About the O3IS |
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| A. Introduction |
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 acceptance by the U.S. Food and Drug Administration (FDA) and the conduct of clinical research studies under such FDA-accepted applications and exemptions. |
| B. Objectives |
The primary objectives of the O3IS are to: - provide a centralized resource of information, expertise, and support related to addressing the complex regulatory requirements, obligations, and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs;
- guide University researchers in their compliance with the regulatory requirements, obligations and responsibilities associated with the conduct of clinical research studies under investigator-sponsored INDs and IDEs; and
- ensure appropriate institutional oversight of commitments made under investigator-sponsored INDs and IDEs; the preparation (i.e., “manufacturing”) of drugs and devices for evaluation under investigator-sponsored INDs and IDEs; and the conduct of clinical research studies under investigator-sponsored INDs and IDEs.
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| C. Services |
| Specific services offered by the O3IS include, but are not limited to, the following: - Maintain information regarding current FDA regulations and guidance documents pertinent to the preparation and submission of investigator-sponsored INDs and IDEs and the conduct of clinical research studies under such FDA-accepted applications and exemptions
- Provide education to University researchers regarding the regulatory requirements, obligations, and responsibilities associated with the conduct of clinical research studies under investigator-sponsored INDs and IDEs
- Assist University researchers in determining if there is a requirement for the submission of an investigator-sponsored IND or IDE for their planned clinical research studies
- Assist University researchers in identifying appropriate expertise and facilities as necessary for the preparation (i.e., “manufacturing”) of drugs and devices being evaluated under investigator-sponsored INDs and IDEs
- Assist University researchers with the preparation and submission of investigator-sponsored INDs and IDEs
- Assist University researchers with FDA communications concerning planned, submitted, or accepted investigator-sponsored INDs and IDEs
- Guide University researchers in achieving compliance with the regulatory requirements and obligations associated with the conduct of clinical research studies under investigator-sponsored INDs and IDEs
- Ensure institutional awareness of planned clinical research studies requiring the submission of investigator-sponsored INDs and IDEs and/or of planned services to support the submission of investigator-sponsored INDs and IDEs
- Ensure institutional awareness of the submission of investigator-sponsored INDs and IDEs and respective FDA communications
- Coordinate Research Conduct and Compliance Office monitoring of the preparation (i.e., “manufacturing”) of drugs and devices in accordance with FDA-accepted, investigator-sponsored INDs and IDEs and/or applicable standards
- Coordinate Research Conduct and Compliance Office monitoring of the conduct of clinical research studies in accordance with FDA-accepted, investigator-sponsored INDs and IDEs and the FDA’s current Good Clinical Practice (GCP) standards
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| D. Contact Information: |
Dennis P. Swanson, RPh, MS
Director, Office for Sponsor-Investigator IND and IDE Support
Hieber Building, Suite 204
3500 Fifth Avenue
Pittsburgh, PA 15213
E-mail: swansondp@upmc.edu
Telephone: 412-383-1399 |
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