Guidelines on Data Monitoring Committees
De pagina ‘International Guidelines‘ is uitgebreid met een set richtlijnen die betrekking hebben op Data Monitoring Committees (DMC).
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
*update 12 mei 2018: Alle NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials zijn nu samengebracht op één pagina.