SAEs
An adverse event occurring during a clinical trial is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to the regulatory authority when the patient outcome is:
- Death
- Life-Threatening
- Hospitalization (initial or prolonged)
- Disability
- Congenital Anomaly
- Requires Intervention to Prevent Permanent Impairment or Damage
SUSAR
A SUSAR is a Suspected Unexpected Serious Adverse Reaction occurring during a study and is to be reported to the regulatory authority by using the CIOMS form:
- The event must be a SAE.
- There must be a certain degree of probability that the event is an adverse reaction on the administered drug.
- The adverse reaction must be unexpected, that is to say, not foreseen in the SPC text (Summary of Product Characteristics (for an authorised medicinal product)) or the Investigator’s Brochure (for an unauthorised medicinal product).