Definitions
Adverse Drug Experience:
Any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease associated with the use of medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
- Fatal adverse drug experience:
Any adverse drug experience that causes the death of the subject. - Life-threatening adverse drug experience:
Any adverse drug experience that places the subject at immediate risk of death from the reaction as it occurred. -
Serious adverse drug experience:
Any adverse drug experience occurring at any dose that results in any of the following outcomes:- Death
- Life-threatening adverse drug experience
- Inpatient hospitalization or prolongation of existing hospitalization
- Persistent or significant disability/incapacity
- Congenital anomaly/birth defect
- Unexpected adverse drug experience:
Any adverse drug experience, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current IND application and that has not been previously observed.
Sponsor-Investigator:
An individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The sponsor-investigator must comply with the FDA's specific responsibilities of both the sponsor and the investigator.
Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu
