The preparation of study medications or devices for clinical studies is a time-consuming process and often rate-limiting in initiating the study, particularly with double-blind designs. Requisition, labeling and packaging are some of the important considerations.
Requisition of study medication/device (including placebo and comparator products, if relevant) must be initiated at an early stage to allow sufficient time to procure the study medications/devices and to prepare the final labeling and packaging, taking into account any special circumstances for blind studies and for import requirements.
The principles of safe labeling and packaging require compliance with the following principles: the contents of a container can be identified; a contact name, address and telephone number is available for emergencies and enquiries; and the study subject (or the person administering the medication/device) is knowledgeable about storing and administering the study medication/device, and that the packing process can be audited against a standard Operating Procedure.
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