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)

• Procedure MG.O-001.01 — OnCore Pathway to Billing Compliance (Version Date: 12/01/2021)

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

• Procedure MG.O-002.01 — OnCore Protocol Numbering (Version Date 12/01/2021)
• Procedure MG.O-002.02 — OnCore Required Data Fields (Version Date 12/01/2021)
• Procedure MG.O-002.03 — OnCore Subject Visit Tracking (Version Date 12/01/2021)

• Procedure MG.O-002.04 — OnCore Study Initiation (Version Date 12/01/2021)

• Procedure MG.O-002.05 — Registering a New Subject in OnCore (Version Date 12/01/2021)
• Procedure MG.O-002.06 — OnCore Subject Record Merge (Version Date 12/01/2021)

• Procedure MG.O-002.07 — OnCore Study Closure (Version Date 12/01/2021)

• Procedure MG.O-002.08 — OnCore and MedConnect Integration (Version Date 12/01/2021)

• Procedure MG.O-002.09 — OnCore Financial Events (Version Date 12/01/2021)

• Procedure MG.O-002.10 — OnCore Calendar and Budget Updates (Version Date 12/01/2021)

• Procedure MG.O-002.11 — OnCore Subject Visit Variations (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)

• Glossary MG.O-004.G — MedStar Georgetown Procedure Glossary (Version Date 03/23/2020)

• Procedure MG.O-004.01 — Informed Consent Process and Documentation (Versions Date 4/30/20)
  • Job Aide MG.O-004.01 JA1— Informed Consent Process and Documentation Version Date 4/30/20)
  • Job Aide MG.O-004.01 JA2 — Uploading Signed Informed Consent to MedConnect (Version Date 4/30/20)

• Procedure MG.O-004.02 — Consenting English-Speaking Illiterate and Legally Blind (Version Date 4/30/20)
  • Job Aide MG.O-004.02 JA1 — Consenting English Speaking Illiterate and Legally Blind Subjects (Version Data 4/30/20)

• Procedure MG.O-004.03 — Consenting Non-English Speaking (Version Date 4/30/20)
  • Job Aide MG.O-004.03 JA1— Consenting Non-English Speaking Subjects (Version Date 4/30/20)

• Procedure MG.O-004.04 — Re-Consenting (Version Date 4/30/20)
  • Job Aide MG.O-004.04 JA1— Re-Consenting Research Subjects (Version Date 4/30/20)

• Procedure MG.O-004.05 — Obtaining Consent from the Surrogate (Version Date Pending)
  • Job Aide MG.O-004.05 JA1 — Obtaining Consent for Research from a Surrogate (4/30/20)

• Procedure MG.O-004.06 — Remote Informed Consent and Documentation (Version Date 4/30/20)
  • Job Aide MG.O-004.06 JA1 — Remote Informed Consent Process and Documentation (Version Date 4/30/20)
  • Form MG.O-004.06 FM1 — Person Obtaining Consent Attestation Form (Version Date 4/30/20)
  • Form MG.O-006.06 FM2 — Witness Signature and Attestation Form (Version Date 4/30/2020)
• Procedure MG.O-004.07 — Obtaining Electronic Consent (eIC) with Interlace Health Patient Intake Solution (Version 11/15/2021)

• Procedure MG.O-004.08 — Sponsor Monitoring Visit (Version Date 12/20/2020)

• Procedure MG.O-004.09 — Requesting Restricted Access for Research Monitor to MedStar Network (Version Date 03/23/2020)
  • Form MG.O-004.09 FM1 – Requesting Restricted Access for Research Monitor to MedStar Network (Version Date 03/23/2020)
  • Form MG.O-004.09 FM2— External Research Sponsor Monitor Auditor Confidentiality Agreement (Version Date 03/23/2020)
  • Job Aide MG.O-004.09 JA1 — Requesting Restricted Access for Research Monitor to MedStar Health Network (Version Date 01/2021)
    • (Printable Version) Job Aide MG.O-004.09 JA1 — Requesting Restricted Access for Research Monitor to MedStar Health Network (Version Date 01/2021)

• Procedure MG.O-004.10 — Source Documentation (Version 5/11/20)
  • Form MG.O-004.10 FM1 — Authorization to Release Medical Records (Version Date 5/11/20)
  • Form MG.O-004.10 FM2 — Note to Study File (Version Date 5/11/2020)
  • MedStar Georgetown MedConnect Research Job Aid (Version Date 5/6/2020)
  • MedStar Georgetown MedConnect Frailty Test Job Aid (Version Date 7/2/2019)
  • MedStar Georgetown MedConnect MHRI Common Research Orders (Version Date 3/24/2023)
  • To request access to MedStar Health systems for research purposes, please complete the System Access for Non-MedStar Health Employee Research Associates Form

• Procedure MG.O-004.11 — Adverse Event Evaluation and Reporting (Version Date 5/11/20)
  • Form MG.O-004.11 FM1 — Adverse Event Reporting Log (Version Date 5/11/2020)

ORQA Policies and SOPs

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

• SOP GU-ORQA-P01.01 — Auditing Procedures (Version Date 07/01/2019)
  • GU-ORQA-P01.01— Not-For-Cause Audit Checklist (Version Date 07/01/19)

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-P05.01 — Assessing Study Feasibility (Version Date 05/01/20)
• GU-ORQA-P05.01 — Attachment A Feasibility Checklist (Version Date 05/01/20)

• SOP GU-ORQA-P05.02 — GU CLIA waiver (Version Date Pending)

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