Challenge: Research All Rounder
Question Number 1

According to ICH GCP the sponsor should ensure that written procedures include instructions that the investigator/institution should follow for the handling and storage of investigational product(s) for the trial and documentation thereof. What is missing from the following list of things that these procedures should address:

  • handling
  • storage
  • dispensing
  • retrieval of unused product from subjects
  • return of unused investigational product(s) to the sponsor

 

A
access to IP
B
shipping/transport conditions
C
adequate and safe receipt
D
security and access rights to IP storage

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