Operationalizing Your Study At Grady June 22, 2016 Presented By: The Offices of Research & Grants Administration CHADRICK – Opening of Session Chad Introduction of Self – Shirley – Introduce Dr. Frankel ???? Introduce OGA (Yvette & David). We will all introduce ourselves when we stand to speak

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 DAVID

PATIENT PARTICIPATION FEASIBILITY FINANCE OVERSIGHT ACCESS (Affiliate Institution Determinations) OVERSIGHT (GRADY Study Review & Approval) PATIENT PARTICIPATION FINANCE [Billables, Services, Resources] DAVID – OVERVIEW ONLY Study Feasibility – All of the decisions that need to be made by the Affiliate Institutions. Feasibility SHOULD consider Grady (overall, departments, committees, contracts) Grady Oversight – ROC approval (includes ORA / OGA functions / Grady Departments & Committees) Access – Epic, personnel, CRAs, Data, Medical Records etc Finances – Sponsor budgets, Clinical / Pharmacy other Services, Resources (Staff, equipment, space, technology), Contracts ACCESS (For Personnel, CRAs, & to Data]

CAN GRADY FACILITATE THE NEEDS OF THIS STUDY? Study Feasibility CAN GRADY FACILITATE THE NEEDS OF THIS STUDY? Affiliate Institution Responsibilities Principal Investigator Resource Determinations Affiliate Research Administration Approval IRB Approval Important Considerations 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) DAVID – ONLY GIVE OVERVIEW Principal Investigator Determinations - Staff Allocation & Available Technology Affiliate Research Administration Approval (Pre and Post) – Budgeting etc.

GHS Departments & Committees Grady Oversight ROC ORA OGA GHS Departments & Committees DAVID This slide depicts the interaction between the areas at Grady. Introduce CHAD

Grady Oversight - ORA Research Oversight Committee Approval of Research Research Team Study Start-up Support Access for Personnel Data Access Access for Vendors & CRAs CHAD Discuss ROC (NEW Processes) and Start-up Access is on slides 7 & 8

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 CHAD

Grady Oversight - ORA Access for Vendors & CRAs Vendor Mate Registration To register go to https://gradyhealthsystem.vendormate.com Access to Patient Files Health Information Management (HIM) Provide MRN, Date of Service, Date of Birth Release Of Information (ROI) Keys CHAD

BREAK

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 YVETTE Primary role of OGA in regards to operationalizing a study is providing support for the conduct of the research study at Grady. I. Financial Clearance is both a process and a document The Financial Clearance Form (DOCUMENT) is a required component of the ROC submission. The (PROCESS) has components that can be delineated as pre and post but it continues through the life of the study. This process occurs for BOTH billable and non-billable studies. Patient and non-Patient involved studies. We like to help our affiliates determine a Grady FIT instead of having to come up with a Grady FIX A. PRELIMINARY Consultation / Feasibility - This is an opportunity for the team to provide information to OGA regarding clinical / research processes that need to be integrated into the GRADY processes - Consultation on pricing and service “norms” as it relates to your specific study (CPT codes/prices/lab) - Highlight feasibility considerations (Staff [research vs Grady], Services [clinical/pharmacy etc.], Space [location], Equipment / Devices, Technology) - Administrative support to access departments at Grady – WE: # Encourage research teams to utilize the processes in place # Encourage obtaining departmental approval; providing in-services, building relationships that will support the research and decrease the potential for interruption of patient care. # Discourage negotiating departmental favors because these atypical or ad hoc process can later delay the conduct of the study TIME SENSITIVE items are the Execution of Contracts / Agreements; Grady Departmental Review /Approval for use of Devices; Equipment B. Financial Clearance Review / Approval 1. NON Billable – These studies typically access data and are non-patient related. However, they may use resources, access EPIC (researcher/team), or Data [slides, CD data]. - Obtaining ACCESS has already been discussed by Chad BUT some of these services have fees associated. The invoicing /reconciliation of payments is managed through the Financial Clearance process - Medical Records (Health Information Management); Pathology; Data Pull (Clinical Business Inteligence). 2. Billable – There are many variations to a “Billable” study. The normal billable items / services will be discussed in detail on a subsequent slide - The system used to facilitate patient participation and capture the majority of research charges is Epic (this ties to the ACCESS already discussed) II. Research Team Study Start-up Support Previously discussed by Chad. It’s a joint effort of ORA and OGA to assist PIs and research teams with operationalizing their study at Grady. III. Study Conduct will be discussed in detail on a subsequent slide.

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* YVETTE 1) The determination of billable / non billable services; other ancillary services (Pathology, Lab, Medical Records) 2) IDS / Pharmacy - management by Philip Powers, Kay Woodson 3) Department Resources – Use of ACTSI/ CRN and/or Grady Departments Staff, Space, Time, Equipment 3) Equipment (Grady Biomedical & Clinical Engineering Department) Use of Grady Equipment vs non-Grady Equipment 4) Devices (Value Based Analysis Committee)

Grady Oversight - OGA Study Conduct: 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 YVETTE STUDY CONDUCT includes tasks and activities that occur once you have met all set-up requirements and approval. Includes the management of patient activity (Enrollment, Scheduling, submitting Patient Tracker Forms – charge identification) MRN Merging / Non Grady Participants - Account Management (Distribution /Review / Payment of Invoices) – this is a joint effort between OGA, the study designee and assigned institutional Accounts Payable person. - Continuous assessment of billable activity. Changes based on study amendments; changes based on study activity.

In Summary How to Operationalize YOUR study at Grady 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 DAVID (this is where we “prompt” them to complete the Survey with 10’s.) Slides posted our website.

Information, Processes & Forms Office of Research Administration Central Email: research@gmh.edu Web: http://www.gradyhealth.org/static/office-of-research-administration Office of Grants Administration Central Email: grants@gmh.edu Web: http://www.gradyhealth.org/static/office-of-grants-administration DAVID These documents can also be accessed through the Grady Net – Go to Documents & Resources [then] Grants, Contracts, Research -Note where these links appear on the Emory website (Emory OCR page – Links Tab)

Q & A