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About Us

Administrative Guidelines

The Research Administrative Guidelines were finalized in 2012 and are now available on the IRB website. The purpose of the Guidelines is to outline the processes related to the business and administrative aspects of conducting studies and clinical trials at New Hanover Regional Medical Center (NHRMC).

Because the Guidelines are new, I expect that they will be revised and improved through use and the suggestions from you, the users. Please send any comments and suggestions to anne.patterson@nhrmc.org.

Thank you.

Anne M. Patterson, Clinical Research Officer
910.343.2641 

Number

Guidelines

 

 

 

Table of Contents

 

 

1.0

Introduction

 

 

2.0

Scope of Research at New Hanover Regional Medical Center (NHRMC)

 

 

3.0

Descriptions of Roles in the NHRMC Institutional Review Board (IRB) Department:

 

 

4.0

Administrative Review and Approval of Research Studies/Projects

 

 

5.0

Research Study Coordination and Planning

 

 

6.0

Communication of IRB Approved Research Studies

 

 

7.0

EPIC/NHRMC Connect

 

 

8.0

Clinical Trial Agreements, Contacts and Memorandums of Understanding

 

 

9.0

Billing Analysis, Study Budget Worksheets and Estimated Profit/Loss

 

 

10.0

Medicare Billing Approval – Investigational and Humanitarian Use Devices (IDE, HUD/HDE)

 

 

11.0

Research Accounting, Administrative Start-up Fees and Billing

 

 

12.0

Research Subject Payment Processing

 

 

13.0

Departmental Research Responsibilities

 

 

14.0

External Study Staff in the Clinical Setting – Human Resources Requirements

 

 

15.0

IRB Satisfaction Survey and Turnaround Time (TAT)

 

 
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