Shipment of Study Medications Devices

Clinical study medications/devices should not be dispatched to study sites until all prestudy activities have been completed and regulatory requirements satisfied. The receipt of each shipment of study medication/device should be confirmed in writing by the investigator or pharmacist (or other authorized personnel), who will be instructed to return a completed 'acknowledgement of receipt form' immediately. The recipient at the study site will be instructed to contact the sponsor/CRO immediately if there are any problems (e.g. missing or broken items, defects in labeling, evidence of excursion from temperature ranges) with the shipment. The recipient must be particularly instructed to record the exact date of receipt of the clinical supplies at the study site. This information is necessary so that the monitor can determine that the supplies were secure and correctly stored environmentally during the entire period of shipment.

After the clinical study supplies have been sent to the study site, the monitor must verify as soon as possible that the supplies have arrived satisfactorily. Supplies may not be dispensed to study subjects until the monitor has checked their condition. The monitor will verify that the amount shipped matches the amount acknowledged as received. If there is a lack of reconciliation, or if the shipment is not intact, recruitment may be delayed until the situation is resolved.

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