Background Many agencies across the world have pharmacovigilance requirements.
{"Image DocumentName": "BackgroundMany agencies across the world have pharmacovigilance requirements.", "Image ImageDescription": "The Medicines for Human Use (Clinical Trials) Regulations 2004 transposed ICH-GCP requirements into European law and set out the legal requirements for pharmacovigilance in clinical trials involving participants that evaluate medicines from Europe. The Albumen used in this trial is being provided by Baxter, from Europe and so they have a legal requirement to monitor the trial. More that that. We, as investigators, have an ethical and scientific obligation to ensure optimum safety reporting.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}