Clinical Research Policies, Procedures, and Guidelines

Joint GU/MHRI Policies and Procedure

NameLinkVersion Date
Clinical Research Billing Compliance with Medicare RequirementsPolicy MG.O-00112/01/2021
– OnCore Pathway to Billing ComplianceProcedure MG.O-001.0112/01/2021
OnCore Enterprise Research SystemPolicy MG.O-00212/01/2021
– OnCore Protocol NumberingProcedure MG.O-002.0112/01/2021
– OnCore Required Data FieldsProcedure MG.O-002.0212/01/2021
– OnCore Subject Visit TrackingProcedure MG.O-002.0312/01/2021
– OnCore Study InitiationProcedure MG.O-002.0412/01/2021
– Registering a New Subject in OnCoreProcedure MG.O-002.0512/01/2021
– OnCore Subject Record MergeProcedure MG.O-002.0612/01/2021
– OnCore Study ClosureProcedure MG.O-002.0712/01/2021
– OnCore and MedConnect IntegrationProcedure MG.O-002.0812/01/2021
– OnCore Financial EventsProcedure MG.O-002.0912/01/2021
– OnCore Calendar and Budget UpdatesProcedure MG.O-002.1012/01/2021
– OnCore Subject Visit VariationsProcedure MG.O-002.1112/01/2021
OnCore User ResponsibilitiesPolicy MG.O-00312/01/2021
Investigator Responsibilities; Protecting the Rights, Safety and Welfare of SubjectsPolicy MG.O-00403/23/2020
– MedStar Georgetown Procedure GlossaryGlossary MG.O-004.G03/23/2020
– Informed Consent Process and DocumentationProcedure MG.O-004.014/30/2020
Job Aide MG.O-004.01 JA14/30/2020
– Uploading Signed Informed Consent to MedConnectJob Aide MG.O-004.01 JA24/30/2020
– Consenting English-Speaking Illiterate and Legally Blind SubjectsProcedure MG.O-004.024/30/2020
Job Aide MG.O-004.02 JA14/30/2020
– Consenting Non-English Speaking SubjectsProcedure MG.O-004.034/30/2020
Job Aide MG.O-004.03 JA14/30/2020
– Re-Consenting Research SubjectsProcedure MG.O-004.044/30/2020
Job Aide MG.O-004.04 JA14/30/2020
– Obtaining Consent for Research from a SurrogateProcedure MG.O-004.05Pending
Job Aide MG.O-004.05 JA14/30/2020
– Remote Informed Consent Process and DocumentationProcedure MG.O-004.064/30/2020
Job Aide MG.O-004.06 JA14/30/2020
– Person Obtaining Consent Attestation FormForm MG.O-004.06 FM14/30/2020
– Witness Signature and Attestation FormForm MG.O-006.06 FM24/30/2020
Obtaining Electronic Consent (eIC) with Interlace Health Patient Intake SolutionProcedure MG.O-004.0711/15/2021
Sponsor Monitoring VisitProcedure MG.O-004.0812/20/2020
Requesting Restricted Access for Research Monitor to MedStar NetworkProcedure MG.O-004.0903/23/2020
Form MG.O-004.09 FM103/23/2020
External Research Sponsor Monitor Auditor Confidentiality AgreementForm MG.O-004.09 FM203/23/2020
Requesting Restricted Access for Research Monitor to MedStar Health NetworkJob Aide MG.O-004.09 JA101/2021
(Printable Version) Job Aide MG.O-004.09 JA101/2021
Source DocumentationProcedure MG.O-004.105/11/2020
Authorization to Release Medical RecordsForm MG.O-004.10 FM15/11/2020
Note to Study FileForm MG.O-004.10 FM25/11/2020
MedStar Georgetown MedConnect Research Job AidMedStar Georgetown MedConnect Research Job Aid5/6/2020
MedStar Georgetown MedConnect Frailty Test Job AidMedStar Georgetown MedConnect Frailty Test Job Aid7/2/2019
MedStar Georgetown MedConnect MHRI Common Research OrdersMedStar Georgetown MedConnect MHRI Common Research Orders3/24/2023
Adverse Event Evaluation and ReportingProcedure MG.O-004.115/11/2020
Adverse Event Reporting LogForm MG.O-004.11 FM15/11/2020

GU ORQA Policies and SOPs

NameLinkVersion Date
Quality Management PlanPolicy GU-ORQA-P01Pending
— Auditing ProceduresSOP GU-ORQA-P01.0107/01/2019
— Not-For-Cause Audit ChecklistGU-ORQA-P01.0107/01/2019
— SOP on SOPSOP GU-ORQA-P01.0201/01/2020
— Corrective and Preventive Action (CAPA)SOP GU-ORQA-P01.03Pending
— FDA AuditsSOP GU-ORQA-P01.0407/01/2021
Research Staff CompetenciesPolicy GU-ORQA-P02Pending
— Onboarding of Clinical Research StaffSOP GU-ORQA-P02.01Pending
— Institutional Delegation of AuthoritySOP GU-ORQA-P02.02Pending
— SOP TrainingSOP GU-ORQA-P02.03Pending
— Documentation of Protocol TrainingSOP GU-ORQA-P02.04Pending
Data Safety and Monitoring BoardPolicy GU-ORQA-P04
— Lombardi Comprehensive Cancer Center –Data and Safety Monitoring Committee ProceduresSOP GU-ORQA-P04.017/2020
Clinical Research OperationsPolicy GU-ORQA-P05Pending
— Assessing Study FeasibilitySOP GU-ORQA-P05.0105/01/2020
— Attachment A Feasibility ChecklistGU-ORQA-P05.0105/01/2020
— GU CLIA waiverSOP GU-ORQA-P05.02Pending
— Documentation of CLIA waived testSOP GU-ORQA-P05.03Pending