Identify personnel required for study
- As you spell out your study procedures it is important to detail the study staff that you will need to complete your study tasks.
- It will be important to ask yourself: what are the skill sets that staff will need in order to perform the tasks required of the study? For example, if subject consent is needed, who will obtain it? Who will conduct screening procedures, collect and enter study data, review data for completeness and accuracy? How many hours will it take to complete these tasks?
- Once you have determined the scope of the work required for your project and study staff roles and responsibilities, this information is entered into the protocol’s Regulatory Binder Delegation of Responsibility Log.
- In addition to study staff protocol-specific roles and responsibilities, principal investigators are responsible for their study fund. You must determine who on your study team or your department’s administrative staff will monitor your study fund to assure that expenses charged to the fund are correct and who will be responsible for correcting errors.
▪ Operationalizing Clinical Research Protocols