Joint GU/MHRI Policies and Procedures
Clinical Research Billing Compliance with Medicare Requirements
- 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
- 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
OnCore User Responsibilities
- Policy MG.O-003 (12/01/2021)
Investigator Responsibilities; Protecting the Rights, Safety and Welfare of Subjects
- 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)
- 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 MHRI Common Research Orders
- 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)
GU ORQA Policies and SOPs
Quality Management Plan
- 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
- 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
- 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
- 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)