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University of Pittsburgh

Activities and Services

Sponsor-Investigator IND/IDEs

In 2007, the Office for Investigator-Sponsored IND/IDE Support (O3IS) was established to assist faculty who are sponsor-investigators under the FDA regulations related to investigational new drugs and devices.

The primary mission of the University of Pittsburgh’s O3IS is to provide a centralized resource for expertise and support related to the conduct of clinical research studies conducted under University-based, sponsor-investigator Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.

All research IND/IDE “sponsors” are mandated by federal regulations to provide routine monitoring of the progress and appropriate conduct of all protocols conducted under the respective IND or IDE. The ECO-HSR has assumed responsibility for monitoring these protocols to assure that this function is performed consistently across all University-based IND/IDE protocols.

The initial monitoring visit is an in-depth review of all FDA regulatory requirements, study conduct responsibilities and the related documentation. A monitoring report is written and presented to the IRB Executive Committee.

Subsequent monitoring visits include the review of the regulatory file, the informed consent process, protocol compliance implementation of study procedures, appropriate documentation and reporting of UAPs and SAEs and drug/device accountability. A monitoring report noting any deficiencies is sent to the investigator with a request for a corrective and preventative action plan. The ECO-HSR staff works collaboratively with the investigator to ensure that all deficiencies are satisfactorily resolved.

The number of monitoring visits varies with each protocol and is determined by the monitor after careful review of the protocol.