This document discusses the responsibilities of sponsors and investigators in managing investigational products in clinical trials. It explains that sponsors must ensure sufficient nonclinical and clinical data support human use of investigational products. Sponsors are responsible for providing information on investigational products to investigators through investigator brochures. They must also properly store, package, label, and supply investigational products and placebos to investigators. Investigators are responsible for accountability of investigational products at trial sites and ensuring proper use by subjects according to protocols. Both sponsors and investigators must follow requirements for randomization and blinding in blinded trials.
3. 3
“The available nonclinical and clinical information
on an investigational product should be adequate
to support the proposed clinical trial.”
ICH-GCP Principle 4
7. 7
“Investigational products should be manufactured,
handled, and stored in accordance with applicable
good manufacturing practice (GMP). They should
be used in accordance with the approved protocol.”
ICH-GCP Principle 12
17. 17
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