Roles & Responsibilities — Pre-study Start-up
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 AND RESPONSIBILITIES — PRE-STUDY START-UP
PI and/or Study Coordinator:
- Coordinates submission of FDA 1572 form
- Signs confidentiality agreements (PI)
- Participates in Investigator/start-up meeting
- Receives protocol from sponsor
- Assesses study feasibility – staff, facilities, etc.
- For PI-initiated studies, consults with RMG to create a budget proposal to submit to an industry sponsor
- For PI-initiated studies, works through Spectrum Study Navigator to obtain services as needed
- As needed, advises on feasibility or other requests
- May prepare a feasibility budget prior to IRB submission, if requested by the PI/coordinator
- For PI-initiated studies, develops budget and reviews proposal for submission
- As needed, advises on confidentiality agreements
- OSR will sign off as institutional representative, if required by the sponsor
- As needed, offers training and advice on study start-up, IRB preparation, hospital contacts, sponsor interactions.
- Conducts Coordinator orientation.
- For PI-initiated studies, provides biostatistical, informatics, and ethics consultations.