Adverse event reporting requirements
This section contains the following:
Introduction
During the course of a clinical trial, the occurrence of adverse
events
must be carefully monitored and recorded. Different countries have
different regulations with regard to adverse event reporting, so due
diligence must be taken to follow the appropriate guidance.
Some regulations distinguish between serious adverse events (SAEs)
and suspected unexpected
serious adverse events (SUSARs). A SAE is one which is fatal or life threatening,
disabling or incapacitating, requires or prolongs hospitalisation, causes/results
in congenital anomaly/cancer or is irreversible. A SUSaR is one which is not anticipated, not known to be
related to the disease being studied or the intervention being used.
It is
important that a system for prompt and
efficient
notification of any unexpected or serious adverse event be set up.
Annual reports, if required, should be sent to the regulatory authorities and ethics committee.
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To consider
If an adverse event occurs the coordinating centre should review the incident:
- get a description of the event;
- find out what effect the incident had on patients and staff;
- ask if there was anything the trial could do to prevent it happening again;
- make sure to record actions that were taken to prevent a reoccurence.
Additional resources
Safety reporting definitions
Definitions and relevant websites for safety reporting from the
Centre for Healthcare Randomised Trials, Health Services Research Unit,
University of Aberdeen.
Further reading
WHO GCP Guidelines on the Reporting of Adverse Events. In: Guidelines
for
Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. WHO
Technical
Report Series, No. 850, (pages 97-137). World Health Organization,
Geneva,
Switzerland, 1995. Chapter 7
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This page was last updated March 2009.