Managing Investigational Agents According to GCP Requirements

Investigational drug

"A pharmaceutical form of an in active the gradient or placebo of being tested are used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for in an approved in dictation, or when used to game for the information about an improved use"

Biological Product (or Biologic)

"Any virus, Therapeutics serum, toxin, anti-toxin, or analogous product applicable to the prevention, treatment or cure a disease or injury's"

Device

"Intended to affect the structure or any function in the body of man or another animal, and which does not achieve its primary intent and purpose through chemical action within or on the body of man or another animal and which is not dependent upon being metabolize for the achievement of its primary intended purpose"

Investigational new drug (IND)

A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy.

Investigational product dispensing or administration information for the sponsor is recorded on the:

Case report form

Investigation Product

Define for this module as any unapproved drug, medical device, or biological undergoing clinical trials to provide evidence to regulatory authorities that the product is safe and efficacious

Which of the following is an important component of drug accountability?

Drug shipping and disposition records

Where is information on storage requirements for the investigational product usually found?

In the study protocol

Who has ultimate responsibility for an investigational product?

Investigator

The packaging of investigational drugs should ideally

be designed to help with subject compliance