IND/IDE Assistance

Investigational New Drug (IND)

An IND is an investigational new drug (application).  It is a request to the FDA to allow the administration of investigational drugs to humans.

    A.  Determining if an IND Application is Needed

    To determine if an IND is needed for your clinical research or study, complete the IND exemption checklist (found under "IND/IDE"). 

    B.  Compiling an IND Application

    FDA has set forth the content and format for an IND application in 21 CFR Part 312.23.

    To protect researchers and UC, HRPP staff must review IND applications prior to submission to the FDA (per UC HRPP policy III.08) whenever a UC researcher is serving as Sponsor-Investigator (the person who both initiates an FDA regulated study and has the regulatory responsibility; sponsor in this roles is not related to funding).  Also see definition according to 21 CFR 312.3(b).

    If you have questions regarding compiling and maintaining an IND application, please contact Angela Braggs-Brown or Kareemah Mills.

    C.  IND Application Approval Process

    Following submission, the FDA may request additional information or place full or partial clinical holds on the protocol(s) proposed in the IND application. Research cannot begin until all concerns raised by the FDA have been responded to their satisfaction. The FDA will respond within 30 days with an acknowledgement letter including an IND number. This means that the IND has been successfully filed, however, the clinical investigation cannot start until the IRB has granted approval and 30 days after the date of receipt on the FDA acknowledgement letter, unless an earlier notification by FDA is received stating otherwise.

    In some cases, the FDA may conclude that the protocol(s) proposed in the IND application is(are) exempt. An exemption means that the study or research may be conducted following IRB approval without an IND application; the investigation(s) must be conducted in compliance with 21 CFR Parts 50 and 56.

    D.  Maintaining an IND Application

    Research must be conducted in compliance with FDA and UC policies and procedures.  Researchers must obtain both FDA approval of the IND application, as well as IRB approval of the protocol. All aspects of the study are subject to auditing by the FDA, the UC IRB and its designees.

     

    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