Clinical Research Policies, Procedures, and Guidance

• Clinical Research Billing Compliance with Medicare Requirements
  • Policy MG.O-001 (12/01/2021)
• OnCore Pathway to Billing Compliance
  • Procedure MG.O-001.01 (12/01/2021)

• OnCore Enterprise Research System
  • Policy MG.O-002 (12/01/2021)
• OnCore Protocol Numbering
  • Procedure MG.O-002.01 (12/01/2021)
• OnCore Required Data Fields
  • Procedure MG.O-002.02 (12/01/2021)
• OnCore Subject Visit Tracking
  • Procedure MG.O-002.03 (12/01/2021)
• OnCore Study Initiation
  • Procedure MG.O-002.04 (12/01/2021)
• Registering a New Subject in OnCore
  • Procedure MG.O-002.05 (12/01/2021)
• OnCore Subject Record Merge
  • Procedure MG.O-002.06 (12/01/2021)
• OnCore Study Closure
  • Procedure MG.O-002.07 (12/01/2021)
• OnCore and MedConnect Integration
  • Procedure MG.O-002.08 (12/01/2021)
• OnCore Financial Events
  • Procedure MG.O-002.09 (12/01/2021)

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

• OnCore Subject Visit Variations
  • Procedure MG.O-002.11 (12/01/2021)

OnCore User Responsibilities

• Policy MG.O-003 (12/01/2021)

• Investigator Responsibilities; Protecting the Rights, Safety and Welfare of Subjects
  • Policy MG.O-004 (03/23/2020)
• MedStar Georgetown Procedure Glossary
  • Glossary MG.O-004.G (03/23/2020)
• Informed Consent Process and Documentation
  • Procedure MG.O-004.01 (4/30/2020)
  • Job Aide MG.O-004.01 JA1 (4/30/2020)
• Uploading Signed Informed Consent to MedConnect
  • Job Aide MG.O-004.01 JA2 (4/30/2020)
• Consenting English-Speaking Illiterate and Legally Blind Subjects
  • Procedure MG.O-004.02 (4/30/2020)
  • Job Aide MG.O-004.02 JA1 (4/30/2020)
• Consenting Non-English Speaking Subjects
  • Procedure MG.O-004.03 (4/30/2020)
  • Job Aide MG.O-004.03 JA1 (4/30/2020)
• Re-Consenting Research Subjects
  • Procedure MG.O-004.04 (4/30/2020)
  • Job Aide MG.O-004.04 JA1 (4/30/2020)
• Obtaining Consent for Research from a Surrogate
  • Procedure MG.O-004.05 (Pending)
  • Job Aide MG.O-004.05 JA1 (4/30/2020)
• Remote Informed Consent Process and Documentation
  • Procedure MG.O-004.06 (4/30/2020)
  • Job Aide MG.O-004.06 JA1 (4/30/2020)
• Person Obtaining Consent Attestation Form
  • Form MG.O-004.06 FM1 (4/30/2020)
• Witness Signature and Attestation Form
  • Form MG.O-006.06 FM2 (4/30/2020)
• Obtaining Electronic Consent (eIC) with Interlace Health Patient Intake Solution
  • Procedure MG.O-004.07 (11/15/2021)
• Sponsor Monitoring Visit
  • Procedure MG.O-004.08 (12/20/2020)
• Requesting Restricted Access for Research Monitor to MedStar Network
  • Procedure MG.O-004.09 (03/23/2020)
  • Form MG.O-004.09 FM1 (03/23/2020)
• External Research Sponsor Monitor Auditor Confidentiality Agreement
  • Form MG.O-004.09 FM2 (03/23/2020)
• Requesting Restricted Access for Research Monitor to MedStar Health Network
  • Job Aide MG.O-004.09 JA1 (01/2021)
  • (Printable Version) Job Aide MG.O-004.09 JA1 (01/2021)
• Source Documentation
  • Procedure MG.O-004.10 (05/11/2020)
• Authorization to Release Medical Records
  • Form MG.O-004.10 FM1 (05/11/2020)
• Note to Study File
  • Form MG.O-004.10 FM2 (05/11/2020)
• MedStar Georgetown MedConnect Research Job Aid
  • MedStar Georgetown MedConnect Research Job Aid (05/6/2020)
• MedStar Georgetown MedConnect Frailty Test Job Aid
  • MedStar Georgetown MedConnect Frailty Test Job Aid (07/2/2019)
• MedStar Georgetown MedConnect MHRI Common Research Orders
  • MedStar Georgetown MedConnect MHRI Common Research Orders (03/24/2023)
• Adverse Event Evaluation and Reporting
  • Procedure MG.O-004.11 (05/11/2020)
• Adverse Event Reporting Log
  • Form MG.O-004.11 FM1 (05/11/2020)

• Quality Management Plan
  • Policy GU-ORQA-P01 (Pending)
• Auditing Procedures
  • SOP GU-ORQA-P01.01 (07/01/2019)
• Not-For-Cause Audit Checklist
  • GU-ORQA-P01.01 (07/01/2019)
• SOP on SOP
  • SOP GU-ORQA-P01.02 (01/01/2020)
• Corrective and Preventive Action (CAPA)
  • SOP GU-ORQA-P01.03 (Pending)
• FDA Audits
  • SOP GU-ORQA-P01.04 (07/01/2021)

• 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
  • SOP GU-ORQA-P04.01 (7/2020)

• Clinical Research Operations
  • Policy GU-ORQA-P05 (Pending)
• Assessing Study Feasibility
  • SOP GU-ORQA-P05.01 (05/01/2020)
• Attachment A Feasibility Checklist
  • GU-ORQA-P05.01 (05/01/2020)
• GU CLIA waiver
  • SOP GU-ORQA-P05.02 (Pending)
• Documentation of CLIA waived test
  • SOP GU-ORQA-P05.03 (Pending)

FDA Inspection Preparation Guide and Resources

FAQs – Remote and Electronic Consent

Guidance Document for Obtaining Consent from Non-English Speakers

Guidance for Use of 21CFRPart11 Compliant Systems