

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Legal

• Blog
  • Medicaldeviceslegal (Erik Vollebregt)
• Journal, tijdschriften
  • European Data Protection Law Review
• Legal
  • Axon Lawyers
  • Legal Beetle (Joost Gerritsen)
  • MedLawConsult
    • Stichting MLC Foundation (MLCF)

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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
• European Union (EU)
  • Register of delegated and implementing acts
• Nederland
  • Beleidsregels gunstbetoon
    • Beleidsregels gunstbetoon Geneesmiddelenwet 2018
    • Beleidsregels gunstbetoon Wet medische hulpmiddelen
    • IGJ
      • Toezicht op gunstbetoon
      • Vragen en antwoorden verbod op gunstbetoon medische hulpmiddelen
      • Wat zijn geneesmiddelenreclame en gunstbetoon?
    • 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
        • Wetsvoorstel ‘Regels over de veiligheid en kwaliteit van medische hulpmiddelen (Wet medische hulpmiddelen)’
      • 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
        • Nieuwe wetgeving medische hulpmiddelen
  • Wet medisch-wetenschappelijk onderzoek met mensen (WMO)
    • niet-WMO plichtig onderzoek (vs. WMO plichtig onderzoek)
      • Toetsingskader Niet-WMO plichtig onderzoek (in beheer DCRF)
      • Definities
        • CCMO: Uw onderzoek: WMO-plichtig of niet?
        • CCMO-notitie reikwijdte gedragswetenschappelijk onderzoek
        • CCMO-notitie Definitie medisch-wetenschappelijk onderzoek
      • 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
      • ZonMw, Derde evaluatie Wet medisch-wetenschappelijk onderzoek met mensen, Den Haag: ZonMw april 2018. Reeks evaluatie regelgeving: deel 44.
      • ZonMw, Tweede evaluatie Wet medisch-wetenschappelijk onderzoek met mensen, Den Haag: ZonMw maart 2012. Reeks evaluatie regelgeving: deel 30.
  • Wet op het bevolkingsonderzoek (WBO)
    • Gezondheidsraad
      • Wet be­vol­kings­on­der­zoek: knel­pun­ten in de toe­pas­sing – voor­stel­len ter ver­be­te­ring. Den Haag: Ge­zond­heids­raad, 2009; pu­bli­ca­tienr. 2009/04WBO.
  • Wet op de geneeskundige behandelingsovereenkomst (WGBO)
  • Wet zeggenschap lichaamsmateriaal (Wzl)
    • Consultatie Wet zeggenschap lichaamsmateriaal
    • Geesink, I. & Steegers, C. (2009). Nader gebruik nader onderzocht. Zeggenschap over lichaamsmateriaal. Den Haag: Rathenau Instituut.

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Measurement instruments (questionnaires, surveys, rating scales, projective techniques, interview schedules, and tests)

• LUMC Walaeus Bibliotheek
  • Wallaeus Wegwijzers: Meetinstrumenten / Vragenlijsten / Tests
• Meetinstrumenten in de zorg
  Deze website geeft een overzicht van meer dan 400 vragenlijsten (PROMs), observatie- en performancetesten voor gebruik in de zorg.

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Medical Devices & In Vitro Diagnostic Medical Devices

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(Investigational) Medicinal Products

Wij willen dit onwenselijke gevolg voorkomen door gebruik te maken van de in artikel 13d opgenomen uitzonderingsmogelijkheid om bij algemene maatregel van bestuur te bepalen dat de verplichting dat geneesmiddelen voor onderzoek gratis door de verrichter ter beschikking moeten worden gesteld, niet geldt voor geneesmiddelenonderzoek met geregistreerde geneesmiddelen, ongeacht de dosering of de indicatie.

bron: Nadere Memorie van Antwoord (28 804) d.d. 02-09-2004

In artikel 19 van de bovengenoemde richtlijn is bepaald dat geneesmiddelen voor onderzoek gratis door de opdrachtgever ter beschikking moeten worden gesteld, tenzij de lidstaten precieze voorwaarden hebben vastgesteld voor uitzonderingsgevallen. Aan deze bepaling uit de richtlijn zou in eerste instantie invulling worden gegeven door middel van een algemene maatregel van bestuur. Omwille van de kenbaarheid voor het veld is echter op verzoek van de Eerste Kamer besloten tot opname in de wet.

In artikel 13d, onderdeel b, is als gevolg van deze wijziging bepaald dat de verplichting, dat geneesmiddelen voor onderzoek gratis door de verrichter ter beschikking moeten worden gesteld, niet geldt voor geneesmiddelenonderzoek met geregistreerde geneesmiddelen, ongeacht de dosering of de indicatie. Deze uitzondering zal met name ten goede komen aan het niet door de farmaceutische industrie gefinancierde onderzoek. Dit onderzoek betreft veelal het testen van bepaalde behandelmethoden waarvan ook geneesmiddelen deel uitmaken, met als doel deze methoden te verbeteren. Deze belangrijke vorm van geneesmiddelenonderzoek zou als gevolg van de wettelijke verplichting van de verrichter om de onderzoeksgeneesmiddelen gratis te verstrekken, mogelijk in gevaar komen. Dit onwenselijke gevolg wordt door middel van deze bepaling voorkomen. De financiering van de in dit soort onderzoek gebruikte geneesmiddelen zal geschieden op de wijze die reeds gebruikelijk is voor wijziging van de wet. Op grond van de informatie over onderzoek met geneesmiddelen die de centrale commissie medisch-wetenschappelijk onderzoek (CCMO) ontvangt, kan achteraf worden bekeken hoe vaak en door wie van deze uitzondering gebruik wordt gemaakt.

bron: Memorie van Toelichting (30 194) d.d. 04-08-2005

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

Medical Dictionary for Regulatory Activities (MedDRA)

• Medical Dictionary for Regulatory Activities (MedDRA)

RxISK

• RxISK – drug safety website (Data Based Medicine Americas Ltd.)

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Pediatric research

• Kind en onderzoek
  • Voor professionals

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Quality of research

Accreditation

• Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Bloedafnames, bloedsamples

• Richtlijnen voor bloed(-afnames)

Compliance

• Advarra
  • Coronavirus Guidance – Answers to Your Urgent Questions About the Research Impact of COVID-19

Consent

• Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial (3 April 2020). Journal of Empirical Research on Human Research Ethics.

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
  • The Clinical Endpoint Adjudication Handbook
  • Event Adjudication Charter Guide
  • Endpoint Adjudication Resources
  • Clinical outcomes, endpoints, primary, secondary, direct or surrogate (30 april 2019).

Endpoints, Outcomes

• COVID-19
  • COVID-19 Core Outcomes (COVID-19-COS)
• 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

• Multi-Regional Clinical Trials (MRCT) Center Brigham and Women’s Hospital and Harvard University
  • Li RH, Wacholtz MC, Barnes M, et al. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. Journal of Medical Ethics 2016;42:229-234.

Open Science, projectmanagement & data-sharing

• Directory of Open Access Journals (DOAJ)
• Open Science Framework (OSF)

Process map

• Clinical Trials Toolkit Routemap
• Global Health Research Process Map (.pdf)

Protocol violations, deviations

• Ethical GmbH
  • Manage the Protocol Deviation process faster, easier and more efficiently

Research ethics

• Altman D G. Statistics and ethics in medical research. Misuse of statistics is unethical. Br Med J 1980; 281 :1182 doi:10.1136/bmj.281.6249.1182.

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Radiological Protection & Non-Ionizing Radiation Protection

International Commission on Non-Ionizing Radiation Protection (ICNIRP)

• 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

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Regulatory Authorities

European Union (EU)

• Council of Europe
  • The Chair of the Committee of Convention 108 and the Data Protection Commissioner of the Council of Europe recall the principles of data protection in these times of fight against the COVID-19 pandemic (30 March 2020).
  • Saving lives, respecting data protection (30 March 2020).
• EU Science Hub
• European Centre for Disease Prevention and Control (ECDC)
  • COVID-19 pandemic
• European Commission (EC)
  • Advanced therapies
  • COVID-19
    • Coronavirus research
    • Monitor research landscape Covid 19
    • Coronavirus response: Public health
    • European Commission research actions on Coronavirus (Coronavirus factsheet) (March 2020).
  • Good Laboratory Practice (GLP)
  • Public health
• European Council
  • Conclusions by the President of the European Council following the video conference on COVID-19 (10 March 2020).
• European Directorate for the Quality of Medicines & HealthCare (EDQM).
• European network of paediatric research at the European Medicines Agency (Enpr-EMA)
  • EnprEMA Network Database
• European Medicines Agency (EMA)
  • Brexit: the United Kingdom’s withdrawal from the European Union
  • Clinical Data Publication
  • COVID-19
    • Coronavirus disease (COVID-19).
    • COVID-19 guidance: research and development
      • Guidance on remote GCP inspections during the COVID-19 pandemic.
      • 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.
    • COVID-19 vaccines: development, evaluation, approval and monitoring
    • COVID-19: What’s new
  • Clinical Trial Regulation
  • Conditional marketing authorisation
  • Medical devices
    • Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (21 october 2019).
    • Quality requirements for drug-device combinations
  • Paediatric investigation plans
  • Q&A: Good clinical practice (GCP)
• European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
  • EU PAS Register
• Heads of Medicines Agencies
  • Clinical Trials Facilitation Group (CTFG)
    • CTFG Activity Report 2008 – 2009
    • CTFG Activity Report 2010 – 2011
  • Link to National guidance on CT management during the COVID-19 pandemia
  • Documents
    • Brexit
      • Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU
      • VHP – Brexit and Christmas Break (October 2020)
      • VHP procedures in preparation and in case of a no-deal Brexit (14 June 2021).
    • Clinical Trial Regulation EU 536/2014
      • European Union Member States national pilot projects in support of the transition to the new Clinical Trial Regulation EU 536/2014 (October 2020).
      • Best Practice Guide for sponsors of transition multinational clinical trials (CTFG Version 24, April 2018)
    • Clinical Trials Safety
      • DSUR Q and As, 2012
      • Q&A document – Reference Safety Information, November 2017
      • Covering Note – Q&A Reference Safety Information, March 2018
    • COVID-19
      • Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (20 March 2020).
      • Link to National guidance on CT management during the COVID-19 pandemia
    • Guidance
      • Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials (12 February 2019).
      • Q and As on GLP (March 2017).
      • Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1 (21 september 2020).
    • National fees/information
      • Overview of the fees charged by NCAs for submission of different types of clinical trial or amendments (January 2012).
      • Q and As – Frequently asked questions on CTs (updated January 2012).
    • 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)

• International Coalition of Medicines Regulatory Authorities (ICMRA)
• COVID-19

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
  • Medicines Control Council (MCC)
  • South African Health Products Regulatory Authority (SAHPRA)
    • Clinical trials
    • Guidelines
  • SAHPRA Policy on Conduct of Clinical Trials of Health Products during the current COVID-19 Pandemic
  • South African Medical Research Council (SAMRC)
  • South African National Clinical Trials Register (SANCTR)

Asia

• Japan
  • Japanese Society of Quality Assurance (JSQA)
  • Pharmaceuticals and Medical Devices Agency (PMDA) [EN]
• Singapore
  • Health Sciences Authority (HSA)
  • The Singapore Statement on Research Integrity

Europe

• Austria
  • Austrian Federal Ministry of Education, Science and Research (BMBWF)
    • Best Practice Guide for Research Integrity and Ethics (October 2020).
  • Austrian Federal Office for Safety in Health Care (BASG)
    • Clinical trials
    • COVID-19
      • Clinical studies and COVID-19
      • Frequently Asked Questions
      • Häufige Fragen
• 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)
  • Federale overheidsdienst (FOD) Volksgezondheid, Veiligheid van de Voedselketen en Leefmilieu. CT-College (College Klinische Proeven).
    • CT-College: Implementation of CTR in Belgium and the ethical review process (12 December 2017)
  • Federale commissie voor embryo’s
• 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
    • Agence nationale de sécurité du médicament et des produits de santé (ANSM)
    • Commission nationale de l’informatique et des libertés (CNIL)
    • Institut national de la santé et de la recherche médicale (Inserm) [EN]
  • Organisations
    • French Quality Assurance Society – Société Française d’Assurance Qualité (SOFAQ)
• 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)
  • Organisations
    • BBMRI.de – German Biobank Node (GBN)
    • Covid-19: Gemeinsam gegen das Coronavirus
    • Covid-19: Arbeiten mit SARS-CoV-2-Proben
    • German Quality Management Association (GQMA) | English
    • KKS-Netzwerk e. V. – Koordinierungszentren für Klinische Studien / association of academic coordinating centres for clinical studies in Germany
  • Wet en regelgeving
    • Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte (Medizinprodukterecht-Durchführungsgesetz – MPDG)
• Greece – Εθνικός Οργανισμός Φαρμάκων (National Organization for Medicines)
• Hungary – Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) [EN]
• Ireland
  • Health Products Regulatory Authority – Clinical Trials
  • Medical devices – Clinical Investigations
• Italy
  • Agenzia Italiana del Farmaco (AIFA) / Italian Medicines Agency
    • COVID-19 Emergency
  • BBMRI.it
    • Biobancare per la ricerca COVID-19
  • Istituto Superiore di Sanità (ISS) / National Institute of Health
  • Garante per la protezione dei dati personali (GPDP) / Italian Data Protection Authority
• 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
      • Advies voor de uitvoering van klinisch onderzoek (23 maart 2021).
      • Informatie CCMO naar aanleiding van uitbraak coronavirus.
    • Model documenten/Standard research file
    • Notities
      • CCMO-notitie Stappenplannen inzake uitgestelde toestemming (‘deferred consent’) bij onderzoek in noodsituaties (25 February 2020).
    • Onderzoek met medische hulpmiddelen vanaf 26 mei 2021
    • Richtsnoeren/Leidraden
      • Leidraad voor erkende METC’s/CCMO voor de beoordeling van de meldingsprocedure van SAE’s aan de toetsingscommissie, 14 september 2015
      • Leidraad MDR: Review of a clinical investigation with a medical device – guidance document for MRECs (17 mei 2021).
  • College ter Beoordeling van Geneesmiddelen (CBG)
    • ‘Aanvraagprocedure toelating nieuw voedingsmiddel’
    • COVID-19
      • Column ‘Over medicijnen’: Waarom doen we zo moeilijk? (6 May 2020).
      • Speciaal wetenschappelijk advies voor onderzoek naar medicijnen tegen COVID-19 (23 April 2020).
      • Updates: vaccins en medicijnen tegen het coronavirus
    • ‘Melden van bijwerkingen tijdens klinisch onderzoek’
    • ‘Wetenschappelijk en regulatoir advies’
  • Inspectie Gezondheidszorg en Jeugd (IGJ)
    • COVID-19
      • Coronavirus (COVID-19): impact op het verrichten en uitvoeren van klinisch onderzoek dat onder de Wet medisch wetenschappelijk onderzoek met mensen (WMO) valt. Versie 5 (13 augustus 2020)
      • Voorwaarden (her)start klinisch onderzoek, inclusief klinisch onderzoek op CRU’s
    • Interventiebeleid medisch-wetenschappelijk onderzoek met mensen (28-09-2022)
      • Bestuurlijke boete
        • Besluit van de Minister van Volksgezondheid, Welzijn en Sport, de Minister voor Medische Zorg en de Staatssecretaris van Volksgezondheid, Welzijn en Sport van 19 april 2021, kenmerk 2342978-1006451-WJZ, houdende de wijziging van de Beleidsregels bestuurlijke boete Ministerie Volksgezondheid bestuurlijke boete Ministerie Volksgezondheid (28-04-2021).
        • Beleidsregel van de Minister van Volksgezondheid, Welzijn en Sport en de Staatssecretaris van Volksgezondheid, Welzijn en Sport van 1 december 2021, kenmerk 3282478-1019889-WJZ, houdende de wijziging van de Beleidsregels bestuurlijke boete Ministerie Volksgezondheid Welzijn en Sport 2019 (09-12-2021).
      • Bestuursdwang
    • ‘Medische technologie’
      • Achtergrond toezicht medische technologie
      • Klinisch onderzoek
        • A – Relevante wet en regelgeving
        • B – Het kader van klinisch onderzoek met medische hulpmiddelen
    • ‘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]
        • Overgangsbeleid heretiketteren of herverpakken bij klinisch onderzoek met geneesmiddelen
        • Wijzigingen WMO in 2021 en 2022
    • ‘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.
      • Croonen , H. (2009). Het donkere woud van fase-IV-onderzoek. Medische Contact, 2009(21) : http://medischcontact.artsennet.nl/Tijdschriftartikel/Het-donkere-woud-van-faseIVonderzoek.htm
    • Handreiking inzake status van producten voor onderzoek. voedingsmiddel of geneesmiddel voor onderzoek? IGZ, 17 december 2009
  • Nederlandse Voedsel- en Warenautoriteit (NVWA)
    • Handboek Voedings- en gezondheidsclaims
      • Handboek Voedings- en gezondheidsclaims (10 mei 2021). Keuringsraad.
• 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)
  • Ensaios clínicos
• Romania – National Agency for Medicines and Medical Devices of Romania (NAMMD)
  • COVID-19 Clinical Trials Information
• 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
  • Läkemedelsverket / Swedish Medical Products Agency
  • Swedish Association of Research Quality Assurance (SARQA)
• Switzerland – Swissmedic
  • Klinische Versuche

North America

• Canada
  • Canada
  • Canadian Association of Radiologists (CAR)
  • Government of Canada
  • Health Canada
    • Research Ethics Board: About the Health Canada and Public Health Agency of Canada REB
    • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)

Middle East

• Jordan – Jordan Food & Drug Administration
• Turkey – Türkiye İlaç ve Tıbbi Cihaz Kurumu / Turkish Medicines and Medical Devices Agency

Oceania

• Australia
  • Australian Clinical Trials
    • Australian Clinical Trials – for researchers
  • Australian Government – Department of Health
  • Clinical Trials Project Reference Group (CTPRG)
  • National Health and Medical Research Council (NHMRC)
  • Therapeutic Goods Administration (TGA)
  • The Royal Australian and New Zealand College of Radiologists (RANZCR)
• 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)

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Research Data Management

Clinical Data Interchange Standards Consortium (CDISC)

• Clinical Data Interchange Standards Consortium
  • What’s New
  • Standards
    • Therapeutic Areas
      • Interim User Guide – COVID-19.

(Clinical study) Data Repositories

• Clinical study data
  • ClinicalStudyDataRequest.com – Patient Level Data Request System
  • Vivli – Center for Global Clinical Research Data
    • Share your COVID-19-related Trials on the Vivli Portal
• 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
  • FORS
  • GESIS – Leibniz-Institut für Sozialwissenschaften
  • Journal of Open Psychology Data (JOPD)
  • PsychFileDrawer.org – Archive of Replication Attempts in Experimental Psychology
• Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA) Openbare Databank
• Open Science
  • ZENODO
  • Center for Open Science
    • Center for Open Science. Coronavirus Outbreak Research Collection.
    • COS Search term ‘covid-19’

Journals

• E-data & Research

Science Europe

• Practical Guide to the International Alignment of Research Data Management

Society for Clinical Data Management (SCDM)

• Society for Clinical Data Management
  • Collections: Good Clinical Data Management Practices (GCDMP©)
  • Journal of the Society for Clinical Data Management

Please use the contact form to report broken links, outdated information and missing webpages.

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Research output, Publications

Committee on Publication Ethics (COPE) Committee on Publication Ethics (COPE) Code of conduct and best practice guidelines for journal editors. Committee on Publication Ethics (2011) COPE Guidelines (website) Journals’ Best Practices for Ensuring Consent for Publishing Medical Case Reports, version 1, published december 2016. International Committee of Medical Journal Editors (ICMJE) Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors – June 2017 Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals

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

• Center for Open Science
  • Center for Open Science. Coronavirus Outbreak Research Collection.
  • COS Search term ‘covid-19’

European Commission

• Commission recommendation of 17.7.2012 on access to and preservation of scientific information

OECD

• Recommendation of the OECD Council concerning Access to Research Data from Public Funding
  • Making data for science as open as possible to address global challenges (20 januari 2021).

UNESCO

• Policy guidelines for the development and promotion of open access; 2012

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

• Nature: Editorial policies – Ethics and biosecurity

Reporting Guidelines

• EQUATOR Network
• EQUATOR Network – Enhancing the QUAlity and Transparency Of health Research (EQUATOR)
• Sex and Gender Equity in Research (SAGER) guidelines
  • Heidari, S., Babor, T.F., De Castro, P. et al. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev 1, 2 (2016).
• 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

• Factsheet – Salami Slicing (March 2019). Elsevier.

Systematic reviews

• PROSPERO – International prospective register of systematic reviews

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Training, education and practical

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

Q&A

Please use the contact form to report broken links, outdated information and missing webpages.

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United Kingdom (UK)

Research Application System

• Integrated Research Application System (IRAS)

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United States of America

Authorities & organisations

Centers for Disease Control and Prevention (CDC)

• Centers for Disease Control and Prevention (CDC)
  • COVID-19
    • Information for Laboratories about Coronavirus (COVID-19)
    • Guidelines
      • Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing
      • Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)
    • Information for Laboratories about Coronavirus (COVID-19)

National Academy of Sciences, Engineering, and Medicine

• Integrating Clinical Research into Epidemic Response: The Ebola Experience. 2017.

National Institutes of Health (NIH)

• National Institutes of Health (NIH)
  • COVID-19
    • Coronavirus (COVID-19)
    • NIH COVID-19 Research
  • Ethical Considerations for Zika Virus Human Challenge Trials. Report and Recommendations. 2017.
  • Grants & Funding
  • NIH and Other Federal Guidelines/Policies for Clinical Research (via NIAMS)
• NIH Pragmatic Trials Collaboratory – Rethinking Clinical Trials

U.S. Department of Health & Human Services (HHS)

• U.S. Department of Health & Human Services (HHS)
  • Office for Human Research Protections
    • OHRP Guidance on COVID-19

U.S. Food and Drug Administration (FDA)

• Clinical Trials Guidance Documents
• COVID-19
  • COVID MyStudies Application (App)
  • Google Play: COVID MyStudies [obsolete]
• FDA’s MyStudies Application (App)
  • FDA’s MyStudies Application (App) Technical Background
  • GitHub: FDA MyStudies Mobile Application System
• 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

• Federal Policy for the Protection of Human Subjects (the Common Rule): HHS regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and FDA human subject protection regulations.

Organizations and associations

• American Board of Radiology (ABR)
• American College of Physicians (ACP)
  • American College of Physicians Ethics Manual: Seventh Edition. (15 januari 2019). Annals of Internal Medicine.
• American College of Radiology (ACR)
• American Lung Association
• American Medical Association (AMA)
  • Code of Medical Ethics: Research & innovation
  • Release of Data from Unethical Experiments
• 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
  • Integrating Clinical Research into Epidemic Response: The Ebola Experience. 2017.
• Radiological Society of North America (RSNA)
  • Radiology of Coronavirus: Spectrum of imaging findings
  • RSNA Case Collection: Coronavirus Cases
  • Images in Radiology

Please use the contact form to report broken links, outdated information and missing webpages.

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Universities

• Johns Hopkins University
  • COVID-19 Research Response (guidance & communications)
• University of California San Francisco
  • COVID-19 Biospecimen Guidelines (15 March 2020).

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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).
    • 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.

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News

Events

Consultations