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Home | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh

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 Science Institute, and the Research Conduct and Compliance Office; established for the purpose of providing assistance to University researchers involved in the development and submission of investigator-sponsored Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs) for acceptanc

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Home | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh | o3is.pitt.edu Reviews

https://o3is.pitt.edu

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 Science Institute, and the Research Conduct and Compliance Office; established for the purpose of providing assistance to University researchers involved in the development and submission of investigator-sponsored Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs) for acceptanc

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Safety Reporting | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh

http://o3is.pitt.edu/node/332

RESEARCH CONDUCT AND COMPLIANCE OFFICE. OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS). 1) What documents are required for submitting an IND Safety Report to the FDA? B) Form FDA 1571. C) Form FDA 3500A. D) Narrative description of the event, including a discussion of DSMB and IRB reviews of the incident and outcomes of the event. Please see the link below for the time frame of reporting IND Safety Reports to the FDA. Http:/ www.o3is.pitt.edu/ind. For IDE’S: Please submit the following:.

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Templates | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh

http://o3is.pitt.edu/ide/templates

RESEARCH CONDUCT AND COMPLIANCE OFFICE. OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS). 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. Pre-Submission IDE Meeting Request with the FDA. Methods, Facilities, and Control Information. Click Here for IND Guidance.

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Templates | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh

http://o3is.pitt.edu/ind/templates

RESEARCH CONDUCT AND COMPLIANCE OFFICE. OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS). Content and Format of an Initial IND Application. Formatting and Submission Requirements for IND Submissions. Chemistry, Manufacturing and Control Information. Pharmacology and Toxicology Information. IND Change of Sponsor. IND Meeting Requests with the FDA. IND Inactive Status Request. Requesting O3IS Approval for External Study Sites. Am I required to submit an IND or IDE application?

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About | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh

http://o3is.pitt.edu/node/289

RESEARCH CONDUCT AND COMPLIANCE OFFICE. OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS). 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. Revised Policies and Procedures. OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT(O3IS). Suite 303, Hieber Building. Pittsburgh, PA 15213. Cynthia Kern, RN, CCRC, CIP.

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Research Conduct and Compliance

http://www.rcco.pitt.edu/InvestigatorDeparture.htm

You are using an older browser that does not support current Web standards. Although this site is viewable in all browsers, it will look much better in a browser that supports Web standards. Research Conduct and Compliance Office. Education and Compliance for Animal Research. Education and Compliance for Human Subject Research. Human Stem Cell Research Oversight Committee. Institutional Animal Care and Use Committee (IACUC). Institutional Biosafety (rDNA) Office. Institutional Review Board (IRB). Bull; T...

ctsi.pitt.edu ctsi.pitt.edu

Clinical & Translational Science Institute

http://www.ctsi.pitt.edu/regulatory.shtml

How to Access CTSI/Facilitators. Research Facilities and Networks. Responsible Conduct of Research. Connecting with the Community. The Regulatory Knowledge and Support Core of the Clinical and Translational Science Institute (CTSI) promotes good clinical practice and facilitates regulatory compliance in clinical and translational research. CTSI provides hands-on education, training, services, and resources for researchers, students, fellows, research staff, and health professionals. Office of Clinical Re...

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Home | OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (O3IS) | University of Pittsburgh

RESEARCH CONDUCT AND COMPLIANCE OFFICE. OFFICE FOR INVESTIGATOR-SPONSORED IND AND IDE SUPPORT (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.

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