AEMPS UPDATES GCP SECTION

AEMPS UPDATES GCP SECTION On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated: New version of serious protocol breaches notification form. Prohibition of FDA 1572 form in clinical trials carried out in…

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BIOETHICS IN CLINICAL TRIALS

BIOETHICS IN CLINICAL TRIALS The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the…

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