Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards
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These Operational Guidelines are intended to provide international guidance to health research sponsors for the establishment and functioning of data and safety monitoring boards (DSMBs). The guidelines are based on a review of the existing guidances and requirements for DSMBs from national and international organisations, as well as on observation of existing practices of DSMBs in countries and institutions around the world.
Ethical and scientific standards for carrying out biomedical research on humans have been developed and established in international guidelines, including the Declaration of Helsinki, the Council of International Organisations of Medical Sciences (CIOMS) international ethical guidelines for biomedical research involving humans, and the World Health Organization (WHO) and International Conference on Harmonisation (ICH) guidelines for good clinical practice. The WHO/Special Programme for Research and Training in Tropical Diseases (TDR) operational guidelines for...
KeywordsSafety Monitoring Operational Guideline Independent Consultant Closed Session Unblinded Data
Comments and suggestions on all aspects of these Operational Guidelines are welcome for consideration in future revisions of this document.
Please correspond with Dr Juntra Karbwang, Clinical Coordinator, TDR, World Health Organization, CH-1211 Geneva 27, Switzerland, or e-mail email@example.com