For all Investigator-Initiated Trials (IITs) requiring an Investigational New Drug Application (IND) to be filed with the United States Food and Drug Administration (FDA), Office of Research Regulatory Affairs (ORRA) acts as sponsor on behalf of UAMS. The following are the functions and services of the ORRA Regulatory Unit:
- Regulatory Strategy — assist in helping investigators with all regulatory needs throughout the lifecycle of an investigation.
- FDA Interaction — conduct and coordinate all communication or correspondence with FDA including submissions, teleconferences, and meetings.
- Regulatory Review — review clinical protocols to determine if an IND application is needed or whether the trial can be exempted.
- An IND Application will be needed if the research involves a drug, the research is a clinical investigation as defined in the IND regulations (21 CFR 312.3), and the clinical investigation is not otherwise exempt from the IND requirements in part 312 (see this guidance).
- An IND Application will not be needed (a clinical investigation of a lawfully marketed drug is exempt from the IND requirements) if all of the criteria for an exemption are met: the investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling or advertising of the drug, the investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product, and the investigation is not intended to promote or commercialize the drug product.
- Investigational New Drug Application — complete and submit the IND application to the FDA, coordinate FDA interactions, maintain sponsor records and inform investigators of their responsibilities.
- Investigational New Drug Exemption — communicate with investigators and FDA (if necessary) to determine exemption, maintain sponsor records and inform investigators of their responsibilities.
- Filing and Maintenance — assist investigators in the preparation, filing, and maintenance of all applicable regulatory documents required for FDA submission.