You may wish to conduct a needs assessment in advance to determine your human resource requirements to perform the study. For example, how much work will this study entail and what sort of training is required? For Health Canada-regulated clinical trials, you are required to conduct this needs assessment prior to hiring staff.
You are legally obligated to ensure that both you and your staff have sufficient time to conduct the trial and that all personnel affiliated with the trial are sufficiently trained for their position and their duties during their trial. Advancing Health can help you with this assessment. We also have many qualified research coordinators/assistants on staff who may be able to provide assistance. Contact email@example.com for further information.
Defining Roles And Responsibilities
If you are acting as a sponsor-investigator for a multi-centre study, or you are receiving some support from an industry partner, it is suggested to document who is responsible for each study activity. This is often required when negotiating a contract with another institution.