Good Clinical Practices (Final With Links)
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This document summarizes key principles of Good Clinical Practice (GCP) for conducting clinical trials. It outlines requirements for investigators, including being qualified, having sufficient time, and committing to comply with GCP principles. It also summarizes important rules for investigators, such as knowing and following the study protocol, selecting and training personnel, obtaining informed consent from subjects, and maintaining product and data accountability. Adhering to GCP helps protect subject safety and ensures trial quality and integrity.
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Jasmine should not have begun data collection without IRB approval. She will need to discard any data collected prior to receiving approval and restart the study only after obtaining approval. Researchers cannot apply for retrospective approval or use data collected without approval.
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