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Study Code of Federal Regulations (CFR) the investigator's brochure, a sample consent document and any advertising intended to be seen or heard by prospective study subjects.
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Investigator Investigator Responsibilities — Adverse Event (21 CFR 312.32(a)) 90 that listed in the protocol or investigator brochure 91 .
Formula (5) Investigator's brochure. If required under § 312.55, a copy of the investigator's brochure, containing the following information: (i) A brief description of the drug substance and the formulation, including the structural formula, if known.
Regulatory (21 CFR 312.23) • Regulatory and Administrative Components – Cover Letter – Regulatory Forms (Form 1571, Form 1572, Form 3674) – Table of Contents – Introductory Statement and General Investigational Plan – Investigator Brochure • Non-Clinical Components – Chemistry, Manufacturing and Controls (CMC)
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Unless Drug Master Files (21 CFR 314.42), Product License Applications (21 CFR Part 601), or the Investigator’s Brochure are generally not required. If a product will be provided in a nonapproved form, then manufacturing and controls information, pharmacology and toxicology data, or data from prior human studies will be required, unless that
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Interestingly Interestingly, the FDA notes that an Investigator Brochure (IB) is not required for an SI investigation; however, the SI should obtain the IB if it does exist in order to “ensure subject safety and to facilitate identification of serious and unexpected adverse reactions that may require expedited reporting to the FDA.” 21 CFR Parts 50
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