Professional CCRP Certification Test! Trivia Quiz
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What is the full meaning of CCRP?
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Certification of Clinical Research Personnel
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Certified Clinical Research Professional
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Certified Coding Research Personnel
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Clinical Capital and Reimbursement Procedure
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The certified clinical research professional is an advanced medical course into researching and studying of different project as pertaining to health. It is available to both members and non members of SOCRA and available to all persons working in clinical research. One certification covers human clinical research of pharmaceuticals, biologics, medical devices and behavioral research.
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- 2.
How many types of clinical research profession are there?
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2
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3
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4
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1
Correct Answer
A. 2Explanation
There are two types of clinical research professions.Rate this question:
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- 3.
Which of these codes deals with electronic MRs, and electronic signatures?
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21CFR01
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21CFR99
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21CFR54
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21CFR11
Correct Answer
A. 21CFR11Explanation
21CFR11 is the correct answer because it specifically deals with electronic MRs (medical records) and electronic signatures. The other options, 21CFR01, 21CFR99, and 21CFR54, do not mention electronic MRs or electronic signatures, making them incorrect choices.Rate this question:
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- 4.
How long are investigators mandated to disclose their financial interests after a study is completed?
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1 years after study closure
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3years after study closure
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Immediately after research
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6 months after study closure
Correct Answer
A. 1 years after study closureExplanation
Investigators are mandated to disclose their financial interests for 1 year after study closure. This means that they are required to report any financial interests they have related to the study for a period of one year after the study is completed. This disclosure is important to ensure transparency and to prevent any potential conflicts of interest that could compromise the integrity of the research.Rate this question:
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- 5.
Which of these has an outlined ethical principles of research, including: respect for persons, beneficence, and justice?
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Belmont Code
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Nuremberg code
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Nuremberg Trial
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Belmont Report
Correct Answer
A. Belmont ReportExplanation
The Belmont Report is the correct answer because it is a document that outlines ethical principles for research involving human subjects. It emphasizes the importance of respect for persons, beneficence (maximizing benefits and minimizing harm), and justice in conducting research. The report was published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to ethical violations in research, such as the Tuskegee Syphilis Study. It has since become a foundational document in the field of research ethics.Rate this question:
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- 6.
Whose role is to protect the rights and welfare of human subjects participating in clinical trials?
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CRC
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ITD
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IRB
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CDM
Correct Answer
A. IRBExplanation
The role of the IRB (Institutional Review Board) is to protect the rights and welfare of human subjects participating in clinical trials. The IRB is responsible for reviewing and approving research protocols, ensuring that the risks to participants are minimized, and that their rights and well-being are protected. They also monitor ongoing trials to ensure compliance with ethical standards and regulations. The other options (CRC, ITD, CDM) do not have specific roles in protecting the rights and welfare of human subjects in clinical trials.Rate this question:
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- 7.
Which FDA form is used for Investigational New Drugs?
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IND1548
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1571
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12EIND
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1865IND
Correct Answer
A. 1571Explanation
FDA form 1571 is used for Investigational New Drugs (IND). This form is required by the Food and Drug Administration (FDA) for sponsors who wish to conduct clinical trials on new drugs. It provides detailed information about the drug, its manufacturing process, proposed clinical trials, and the qualifications of the investigators involved. The form helps the FDA evaluate the safety and effectiveness of the new drug before it can be approved for wider use.Rate this question:
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- 8.
FDA requires that all study records be retained for how long after a marketing application is approved?
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8 months
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2 years
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3 Years
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A year
Correct Answer
A. 2 yearsExplanation
The FDA requires that all study records be retained for 2 years after a marketing application is approved. This is to ensure that the data and information used in the application can be accessed and reviewed if needed, particularly for post-marketing surveillance and monitoring purposes. Retaining study records for this period allows for ongoing evaluation of the safety and efficacy of the approved product, as well as compliance with regulatory requirements.Rate this question:
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- 9.
What happens in phase III of Trial Assess?
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Establishment of some efficacy and safety
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Safety profile of a compound is expanded upon and efficacy is further explored
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Aftermarket trials
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Dose escalation and optimization, first in human
Correct Answer
A. Establishment of some efficacy and safetyExplanation
In phase III of Trial Assess, the focus is on establishing some efficacy and safety of a compound. This means that the trial aims to gather more data on the effectiveness and safety profile of the compound, building upon the information collected in earlier phases. Phase III trials are typically larger and involve a larger number of participants to provide more robust evidence on the compound's efficacy and safety. This phase is crucial in determining whether the compound is effective and safe enough to be considered for regulatory approval and subsequent use in the market.Rate this question:
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- 10.
When should serious Adverse Events be reported to the sponsor?
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Less than an hour
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Within 48hours
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Within the hour
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Within 24hours
Correct Answer
A. Within 24hoursExplanation
Serious Adverse Events should be reported to the sponsor within 24 hours. This is important because serious adverse events are unexpected and potentially life-threatening events that occur during a clinical trial. Reporting them promptly allows the sponsor to assess the event, determine its relationship to the investigational product, and take appropriate actions to ensure participant safety. Waiting longer than 24 hours could lead to delays in addressing any potential risks or issues, which could compromise the integrity of the trial and the well-being of the participants.Rate this question:
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Current Version
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Mar 21, 2023Quiz Edited by
ProProfs Editorial Team -
Jun 15, 2019Quiz Created by
Gregorynaomi
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