Regulatory is the day-to-day management of policy and support provided to ensure that clinical trials are appropriately evaluated, investigated and submitted.
GRADY
Office of Research Administration
Mission
The Office of Research Administration partners with Grady’s Research Oversight Committee and Research personnel to protect the rights, welfare, and well-being of human subjects involved in research within Grady Health System.
Services
The Office of Research Administration has the responsibility of adhering to and abiding by all regulatory requirements including those from the Office of Human Research Protections (OHRP), the Institutional Review Boards of the affiliated institutions (IRBs) and The Joint Commission.
The Office of Research Administration provides Oversight and support for the initiation and execution of research within Grady Health System. ORA consists of Administrative and Financial units.
The Office of Research Administration has the responsibility of maintenance for various systems required for providing management reports. Those services include:
- Review all research protocols and required documents in order to support Grady’s Research Oversight Committee in determining risks and benefits to patients.
- Serve as liaisons for but not limited to Grady’s Research Oversight Committee, Compliance, Information Security, Information Technology, Legal and On-Boarding/Training departments
Additionally, we share a strong affiliation with Grady’s Office of Grants Administration.
The following forms should be used to conduct a study at Grady.
Forms
ORA FORMS
- ROC-Combined-Forms v06.2022
- Badge Request Form v06.2022
- Epic-Remote Access v06.2022
- Research Data Request Form v06.2022
- MRN Request Form v06.2022
- Research Financial Clearance Form v06.2022
- 2022 ROC Meeting Calendar
- Clinical Trials Research FAQs_v05.2022
Conduct of Research Forms & Tip Sheets
- Financial Clearance Completion Tip Sheet_v05.2022
- Managing Patient Enrollment Tip Sheet_v05.2022
- Managing Patient Research Visits Tip Sheet_v05.2022
- Managing Radiology Patient Research Visits Tip Sheet_v05.2022
- Managing Oncology Patient Research Visits Tip Sheet_v05.2022
- Research Patient Pre-Registration Form v05.2022
- Research Patient Pre-Registration Form – Radiology v05.2022
- Research Patient Tracker Form v05.2022
- Research Medical Equipment Use Form v05.2022
GRADY ORA STAFF
Chadrick Anderson, Director
Office of Research Administration and Grady Clinical Research Center
Shirley Marshall, Research Administration Specialist
Office of Research Administration
Yvette Benjamin, Sr. Research Financial Analysist
Office of Research Administration-Finance
Grady Hospital
80 Jesse Hill Jr. Drive, SE,
Room #3A020
Atlanta, Georgia 30303
Roles and Responsibilities
- Obtaining a copy all investigators and coordinators licenses, human subjects training, HIPAA, picture identification and NIH biosketches
- Maintaining all regulatory documents for each clinical trial. A completed CRC application is needed for all trials utilizing the CRC or its resources.
- Maintaining a record of Adverse Events, Serious Adverse Events and other safety information as required by institutional, sponsor, NIH or federal guidelines
- Dispersing a variety of information associated with clinical protocols and the daily operations of clinical trials
- Serving as a liaison to MSM Institutional Review Board (IRB) and Grady Research Oversight Committee (ROC) as well as assisting in the preparation of materials to be submitted
Click here for link to register in IRB Net
Contact:
Carla Holloway
Regulatory
Morehouse School of Medicine
Clinical Research Center
720 Westview Drive, S.W.
Atlanta, Georgia 30310
Phone: (404) 752-8452