Clinical Research Policies and SOPs

Joint GU/MHRI Policies and Procedures

Policy MG.O-001 — Clinical Research Billing Compliance with Medicare Requirements (Version Date: 12/01/2021)

Policy MG.O-002 — OnCore Enterprise Research System (Version Date 12/01/2021)

Policy MG.O-003 — OnCore User Responsibilities (Version Date 12/01/2021)

Policy MG.O-004 — Investigator Responsibilities; Protecting the Rights, Safety and Welfare of Subjects (Version Date 03/23/20)

ORQA Policies and SOPs

Policy GU-ORQA-P01 — Quality Management Plan (Version Date Pending)

SOP GU-ORQA-P01.02 — SOP on SOP (Version Date 01/01/20)

SOP GU-ORQA-P01.03 — Corrective and Preventive Action (CAPA) (Version Date Pending)

SOP GU-ORQA-P01.04 — FDA Audits (Version Date 07/01/2021)

Policy GU-ORQA-P02 — Research Staff Competencies (Version Date Pending)

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

Policy GU-ORQA-P04 — Data Safety and Monitoring Board

  • SOP GU-ORQA-P04.01 — Lombardi Comprehensive Cancer Center –Data and Safety Monitoring Committee Procedures (Revised 11/29/2023)

Policy GU-ORQA-P05 — Clinical Research Operations (Version Date Pending)

  • SOP GU-ORQA-P05.02 — GU CLIA waiver (Version Date Pending)
  • SOP GU-ORQA-P05.03 — Documentation of CLIA waived test (Version Date Pending)