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Procedure: Internal Review, Research Proposals and Study ...
If your protocol is a sub-study of an existing study, please include a brief description of the parent study, the current status of the parent study, and how the sub-study will fit with the parent study.
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Failure to have an adequate quality control unit and adequate laboratory facilities available for the quality control unit for the testing and approval (or rejection) of components, in-process materials, drug products, and all procedures or specifications impacting on the identity, strength, quality, and purity of the drug products as required by 21 CFR § 211.22(a), 211.22(b), and 211.22(c).
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