It is the investigator’s responsibility to ensure that all research personnel are trained appropriately and in a timely manner for all aspects of the clinical trial for which they are accountable. Training may include, but is not limited to, the following topics:
Data collection, maintenance and storage
Drug dispensing, accountability, and destruction
Management and reporting of Adverse Events (AE), Serious Adverse Events (SAE), Unanticipated Adverse Device Effects (UADE), and Unanticipated Problems (UaP), and other reportable occurrences
It is important to provide documentation that training has been provided. Standard Practice Guidelines for the documentation of the training might include the use of training logs or agendas. It is also important to maintain the appropriate level of training throughout the course of the clinical trial in order to accommodate changes in the protocol, work process, and the use of new equipment or technology.
Contact us at MICHR-SPGSupport@umich.edu.