Index
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Worldwide
An useful document is the International Compilation of Human Research Standards. It contains an overview of laws, regulations and guidelines from more than 100 countries and organisations.
Internationaal
- Nuremberg Code
- Cochrane Collaboration
- Council for International Organizations of Medical Sciences (CIOMS)
- International Commission on Non-Ionizing Radiation Protection (ICNIRP)
- International Coalition of Medicines Regulatory Authorities (ICMRA)
- International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- International Organization for Standardization (ISO)
- Medical Dictionary for Regulatory Activities (MedDRA)
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
- Organisation for Economic Co-operation and Development (OECD)
- OECD Best Practice Guidelines for Biological Resource Centres (2007)
- OECD ‘Good Laboratory Practice (GLP)’
- OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
- OECD Guidelines on Human Biobanks and Genetic Research Databases 2009
- OECD report Best Practices for Ensuring Scientific Integrity and Preventing Misconduct, 2007
- Pan American Health Organization (PAHO)
- UNESCO/International Bioethics Committee
- Unicef
- United Nations
- United Nations Educational, Scientific, and Cultural Organization (UNESCO)
- Code of Conduct and Ethical Guidelines for Social Science Research
- International Declaration on Human Genetic Data: Section 22 of Major Programme III – Social and Human Sciences (2003)
- Statement on COVID-19: ethical considerations from a global perspective
- Universal Declaration on Bioethics and Human Rights (2005)
- Universal Declaration on the Human Genome and Human Rights Section 16 of III Programme for 1998 – 1999 (1997)
- World Health Organization (WHO)
- Development of the TDR global competency framework for clinical research
- Epidemic Intelligence from Open Sources (EIOS)
- International Clinical Trials Registry Platform (ICTRP)
- Nuremberg code turns 60. Bulletin of the World Health Organization, Volume 85, Number 8, August 2007, 569-648.
- REGTRAC: The WHO Database of Regulatory Information Tracking of Clinical Trials Registration & Ethics Committees
- Resolution WHA 58.34 (2005)
- The WHO Ethics Review Committee (ERC)
- COVID-19
- Country & Technical Guidance – Coronavirus disease (COVID-19)
- Coronavirus disease (COVID-19): Vaccines (Q&A).
- Coronavirus disease (COVID-19): Vaccine research and development (Q&A)
- Ethics and COVID-19: resource allocation and priority-setting (20 April 2020).
- Global research on coronavirus disease (COVID-19)
- R&D Blueprint and COVID-19. Coronavirus disease (COVID-2019).
- Guidance
- Ethics
- Ethical Standards for Research During Public Health Emergencies: Distilling Existing Guidance to Support COVID-19 R&D. 2020.
- Guidelines on Ethical Issues in Public Health Surveillance (2017)
- Ethical Considerations for Use of Unregistered Interventions for Ebola Viral Disease: Report of an Advisory Panel to WHO. 2014.
- Ethical Issues in Patient Safety Research: Interpreting Existing Guidance (2013)
- Standards and Operational Guidance for Ethics Review of Health – Related Research with Human Participants (2011)
- Handbook for good clinical research practice (GCP) : guidance for implementation (2005)
- Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
- Laboratory tests, Biospecimens
- Laboratory testing for coronavirus disease (COVID-19) in suspected human cases: interim guidance (19 March 2020).
- Laboratory biosafety guidance related to coronavirus disease (COVID-19): interim guidance (19 March 2020).
- Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus: interim guidance (2 March 2020)
- Laboratory testing of human suspected cases of novel coronavirus (nCoV) infection: interim guidance (10 January 2020)
- Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research (2003)
- Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens (1997)
- Research
- Core Protocol for vaccines against COVID-19 (17 April 2020).
- Overview of the types/classes of candidate therapeutics (21 March 2020).
- COVID-19 Therapeutic Trial Synopsis (18 February 2020).
- Outline of trial designs for experimental therapeutics (27 January 2020).
- Outline of designs for experimental vaccines and therapeutics (20 January 2020).
- Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)
- Clinical management,Vaccination
- Guiding principles for immunization activities during the COVID-19 pandemic (24 April 2020).
- Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected, Interim guidance (13 March 2020).
- Vaccination in Acute Humanitarian Emergencies. A Framework for Decision Making. May 2017.
- Ethics
- World Medical Association (WMA)
- Human, D. & Fluss, S.S. (2001). The World Medical Association’s Declaration of Helsinki: Historical and Contemporary Perspectives.
- WMA Declaration of Geneva, amended by the 68th WMA General Assembly, Chicago, United States, October 2017
- WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 64th WMA General Assembly, Fortaleza, Oct 2013
- WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, revised by the 67th WMA General Assembly, Taipei, Taiwan, October 2016
- WMA Declaration on Medical Ethics and Advanced Medical Technology, revised by the 63rd WMA General Assembly, Bangkok, Thailand, October 2012
- WMA Statement on Animal Use in Biomedical Research, reaffirmed by the 203rd WMA Council Session, Buenos Aires, Argentina, April 2016
- WMA Statement on Embryonic Stem Cell Research, 60th WMA General Assembly, New Delhi, India, October 2009
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Animal research
- European Consensus-Platform for Alternatives (ecopa)
- National Centre for the 3Rs (NC3Rs)
- Norway’s National Consensus Platform (Norecopa)
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Biobanking & genetics
- BBMRI-NL
- BBMRI-ERIC – European research infrastructure for biobanking
- Biobanken
- European Science Foundation (ESF)
- Human Genome Organisation
- Imagined Futures: Capturing the Benefits of Genome Sequencing for Society, December 2014
- International code of conduct for genomics and health-related data sharing, June 2014
- Statement on Benefit Sharing, April 2000
- Statement on Cloning, March 1999
- Statement on DNA Sampling: Control and Access (February 1998)
- Statement on Gene Therapy Research (April 2001)
- Statement on Human Genomic Databases (December 2002)
- Statement on Stem Cells, November 2004
- Statement on Supreme Court: Genes are not patentable, June 2013
- Statement on the Principled Conduct of Genetic Research (December 1995)
- The Human Genome Organisation: towards next generation ethics, April 2013
- Human Tissue Authority (UK)
- International Society for Biological and Environmental Repositories (ISBER)
- Public Population Project in Genomics (P3G) – research project of the Centre of Genomics and Policy (CGP) (McGill University)
- Vereniging Samenwerkende Ouder- en Patiëntenorganisaties (VSOP)
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Clinical Trial Registries
- Europa
- Verenigde Staten
- World Health Organization
- Overig
- Australian New Zealand Clinical Trials Registry (ANZCTR)
- Brazilian Clinical Trials Registry (ReBec)
- Chinese Clinical Trial Registry (ChiCTR)
- Clinical Research Information Service (CRiS), Republic of Korea
- Clinical Trials Registry – India (CTRI)
- Cuban Public Registry of Clinical Trials (RPCEC)
- Iranian Registry of Clinical Trials (IRCT)
- ISRCTN Register
- Japan Primary Registries Network (JPRN)
- Pan African Clinical Trial Registry (PACTR)
- PROSPERO – International database for prospective registration of systematic reviews
- Sri Lanka Clinical Trials Registry (SLCTR)
- Thai Clinical Trials Registry (TCTR)
- Commercieel/Industrie
- Bayer Clinical Trials
- Boehringer Ingelheim Ongoing & Completed Studies
- Eli Lilly and Company Clinical Trial Registry
- Genzyme Clinical Trials & Results
- GSK Clinical Study Register
- Novartis: Clinical trials
- Roche Clinical Trial Protocol Registry and Results Database
- Sanofi Pharma & Sanofi Pasteur Clinical study results
- Takeda Clinical Trials
- UCB Sponsored Clinical Studies
- ViiV Healthcare Clinical Study Register
- Pre-Clinical Trials
- Systematic reviews
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Clinical trial results reporting
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Data Protection
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Data Repositories
- ClinicalStudyDataRequest.com – Patient Level Data Request System
- Dryad Digital Repository
- Dutch Dataverse Network
- EASY – online archiving system of Data Archiving and Networked Services (DANS)
- figshare
- FORS
- GESIS – Leibniz-Institut für Sozialwissenschaften
- Harvard Dataverse Network
- Journal of Open Psychology Data (JOPD)
- OpenfMRI
- Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA) Openbare Databank
- PsychFileDrawer.org – Archive of Replication Attempts in Experimental Psychology
- re3data.org – Registry of Research Data Repositories
- YODA Project (Yale University)
- ZENODO
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(Investigational) Medicinal Products
- Good Manufacturing Practice (GMP)
- RQA – Good Manufacturing Practice (GMP) Committee
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Medical Devices
- International Medical Device Regulators Forum (IMDRF)
- Statement Regarding Use of ISO 14155:2011 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice ” (2015)
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Organisations
- Association of Clinical Research Organizations (ACRO)
- Association of Clinical Research Professionals (ACRP)
- Clinical Data Interchange Standards Consortium (CDISC)
- Clinical Trials Transformation Initiative (CTTI)
- Coalition for Epidemic Preparedness Innovation (CEPI)
- Cochrane
- Decentralized Trials and Research Alliance (DTRA)
- Drug Information Association (DIA)
- Global Infectious Diseases and Epidemiology Network (GIDEON)
- Global Research Collaboration for Infectious Disease Preparedness (GloPID-R)
- International Association of Privacy Professionals (IAPP)
- Internation Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
- International Pharmaceutical Federation (FIP)
- Nuffield Council on Bioethics
- Patient Focused Medicines Development (PFMD)
- RxISK – independent drug safety website
- Society for Clinical Data Management (SCDM)
- Society for Clinical Research Sites (SCRS)
- Society of Critical Care Medicine (SCCM)
- TransCelerate BioPharma Inc.
- 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).
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Publications
- Committee on Publication Ethics (COPE)
- International Committee of Medical Journal Editors (ICMJE)
- International DOI Foundation (IDF)
- Open Access
- European Commission
- OECD
- UNESCO
- Publication of negative results
- Systematic reviews
- Tilburg University – Bronvermelding volgens de richtlijnen van de APA (.pdf)
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Quality of research
- Accreditation
- Bloedafnames, bloedsamples
- 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
- Multi-Regional Clinical Trials (MRCT) Center Brigham and Women’s Hospital and Harvard University
- IDEAL: The IDEAL Collaboration – Idea, Development, Exploration, Assessment, Long-term follow-up
- SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
- Open Science, projectmanagement & data-sharing
- Process map
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- TRIPOD
- Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): The TRIPOD Statement (6 januari 2015). Ann Intern Med.
- Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD): Explanation and Elaboration (6 januari 2015). Ann Intern Med.
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Research Data Management
- Clinical Data Interchange Standards Consortium
- Science Europe
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Research Integrity
- SOPs4RI (Standard Operating Procedures for Research Integrity)
- The Hong Kong Principles for assessing researchers: Fostering research integrity. PLoS Biol. 2020 Jul 16;18(7):e3000737.
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Training, education and practical
- Books
- Catalogue of Bias. Centre for Evidence-Based Medicine.
- Consent for publication. A best practice guide for authors. BMJ.
- Courses and training
- Collaborative Institutional Training Initiative (CITI Program)
- Coursera
- GCP Central
- Elevate
- European Compliance Academy (ECA) – GMP/GDP
- Johns Hopkins University
- National Institutes of Health (NIH)
- Paul Janssen Futurelab Leiden
- Stanford Online
- The Global Health Network
- Informative
- Practical toolbox
- EDGAR – Experimental Design Generator And Randomiser On-line software to randomise simple experimental designs.
- Free Statistics Calculators
- GPOWER: A general power analysis program
- On-line Statistical Power Calculator. – Java applets for power and sample size
- Simple Interactive Statistical Analysis – SISA allows you to do statistical analysis directly on the Internet
- SPSS
- StatTools
- The R Project for Statistical Computing
- UCLA Statistical Calculators
- Good Practice Cases
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