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Roles & Responsibilities — Pre-study Start-up

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
Primary Contact

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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

RMG

  • 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

OSR Contracts

  • As needed, advises on confidentiality agreements
  • OSR will sign off as institutional representative, if required by the sponsor

Spectrum

  • 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.