Good Clinical Practice (GCP) well answered graded A+
Good Clinical Practice (GCP)GCP Principle 1 - correct answer 'The rights, safety and wellbeing of the trial subjects shall prevail over the interests of science and society.' GCP Principle 2 (staff) - correct answer 'Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.' GCP Principle 3 - correct answer 'Clinical trials shall be scientifically sound and guided by ethical principles.' GCP Principle 4 - correct answer 'The necessary procedures to secure the quality of every aspect of the trial shall be complied with.' GCP Principle 5 - correct answer 'The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.' GCP Principle 6 - correct answer 'Clinical trials shall be conducted in accordance with the principles of the Declaration of Helsinki.' GCP Principle 7 - correct answer 'The protocol shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.' GCP Principle 8 - correct answer 'The Investigator and sponsor shall consider all relevant guidance with respect to commencing ang conducting a clinical trial.' GCP Principle 9 - correct answer 'All clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.'
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- January 15, 2024
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good clinical practice gcp
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