1. 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

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
DAVID

3. 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]

4. 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.

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

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
CHAD
Discuss ROC (NEW Processes) and Start-up
Access is on slides 7 & 8

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
CHAD

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
CHAD

9. BREAK

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
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.

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*
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)

12. 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.

13. 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.

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

15. Q & A