CERTIFIED CLINICAL RESEARCH PROFESSIONAL (CCRP) EXAM 2024

CERTIFIED CLINICAL RESEARCH PROFESSIONAL (CCRP) EXAM 2024 When isn't an IND application needed? - correct answer 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) - correct answer 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) - correct answer 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) - correct answer -If there are change