About the Research Support Center
The Research support Center (RSC) offers services and resources for your study to be a success from the beginning. The RSC will guide you through the submission process by offering the assistance from each of the established units. If you have questions please contact us at 526-6876.
Project Team Unit - Research Protocol Development and Review
The Project Team Unit reviews investigator-initiated human research protocols and informed consent documents to determine the presence of basic elements and the coherency of objectives, design and methodology. If necessary, based upon their professional experience, the staff will provide constructive comments/suggestions to the Principal Investigator and research staff. The staff is also available to assist with protocol development, including the provision of templates and IRB required language. the Project Team Unit facilitates the involvement of the other RSC units when needed to promote high quality FDA and non-FDA clinical research projects.
Regulatory Affairs Unit - Regulatory Review and Management
Wondering if your investigator-initiated study will require an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) application with the FDA? The Regulatory Affairs Unit provides a service to evaluate your study, in accordance with applicable regulations, to determine if an official filing with FDA is required. If a filing is required, we well also manage it for you. Regulatory Affairs works closely with the FDA, the investigator, and study staff in the filing and subsequent maintenance of all University held Investigational New Drugs (IND), Investigational Device Exemptions (IDE), SAEs, Protocol Deviations, new studies to existing INDs, annual reports, and any other filings necessary to comply with FDA regulations. The RSC Regulatory Unit offers complete regulatory support for investigator-initiated drug or device studies.
Quality Assurance Unit - GMP/GTP/GLP
The Quality Assurance Unit (QAU) supports UAMS investigators by focusing on key quality issues associated with research protocols. The mission of the QAU 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. Relying on QAU experience, the investigator may avoid delays in obtaining FDA and/or IRB approvals. The QAU will assist in identifying and preparing documentation necessary for use of any drug, biological or device made by UAMS researchers for use in pre-clinical or clinical trials. In addition, QAU is able to evaluate the need for standard operating procedures, equipment qualifications, spreadsheet validation, processing records and controls and environmental monitoring. The RSC QAU has been designated to fill the quality unit role for pre-clinical studies at UAMS conducted under the Good Laboratory Practice (GLP) regulations.
Monitoring Unit - Clinical Trial Monitoring
The Monitoring Unit is responsible for monitoring all UAMS-sponsored investigator-initiated IND-IDE clinical research trials. If your research study requires an IND or IDE, this group will work with you to ensure your study is monitored as required by federal regulations. The services provided by the Monitoring Unit include: site prequalification (for mult-site studies), preparation of essential documents (including Case Report Forms), site initiation visits, interim monitoring visits, final close-out visits, and audit preparation assistance.
Financial Unit - Budget and Medicare Coverage Review
The Financial Unit functions to provide a comprehensive mechanism for institutional review of clinical research budgets, Medicare coverage analysis, and training for clinical researchers who need assistance developing budgets. By adopting a greater role in assisting investigators with budget preparation and negotiation, especially for industry-sponsored studies, the Financial Unit seeks to shorten the time required for the review and approval. The group performs a Medicare coverage analysis when necessary to assist investigators and the hospital with identifying those procedures that can be billed to Medicare and/or other third party payers and those that must be billed to a research account. The Financial Unit also serves as the first point of contact for CRIMSON related questions, problem solving and training sessions.
Legal Unit - Contract and
University of Arkansas for Medical Sciences,
4301 W. Markham St. Slot 813, Little Rock, AR 72205