CRA Regulatory Submissions & FDA Requirements Flashcards
6 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
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Under 21 CFR Part 312, how long must a sponsor retain IND records after the drug is no longer under investigation?
Answer: 2 years
Under 21 CFR Part 312.57, sponsors must retain IND records for 2 years after the investigation is discontinued and FDA is notified.
Which type of FDA meeting is used specifically to discuss data needed to support a marketing application before it is submitted?
Answer: Type B Pre-NDA/BLA Meeting
A Type B Pre-NDA/BLA meeting is held to discuss the data package and any outstanding issues before the sponsor submits a marketing application.
What is the primary purpose of a Clinical Study Report (CSR) submitted as part of an NDA?
Answer: To provide a comprehensive integrated description of study methods and results
A CSR provides a complete and transparent integrated description of the clinical study's methods, conduct, and results per ICH E3 guidelines.
Which FDA pathway is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need?
Answer: Fast Track Designation
Fast Track Designation is designed to facilitate the development of drugs for serious conditions that fill an unmet medical need by allowing more frequent FDA interactions.
Under FDA regulations, what must a sponsor do if a clinical study is discontinued?
Answer: Notify the FDA in writing within 30 days
Per 21 CFR Part 312.38, a sponsor must notify the FDA in writing within 30 days if an IND clinical investigation is discontinued.
What is the regulatory purpose of a Form FDA 1572 (Statement of Investigator)?
Answer: To commit the investigator to comply with FDA regulations and conduct the study as approved
Form FDA 1572 is a legally binding commitment by the principal investigator to comply with FDA regulations and conduct the study as described in the protocol.