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IRB Approval: 11/20/2017 IRB Accepted: 11/20/2017 IRB Expiration: 11/19/2018Study Volunteer InitialsLifespan Affiliate Site where research will be conducted Rhode Island Hospital Bradley Hospitalize
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What is wwwfdagovscience-researchclinical-trials-andregulations good clinical practice?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. It ensures that the rights, safety, and well-being of trial subjects are protected.
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All sponsors, investigators, and IRBs involved in the conduct of clinical trials are required to follow Good Clinical Practice (GCP) guidelines.
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GCP guidelines can be filled out by ensuring compliance with the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
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The purpose of Good Clinical Practice (GCP) is to provide a unified standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
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Information such as protocol adherence, study subject eligibility, informed consent documentation, adverse events, and data integrity must be reported on Good Clinical Practice (GCP) forms.
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