GCP Training Quiz For Clinical Research Professionals

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GCP Training Quiz For Clinical Research Professionals - Quiz

Would you like to take this GCP training quiz created for clinical research professionals? For medical students and medical professionals, we have made this special quiz. Fear No Yellow Stickies! Clinical research is a branch of healthcare science to determine the safety, use, and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. So, take these questions to test and expand your knowledge. All the best to you.


Questions and Answers
  • 1. 

    The primary purpose of ______________ is to standardize study conduct and requirements among countries so that studies do not have to be repeated in individual countries.

    • A.

      Good Clinical Practice

    • B.

      ICH Guidelines

    • C.

      Declaration of Helsinki

    • D.

      Belmont report

    Correct Answer
    B. ICH Guidelines
    Explanation
    The correct answer is ICH Guidelines. The International Council for Harmonisation (ICH) developed guidelines to standardize the conduct of clinical studies and ensure that they meet regulatory requirements across different countries. By following these guidelines, researchers can avoid the need to repeat studies in each country, saving time and resources. These guidelines cover various aspects of study conduct, including ethical considerations, data management, safety reporting, and regulatory submissions.

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  • 2. 

    During the drug development process, only 1 in 25 compounds was studied to make it into preclinical testing.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The statement suggests that only 1 out of every 25 compounds studied in the drug development process makes it into preclinical testing. However, the correct answer is False. This means that the statement is not accurate. It implies that more than 1 in 25 compounds are studied and proceed to preclinical testing during the drug development process.

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  • 3. 

    The main purpose of an IRB is to ensure that the data submitted to the FDA is accurate.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The main purpose of an IRB (Institutional Review Board) is not to ensure the accuracy of data submitted to the FDA. Instead, the primary role of an IRB is to protect the rights and welfare of human research participants. IRBs review research protocols to ensure that they are ethical, comply with regulatory requirements, and minimize potential risks to participants. They also oversee the informed consent process and monitor ongoing research activities to ensure participant safety. Therefore, the given statement is false.

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  • 4. 

    When an SMO is involved in the conduct of a study, they become ultimately responsible for how the study is conducted, removing this burden from the investigator.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The statement suggests that when a SMO (Site Management Organization) is involved in a study, they take ultimate responsibility for the study's conduct, relieving the investigator of this burden. However, the correct answer is false. While SMOs can provide support and assistance in managing the study, the ultimate responsibility for conducting the study lies with the investigator. The SMO's role is to facilitate and streamline the study process, but they do not remove the burden of responsibility from the investigator.

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  • 5. 

    You have been offered a study where the entire trial is to enroll 4000 subjects and to test the effectiveness of a new drug. This is most likely a phase _____ trial.

    • A.

      I

    • B.

      II

    • C.

      III

    • D.

      IV

    Correct Answer
    C. III
    Explanation
    This is most likely a phase III trial because phase III trials involve large numbers of participants (in this case, 4000 subjects) and are conducted to evaluate the effectiveness of a new drug. Phase I trials are typically small and focused on safety, phase II trials involve a larger number of participants to assess efficacy and side effects, and phase IV trials are conducted after the drug has been approved and are focused on long-term safety and effectiveness.

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  • 6. 

    The purpose of a phase III trial is to evaluate whether a drug treats the condition it is expected to treat.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    A phase III trial is the final stage of clinical trials before a drug can be approved for public use. During this phase, the drug is tested on a large number of participants to determine its effectiveness in treating the specific condition it is intended for. The purpose of this trial is to gather enough evidence to confirm whether the drug is indeed effective in treating the targeted condition. Therefore, the statement that the purpose of a phase III trial is to evaluate whether a drug treats the condition it is expected to treat is true.

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  • 7. 

    If your investigator wants to find the regulations that govern the policy, procedure, and process of the IRB, he/she could reference which of the below parts of the Code of Federal Regulations?

    • A.

      45 CRF part 46

    • B.

      21 CRF part 50

    • C.

      21 CRF part 56

    • D.

      ICH Guidelines

    Correct Answer
    C. 21 CRF part 56
    Explanation
    The correct answer is 21 CRF part 56. This part of the Code of Federal Regulations specifically pertains to Institutional Review Boards (IRBs) and provides the regulations governing the policy, procedure, and process of IRBs. It outlines the requirements for the composition, responsibilities, and functions of IRBs, as well as the criteria for IRB approval of research protocols. Therefore, if an investigator wants to find the regulations that govern the IRB, they should reference 21 CRF part 56.

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  • 8. 

    Recent industry reports indicate the cost to develop one drug and bring it to the marketplace stands at:

    • A.

      100 million

    • B.

      550 million

    • C.

      800 million

    • D.

      1 billion

    Correct Answer
    C. 800 million
    Explanation
    The recent industry reports suggest that the cost to develop and bring one drug to the marketplace is estimated to be around 800 million dollars. This indicates that the process of drug development involves significant financial investment. The high cost can be attributed to various factors such as research and development, clinical trials, regulatory approvals, manufacturing, and marketing. These expenses highlight the complexity and rigorous nature of the drug development process, which requires substantial resources to ensure safety, efficacy, and compliance with regulatory standards.

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  • 9. 

    Your Investigator has a large financial interest in a pharmaceutical company that wants to have your site participate in a study of a new drug. From the list below, which would require your Investigator to "check yes" and disclose this interest:

    • A.

      $20,000 in stock options of Sponsor

    • B.

      $10,000 in speaker fees discussing the Sponsor's products

    • C.

      $50,000 worth of equipment, provided to conduct the trial

    • D.

      $75,000 in stock of Sponsor

    • E.

      C and D

    Correct Answer
    D. $75,000 in stock of Sponsor
    Explanation
    The Investigator would need to disclose their interest in the pharmaceutical company if they have $75,000 worth of stock in that company. This is a significant financial interest that could potentially bias their decisions and actions during the study. Therefore, it is important for transparency and to ensure the integrity of the study that this information is disclosed.

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  • 10. 

    An IRB is required to review studies involving human subjects under FDA regulations but not those under HHS.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    False. An IRB (Institutional Review Board) is required to review studies involving human subjects under both FDA (Food and Drug Administration) regulations and HHS (Department of Health and Human Services) regulations. The IRB ensures that the rights and welfare of human subjects are protected in research studies.

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  • 11. 

    The IRB at your institution is very strict and has many institutional requirements.  When, if ever, is your site allowed to utilize another IRB to review your studies?

    • A.

      This is never allowed.

    • B.

      Only when this process is pre-approved by your local IRB

    • C.

      When approved by the Sponsor

    • D.

      When approved by the Investigator

    Correct Answer
    B. Only when this process is pre-approved by your local IRB
    Explanation
    Utilizing another IRB to review studies is only allowed when this process is pre-approved by the local IRB. This means that the strict IRB at the institution must give permission for the use of another IRB. This ensures that all institutional requirements and ethical considerations are still met, even if an external IRB is involved in the review process.

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  • 12. 

    According to FDA regulations, the sponsor is responsible for interacting with the IRB in order to ensure human subject protection.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    According to FDA regulations, the sponsor of a study is responsible for interacting with the Institutional Review Board (IRB) to ensure the protection of human subjects. This means that the sponsor is responsible for coordinating and communicating with the IRB regarding the study design, informed consent process, and any potential risks or benefits to the participants. The sponsor plays a crucial role in ensuring that the study is conducted ethically and in compliance with regulatory requirements. Therefore, the statement "True" is correct.

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  • 13. 

    The following group(s) may represent a special population and, therefore additional oversight relative to human subject protection:

    • A.

      Medical school students

    • B.

      Cognitively-impaired

    • C.

      Prisoners

    • D.

      B & C

    • E.

      All of the above

    Correct Answer
    D. B & C
    Explanation
    Medical school students, cognitively-impaired individuals, and prisoners may represent a special population that requires additional oversight in terms of human subject protection. Medical school students may be considered vulnerable due to their limited experience and power dynamics within the medical field. Cognitively-impaired individuals may have difficulty understanding the risks and benefits of participating in research, requiring extra safeguards to protect their rights and well-being. Prisoners may also be vulnerable due to their restricted autonomy and potential coercion. Therefore, the correct answer is B & C, indicating that both cognitively-impaired individuals and prisoners may require additional oversight in human subject protection.

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  • 14. 

    One requirement of appropriate IRB review of clinical research involving humans includes the approval of the IRB chairman and one other scientific member of the committee.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The statement is false because the requirement for appropriate IRB review of clinical research involving humans is not limited to the approval of the IRB chairman and one other scientific member of the committee. In fact, IRB review typically involves the evaluation and approval of the entire committee, which consists of various members with diverse expertise and backgrounds. This ensures a comprehensive and well-informed review process to protect the rights and welfare of human research participants.

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  • 15. 

    Per the FDA Regulations, the IRB is required to conduct continuing review of protocols at least ___________.

    • A.

      Quarterly

    • B.

      Every 6 months

    • C.

      Based on the risk level of the trial

    • D.

      Annually

    Correct Answer
    D. Annually
    Explanation
    Per the FDA Regulations, the Institutional Review Board (IRB) is required to conduct continuing review of protocols on an annual basis. This means that the IRB must review and evaluate the progress of ongoing research studies at least once every year to ensure that the rights and welfare of human subjects are protected and that the study is still scientifically valid. This requirement helps to ensure that research studies are conducted ethically and that any potential risks to participants are minimized.

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  • 16. 

    Your doctor wants to treat you with an approved drug for your illness. However, your diagnosis is not listed within the package insert of the medication.  Your doctor notes this is considered off-label use.  What would your physician need to utilize this therapy?

    • A.

      File an IND since the product is not FDA approved for your diagnosis

    • B.

      Obtain IRB approval since this is a protocol

    • C.

      This is considered the treatment of an individual patient, and the physician may prescribe as deemed appropriate.

    • D.

      Sponsor approval to use the drug in an off-label environment

    Correct Answer
    C. This is considered the treatment of an individual patient, and the physician may prescribe as deemed appropriate.
    Explanation
    The correct answer states that in this situation, the physician can prescribe the medication for off-label use as deemed appropriate. Off-label use refers to the use of an approved drug for a condition or patient population that is not specifically listed in the drug's package insert. In such cases, physicians have the discretion to prescribe medications based on their clinical judgment and knowledge of the patient's condition, even if it is not explicitly approved by the FDA for that particular use. This allows for flexibility in treatment options and enables physicians to tailor therapies to individual patient needs.

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  • 17. 

    Patients often participate in studies seeking treatment for their condition; therefore, its critical that research professionals distinguish study participation as not usually considered "treatment."

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    Research studies are designed to investigate the effectiveness of potential treatments, interventions, or therapies for various conditions. However, it is important for research professionals to distinguish study participation from actual treatment. This is because participating in a study does not guarantee that the patient will receive the intended treatment or experience the desired outcome. Instead, the purpose of the study is to gather data and evaluate the effectiveness of the treatment being tested. Therefore, it is critical for research professionals to communicate to patients that study participation is not typically considered as a form of treatment.

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  • 18. 

    Per ICH, the investigator is requested to inform a subject's primary care physician of study participants provided the subject agrees to this notification.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    According to ICH guidelines, it is recommended for the investigator to inform a study participant's primary care physician if the subject agrees to this notification. This ensures that the participant's primary healthcare provider is aware of their involvement in the study, allowing for better coordination of care and monitoring of any potential effects or interactions with the study intervention.

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  • 19. 

    Your subject reports that he has been having headaches for years, but they seem to have become more frequent since starting the study.  The PI believes this is not related to the study medication. How would you likely report this event?

    • A.

      Does not require reporting since part of the subject's medical history

    • B.

      Adverse event, since the complaint is more frequent.

    • C.

      Serious Adverse Event

    • D.

      Updated medical history form

    Correct Answer
    B. Adverse event, since the complaint is more frequent.
    Explanation
    The correct answer is "Adverse event, since the complaint is more frequent." This is because the subject's headaches have become more frequent since starting the study, which indicates a change in their condition. Even though the headaches have been present for years, the increase in frequency is considered an adverse event and should be reported.

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  • 20. 

    You enroll someone in a study during her hospitalization. The subject develops pneumonia and has to stay an extra 2 days in the hospital.  How is pneumonia reported?

    • A.

      SAE because it meets the criteria of prolonging hospitalization

    • B.

      Not reported since the subject was already hospitalized

    • C.

      Adverse event

    • D.

      Updated medical history form

    Correct Answer
    A. SAE because it meets the criteria of prolonging hospitalization
    Explanation
    Pneumonia is reported as a Serious Adverse Event (SAE) because it meets the criteria of prolonging hospitalization. The subject's development of pneumonia resulted in an extended stay in the hospital, which is considered a serious outcome. Therefore, it is necessary to report it as an SAE in order to document and monitor any potential adverse effects of the study.

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  • 21. 

    If a subject dies while in a study, the sponsor has 24 hours to report this to the FDA.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    When a subject participating in a study dies, it is important for the sponsor to report this to the FDA within 24 hours. This is crucial for ensuring the safety and ethical considerations of the study. Reporting the death allows the FDA to assess any potential risks or factors that may have contributed to the subject's death, ensuring that appropriate actions can be taken to protect the well-being of other participants. Therefore, the statement is true.

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  • 22. 

    ___________ is the term routinely used to describe any location where original data is recorded.

    • A.

      FDA Form 1572

    • B.

      CRF

    • C.

      Regulatory binder

    • D.

      Source document

    Correct Answer
    D. Source document
    Explanation
    A source document is the term routinely used to describe any location where original data is recorded. This document serves as evidence of the information collected during a study or research. It is considered the primary record and is used to verify the accuracy and authenticity of the data. Source documents can include medical records, laboratory reports, questionnaires, and other forms of documentation that contain the original data.

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  • 23. 

    In this lesson, the following items were used to define a successful clinical research professional.

    • A.

      Timeliness

    • B.

      Responsive and persistent

    • C.

      Only perform those tasks licensed or trained to do

    • D.

      All of the above

    Correct Answer
    D. All of the above
    Explanation
    The correct answer is "All of the above" because all three items mentioned - timeliness, being responsive and persistent, and only performing tasks that one is licensed or trained to do - are important qualities that define a successful clinical research professional. Being timely ensures that deadlines are met and projects progress smoothly. Being responsive and persistent helps in effectively communicating and following up on tasks. And only performing tasks that one is licensed or trained to do ensures compliance with regulations and maintains the integrity of the research process.

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  • 24. 

    Per FDA Regulations, only a physician can be a sub-investigator.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    According to FDA regulations, a sub-investigator does not have to be a physician. This means that individuals who are not physicians can also be sub-investigators. Therefore, the given statement is false.

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  • 25. 

    Per FDA and ICH, the _________ is the individual with ultimate responsibility for local study conduct.

    • A.

      CRC

    • B.

      SI

    • C.

      Sponsor

    • D.

      IRB

    • E.

      PI

    Correct Answer
    E. PI
    Explanation
    The PI, or Principal Investigator, is the individual with ultimate responsibility for local study conduct according to FDA and ICH guidelines. The PI is typically a qualified physician or researcher who oversees the entire study, including the recruitment and enrollment of participants, data collection and analysis, and ensuring compliance with regulatory requirements. They are responsible for the overall conduct and management of the study at the local site.

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  • 26. 

    In drug studies regulated by FDA, the _______ is a regulatory document that outlines the individual commitments of the PI.

    • A.

      FDA Form 1571

    • B.

      IND

    • C.

      FDA Form 1572

    • D.

      Investigator agreement (this is used in device studies)

    Correct Answer
    C. FDA Form 1572
    Explanation
    The FDA Form 1572 is a regulatory document that outlines the individual commitments of the Principal Investigator (PI) in drug studies regulated by the FDA. It is a crucial document that provides information about the qualifications and responsibilities of the PI, including their agreement to follow the protocol, comply with regulations, and report any adverse events or changes in the study. This form helps ensure that the PI understands and agrees to their obligations in conducting the study in accordance with FDA regulations.

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  • 27. 

    During study visits, your write blood pressure measurements on a sticky note as they are being taken and later transcribe them into your clinical chart, and then later the CRF.  In this example, what item is considered to be the source document?

    • A.

      Clinic chart

    • B.

      CRF

    • C.

      Sticky-note

    • D.

      None are considered a source document.

    Correct Answer
    C. Sticky-note
    Explanation
    In this example, the sticky-note is considered to be the source document. This is because the blood pressure measurements are initially written on the sticky-note as they are being taken, making it the original record of the data. The sticky-note serves as the immediate source of information before it is transcribed into other documents such as the clinical chart and the CRF.

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  • 28. 

    The FDA requirement for source documents and CRF storage is _______ years after an NDA is submitted or IND withdrawn.

    • A.

      2 years

    • B.

      5 years

    • C.

      9years

    • D.

      10 years

    Correct Answer
    B. 5 years
    Explanation
    The FDA requirement for source documents and CRF storage is 5 years after an NDA is submitted or IND withdrawn. This means that the FDA mandates that these documents must be retained and kept accessible for a period of 5 years after the submission of a New Drug Application (NDA) or after an Investigational New Drug (IND) is withdrawn. This is important for ensuring the availability of relevant information for regulatory purposes and potential audits or inspections.

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  • 29. 

    In a study where source document worksheets are used, FDA will still review the original clinic chart to further determine the validity of study data.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    In this study, the FDA will review the original clinic chart in addition to the source document worksheets. This is done to ensure the validity of the study data. The source document worksheets may provide some information, but the FDA wants to further evaluate the data by referring to the original clinic chart. Therefore, the statement is true.

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  • 30. 

    Which of the following agreements is NOT outlined on FDA Form 1572?

    • A.

      Agreement to follow the protocol

    • B.

      Agreement to personally supervise the study

    • C.

      Agreement to medically evaluate the usefulness of the study drug

    • D.

      Agreement to inform the Sponsor of adverse events

    Correct Answer
    C. Agreement to medically evaluate the usefulness of the study drug
    Explanation
    FDA Form 1572 is a document that investigators participating in clinical trials must complete. It outlines various agreements and responsibilities of the investigator. The agreement to medically evaluate the usefulness of the study drug is not specifically mentioned on FDA Form 1572. This agreement falls under the general responsibility of the investigator to conduct the study in accordance with good clinical practices and to ensure the safety and welfare of the study participants. However, it is not explicitly outlined as a separate agreement on the form.

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  • Current Version
  • Aug 27, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Nov 27, 2009
    Quiz Created by
    Deuce4lsu
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