IND reporting

Question 1

Adverse Event

Answer 1

Any untoward medical occurence associated with the use of the drug in humans, whether or not considered drug related

Question 2

Life-Threatening Adverse Event or Life-Threatning Suspected Adverse Reaction

Answer 2

An adverse event is considerd “life-threatning” if in the view of either the investigator or sponsor, it’s occurence places the subject at immediate risk of death

Question 3

Serious Adverse Event or Serious Suspected Adverse Reaction

Answer 3

An adverse event or suspected adverse reaction is considered serious if it results in any of the following:
1. Death
2. A life-threatening adverse event
3. Inpatient hospitalization
4. Persistent or significant incapacity or disruption of the ability to conduct normal life functions
5. A congenital anomaly/birth defect

Question 4

Suspected Adverse Reaction

Answer 4

Any adverse event for which there is a reasonable possibility that the drug caused the adverse event (Causal relation between the drug and the adverse event)

Question 5

Unexpected Adverse Event or Unexpected Suspected Adverse Reaction

Answer 5

-An adverse reaction is considrerd unexpcted if it is
1. Not listed in the IB, or not listed in the specificity or severity that has been observed
2. The investigator brochure is not required or available
3. is not consistent with the risk information described in the general investigational plan