About the Research Support Center

The following is a list of services offered by Research Support Center.  If you have questions please contact us at 526-6876.

Good Manufacturing Quality Assurance Unit -- GMP/GTP/GLP

The mission of the GMP Quality Assurance Unit is to maintain a quality program that ensures compliance with all federal, state and local regulations governing the manufacture of drugs, biologics, devices, human cells, tissues or tissue-based products to promote the health and safety of employees and research subjects at UAMS.  We will accomplish this mission through quality assurance and control functions including, but not limited to, educating, training, auditing, investigating and establishing appropriate procedures.

Education Division

The mission of the Education Division is to provide training on all aspects of Human Subject Research to ensure investigators and study staff know how to protect human research subjects, themselves, and the University.
 

We provide online training programs for both Biomedical and Behavioral Human Subject Protection in Research, as well as online HIPAA for Human Subject Research Training. We also provide face-to-face didactic presentations and educational forums for investigators and coordinators. If requested, we can do one-on-one training or departmental educational sessions.

We also oversee the Certified Research Specialist program which is a university level certification which recognizes research personnel who have gotten advanced training in human subject research.

Monitoring Division
The monitoring division works with investigator and study staff in the preparation of Data Safety Monitoring Plans, FDA required Investigational New Drug (IND) exemptions, Investigational Device Exemptions (IDE) Monitoring Plans, and data collection or case reporting forms.  Monitoring and review of monitoring reports of IND or IDE studies of UAMS investigator-initiated studies is also a function of this group.

Mission Statement: For the assurance of human subject protection, collection of verifiable research data, investigator and research staff education, and a commitment to promote growth in research education throughout the community.  The Monitoring Division of UAMS RSC shall work in a collaborative effort with other divisions, to enhance the institution’s competitiveness for clinical and translational research activities.

Contact us at any time for questions or to schedule a consultation at 501-526-5233.

Regulatory Affairs Division

The mission of the Regulatory Affairs Division is to ensure the safety and welfare of human research subjects, ensure the quality and integrity of research studies, support the needs and objectives of research investigators and their study staff, and to serve as the liaison between the University and the Food and Drug Administration (FDA).

Regulatory Affairs works closely with the FDA, the investigator, and study staff in the filing and subsequent maintenance of all University held Investigational New Drug (IND) exemptions, Investigational Device Exemptions (IDE), SAEs, Protocol Deviations, new studies to existing INDs, annual reports, and any other filings necessary to comply with FDA regulations.  Upon request, Regulatory Affairs assists the sponsor-investigator regarding the regulatory aspect of their IND.

• Assistance with establishing study specific data safety monitoring plans

• Assistance with establishing Department Level Quality Improvement Plans for research data and safety monitoring.

• Please feel free to contact us if you would like information on educational opportunities or for a personal consultation on any of your research projects.

• Watch the Event Calendar section of this website for educational offerings that may be of interest to the research community.