Book 16: 2025 Preambles to Good Clinical Practice RegulationsDescription Contents Cover A great companion to Book 1, this spiral bound, 8 1 2" x 11" book is a compilation of preambles to the GCP regulations, 21CFR parts 11, 50, 54, 56, 312 and 314. A preamble is the explanatory text that precedes a new or revised regulation when it is published by the federal government. Preambles provide important background information on a regulation such as: The reason(s) for the regulation or change in in the regulation
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Book 16: 2025 Preambles to Good Clinical Practice Regulations