Complaints, Product Recall and Emergency Un-Blinding

A system must be established to thoroughly investigate all complaints. Ifthe situation so demands, there must be procedures in place to effectively recall a product from the market. This requires the retention of distributor contact details and precise distribution records so that the destination of each shipment can be determined. 

The regulatory authorities must be informed of any planned recall actions (see Chapter 12). Procedures are also required for emergency un-blinding of materials undergoing clinical trial. The responsibility for complaints and the initiation of product recalls should be assigned to designated individuals. 

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