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E-BOOK
Title Compact Regs Parts 50, 54, 56, and 312 : CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack).
Imprint Boca Raton : CRC Press, 2002.
©2005

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 Internet  Electronic Book    AVAILABLE
Edition 2nd ed.
Description 1 online resource (200 pages)
Note Available only to authorized UTEP users.
Publisher supplied metadata and other sources.
Subject Clinical trials -- Law and legislation -- United States.
Drugs -- Testing -- Law and legislation -- United States.
Human experimentation in medicine -- Law and legislation -- United States.
United States.
Contents Book Cover -- Title -- Copyright -- PART 50 -PROTECTION OF HUMAN SUBJECTS -- PART 54 -FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS -- PART 56 -INSTITUTIONAL REVIEW BOARDS -- PART 312 -INVESTIGATIONS. NEW DRUG APPLICATION -- KEYWORD INDEX TO 21 CFR PARTS 50, 54, 56, AND 312.
Summary (A) This part applies to all clinical investigations regulated by the Food and DrugAdministration under sections 505(i) and 520(g) of the Federal Food, Drug, and CosmeticAct, as well as clinical investigations that support applications for research or marketingpermits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infantformulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Additional specificobligations and commitments of, and standards of conduct for, persons who sponsor ormonitor clinical investigations involving particular test articles may also be found inother parts (e.g., parts 312 and 812).
Other Title Print version: Drug Administration, Food and. Compact Regs Parts 50, 54, 56, and 312 : CFR 21 Parts 50, 56, and 312 Good Clinical Practices (10 Pack). Boca Raton : CRC Press, ©2002 9780849321887