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

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O3IS

The University of Pittsburgh Office for Investigator-Sponsored IND and IDE Support (O3IS) is a combined service of the Office of Clinical Research, Health Sciences, the Clinical and Translational... Learn More >>

Investigational Device Exemption Templates

  • Content and Format of an Initial IDE Application
  • Formatting and Submission Requirements for IDE Submissions
  • Cover Letter for Original IDE Application
  • Report of Prior Investigation(s) of the Device
  • Investigational Plan - Feasibility Study
  • Investigational Plan - Pivotal Study
  • Methods, Facilities, and Control Information
  • Example Investigator's Agreement
  • Cover Letter for Supplemental IDE Application
  • Progress Report
  • Final Report

Investigational New Drug Templates

  • Content and Format of an Initial IND Application
  • Formatting and Submission Requirements for IND Submissions
  • Clinical Study Protocol
  • Chemistry, Manufacturing and Control Information
  • Pharmacology and Toxicology Information
  • IND Annual Report
  • IND Change of Sponsor
  • IND Information Amendment
  • IND Inactive Status Request
  • IND Protocol Amendment
  • IND Withdrawal Request
  • Certification/Disclosure of Financial Interest of Clinical Investigators
  • Home
  • About
    • Objectives
    • Services
  • Policies and Procedures
  • IND
    • Templates
  • IDE
    • Templates
  • Guidance
  • FDA Forms
  • FAQ
  • News & Events
  • Contact Us

Where to Begin

Contact Us to Discuss Your Protocol

Cynthia Kern
RN, CCRC, CIP
O3IS Director
412-383-1710
kerncm@upmc.edu

Policies and Procedures

Revised Policies and Procedures

Expanded Access

Individual Patient

Intermediate-sized Patient Population

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

Suite 303, Hieber Building
Pittsburgh, PA 15213

 

Cynthia Kern, RN, CCRC, CIP

O3IS Director
412.383.1710
kerncm@upmc.edu

Courtney Wilkes, BA, MA
O3IS Office Coordinator
412.383.1502
wilkescr@upmc.edu

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