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Protocol and Protocol Amendments
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Item Number: NWRR4081
An 11-page procedure, including two attachments (Protocol Format Requirements, and Protocol Amendment Template), that describes the steps involved in the development, review, and approval of protocols and protocol amendments for nonclinical laboratory studies. This procedure applies to all nonclinical laboratory studies that support or are intended to support applications for products regulated by the Food and Drug Administration (FDA). The document assigns responsibility for each step of the procedure, including protocol numbering, protocol development, protocol amendments, and protocol and protocol amendment maintenance.
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