Certified Clinical Research Professional (CCRP) Exam (with Complete Solutions)

When isn't an IND application needed? correct answers 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 answers 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 answers 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 answers -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 --Response to clinical hold --Response to FDA request for information --IRB Annual report What are t he requirements for expanded access? (21 CFR Part 312.300 - Subpart 1) correct answers -Population must have serious or life-threatening disease or condition -No comparable/significant alternate therapy/treatment -Patient cannot obtain drug under another IND or protocol -Potential benefit outweighs risks of treatment -Expanded access won't interfere with completion of studies that could support marketing approval -Must apply to treatment protocols and should be for individual use (1 person) How many days does a Physician or Sponsor have to submit written summary of expanded access to the FDA after use? correct answers 15 days