B R I T T A N Y H A G E N B S R N O C N C C R C C L I N I C A L R E S E A R C H M A N A G E R

O H C , I N C .

OHC Research

OHC – An Overview

Founded in 1985, OHC is the Largest Private Oncology Practice in the Region

Oncology Medical Home Specialists in Cancer and Blood Disorders Medical Oncology, Radiation Oncology, Gynecologic Oncology, Neuro

Oncology, Blood Cancers and Palliative Care Performed More Bone Marrow Transplants than Any Other Provider in

Region 17 Offices - Ohio, Kentucky and Indiana 7 Offices with Research Staff On Site

Partnership with Sarah Cannon Research Institute Largest Clinical Trial Menu in Region More than 120 Available Clinical Trials TWICE Received ASCO’s Clinical Trials Participation Award

Nationwide, Only TWO Practices Have Received This Designation More Than Once

OHC Research – An Overview

Leadership Team: Dave Waterhouse, Chair of Research Lynnetta Hart, Director of Research Brittany Hagen, Research Clinical Manager Nicole Given, Research Non-Clinical Manager

Staff: 12 Research Nurses 3 Research Assistants 3 Regulatory Specialists 6 Data Managers 1 Budgets & Contracts Specialist 1 Personalized Medicine Navigator 1 Research Blood Cancer Program Coordinator 1 Administrative Assistant

OHC Research

What Types of Trials Do We Offer? Pharmaceutical Intervention Studies Observational Studies Chart Review Studies Correlational Studies

How Do Our Doctors Know About the Trials? Clinical Trial Review Internal Communication OHC Intranet

How Do Patients Get Enrolled? MD Presentation RN Discussion

OHC Research – Job Functions

Regulatory Training, IRB Communications, Trial Management

Data Management Data Entry, Query Resolution, Audit Preparation

Research Assistants Lab Kit Assembly, Central Labs, Tissue Collection, Bone

Marrow Collection, EKGs, Imaging

Clinical Research Data Nurses Query Resolution, SAE Reports and Follow-Ups, Audit

Responses, Screening

OHC Research – Job Functions

Research Nurse ‘Study Coordinator’ and MORE

RN Requirement, Previous Experience in Oncology or Research Preferred, Certifications Encouraged

Nine pursuing BSN, MSN, MBA Screening, Enrollment, Study Visits, Protocol Assessments,

Submission of Clean Data, Coordination of Care Documentation of Adverse Events, Concomitant Medications,

Assessments, Training Works Closely with Investigators Develops Relationships with Other OHC Non-Research Staff

Members

OHC Research – A Day in the Life

Eight or Ten Hour Days Office Dependent

Office Maintenance Temperatures, Drug Inventory, Filing Paperwork

Emails, Emails, Emails Monitors, Sponsors and Internal

Patient Visits Assess Patient, Dispense Drug, Training, Monitoring, Central Labs

Documentation, Documentation, Documentation Screening RNs Responsible for New Patients, MDs Responsible for Existing

Patients Trainings SIVs, Investigator Meetings, OHC SOPs

OHC Research - Speedbumps

Non-Research OHC Staff Buy-In Building Relationships Mutual Understanding of Job Functions

Turnover Constant Sponsors, CROs Combatting the Loss

Enrollment Ebbs and Flows Pressure from MDs, OHC, SCRI, Sponsors

OHC Research – Future

Strategic Planning Phase I Opportunities First Phase I Trial Opened in March 2014 Fourteen Through Today

Inpatient Bone Marrow Studies Jewish Hospital BMT Unit

Acute Leukemics, Graft Versus Host Disease

Radiation Oncology Studies

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