where is information on storage requirements for the investigational product usually found?

Information on storage requirements for an investigational product is usually found on the labeling materials affixed to the packaging of the investigational product. These labels indicate important storage conditions such as temperature range and protection from light. Additionally, the detailed storage and handling requirements are compiled in the Investigator’s Brochure (IB), which is provided by the study sponsor based on stability studies conducted during the drug development phase. These instructions are critical to preserving drug potency and ensuring patient safety and must be strictly followed. The sponsor or manufacturer typically provides these guidelines, and any storage details should be documented in pharmacy Standard Operating Procedures (SOPs) during the trial setup.