UAMS Office of Research Regulatory Affairs (ORRA) offers complete regulatory support for investigator-initiated drug or device studies. UAMS acts as the sponsor for all Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE) filed on behalf of our investigators.
ORRA, in concert with other UAMS regulatory departments, ensures that IND and IDE studies remain in compliance as required under Title 21 of the Code of Federal Regulations.
We provide a number of support services including: regulatory evaluation/assistance, monitoring, Good Tissue Practice (GTP), and ClinicalTrials.gov registration and maintenance.
Regulatory
ORRA Regulatory Unit, in accordance with applicable regulations, will review your study to determine the need for an IND or IDE.
If an IND or IDE is required, we will work with the Principal Investigator and their staff throughout the life of the study to compile, build, file, and manage the IND/IDE from initial submission through withdrawal/termination/closure.
We also provide guidance/assistance with orphan drug applications and submissions, compassionate use drug or device requests, expanded access programs, and pre-submission meetings with the FDA.
Monitoring
Monitors are responsible for monitoring all UAMS-sponsored investigator-initiated IND and IDE studies and are involved throughout the life of the study.
Prior to study initiation, we provide assistance with the preparation of essential study documents (regulatory binders, source documentation, case report forms, etc.) and continue our involvement by conducting required pre-study, site initiation, interim monitoring and closeout visits.
We can also assist with audit preparations.
The monitoring team aims to ensure subject safety, quality data collection, adherence with the investigational plan, and compliance with applicable regulations.
Good Tissue Practices
The quality oversight of non-research activities is provided as a result of quality program mandates under the FDA Good Tissue Practices (GTP) regulations finalized May 25, 2005. These regulations give the agency more authority and oversight over a broader range of tissues and the establishments that process them. Our Good Tissue Practices specialist accomplishes FDA’s mission through quality assurance and control functions including, but not limited to, education, training, auditing, inspecting, and establishing appropriate procedures.
Contact the Regulatory Affairs team at RegulatoryAffairs@uams.edu.