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Start Over Author "Bowers, Alison" Journal applied clinical trials
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1. Ins and outs of IRB registration: registration is required for FDA-regulated IND studies, but is it needed for non-IND studies?

Author

Bowers, Alison and Woodring, Anita

Subjects
United States. Food and Drug Administration -- Powers and duties, Institutional review boards (Research ethics) -- Powers and duties, Clinical trials -- Management, Pharmaceutical industry -- Product development, Company business management, General interest, Health
Abstract

This article seeks to inform sponsors preparing for study start-up and enrollment by providing a brief review of the requirements of 21 CFR 56.106. While institutional review board (IRB) registration [...]

Published
2011

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