Committee on Publication Ethics (COPE)
Consolidated Standards of Reporting Trials (CONSORT)
Council for International Organizations of Medical Sciences (CIOMS)
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
Enhancing the QUAlity and Transparency Of health Research (EQUATOR)
Good Manufacturing Practice (GMP)
Human Biobanks and Research Databases
International, accreditation
International, blood
International Ethics
International, publication
International Commission on Non-Ionizing Radiation Protection (ICNIRP)
International Committee of Medical Journal Editors (ICMJE)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
International Medical Device Regulators Forum (IMDRF)
International Society for Biological and Environmental Repositories (ISBER)
Organisation for Economic Co-operation and Development (OECD)
Organisations and associations
- Dutch Association of Research Quality Assurance (DARQA)
- European Forum for Good Clinical Practice (EFGCP)
- European Network of Research Ethics Committees (EUREC)
- European Quality Assurance Confederation (EQAC)
- French Quality Assurance Society – Société Française d’Assurance Qualité (SOFAQ)
- German Society for Good Research Practice – Deutsche Gesellschaft für Gute Forschungspraxis (DGGF)
- Japanese Society of Quality Assurance (JSQA)
- Research Quality Association (RQA)
- Society of Quality Assurance (SQA)
- Swedish Association of Research Quality Assurance (SARQA)
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
The Cochrane Collaboration
The IDEAL Collaboration
World Health Organization (WHO)
World Medical Association (WMA)
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