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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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