ICH GCP Guidelines Quiz: Test!

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| By Christine Obercian

Christine Obercian

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Quizzes Created: 1 | Total Attempts: 19,708

Questions: 60 | Attempts: 19,708 | Updated: Sep 3, 2024

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Embark on a journey through the realm of clinical research standards with our ICH GCP Guidelines Quiz. The International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines are pivotal in ensuring the ethical and scientific integrity of clinical trials. This quiz will test your grasp of these guidelines, covering vital aspects such as patient safety, data integrity, and regulatory compliance. Whether you're a seasoned researcher or a newcomer to the field, this quiz offers an opportunity to assess your knowledge and understanding of ICH GCP principles. Get ready to challenge yourself and enhance your expertise in clinical research practices. Read moreGood luck!

Questions and Answers

1.

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR): Any untoward medical occurrence that at any dose: (A) Results in death (B) Is life-threatening (C) Requires inpatient hospitalization or prolongation of existing hospitalization (D) Results in persistent or significant disability/incapacity (E) Is a congenital anomaly/birth defect.
- A.
  
  A and C
- B.
  
  A, C, and E
- C.
  
  B, C, D and E
- D.
  
  All of the above
Correct Answer
D. All of the above

Explanation
The correct answer is "all of the above". This means that a Serious Adverse Event or Serious Adverse Drug Reaction can result in death, be life-threatening, require hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or be a congenital anomaly/birth defect. In other words, any untoward medical occurrence that meets any of these criteria would be considered a Serious Adverse Event or Serious Adverse Drug Reaction.

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2.

The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains all required documentation.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The correct answer is true because it is important for the sponsor to obtain all required documentation before supplying the investigator or institution with the investigational product(s). This ensures that all necessary approvals and permissions are in place and that the study can be conducted in compliance with regulatory requirements. Providing the investigational product(s) without the required documentation may lead to ethical and legal issues and compromise the integrity of the study.

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3.

The sponsor should verity that each ______ has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
- A.
  
  Site
- B.
  
  Subject
- C.
  
  Doctor
- D.
  
  Monitor
Correct Answer
B. Subject

Explanation
The correct answer is "subject." In clinical trials, it is important for the sponsor to ensure that each participant (or subject) has given their written consent to allow direct access to their original medical records for various purposes such as trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. This is crucial for maintaining transparency, ensuring participant safety, and complying with regulatory requirements.

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4.

According to ICH GCP (International Conference on Harmonization - Good Clinical Practice) guidelines, which document outlines the objective(s), design, methodology, statistical considerations, and organization of a clinical trial?
- A.
  
  Informed Consent Form
- B.
  
  Investigator's Brochure
- C.
  
  Clinical Study Protocol
- D.
  
  Case Report Form
Correct Answer
C. Clinical Study Protocol

Explanation
The Clinical Study Protocol is the correct answer. It is a comprehensive document that outlines the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. It serves as the blueprint for conducting the study.

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5.

The investigator/institution should permit monitoring and ________ by the sponsor, and inspection by the appropriate regulatory authority(ies).
- A.
  
  Drug testing
- B.
  
  Auditing
- C.
  
  Re-consenting
Correct Answer
B. Auditing

Explanation
The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). This means that the sponsor and regulatory authority should be allowed to review and assess the conduct of the study, ensuring that it is being carried out in compliance with the applicable regulations and protocols. Auditing involves a systematic review of the study documentation and processes to ensure accuracy and compliance, providing assurance that the study is being conducted ethically and with integrity.

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6.

The sponsor is not obligated to submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s)
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The statement is false because sponsors are indeed obligated to submit all safety updates and periodic reports to the regulatory authority(ies) as required by applicable regulatory requirements. This is an essential part of ensuring the safety and efficacy of any product or intervention that is being developed and tested. Failing to submit these updates and reports can lead to regulatory non-compliance and potential harm to the public.

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7.

Monitor should be appointed by the ______.
- A.
  
  Site
- B.
  
  FDA
- C.
  
  Sponsor
- D.
  
  Subject
Correct Answer
C. Sponsor

Explanation
The correct answer is "sponsor" because the sponsor is responsible for overseeing the conduct of a clinical trial and ensuring that it is conducted according to the protocol and applicable regulations. The monitor is appointed by the sponsor to monitor the trial activities, including site visits, data collection, and compliance with regulatory requirements. The monitor acts as a liaison between the sponsor and the investigative site, ensuring that the trial is conducted in a manner that protects the rights and welfare of the subjects and maintains the integrity of the data.

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8.

The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The investigator should maintain a list of appropriately qualified persons to whom they have delegated significant trial-related duties. This is important to ensure that the delegated tasks are being carried out by competent individuals who have the necessary qualifications and expertise. By maintaining such a list, the investigator can also keep track of who is responsible for each specific duty and ensure that the trial is being conducted in a thorough and organized manner.

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9.

The ______ should have sufficient time to properly conduct and complete the trial within the agreed trial period.
- A.
  
  Monitor
- B.
  
  Investigator
- C.
  
  Auditor
- D.
  
  IRB
Correct Answer
B. Investigator

Explanation
The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period. This is because the investigator is responsible for overseeing and managing the entire trial process, including recruiting participants, collecting data, analyzing results, and ensuring compliance with ethical and regulatory guidelines. Therefore, it is crucial for the investigator to have enough time to carry out these tasks effectively and efficiently.

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10.

It is recommended that the ______ inform the subject's primary physician about the subject's participation in the trial if the subject has a primary care physician and if the subject agrees to the primary care physician being informed.
- A.
  
  Monitor
- B.
  
  Auditor
- C.
  
  Investigator
Correct Answer
C. Investigator

Explanation
The investigator should inform the subject's primary physician about their participation in the trial if the subject has a primary care physician and agrees to the physician being informed. This is important because the primary physician should be aware of any potential changes in the subject's health or medication that may occur during the trial. By informing the primary physician, they can provide necessary medical support and ensure the subject's well-being throughout the trial.

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11.

The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The statement is true because for a trial to be conducted properly and safely, the investigator needs to have a sufficient number of qualified staff and appropriate facilities. This ensures that the trial is conducted efficiently, with proper monitoring and supervision, and that any potential risks or adverse events can be handled effectively. Without adequate resources, the trial may be compromised, leading to inaccurate results or potential harm to participants. Therefore, it is crucial for the investigator to have the necessary staff and facilities to ensure the integrity and safety of the trial.

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12.

Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The statement is true because while a subject is not obligated to provide reasons for withdrawing from a trial prematurely, it is the responsibility of the investigator to make a reasonable effort to understand the reasons. Respecting the subject's rights is crucial in this process, ensuring that their decision to withdraw is understood and respected.

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13.

During the trial, the investigator is not obligated in any way to provide to the IRB/IEC all documents subject to review.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The investigator is obligated to provide all documents subject to review to the IRB/IEC during the trial. This is because the IRB/IEC needs access to all relevant documents to ensure the safety and welfare of the trial participants and to assess the validity and integrity of the trial. Failing to provide all necessary documents could compromise the ethical conduct of the trial and potentially put the participants at risk.

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14.

If the sponsor discontinues the clinical development of an investigational product, the sponsor is not obligated to notify trial investigators/institutions nor regulatory authorities.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The statement is false because when a sponsor discontinues the clinical development of an investigational product, they are indeed obligated to notify trial investigators/institutions and regulatory authorities. This is important for transparency and ensuring that all parties involved are aware of the discontinuation and can take appropriate actions.

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15.

Fill in the blank: The investigator, or person designated by the investigator, should document and explain any deviation from the approved_________.

Correct Answer
protocol, Protocol

Explanation
The investigator, or a person designated by the investigator, should document and explain any deviation from the approved protocol. The protocol is the formal plan or set of guidelines for a clinical trial, and any deviations from it must be properly documented and justified to ensure the integrity and reliability of the study's results, as well as to maintain compliance with regulatory standards.

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16.

Responsibility for investigational product(s) accountability at the trial site(s) rests with the_____.
- A.
  
  Investigator/institution
- B.
  
  Project manager
- C.
  
  Study coordinator
- D.
  
  Monitor (CRA)
Correct Answer
A. Investigator/institution

Explanation
The responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. This means that it is the duty of the investigator and the institution conducting the trial to ensure proper management and tracking of the investigational products used in the study. They are responsible for maintaining accurate records of the product's receipt, storage, dispensing, and return, as well as ensuring compliance with regulatory requirements and good clinical practice. This is crucial to maintain the integrity of the study and ensure the safety and efficacy of the investigational products.

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17.

The ______ should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).
- A.
  
  Subject(s)
- B.
  
  Investigational product(s)
- C.
  
  Glove(s)
- D.
  
  Office supply(ies)
Correct Answer
B. Investigational product(s)

Explanation
The correct answer is "investigational product(s)". In clinical trials, investigational products refer to the drugs, devices, or treatments being tested. These products need to be stored as specified by the sponsor, who is responsible for conducting the trial, and in accordance with applicable regulatory requirements to ensure their safety and efficacy. This includes following specific storage conditions, such as temperature, humidity, and light exposure, to maintain the integrity and stability of the investigational products throughout the trial.

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18.

The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The investigator should follow the trial's randomization procedures to ensure that the allocation of participants to different groups is done in a random and unbiased manner. This helps to minimize any potential confounding factors and ensures that the results of the trial are more reliable and valid. Additionally, breaking the code only in accordance with the protocol helps to maintain the blinding of the study, which further reduces the risk of bias in the results. Therefore, it is important for the investigator to adhere to these procedures and guidelines.

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19.

Clinical trial protocols and protocol amendments should address the following:
- A.
  
  Trial objectives and purpose
- B.
  
  Trial design
- C.
  
  Selection and withdrawal of subjects
Correct Answer(s)
A. Trial objectives and purpose
B. Trial design
C. Selection and withdrawal of subjects

Explanation
Clinical trial protocols and protocol amendments should address trial objectives and purpose, trial design, and the selection and withdrawal of subjects. These elements are crucial for ensuring the integrity and validity of the trial. Clearly defined objectives and purpose help guide the research and ensure that the trial is conducted with a specific goal in mind. The trial design outlines the methodology and procedures to be followed, including the allocation of subjects to different groups and the measurements to be taken. Selection and withdrawal of subjects are important considerations to ensure that the trial population is representative and that ethical considerations are met.

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20.

Clinical trials should be scientifically sound, and described in clear, detailed protocol.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Clinical trials should be scientifically sound and described in clear, detailed protocols in order to ensure the validity and reliability of the results. A scientifically sound trial means that it is designed with appropriate methodology and controls to minimize bias and confounding factors. Clear and detailed protocols provide a step-by-step guide for conducting the trial, ensuring consistency and reproducibility. This is crucial for transparency, allowing other researchers to replicate the study and verify its findings. In addition, clear protocols help protect the rights and safety of participants by ensuring that the trial is conducted ethically and according to established guidelines.

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21.

If the trial is ______, the investigator should promptly document and explain to the sponsor any premature unblinding of the investigational product(s).
- A.
  
  Difficult
- B.
  
  Blinded
- C.
  
  Private
- D.
  
  International
Correct Answer
B. Blinded

Explanation
If the trial is "blinded," it means that the participants and/or investigators are unaware of which treatment or intervention they are receiving. In such cases, if there is any premature unblinding of the investigational product(s), the investigator should promptly document and explain it to the sponsor. This is important to maintain the integrity and validity of the trial, as unblinding can introduce bias and affect the reliability of the results.

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22.

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
This statement is true because it is important for every individual involved in conducting a trial to have the necessary qualifications, including education, training, and experience. This ensures that they have the knowledge and skills required to perform their respective tasks effectively and accurately. Without proper qualifications, there is a higher risk of errors or misconduct during the trial process, which can compromise the validity and fairness of the trial. Therefore, it is crucial to have qualified individuals involved in every aspect of the trial to maintain its integrity.

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23.

The sponsor should appoint individuals, who are independent of the clinical trial/data collection system(s), to conduct audits.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The statement is true because having independent individuals conduct audits ensures unbiased and objective evaluations of the clinical trial and data collection systems. These individuals are not affiliated with the trial or the data collection process, which reduces the risk of any conflicts of interest or potential manipulation of the results. Independent audits help to ensure the integrity and reliability of the trial data, which is crucial for maintaining the credibility and validity of the study.

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24.

The purposes of trial monitoring are to verify that: (A) The rights and well-being of human subjects are protected.(B) The reported trial data are accurate, complete, and verifiable from source documents.(C) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
- A.
  
  A only
- B.
  
  A and C only
- C.
  
  All of the above
- D.
  
  None of the above
Correct Answer
C. All of the above

Explanation
Trial monitoring serves multiple purposes, including the protection of the rights and well-being of human subjects (A), ensuring the accuracy, completeness, and verifiability of reported trial data (B), and ensuring that the trial is conducted in compliance with the approved protocol, Good Clinical Practice (GCP), and applicable regulatory requirements (C). Therefore, the correct answer is "All of the above."

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25.

If a trial is terminated prematurely or suspended, the sponsor should promptly inform the investigators/institutions, and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s).
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
In clinical trials, if a trial is terminated or suspended before its planned completion, it is important for the sponsor to promptly inform the investigators, institutions, and regulatory authorities. This is necessary so that all relevant parties are aware of the termination or suspension and can take appropriate actions. Additionally, the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) should also be informed promptly and provided with the reason(s) for the termination or suspension. This ensures transparency and compliance with applicable regulatory requirements. Therefore, the statement "True" is correct.

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26.

Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: [select all that apply]
- A.
  
  That the trial involves research
- B.
  
  The purpose of the trial
- C.
  
  The subject's responsibilities
- D.
  
  Directions to the site
Correct Answer(s)
A. That the trial involves research
B. The purpose of the trial
C. The subject's responsibilities

Explanation
The informed consent discussion and the written informed consent form should include explanations of the trial involving research, the purpose of the trial, and the subject's responsibilities. These explanations are necessary to ensure that the subjects fully understand the nature of the trial, why it is being conducted, and what their role and obligations will be. Additionally, providing directions to the site may be helpful for subjects to easily locate the trial site, but it is not a mandatory inclusion in the informed consent discussion or the written informed consent form.

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27.

Data reported on the ______, which are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.
- A.
  
  Statistical Analysis Plan (SAP)
- B.
  
  Case Report Form (CRF)
- C.
  
  Protocol
Correct Answer
B. Case Report Form (CRF)

Explanation
The correct answer is Case Report Form (CRF). CRFs are documents used in clinical trials to collect data on each study participant. The data reported on CRFs should be consistent with the source documents, such as medical records or laboratory results. If there are any discrepancies between the data reported on the CRF and the source documents, they should be explained. This ensures the accuracy and reliability of the data collected during the trial. The Statistical Analysis Plan (SAP) and Protocol are also important documents in clinical trials, but they do not directly involve the collection and reporting of data like the CRF does.

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28.

The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once every ______ year(s).
- A.
  
  One
- B.
  
  Five
- C.
  
  Three
- D.
  
  Ten
Correct Answer
A. One

Explanation
The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once every one year. This ensures that the trial is being conducted ethically and that the rights and welfare of the human subjects are protected throughout the duration of the study. Regular reviews allow the IRB/IEC to assess any changes or developments in the trial, evaluate the ongoing consent process, and make any necessary adjustments to ensure the safety and well-being of the participants.

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29.

Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: [select all that apply]
- A.
  
  Darwinism
- B.
  
  The anticipated expenses, if any, to the subject for participating in the trial
- C.
  
  The subject's responsibilities
- D.
  
  The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
Correct Answer(s)
B. The anticipated expenses, if any, to the subject for participating in the trial
C. The subject's responsibilities
D. The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.

Explanation
The correct answer includes the anticipated expenses, if any, to the subject for participating in the trial, the subject's responsibilities, and the foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated. These are important aspects that should be explained to the subject in both the informed consent discussion and the written informed consent form.

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30.

Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records only if a comprehensive list of such is provided at least 15 business days prior to the date of review/access.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The statement as presented is false because, according to Good Clinical Practice (GCP) guidelines and typical regulatory requirements, investigators and institutions are required to make trial-related records available for direct access upon request by monitors, auditors, Institutional Review Boards/Ethical Committees (IRB/IEC), or regulatory authorities without the precondition of receiving a comprehensive list 15 business days in advance. This flexibility ensures that the oversight entities can effectively perform their roles in real-time, safeguarding participant safety, and ensuring the integrity of the data collected during clinical trials. These entities must be able to inspect, review, and verify the data and procedures of the trial at any point without such restrictions to fulfill their regulatory and ethical oversight functions effectively.

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31.

The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The ICH GCP Guideline aims to establish a common standard for the EU, Japan, and the US, allowing the regulatory authorities in these regions to accept clinical data from each other. This unified standard helps streamline the approval process for clinical trials and ensures that data collected in one jurisdiction can be recognized and accepted in the others. Therefore, the statement is true.

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32.

Monitors act as the main line of communication between the sponsor and the investigator.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Monitors play a crucial role in clinical trials as they facilitate communication between the sponsor (who funds the trial) and the investigator (who conducts the trial). They ensure that the trial is conducted in compliance with the protocol, regulations, and good clinical practice. By monitoring the progress of the trial, collecting data, and resolving any issues or queries, monitors act as the main line of communication between the sponsor and the investigator. Therefore, the statement "Monitors act as the main line of communication between the sponsor and the investigator" is true.

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33.

The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the ______ and in all required reports.
- A.
  
  CRFs
- B.
  
  Office
- C.
  
  Newspaper
- D.
  
  Internet
Correct Answer
A. CRFs

Explanation
The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports. CRFs stands for Case Report Forms, which are documents used in clinical research to record the data collected during a study. These forms are crucial in maintaining accurate and complete records of the study participants' data. Therefore, it is essential for the investigator to ensure the accuracy, completeness, legibility, and timeliness of the data reported in the CRFs to provide reliable information to the sponsor.

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34.

Neither the investigator nor the trial staff should ________ or unduly influence a subject to participate or to continue to participate in a trial.
- A.
  
  Convince
- B.
  
  Coerce
- C.
  
  Compel
- D.
  
  Change the opinion
Correct Answer
B. Coerce

Explanation
The correct answer is "Coerce". Coercion refers to the act of using force, threats, or pressure to persuade someone to do something against their will. In the context of a trial, it is important that both the investigator and trial staff do not exert any undue influence or manipulate the subjects into participating or continuing to participate in the trial. This ensures that the subjects' decision to participate is voluntary and not influenced by external factors.

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35.

The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The statement is true because according to the given information, the investigator is required to submit written summaries of the trial status to the IRB/IEC annually. It is also mentioned that the frequency of submission can be more frequent if requested by the IRB/IEC. Therefore, it is necessary for the investigator to provide regular updates to the IRB/IEC regarding the trial status.

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36.

Informed consents should include an explanation of the subject's responsibilities.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Informed consents should include an explanation of the subject's responsibilities because it is important for individuals to understand what is expected of them when participating in a study or medical procedure. By including this information in the consent form, participants can make an informed decision about whether or not they are willing and able to fulfill these responsibilities. This helps ensure that they have a clear understanding of their role in the process and can actively participate in their own healthcare decisions.

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37.

The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: [SELECT ALL THAT APPLY]
- A.
  
  At least 100 members
- B.
  
  At least one member whose primary area of interest is in a nonscientific area
- C.
  
  At least one member who is independent of the institution/trial site.
Correct Answer(s)
B. At least one member whose primary area of interest is in a nonscientific area
C. At least one member who is independent of the institution/trial site.

Explanation
The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include at least one member whose primary area of interest is in a nonscientific area, as this ensures a diverse perspective and consideration of ethical implications beyond the scientific aspects. Additionally, having at least one member who is independent of the institution/trial site helps to ensure unbiased evaluation and decision-making.

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38.

Who is responsible for the conduct of the clinical trial at a trial site?
- A.
  
  Clinical Research Coordinator
- B.
  
  Monitor
- C.
  
  Investigator
- D.
  
  Sponsor
Correct Answer
C. Investigator

Explanation
The investigator is responsible for the conduct of the clinical trial at a trial site. The investigator is typically a qualified healthcare professional who oversees the trial, ensures the safety and well-being of the participants, and follows the protocol and regulations set by the regulatory authorities. They are responsible for recruiting and enrolling participants, collecting and analyzing data, and reporting any adverse events or outcomes. The investigator plays a crucial role in ensuring the integrity and success of the clinical trial.

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39.

Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly,
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Quality control is an essential practice in data handling to ensure the reliability and accuracy of the processed data. By applying quality control at each stage of data handling, errors and inconsistencies can be identified and corrected, ensuring that the final data is reliable and accurate. Without quality control, there is a higher risk of incorrect or unreliable data being used for analysis or decision-making purposes, leading to potential negative consequences. Therefore, it is important to apply quality control measures at each stage of data handling to ensure data integrity and reliability.

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40.

Which is NOT one of the purposes of trial monitoring?
- A.
  
  To verity that the rights and well-being of human subjects are protected.
- B.
  
  To verify that the reported trial data are accurate, complete, and verifiable from source documents.
- C.
  
  To verify that all financial obligations between the Sponsor and the Investigator are fulfilled.
- D.
  
  To verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
Correct Answer
C. To verify that all financial obligations between the Sponsor and the Investigator are fulfilled.

Explanation
Trial monitoring is a process that ensures the ethical conduct of clinical trials. It involves various purposes such as protecting the rights and well-being of human subjects, verifying the accuracy of trial data, ensuring compliance with protocols and regulatory requirements. However, one purpose that is NOT included in trial monitoring is verifying financial obligations between the Sponsor and the Investigator. This aspect is typically handled through financial audits or contractual agreements, rather than trial monitoring.

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41.

The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The sponsor should ensure that the protocol or written agreement explicitly states that the investigator or institution will provide direct access to source data/documents for various purposes such as trial-related monitoring, audits, IRB/IEC review, and regulatory inspection. This means that the sponsor should ensure that there is a clear provision in place for accessing the original data and documents related to the trial, which is essential for ensuring the integrity and validity of the study.

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42.

The ICH GCP guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the Association of Advanced Neurology.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The ICH GCP (International Conference on Harmonisation Good Clinical Practice) guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, and the Nordic countries. There is no mention of the Association of Advanced Neurology in the context of contributing to the development of ICH GCP.

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0
43.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that must have a causal relationship with this treatment.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject who has been administered a pharmaceutical product, but it does not necessarily have to have a causal relationship with the treatment. The event can occur regardless of whether there is a direct link between the treatment and the adverse event. The key point is that the event happens after the administration of the product.

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44.

Please fill in the blank. _______ subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Correct Answer
Vulnerable

Explanation
The term "vulnerable" is used to describe a group of individuals who are at a higher risk of harm or exploitation due to their circumstances or characteristics. In this context, vulnerable subjects refer to individuals who are more susceptible to physical, emotional, or social harm. This can include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. These individuals require special attention and protection to ensure their well-being and safeguard their rights.

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45.

What document includes an explanation of anticipated expenses, if any, to the subject for participating in the trial?
- A.
  
  Investigator's Brochure
- B.
  
  Statistical Analysis Plan (SAP)
- C.
  
  Auditing Plan
- D.
  
  Informed Consent
Correct Answer
D. Informed Consent

Explanation
Informed Consent is the document that includes an explanation of anticipated expenses, if any, to the subject for participating in the trial. This document ensures that the subject is fully aware of the potential costs associated with their participation and gives them the opportunity to make an informed decision about their involvement in the study. It outlines any expenses that the subject may be responsible for, such as travel costs or medical procedures not covered by insurance.

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46.

Clinical trials should be conducted in accordance with the ethical principles that are consistent with GCP and the applicable regulatory requirement(s), and that have their origin in the Declaration of ___________.
- A.
  
  Clinical Research Regulations
- B.
  
  Independence
- C.
  
  Geneva Conference
- D.
  
  Helsinki
Correct Answer
D. Helsinki

Explanation
Clinical trials should be conducted in accordance with ethical principles that are consistent with Good Clinical Practice (GCP) and regulatory requirements. These ethical principles have their origin in the Declaration of Helsinki. The Declaration of Helsinki is a set of ethical guidelines for medical research involving human subjects, developed by the World Medical Association. It provides a framework for the protection of the rights, safety, and well-being of research participants. Adhering to the principles outlined in the Declaration of Helsinki ensures that clinical trials are conducted ethically and with the best interests of the participants in mind.

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47.

Freely given informed consent should be obtained from every subject prior to clinical participation after an investigational product is taken.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
The statement is false because freely given informed consent should be obtained from every subject prior to clinical participation, regardless of whether an investigational product is taken or not. The use of investigational products may require additional consent and information, but informed consent is a necessary requirement for all clinical participation.

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48.

Investigational projects should be manufactured, handled, and stored in accordance with applicable _____.
- A.
  
  GCP
- B.
  
  GMP
- C.
  
  ACRP
- D.
  
  IRB
Correct Answer
B. GMP

Explanation
Investigational projects should be manufactured, handled, and stored in accordance with applicable GMP (Good Manufacturing Practices). GMP is a set of guidelines and regulations that ensure the quality, safety, and efficacy of pharmaceutical products. It covers various aspects of manufacturing, including facility design, equipment qualification, personnel training, documentation, and quality control. Adhering to GMP standards is crucial to ensure that investigational projects are produced and handled in a consistent and controlled manner, minimizing the risks associated with their use.

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49.

Which documents should the IRB/IEC obtain and review prior to approving a clinical trial? (select all that apply)
- A.
  
  Trial protocol(s)/amendments
- B.
  
  Written ICFs
- C.
  
  Subject recruitment procedures
- D.
  
  Monitoring confirmation letters
- E.
  
  Investigator's Brochure
Correct Answer(s)
A. Trial protocol(s)/amendments
B. Written ICFs
C. Subject recruitment procedures
E. Investigator's Brochure

Explanation
The IRB/IEC should obtain and review the trial protocol(s)/amendments to understand the study design and procedures. They should also review the written informed consent forms (ICFs) to ensure that participants are adequately informed about the study and its risks. The subject recruitment procedures should be reviewed to ensure that participants are being recruited in an ethical and appropriate manner. Lastly, the Investigator's Brochure should be reviewed to understand the background and safety information of the investigational product being studied.

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50.

The IRB/IEC should consider the qualifications of the investigator and the monitor for the purposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The statement is true. Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) responsible for reviewing and approving clinical trials should indeed consider the qualifications of the investigator and the monitor. This information is typically documented in a current curriculum vitae (CV) or resume provided by the investigator and the monitor. The qualifications of these individuals are crucial in ensuring the safety and ethical conduct of the trial, and the IRB/IEC may request additional relevant documentation to assess their competence and expertise.

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ICH GCP Guidelines Quiz: Test!

The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains all required documentation.

The sponsor should verity that each ______ has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.

According to ICH GCP (International Conference on Harmonization - Good Clinical Practice) guidelines, which document outlines the objective(s), design, methodology, statistical considerations, and organization of a clinical trial?

The investigator/institution should permit monitoring and ________ by the sponsor, and inspection by the appropriate regulatory authority(ies).

The sponsor is not obligated to submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s)

Monitor should be appointed by the ______.

The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties

The ______ should have sufficient time to properly conduct and complete the trial within the agreed trial period.

It is recommended that the ______ inform the subject's primary physician about the subject's participation in the trial if the subject has a primary care physician and if the subject agrees to the primary care physician being informed.

The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.

During the trial, the investigator is not obligated in any way to provide to the IRB/IEC all documents subject to review.

If the sponsor discontinues the clinical development of an investigational product, the sponsor is not obligated to notify trial investigators/institutions nor regulatory authorities.

Fill in the blank: The investigator, or person designated by the investigator, should document and explain any deviation from the approved_________.

Responsibility for investigational product(s) accountability at the trial site(s) rests with the_____.

The ______ should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).

The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol.

Clinical trial protocols and protocol amendments should address the following:

Clinical trials should be scientifically sound, and described in clear, detailed protocol.

If the trial is ______, the investigator should promptly document and explain to the sponsor any premature unblinding of the investigational product(s).

Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

The sponsor should appoint individuals, who are independent of the clinical trial/data collection system(s), to conduct audits.

Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: [select all that apply]

Data reported on the ______, which are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.

The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once every ______ year(s).

Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: [select all that apply]

Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records only if a comprehensive list of such is provided at least 15 business days prior to the date of review/access.

The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Monitors act as the main line of communication between the sponsor and the investigator.

The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the ______ and in all required reports.

Neither the investigator nor the trial staff should ________ or unduly influence a subject to participate or to continue to participate in a trial.

The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC.

Informed consents should include an explanation of the subject's responsibilities.

The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: [SELECT ALL THAT APPLY]

Who is responsible for the conduct of the clinical trial at a trial site?

Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly,

Which is NOT one of the purposes of trial monitoring?

The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.

The ICH GCP guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the Association of Advanced Neurology.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that must have a causal relationship with this treatment.

Please fill in the blank. _______ subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

What document includes an explanation of anticipated expenses, if any, to the subject for participating in the trial?

Clinical trials should be conducted in accordance with the ethical principles that are consistent with GCP and the applicable regulatory requirement(s), and that have their origin in the Declaration of ___________.

Freely given informed consent should be obtained from every subject prior to clinical participation after an investigational product is taken.

Investigational projects should be manufactured, handled, and stored in accordance with applicable _____.

Which documents should the IRB/IEC obtain and review prior to approving a clinical trial? (select all that apply)

The IRB/IEC should consider the qualifications of the investigator and the monitor for the purposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.