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.