Clinical Research Policies, Procedures, and Guidance

Joint GU/MHRI Policies and Procedures

OnCore User Responsibilities

GU ORQA Policies and SOPs

  • Research Staff Competencies
    • Policy GU-ORQA-P02(Pending)
  • Onboarding of Clinical Research Staff
    • SOP GU-ORQA-P02.01 (Pending)
  • Institutional Delegation of Authority
    • SOP GU-ORQA-P02.02 (Pending)
  • SOP Training
    • SOP GU-ORQA-P02.03 (Pending)
  • Documentation of Protocol Training
    • SOP GU-ORQA-P02.04 (Pending)

  • Data Safety and Monitoring Board
    • Policy GU-ORQA-P04
  • Lombardi Comprehensive Cancer Center –Data and Safety Monitoring Committee Procedures

  • Clinical Research Operations
  • Assessing Study Feasibility
  • Attachment A Feasibility Checklist
  • GU CLIA waiver
    • SOP GU-ORQA-P05.02 (Pending)
  • Documentation of CLIA waived test
    • SOP GU-ORQA-P05.03 (Pending)

Guidance Documents