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.

 

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