Certified Clinical Research Professional (CCRP) Exam with precise detailed answers

Certified Clinical Research Professional (CCRP) ||\\|//|| ||\\|//|| ||\\|//|| ||\\|//|| ||\\|//||




Exam with precise detailed answers ||\\|//|| ||\\|//|| ||\\|//|| ||\\|//||




When isn't an IND application needed? - correct answer✔✔IND Application is not needed
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if investigation does not support change in labeling
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What information must the general IND include? (21 CFR Part 312.23) - correct
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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
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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
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there are changes to the protocol that affects safety of subjects, scientific quality of the
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study, or scope of investigation ||\\|//|| ||\\|//|| ||\\|//|| ||\\|//||




-If a new investigator is added to the study
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, -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) -
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correct answer✔✔-Population must have serious or life-threatening disease or condition
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-No comparable/significant alternate therapy/treatment
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-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)
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How many days does a Physician or Sponsor have to submit written summary of expanded
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access to the FDA after use? - correct answer✔✔15 days
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21 CFR Part 312.34 - correct answer✔✔Treatment use of an Investigational new drug
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During which phases is a treatment protocol usually made available? - correct
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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
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marketing approval ||\\|//||