IND/IDE Assistance

Frequently Asked Questions

Below are some of the most commonly asked questions in regards to IND/IDE applications. If you have additional questions that were not answered here, please contact Angela Braggs-Brown or Kareemah Mills.

FDA IND/IDE

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  • CENTER FOR DRUG EVALUATION AND RESEARCH CONTACTS

  • CLINICAL INVESTIGATOR

  • CLINICAL TRIALS

  • CONFIDENTIALITY

  • DATA SAFETY MONITORING

  • EARLY COLLABORATION

  • HUMANITARIAN DEVICE EXEMPTION

  • IN VITRO DIAGNOSTIC DEVICES

  • IND SUBMISSION

  • INSTITUTIONAL REVIEW BOARD (IRB)

  • LABELING

  • NEW INDICATION FOR MARKETED DEVICE

  • STATEMENT OF INVESTIGATOR FORM

  • WAIVERS

Contact Us


Human Research Protection Program
(ML0567)
University Hall, Suite 300
51 Goodman Drive
PO Box 210567
Cincinnati, OH 45221-0567
General Inquiries:
513-558-5259
irb@ucmail.uc.edu

Click here to identify the person dedicated to serving your research group

 

Angela Braggs-Brown, RAC, CIP, MA
Director
513-558-3005
angela.braggs-brown@uc.edu

Kareemah Mills, CIP
Assistant Director
513-558-3576
kareemah.mills@uc.edu

Claudia Norman, CIP
Education and Outreach Specialist
513-558-5784
claudia.norman@uc.edu

Human Protection Administrators

Laura Goins
513-558-0479
laura.goins@uc.edu

Martina Harmon, MS
513-558-1881
martina.harmon@uc.edu

Tara Knipp, CIP
513-558-3731
tara.knipp@uc.edu

Christa Preston, CIP
513-558-2087
christa.preston@uc.edu

Deborah Quinones-Stewart
513-558-6915
deborah.quinones-stewart@uc.edu

Quality Assurance Auditors
Jackie Glass, CCRP
513-558-0453
jacklyn.glass@uc.edu

Brianna Mills
513-558-2286
brianna.mills@uc.edu

StrokeNet CIRB
Susan Roll, RN, BSN, CCRP
CIRB Liaison
513-558-6061
susan.roll@uc.edu

Jo Ann Behrle
Human Protection Administrator
513-558-5273
joann.behrle@uc.edu

Keeley Lynch
CIRB Coordinator
513-558-5209
keeley.lynch@uc.edu