Overview & Instructions

Protocol Assessment

  1. Desirability
  2. Feasiblity

Initial Planning

  1. Prepare Document Summary Sheet (DSS) by completing the eProposal on the Campus Information System webpage and submit electronically to the Office of Sponsored Projects (OSP). The DSS may be prepared by the Principal Investigator, study coordinator, or administrative staff. The budget area of the DSS is an estimate only.
  2. Prepare Detailed Internal Budget and Classify Patient Care Costs
    • Review Protocol
    • Complete Protocol Billing Grid
    • Determine Technical & Professional prices for research related Patient Care procedures, see How to Acquire Pricing
    • Develop Detailed Internal Budget
    • Negotiate budget with Sponsor if necessary
    • Submit final Detailed Internal Budget and Budget Summary to OSP 
  3. Contractual*
    • Clinical Service Agreement (to be negotiated and signed by OSP)
    • Confidentiality Disclosure Agreement (to be negotiated and signed by the OSP)
  4. Regulatory and Compliance Documents*
    • Prepare and submit IRB application
    • Attach completed Protocol Billing Grid to Other Documents under the Documents Attachments page of the Application in ERICA
    • Prepare and submit other required regulatory paperwork (CCIC, Biosafety)
    • Obtain IRB approval and submit copy of approval to OSP
    • Compile Licenses and CVs of all study personnel
    • Complete any required forms (Form 1572, Conflict of Interest)
  5. Enter Study into uTRAC

Study Performance

  1. Recruitment & Enrollment
  2. Study Performance and Documentation
    • Perform protocol required tasks
    • Complete study required documentation (Case Report Forms, reports)
    • Financial Management
      • Charge Study Personnel time to project
      • Charge all study costs to project
      • Invoice sponsor
      • Reconcile sponsor reimbursement
      • Reconcile Patient Care charges
      • Review monthly Management Reports
  3. Complete Quarterly and Final Reports as required by protocol

Study Closeout

  1. Final report to IRB
  2. Final reconciliation of project
  3. Transfer residual funds

Store Study Related Documentation as required by FDA and/or contract.

*See Checklist of documents which are required prior to performing a clinical research trial.