What must the packaging list or shipping invoice detail?

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The packaging list or shipping invoice must detail the quantity of investigational products shipped because it is essential for tracking and accountability. This documentation ensures that the correct amounts of products are sent to clinical trial sites, facilitating inventory management and compliance with regulatory requirements. Accurately reflecting the quantity of investigational products also helps avoid potential issues such as overstocking or understocking, which can disrupt the trial's timeline and integrity.

In contrast, details such as all patients involved in the study are typically maintained in separate records or databases, and are not relevant to the shipping documentation. Dates of clinical trials are related to the overall study timeline but do not necessarily pertain to the specifics of shipping and inventory. Lastly, methods of product destruction, while important for compliance and safety, are also not applicable to the shipping invoice or packaging list, as they relate to the handling of products after the trial or in the event of a product recall or disposal.

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