Managing Investigational Agents According to GCP Requirements | Questions with 100% Correct Answers | Verified | Updated 2023

Which of the following is an important component of drug accountability? - Drug shipping and disposition records Who has ultimate responsibility for an investigational product? - Investigator Investigational product dispensing or administration information for the sponsor is recorded on the: - Case report form The packaging of investigational drugs should ideally - be designed to help with subject compliance Where is information on storage requirements for the investigational product usually found? - In the study protocol 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