Topics: CLPT, M.Pharmacy, Pharmaceutics; Regulatory Affairs Quiz
The IMPD should also provide data from nonclinical trials and any information on the previous clinical use of the IMP or justify in the application why information is not provided.
A. TRUE
B. FALSE
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Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures.
A. TRUE
B. FALSE