Regulatory & FDA Support

The Regulatory & FDA Support Core are a team of dedicated support staff who are well versed in the regulatory approval and startup processes of the FDA and the Institutional Review Board (IRB). As a fee for service team, the FDA & Regulatory Support Core can provide flexible services based on the individual needs of each department/investigator and can begin at any point in the research trial.

Upon request, services from the core can begin immediately and be maintained on a short- or long-term basis. In addition, the FDA & Regulatory Support Core are available to provide consultation services prior to the start of a clinical trial to assist investigators with drug/device/biologic pre-clinical questions, biostatical support, and guidance on the correct regulatory pathway with the FDA and IRB.

FDA support services include:

• Protocol review and evaluation
• Drug and device risk determination
• IND/IDE application assistance
• Regulatory document/binder creation
• Source document creation
• FDA regulatory monitoring
• Long term FDA maintenance
• Biostatistician support

Regulatory support services:

• IRB application and study start-up support
• Regulatory document/binder creation
• Investigator and study team education/training
• Regulatory prep/clean-up for monitoring visits
• Long-term regulatory maintenance
• Study closure support

To request service, please complete this form:

Regulatory/FDA Guidance Core Work Request Form

For additional information, email our Central Inbox at FDARegSupport@UHhospitals.org or contact Jenna Arlow, Manager, Regulatory & FDA Support Core at Jenna.Stump@UHhospitals.org or at 216-286-0754.