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21st Aug 2013, 09:38 AM
#1
Licensed IMP used for licensed indication - accountability required?
A phase four trial using a licensed IMP for a licensed indication. IMP to be taken from commercial stock in a clinical area; as such no records of IMP delivery from supplier or temperature monitoring records are to be kept. Accountability limited to clinician entering brand and batch number of product on trial documentation when IMP used. Is this acceptable?
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