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

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Guidance

University of Pittsburgh Guidance Documents

  • Conducting a Clinical Trial at Multi-Center, External Study Sites Under a University-based IND/IDE Application

FDA Guidance Documents

  • Center for Drug Evaluation and Research Guidance Documents
  • Center for Biologics Evaluation and Research Guidance Documents
  • Center for Devices and Radiological Health Guidance Documents
  • Dockets Open for Comment
  • Preparing a Claim of Categorical Exclusion or an Environmental Assessment
  • Clinical Trials Registration Requirements
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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

 

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