ICH Clinical Safety Data Management

Question 1

Adverse Event (or Adverse Experience)

Answer 1

any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Question 2

Adverse Drug Reaction (ADR) definition #1

Answer 2

All noxious and unintended responses to a medicinal product related to any dose. “responses to medicinal product” means that a causal relationship between medicinal product and AE is at least possible.

Question 3

Adverse Drug Reaction (ADR) definition #2 (WHO definition)

Answer 3

A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

Question 4

side effect

Answer 4

This term is NOT to be used synonymously with “adverse event” as a side effect can be both negative and positive.

Question 5

SERIOUS adverse event (experience) or reaction

Answer 5

any untwoard medical occurrence that at any dose level 1) results in death 2) is life-threatening. In this context life-threatening would require inpatient hospitalization or prolongation of existing hospitalization, results in persisent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Question 6

Serious vs Severe

Answer 6

NOT to be used synonymously. Severe is often used to describe the intensity of a specific event (as in mild, moderate, or severe mycoardial infarction); the event iteself, however, may be or relatively minor medical significance (such as a severe headache). This is NOT the same as “serious” which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient’s life or functioning.

Question 7

Reporting Time Frames

Answer 7

Fatal or Life-Threatening Unexpected ADRs: no more than 7 calendar days.

All Other Serious, Unexpcted ADRs: No more than 15 calendar days.

Question 8

It is the responsibility of the _____ to decide whether active comparator drug reactions should be reported to the other manufacturer ad/or regulatory agencies

Answer 8

sponsor