Question

For participants discontinuing participation in a study because of a serious adverse event (SAE) or pregnancy, which of the following are correct?

Answer 1

Explanation:

study adverse event (SAE) is correct for your question

Answer 2

Answer:

True

Explanation:

A serious incident is any unwanted experience related to the use of a medical product by a patient. The event is serious and should be reported to the FDA if the patient's outcome is:

Death

Report a suspicion of death as a result of a serious accident, and enter a date if known.

Life-threatening

Report if you suspect that a patient was at high risk of death during a traumatic event, or the use or continued use of the device or other medical product may result in the patient's death.

Hospitalization (first or longer)

Report if hospital admission or extension of hospitalization was the result of a serious incident.

An emergency room visit that does not lead to hospitalization should be evaluated for one of the most serious consequences (e.g., life-threatening; interventions needed to prevent permanent damage or injury; another important medical event).

Report if an accident has caused a serious impairment of a person 's ability to perform normal life activities, that is, a serious accident has caused a significant, continuous or permanent change, damage, injury or disruption to the patient's work / body structure, physical activities. and / or quality of life.

Congenital Anomaly

Report if you suspect that exposure to a prescription product before or during pregnancy may cause adverse effects on the baby.

Interventions Needed To Prevent Permanent Damage or Injury (Devices)

Report if you believe that medical intervention or surgery was necessary to prevent permanent damage to the function of the body, or to prevent permanent damage to the body structure, or any condition suspected to be due to the use of a medical product.

Other Critical Issues (Important Medical Events)

Report when an event does not coincide with other outcomes, but the event may put the patient at risk and may require medical intervention or surgery (treatment) to prevent any of the other side effects.  Examples include allergic brochospasm (a serious respiratory problem) that requires treatment in the emergency room, serious blood dyscrasias (blood disorders) or unconsciousness / seizures that do not cause hospitalization.  The development of drug dependence or drug abuse can also be examples of important medical events.

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