Certified Clinical Research Professional (CCRP) Exam | 100% Correct Answers

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When isn't an IND application needed? - ✔✔IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) -... ✔✔FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How many days after FDA receives IND submission does the IND go into effect? (21 CFR 312.40) [Show More]

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