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

The study protocol is the correct source for information on the storage requirements for an investigational product. This document serves as a comprehensive plan for the clinical trial, detailing all aspects of the study, including the handling of investigational products. It specifies conditions that must be maintained to ensure the integrity and safety of the drug, such as temperature limits, protection from light, and humidity conditions, as well as any other special handling requirements that are crucial for maintaining the product's quality throughout the study.

In contrast, the FDA guidelines provide regulatory standards and oversight for clinical trials but do not offer specific details about storage requirements for individual investigational products. Marketing materials for a product focus on promoting it for commercial use rather than providing procedural details relevant to clinical trials. Participant consent forms convey information about the study to participants but do not include technical details regarding investigational product storage or handling. Hence, the study protocol is the primary resource for these specific requirements.