ACRP - CCRC EXAM PREP - CC - MARCH 2025

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ACRP - CCRC EXAM PREP - CC - MARCH 2025

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -66 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: How long should records regarding medical device studies be kept after termination of trial?

Answer:

• years

Question 2: 5 examples of vulnerable subjects

Answer:

• students

• subordinate employees

• members of the military

• prisoners

• patients with incurable disease
• person in nursing home
• unemployed
• patients in emergency situations
• ethnic minorities
• homeless
• refugees
• minors

Question 3: In what case may the IRB waive the requirement of a signed informed consent? (2 elements)

Answer:

-if the research presents no more than minimal risk or harm to the subjects -involves NO procedures

Question 4: Who is responsible for securing direct access to documents?

Answer:

Sponsor

Question 5: Phase III study

Answer:

-confirmation of short-term efficacy and safety -aim to establish long-term efficacy and safety -goal is to assess overall therapeutic value and establish an overall risk-benefit relationship -usually involves thousands of subjects and end when an NDA (new drug application) is sent to the FDA for approval Question 6: 7 documents that the IRB must obtain and review for conduct of a clinical trial

Answer:

-protocol/amendments -ICF -subject recruitment procedures -patient facing written material -investigator's brochure -safety information -payments/compensation available to subjects -investigators' current CV

Question 7: Additional elements of ICF (3)

Answer:

-new findings developed during study will be provided to subject -number of subjects involved -results will be posted on clintrials.gov

Question 8: Who is responsible for development of an Informed Consent?

Answer:

the sponsor/CRO

Question 9: Purposes of monitoring (3)

Answer:

-verify that the rights and well-being of subjects are protected -verify that reported trial data are accurate, complete, and verifiable from source docs -verify that the conduct of the trial is in compliance with approved protocol, GCP, and regulatory requirements

Question 10: Which 3 countries formed the ICH and when?

Answer:

-United States -European Union -Japan 1990

Question 11: Purpose of ICH E6

Answer:

-establish a guideline for Good Clinical Practice (GCP) -ICH E6 serves as the most important guideline for conducting clinical trials by setting the ethical and scientific quality standard for designing, conducting, recording, and reporting in trials that involve humans

Question 12: device study (post-market)

Answer:

these focus on design improvements, expansion of safety and effectiveness data, and development of new uses

Question 13: How often should the IRB continuing review occur?

Answer:

at least annually

Question 14: Vulnerable subject

Answer:

individual incapable of giving informed consent or whose voluntary participation in a study may be influenced by their health, social, economic, or employment condition

Question 15: 510k clearance process in relation to medical device development

Answer:

applies to class I and II devices -sponsor submits data to show that the device is substantially equivalent to another marketed device -the FDA must review and agree with the sponsor's determination of "substantially equivalent" and notify the sponsor that the device is cleared for marketing

Question 16: How long must the IRB maintain docs after completion of trial?

Answer:

• years

Question 17: IRB definition of minimal risk

Answer:

the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

Question 18: Process associated with using a short form written consent

Answer:

-impartial witness should be required for entire process -all info must be read and explained to subject -oral consent must be given by the patient as well as signing and dating the short form -impartial witness should sign the written summary and short form -person obtaining consent should sign the written summary -copy of both should be provided to subject Question 19: Who should the investigator inform if a patient decides to participate in a trial relevant to their medical care?

Answer:

subjects' primary physicians if subject agrees to it