Regulatory
Overview
Regulatory is the day-to-day management of policy and support provided to ensure that clinical trials are appropriately evaluated, investigated and submitted. .
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
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
Contact
Carla Holloway
Regulatory
Morehouse School of Medicine
Clinical Research Center
720 Westview Drive, S.W.
Atlanta, Georgia 30310
Phone: (404) 752-8452
Regulatory
Morehouse School of Medicine
Clinical Research Center
720 Westview Drive, S.W.
Atlanta, Georgia 30310
Phone: (404) 752-8452
Grady Office of Research Administration
The Office of Research Administration has the responsibility of maintenance for various systems required for providing management reports. Those services include:
1.Review all research protocols and required documents in order to support Grady’s Research Oversight Committee in determining risks and benefits to patients.
2.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.
1.Review all research protocols and required documents in order to support Grady’s Research Oversight Committee in determining risks and benefits to patients.
2.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.
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