Operationalizing Your Study At Grady

Transcription

1 Operationalizing Your Study At Grady June 22, 2016 Presented By: The Offices of Research & Grants Administration

2 Learning Objectives By the end of the session, you will: Understand how to operationalize your study on the Grady Campus Receive an overview of NEW Processes for conducting research at Grady Be familiar with the departments that support research & the Key Contacts at Grady

3 FEASIBILITY (Affiliate Institution Determinations) OVERSIGHT (GRADY Study Review & Approval) FINANCE [Billables, Services, Resources] ACCESS (For Personnel, CRAs, & to Data]

4 Study Feasibility CAN GRADY FACILITATE THE NEEDS OF THIS STUDY? Affiliate Institution Responsibilities Principal Investigator Resource Determinations Affiliate Research Administration Approval IRB Approval GHS Departments (e.g. ED, Cardiology etc.) A Grady Representative should be involved and acknowledge the conduct of research Value Based Analysis Committee (Devices, Supplies, etc) Committee Oversight (Nursing, GCRC, etc)

5 Grady Oversight ROC ORA OGA GHS Departments & Committees

6 Grady Oversight - ORA Research Oversight Committee Approval of Research Research Team Study Start-up Support Access for Personnel Data Access Access for Vendors & CRAs

7 Grady Oversight - ORA Access for Personnel & To Obtain Data Badging Onboarding Employee Health Personnel Records Clinical Business Intelligence Data Access Health Information Management Medical Records Information Security Epic Access Compliance

8 Grady Oversight - ORA Access for Vendors & CRAs Vendor Mate Registration To register go to Access to Patient Files Health Information Management (HIM) Provide MRN, Date of Service, Date of Birth Release Of Information (ROI) Keys

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10 Grady Oversight - OGA Financial Clearance Preliminary Consultation / Feasibility Considerations Financial Clearance Form Review / Approval Research Team Study Start-up Support Study Conduct Patient Activity Financial Responsibilities

11 Grady Oversight - OGA Financial Clearance Components: Patient Clinical Support Services (i.e. Billable / Non-Billable) Investigational Drug Services (Investigational Drug Services) Departmental Resource Assessment Staff Allocation Assessment Available Technology Equipment, Devices, Supplies, Space Non-Grady Equipment / Devices / Supplies Sponsor Provided, Purchase, Leased MedApproved Review System *NEW*

12 Study Conduct: Grady Oversight - OGA Patient Participation Participant Enrollment (Epic) Grady (Non Grady Patients) Scheduling Research Visits Accessing Required Services Pathology, Pharmacy, Radiology etc Billing / Account Maintenance Reporting Services Rendered Submitting Patient Tracker Forms ( Billable / Non-Billable) Invoice Processing / Payment Remittance

13 In Summary You now have an overview of the processes that Grady has implemented to ensure that all research-related procedures are conducted in compliance with the appropriate policies and regulations. We have reviewed: How to Operationalize YOUR study at Grady New Processes in Grady s Offices of Research & Grants Administration The Departments that Support Research at Grady Key Contacts at Grady

14 Information, Processes & Forms Office of Research Administration Central Web: Office of Grants Administration Central Web:

15 Q & A