Certified Clinical Research Professional (CCRP) Exam | 100% Correct Answers | Verified | Latest 2024 Version

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) - An IND goes into effect 30 days after the FDA receives the submission unless the FDA notifies the Sponsor of a clinical hold When must an IND amendment be submitted? (21 CFR Part 312.31) - -If there are changes to the protocol that affects safety of subjects, scientific quality of the study, or scope of investigation -If a new investigator is added to the study -Information amendments must be submitted for chemistry/microbiology, pharm/toxicology, or clinical OTHER SUBMISSIONS: --IND safety reports