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Prospective Clinical Trials Involving the Consent Process: Investigational Product

Investigational Product

For studies that involve the administration of an investigational product this section should include the product information, package insert, and Investigator Brochure.

Investigational Product Tracking

Receipts of investigational product from the sponsor or manufacturer as well as temperature tracking information should be kept here unless these responsibilities have been delegated to the investigational pharmacy service.  Discrepancies on shipments should be noted.  The investigational product tracking form should be utilized to identify who received the product and how much they have received.  For industry sponsored studies this may be supplied. 

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