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Exam (elaborations)

Good Clinical practice (ICH) correctly answered 2023/2024

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Good Clinical practice (ICH)Which of the following is NOT a principle of GCP: (Please select all that apply) Any foreseeable risks and inconveniences must be weighed up against any benefits Information must be recorded, handled and stored in a manner that allows accurate reporting, interpretation and verification and which ensures the confidentiality of participants' records. Publication of results is not required if the study results were not as expected. The study protocol must provide inclusion and exclusion criteria, monitoring details and a publication policy. Available non-clinical and clinical information on the investigational medicinal product being used must be adequate to support the study. The study must be conducted according to the Nuremberg Code of 1947 - correct answer Publication of results is not required if the study results were not as expected. The study must be conducted according to the Nuremberg Code of 1947 ICH-GCP guidelines are a legal requirement and studies found not following it will be terminated. True False - correct answer False It is important for investigators in low-and middle-income countries to adopt good clinical practice guidelines because their studies will conseque... True False - correct answer True

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