Wondering if your Investigator-Initiated Trial (IIT) will require an Investigational New Drug Application (IND) or an Investigational Device Exemption (IDE)?
UAMS Office of Research Regulatory Affairs (ORRA) Regulatory Unit will evaluate your study, in accordance with applicable regulations, to determine if an official filing with the FDA is required.
If a filing is required, the Regulatory Unit offers regulatory support by working closely with the FDA (for IND and Significant Risk IDE studies), Principal Investigator, their staff, and ORRA monitoring specialists throughout the life of the trial to file and maintain necessary documentation and submit all required reports, including adverse events, protocol deviations, the addition of new studies to existing IND applications, annual reports, and any other elements necessary to comply with FDA regulations.
We maintain the regulatory relationship between UAMS and FDA throughout the life of each clinical trial, as applicable.
We also provide guidance/assistance with IRB submission and follow-up.
Contact ORRA Regulatory Unit at ORRARegulatoryUnit@uams.edu.
Staff Contacts
- Laura Adkins, MAP, CCRP, CCRA, AdvCRS
Director of ORRA
LLAdkins@uams.edu
501-686-6092
- Brenda Gannon, Ph.D., AdvCRS
Manager of Regulatory Affairs and QA
BGannon@uams.edu
- Janet Storment, RN, CCRP, AdvCRS
Research Regulatory Specialist III
StormentJanetS@uams.edu
- Kacy Wright, Ph.D., CRS
Research Regulatory Specialist II
KWright@uams.edu
Links
- Food and Drug Administration – Main page
- Food and Drug Administration Warning Letters
- E6(R3) Good Clinical Practice Guidelines
- 21 Code of Federal Regulations Part 312 (Drugs)
- 21 Code of Federal Regulations Part 812 (Devices)
- Expanded Access Program (Drugs)
- Expanded Access Program (Devices)
- Guidance for IND Determination
- Information on Non-Significant and Significant Risk Devices
- UAMS Policy 3.2.01 Record Retention
- UAMS Policy 16.1.17 – Multi-Site Investigator-Initiated Clinical Trials
- UAMS Policy 16.1.10 – Sponsorship for Investigational New Drug Applications
- UAMS Policy 16.1.11 – Sponsorship for Investigational Device Exemptions
- ORRA Policy – Guidance When Submitting Single Patient, Non-Emergency Use Expanded Access Requests