Stanford

Roles & Responsibilities — Administrative Process Initiation

Set-Up Your Study

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.

RMG

  • 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.