Trial oversight committees
The QA plan should have identified what trial oversight committees are to be implemented. The committees should now be formed and guidelines drafted on meeting schedules and responsibilities. For similar information see the Quality Assurance process box.
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Great resource !!
Does anyone have any experience or tips for how to set up a DSMB in an African institution? Many institutions seem to have good capacity to run GCP clinical trials, but very often the DSMBs for all these trials are in the USA or Europe, and capacity has not been built in African institutions for running a DSMB.
Hi Merlin - thanks for your question. You might find some more information from this group - http://mrct.globalhealth.harvard.edu/pages/data-safety-monitoring-committee-project
This paper might also be of interest: Data safety and monitoring boards for African clinical trials, Transactions of the Royal Society of Tropical Medicine and Hygiene
Volume 102, Issue 12, December 2008, Pages 1189–1194