Practice Test Geeks(CRS) Certified Research Specialist Practice Test
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CRS Clinical Research Regulations Flashcards

6 cards from real CRS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 CRS Clinical Research Regulations flashcards as text

  1. Which federal agency oversees the regulation of clinical trials for drugs and biologics in the US?

    Answer: FDA

    The FDA regulates clinical trials for drugs, biologics, and medical devices in the United States.

  2. What does GCP stand for in the context of clinical research?

    Answer: Good Clinical Practice

    GCP (Good Clinical Practice) is an international ethical and scientific quality standard for designing, conducting, and reporting clinical trials.

  3. Under 21 CFR Part 50, which of the following is required before a subject can participate in a clinical trial?

    Answer: Informed consent

    21 CFR Part 50 mandates that informed consent be obtained from all participants before enrollment in a clinical trial.

  4. What is an IND application in clinical research?

    Answer: Investigational New Drug

    An IND (Investigational New Drug) application must be filed with the FDA before testing a new drug in human subjects.

  5. Which federal regulation (the 'Common Rule') governs the protection of human subjects in federally funded research?

    Answer: 45 CFR Part 46

    45 CFR Part 46, known as the Common Rule, establishes federal standards for protecting human research subjects in federally funded studies.

  6. What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?

    Answer: To independently review accumulating safety and efficacy data

    A DSMB independently reviews accumulating safety and efficacy data to protect participant welfare throughout a trial.

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Sources & references

Exam facts on this page (fees, format, dates, passing scores) are checked against these official sources; the date is our last check. Editorial policy

  1. research.uams.edu — Eligibility, renewal, exam format, passing score, score release · verified Oct 2026
CRS Clinical Research Regulations Flashcards — CRS Study Cards with Answers