Data Safety Monitoring Boards (DSMB)

Large multi-centre trials use a Data and Safety Monitoring Board (DSMB) that monitors the trial. While the trial is in progress it will meet approximately once or twice per year. The researchers provide the DSMB with a report stating the number of participants recruited, the number of people who have withdrawn from the trial, side effects and early results. The committee will then make recommendations about whether the trial should continue, continue with some changes or be stopped. A Data and Safety Monitoring Board (DSMB) usually does not have the authority to stop a trial. DSMBs usually only recommend early stopping and the decision to do so or not rests with the Trial Management Committee. The DSMB will also inform the ethics committee of any important results. For a local trial, there is a person/s or committee with the expertise to advise the ethics committee about any serious adverse events in the trial.

Source: www.australiancancertrials.gov.au/about-clinical-trials/setting-up-a-clinical-trial.aspx

See also the NHMRC publication Data Safety Monitoring Boards (DSMBs) 2018 document for further guidance.

Guidelines and templates for researchers wanting to set-up a DSMB in the SLHD:

FDA Guidance for clinical trial sponsors. Establishment and operation of clinical trial data monitoring committees. US Department of Health and Human Services. Food and Drug Administration, March 2006 http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm
Notes for Guidance on Good Clinical Practice (TGA, 2000) website: https://www.tga.gov.au/publication/note-guidance-good-clinical-practice#.U0XyF63xuUk
DSMB Checklist
DSMB Sample Meeting Agenda