Investigational Product

Question 1

Recordkeeping

Answer 1

includes keeping track of the receipt, storage, dispensing, reconciliation, and return of the investigational product.

Question 2

Investigational New Drug

Answer 2

A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes

Question 3

Form FDA 1571

Answer 3

Investigational New Drug (IND)

Question 4

Form FDA 1572

Answer 4

information about the credentials of each investigator and sub-investigator who will use the investigational product as part of the clinical trial.