University of Pittsburgh

Pitt Bar links

  • Pitt Home
  • RESEARCH CONDUCT AND COMPLIANCE OFFICE
  • Find People
OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS)

Search

header image

Policies and Procedures

Policies and Procedures

  • Policies and Procedures for Investigator-Sponsored IND & IDE Applications (PDF)

Certification of IND.IDE Suitability

  • Certification Document of IND.IDE Suitability

  • Home
  • About
    • Objectives
    • Services
  • Policies and Procedures
  • IND
    • Templates
  • IDE
    • Templates
  • Guidance
  • Forms
  • Safety Reporting
  • FAQ
  • News & Events
  • Contact Us
  • Pitt Research home page

Where to Begin

Am I required to submit an IND or IDE application?

Click Here for IND Guidance

Click Here for IDE Guidance

Click Here for Required O3IS Submission Forms

Click Here for Information regarding International Research

Policies and Procedures

Revised Policies and Procedures

Expanded Access

Individual Patient

Intermediate-sized Patient Population

OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT(O3IS)

3500 Fifth Avenue
Hieber Building
Suite 303
Pittsburgh, PA 15213

 

 

Cynthia Kern, RN, CCRC, CIP
Director
412.383.1710
kernc@pitt.edu

Mara J. Horwitz, MD
Associate Director
horwitz@pitt.edu

 

April Lehman, MPPM
Regulatory Specialist
412.383.3411
adl51@pitt.edu

 

Courtney Wilkes, MA
Office Coordinator
412.383.1502
crw29@pitt.edu

 

Copyright 2021 | Send feedback about this site