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 |
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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 |
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OnCore User Responsibilities | Policy MG.O-003 | 12/01/2021 |
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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 | 5/11/2020 |
Authorization to Release Medical Records | Form MG.O-004.10 FM1 | 5/11/2020 |
Note to Study File | Form MG.O-004.10 FM2 | 5/11/2020 |
MedStar Georgetown MedConnect Research Job Aid | MedStar Georgetown MedConnect Research Job Aid | 5/6/2020 |
MedStar Georgetown MedConnect Frailty Test Job Aid | MedStar Georgetown MedConnect Frailty Test Job Aid | 7/2/2019 |
MedStar Georgetown MedConnect MHRI Common Research Orders | MedStar Georgetown MedConnect MHRI Common Research Orders | 3/24/2023 |
Adverse Event Evaluation and Reporting | Procedure MG.O-004.11 | 5/11/2020 |
Adverse Event Reporting Log | Form MG.O-004.11 FM1 | 5/11/2020 |