In general, most trials require a Data Safety and Monitoring Committee or Board (DSMB). The typical exceptions are for open, single arm trials and for those investigating a very safe and well known intervention. Additionally, if the trial is being run over a very short period it might not be practical to set up a DSMB. Sample DSMB charters and guidance notes are here.
If a DSMB is not being put in place this should be explained in the protocol. Normally, local safety monitors will take on the tasks of DSMB in such trials. Supporting and guidance documents for safety committees can be found here. You will find guidance on the composition of a DSMB, how to write a DSBM charter and how to plan for safety analysis.
All trials will need an independent safety monitor. This should be a locally based clinician, who is not working on the trial and who is experienced in the disease area and patient population being studied. The safety monitor should be willing to have their contact details made available (and therefore be reachable!) to the participants.
Ethics committees require an annual safety report and immediate notification of either Suspected Unexpected Serious Adverse Reactions (SUSARs) or all Serious Adverse Events (SAEs). National regulatory bodies might also require reports of SUSARs and SAEs.
To view and download Safety Reporting templates such as AE records, Safety SOPs, SAE Logs etc, visit our extensive Templates library.
This article originally appears on the Global Health Trials resources. Please visit us for more resources relating to trials.