Health Care > EXAM > Certified Clinical Research Professional (CCRP) Exam| ALL QUESTIONS CORRECTLY ANSWERED (All)

Certified Clinical Research Professional (CCRP) Exam| ALL QUESTIONS CORRECTLY ANSWERED

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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 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 Answer: -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 Answer: 15 days 21 CFR Part 312.34 Correct Answer: Treatment use of an Investigational new drug During which phases is a treatment protocol usually made available? Correct Answer: During Phase 3 but if data is compelling, may be available during Phase 2, OR, after all clinical trials have been completed and Sponsor of trials is awaiting/pursuing marketing approval How long is the waiting period before a treatment IND study can be initiated? Correct Answer: 30 days When will the FDA permit use of an investigational drug in widespread use? Correct Answer: -If the criteria for expanded access are met (benefits outweigh risk, illness is life threatening, or if no other alternative treatments are available) -If drug is being investigated in a controlled clinical trial under an IND designed to support a marketing application for the expanded use or all clinical trials are completed What are the steps for withdrawing an IND? (21 CFR Part 312.38) Correct Answer: A sponsor may withdraw an IND at any time without prejudice by: -Notifying the FDA [Show More]

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