How do I know when to use a Data and Safety Monitoring Plan versus a Data and Safety Monitoring Board?
The simple answer to this question is that data and safety monitoring plans (DSMP) are usually appropriate for phase I and II clinical trials whereas a data and safety monitoring board (DSMB) is required for a phase III trial. Certain phase I or II clinical trials may use research strategies or involve vulnerable populations that require a DSMB. See the following guides and decision trees to aid in making this decision. In addition, local institutional review boards often have criteria that must also be considered.
