SOCRA Exam Questions With verified Answers

When isn't an IND application needed? - 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) - 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 - ANSWER-(Administrative Actions) 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 and which section outlines this? - ANSWER-(21 CFR Part 312.31) -If there are changes to the protocol that affects safety of subjects, scientific quality of 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: