Getting Started Set Up Conduct Close Next Steps

As you prepare to conduct a clinical research study, it is important to identify the personnel that you will need to complete the tasks detailed in your protocol.

Here are some key questions to consider:

  • What skill sets will your staff members need in order to perform the required tasks?
  • Who will conduct screening procedures, collect and enter study data, and review data for completeness and accuracy?
  • How many hours will it take to complete these tasks?
  • What additional trainings are needed?

Once you have determined the scope of the work required for your project and outlined the study staff’s roles and responsibilities, this information can be entered into the protocol’s Regulatory Binder delegation of responsibility log.

In addition to study staff protocol-specific roles and responsibilities, principal investigators are ultimately responsible for managing their study funds. You must determine who on your study team or your department’s administrative staff will monitor your study funds to assure that expenses charged to the fund are correct and who will be responsible for correcting errors.

The Mass General Division of Clinical Research (DCR) provides fee-based Study Coordinator and Project Management services for those investigators who might need this support. Click here to see descriptions of DCR services.

Learn More

The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These resources include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCP programs are noted in parentheses.




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