Laws, regulations, and guidelines – by country

• Association for Good Clinical Practice in Nigeria (AGCPN)
• National Health Research Ethics Committee (NHREC)

• Medicines Control Council (MCC)
• South African Health Products Regulatory Authority (SAHPRA)
• South African Medical Research Council (SAMRC)
• South African National Clinical Trials Register (SANCTR)

Please use the “Contact” form to report broken links, outdated information and missing webpages.

• Australian Clinical Trials – for researchers
• Australian Government – Department of Health
• National Health and Medical Research Council (NHMRC)

• Massey University – Research ethics

Please use the “Contact” form to report broken links, outdated information and missing webpages.

• Directives & Regulations
  • ECTD: Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
  • ECTR: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
• Guidance documents
  • EudraLex ‘The rules governing medicinal products in the European Union’
    • Volume 4 – Good Manufacturing Practice (GMP) guidelines
    • Volume 10 – Guidelines for clinical trial
• Mandatory clinical trial registration
  • EU Clinical Trials Register
  • EudraCT : European Clinical Trial Database (EU)
• Pharmacoepidemiological study register
  • EU PAS Register

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

Belgium

• Lægemiddelstyrelsen

• Authorities
  • Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
  • 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 Society for Good Research Practice – Deutsche Gesellschaft für Gute Forschungspraxis (DGGF)

• Health Products Regulatory Authority – Clinical Trials

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

• Go to section “Health & Medical Research in the Netherlands”

Norway

• Statens legemiddelverk (NoMA) / Norwegian Medicines Agency

• Research Application System
  • Integrated Research Application System (IRAS)
• Autorities
  • Human Tissue Authority (UK)
  • Information Commissioner’s Office
    • Data sharing: a code of practice. 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
        • Guidance Notify the MHRA about a clinical investigation for a medical device
      • Manufacturing, wholesaling, importing and exporting medicines
        • Guidance Importing investigational medicinal products into Great Britain from approved countries
        • Guidance Supplying investigational medicinal products to Northern Ireland
      • Vigilance, safety alerts and guidance: detailed information
        • Guidance Completed Paediatric Studies – submission, processing and assessment
        • Guidance Format and content of applications for agreement or modification of a Paediatric Investigation Plan
  • National Institute for Health and Care Excellence (NICE)
  • NHS Health Research Authority (HRA)
• Funding
  • UK Research and Innovation (UKRI)
• Guidance
  • NIHR Clinical Trials Toolkit
  • NIHR Clinical Trials Toolkit: GCP & Serious Breach Reporting
• Organisations
  • Association of the British Pharmaceutical Industry (ABPI)
  • Research Quality Association (RQA)
  • UK Research Integrity Office (UKRIO)
    • Newsletters

Please use the “Contact” form to report broken links, outdated information and missing webpages.

• Canada
• Canadian Association of Radiologists (CAR)

• Authorities & organisations
  • Centers for Disease Control and Prevention (CDC)
    • COVID-19
      • Information for Laboratories
      • Resources for Laboratories Working on 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)
    • 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)
  • 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
    • 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
• Clinical trial registration
  • ClinicalTrials.gov
• 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.
• Medical associations and organizations
  • 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)
  • 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
  • Radiological Society of North America (RSNA)

Please use the “Contact” form to report broken links, outdated information and missing webpages.

South America

Please use this form to report broken/missing links.