clinical research and GCP II …Case Study:Adverse Event Scenario 1

Adverse Event Case Study 1

 A patient in a clinical trial suffers a stroke and is hospitalised. The subject makes a full recovery and is discharged. The investigational site does not find out about this until the subject attends for their next scheduled visit. At this visit the study nurse correctly identifies this as a Serious Adverse Event (SAE) and highlights this to the investigator. The investigator does not check the Investigator’s Brochure but thinks he remembers seeing stroke listed as a potential adverse reaction so classifies the stroke as related but expected. The site does not send the SAE report to the sponsor at this stage. When the monitor next visits the site she checks the Investigators Brochure and sees that stroke is not listed. On discussion with the investigator he still feels the stroke may be related to IMP as the patient did not initially present as being at risk of stroke.

Which of the following are Adverse Events or Serious Adverse Events?

The bunion

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event

The operation

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event

The trip

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event

The damage to the wound

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event