Research Staff Training Standard Practice Guideline

A guide to documenting training sessions diligently and keeping a team’s skills sharp with ongoing updates throughout a study’s lifecycle

What is this resource?

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:

• Subject consent
• Data collection, maintenance and storage
• Regulatory reporting
• Drug dispensing, accountability, and destruction
• Intervention/Interaction procedures
• 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.

How this advances translational science

Implementing best practices in trainings to sustain a talented workforce.