UAMS Office of Research Regulatory Affairs (ORRA) offers complete regulatory support for Investigator-Initiated Trials (IITs) involving Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs).
ORRA, in concert with other UAMS regulatory departments, ensures that IND and IDE trials remain in compliance as required under Title 21 of the Code of Federal Regulations (21 CFR).
We provide a number of support services, including: regulatory evaluation/guidance, monitoring, knowledge of Good Tissue Practice, and assistance with ClinicalTrials.gov registration and maintenance.
Regulatory
ORRA Regulatory Unit, in accordance with applicable regulations, will review your trial 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 trial to compile, build, file, and manage the IND/IDE from initial submission through withdrawal/termination/closure.
We also provide guidance/assistance with expanded access programs and pre-submission meetings with the FDA.
Monitoring
Monitors are responsible for monitoring all UAMS-sponsored IND and IDE IITs and are involved throughout the life of the trial.
Prior to trial initiation, we provide assistance with the preparation of essential records (e.g., regulatory binders, source documentation, case report forms, etc.) and continue our involvement by conducting required pre-study, site initiation, interim monitoring and close-out visits.
The monitoring team aims to ensure: protection of participant rights, safety and well-being, the collection of reliable data with integrity, adherence with the investigational plan (i.e., the protocol), and compliance with applicable regulations, including 21 CFR 312 and 812 and Good Clinical Practice.
We can also assist with audit preparations.
Good Tissue Practice
The quality oversight of non-research activities is provided as a result of quality program mandates under the FDA Good Tissue Practices 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 the 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.
ClinicalTrials.gov
Members of the ORRA Regulatory Unit act as the ClinicalTrials.gov administrators for all UAMS faculty, staff, and students conducting investigator-initiated human research covered under certain provisions (see UAMS Policy 16.1.18). Our assistance as administrators does not apply to industry-sponsored or cooperative group (“co-op”) research or other investigations where UAMS is not the lead site or Sponsor, as these investigations should be registered by the lead site or Sponsor in charge of the investigation.
As administrators, ORRA ClinicalTrials.gov staff may/will assist with the following:
- Making the determination in CLARA on whether registration of a clinical investigation in ClinicalTrials.gov is necessary (e.g., what qualifies as an Applicable Clinical Trial, what is subject to the 2016 NIH Policy, etc.);
- Reminding investigators to register a clinical investigation in ClinicalTrials.gov and creating a new user account, if necessary (e.g., you are new to UAMS and/or the database);
- Performing quality review of the records for accuracy prior to releasing them for Protocol Registration and Results System review, which may include assisting the study team members with any errors, warnings, or notes;
- Transferring ClinicalTrials.gov to a new Sponsor, if applicable (e.g., in the case of PI moving/departing the institution);
- Providing regular maintenance reminders to ensure that timelines are not missed for record verifications, entering results information, updating dates, etc.