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URL: http://eagle-i.itmat.upenn.edu/i/0000013a-bc4e-ecdd-d69a-d90d80000000
Proper Citation: CHOP Clinical Trials Office (RRID:SCR_009725)
Description: Core facility that provides the following services: Clinical trials consultation service, Document storage service, Investigational new drug or investigational device exemption application support service, Institutional Review Board submission service, Additional regulatory submissions support service, Protocol development service, Human subject recruitment support service, Study feasibility service, Study placement service. The Clinical Trials Office (CTO) at The Children''s Hospital of Philadelphia is a centralized office that provides resources and assistance to clinical research investigators, enabling them to carry out clinical research in a manner consistent with the Hospital''s goals ? excellent patient care, top-quality education, and innovative research. The CTO has expertise in implementing, conducting, and monitoring clinical trials and provides a variety of services that benefit both novice and experienced clinical researchers. The CTO is designed to ensure the excellence and compliance of an investigator''s clinical research trial. The Children''s Hospital of Philadelphia established the CTO in 1999 as part of the institution''s emphasis on clinical research. Since then, the CTO has experienced rapid growth. The CTO advances the quality and quantity of clinical research at Children''s Hospital and its associated network. Specifically, the CTO supports research at the Hospital by developing and completing submissions to the Hospital''s Institutional Review Board; assisting in the preparation of Investigational New Drug and Investigational Device exemption application submissions to the Federal Drug Administration; conducting clinical research studies under the guidance of principal investigators; and developing budgets and providing research training for investigators, study coordinators, and administrative staff. The CTO staff works in partnership with investigators to ensure the protection of human subjects in accordance with Good Clinical Practice, federal, state and/or local regulations and the requirements of the study sponsor.
Resource Type: access service resource, core facility, service resource
Keywords: clinical trial technique, human subject recruitment and protection
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