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CLINICAL TRIALS
Background
• Many agencies across the world have pharmacovigilance
requirements.
• 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
Background
• The Regulations/ requirements cover:
– Definitions of adverse events,
– The responsibilities of investigators for recording
of adverse events and the notification of adverse
events to sponsors
– The responsibilities of sponsors for reporting to
regulatory authorities and RECs including
expedited reports of SUSARs and regular Safety
Reports.
Background
• Most agencies (sponsors, country regulators)
accept in principle that a risk-based approach to
trial management and monitoring is appropriate.
This includes the management of
pharmacovigilance.