Roles & Responsibilities — Administrative Process Initiation
The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.
This stage includes activities in areas such as:
- contracts & grant proposals
- IRB approval
- research management compliance
- study budgeting & billing
- required registration of trial
ROLES & RESPONSIBILITIES — ADMINISTRATIVE PROCESS INITIATION
PI and/or Study Coordinator
- Prepares IRB submission
- Negotiates consent form with sponsor
- IRB notifies RMG of submission.
- PI resolves conflicts of interest if necessary, responds to IRB.
- Receives notification from IRB of application submission or from PI of new study.
- Obtains copies of IRB application as needed.
- Reviews study protocol and informed consent to be sure study qualifies for CT F&A (Facilities and Administrative Cost Rates), and to determine if a contract is necessary.