*The responsibility for ensuring that the investigator understands a clinical trial lies with:

FDA

IRB

Sponsor

Coordinator

Correct Answer

C. Sponsor

Explanation

The sponsor is responsible for ensuring that the investigator understands a clinical trial. This includes providing the necessary information and training to the investigator, as well as ensuring that the investigator is aware of and follows all applicable regulations and guidelines. The sponsor also plays a role in monitoring the progress of the trial and addressing any issues or concerns that may arise.

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*What is the minimum number of IRB members?

Correct Answer

B. 5

Explanation

The minimum number of IRB members is 5 because having a minimum of 5 members ensures diversity and represents different perspectives and expertise. This allows for comprehensive review and evaluation of research proposals, ensuring ethical considerations are adequately addressed. With fewer than 5 members, there may not be enough diversity and expertise to effectively assess the ethical implications of the research.

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*Significant risk device is defined as an investigational device that is:

Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.

Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.

For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.

All the above

Correct Answer

D. All the above

Explanation

The correct answer is "All the above" because all three options listed in the question describe the criteria for a device to be considered a significant risk device. A significant risk device is one that is intended as an implant and presents a potential for serious risk to the subject's health, safety, or welfare, or is purported to be for a use in supporting or sustaining human life and presents a potential risk, or is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk.

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*With respect to IRB/IEC membership, both the FDA and the ICH require that

A majority of the members' primary area of interest is in a scientific area

At least one member holds a Ph.D. degree or equivalent

At least one member's primary area of interest is in a nonscientific area

A majority of the members are from or have ties to the institution of record

Correct Answer

C. At least one member's primary area of interest is in a nonscientific area

Explanation

Both the FDA and the ICH require that at least one member's primary area of interest is in a nonscientific area. This means that there should be at least one member on the IRB/IEC whose expertise is not solely focused on scientific matters. This requirement ensures that the review board has a diverse range of perspectives and can consider the ethical, social, and cultural implications of the research being conducted. It helps to prevent any potential biases or conflicts of interest that may arise if all members have a purely scientific background.

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*In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?

The investigator provides his/her written approval

The study drug has an FDA approved marketing application

The FDA provides written approval of the IND

Subjects cannot be enrolled until IRB/IEC approval has been obtained

Correct Answer

D. Subjects cannot be enrolled until IRB/IEC approval has been obtained

Explanation

In a non-emergency situation, subjects cannot be enrolled into a study prior to IRB/IEC approval. This means that even if the investigator provides their written approval or if the study drug has an FDA approved marketing application, subjects still cannot be enrolled until the necessary IRB/IEC approval has been obtained. The FDA providing written approval of the IND also does not allow for subjects to be enrolled prior to IRB/IEC approval.

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*A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct?

This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm

This subject should undergo all study procedures as outlined in the protocol

This subject only needs to undergo the study procedures that pertain specifically to the subject

This subject can undergo the study procedures whenever it is convenient

Correct Answer

B. This subject should undergo all study procedures as outlined in the protocol

Explanation

The correct answer is that this subject should undergo all study procedures as outlined in the protocol. Regardless of being randomized to the non-treatment arm, the protocol states that all subjects should undergo the study procedures within one week of enrollment. Therefore, this subject is still required to follow the protocol and complete all study procedures.

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*A purpose of monitoring clinical trials is to verify that:

The rights, safety, and well-being of human subjects are protected

Investigators receive adequate payment for their participation in the clinical trial

The investigator has received annual reports from the sponsor

The regulatory agency has received all case history information of subjects enrolled on the clinical trial

Correct Answer

A. The rights, safety, and well-being of human subjects are protected

Explanation

The purpose of monitoring clinical trials is to ensure that the rights, safety, and well-being of human subjects are protected. This involves regularly assessing and evaluating the trial to identify any potential risks or adverse events that may occur during the study. Monitoring also ensures that the trial is being conducted in accordance with ethical guidelines and regulatory requirements to minimize any harm to the participants. By verifying that these protections are in place, the monitoring process helps to maintain the integrity and validity of the clinical trial.

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*Which of the following is the proper way to make a correction to a CRF?

Completely blacken the incorrect entry and then enter the correct information

Back date the corrected entry with the date of the original entry

Initial using the initials of the sponsor’s representative who reviewed the change

Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

Correct Answer

D. Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

Explanation

To make a correction to a CRF, the proper way is to add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change. This ensures that the correction is properly documented and attributed to the person responsible for making the change. It also provides clarity and transparency regarding the reason for the correction, if needed.

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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.

True

False

Correct Answer

A. True

Explanation

The ICH GCP Guideline aims to establish a common standard for clinical data acceptance by regulatory authorities in the EU, Japan, and the United States. By providing a unified framework, it facilitates the mutual recognition and acceptance of clinical data across these jurisdictions. This helps streamline the regulatory process, ensuring that clinical trials conducted in these regions meet consistent quality standards and can be relied upon for decision-making purposes. Therefore, the statement "True" accurately reflects the objective of the ICH GCP Guideline.

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10.

The contents of a Protocol should generally contain:

Trial objectives and purpose

Assessment of efficacy

Data handling and record keeping

All of the above

Only A & C

Correct Answer

D. All of the above

Explanation

The contents of a protocol should generally include the trial objectives and purpose, assessment of efficacy, and data handling and record keeping. Including the trial objectives and purpose helps to clearly define the goals and intentions of the study. Assessment of efficacy is crucial in determining the effectiveness of the intervention being studied. Data handling and record keeping ensure that all data collected during the trial is properly documented and organized for analysis. Therefore, all of the above options are necessary components of a protocol.

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11.

Only the principal investigator is allowed to transcribe data from the source document to the CRF?

True

False

Correct Answer

B. False

Explanation

False. The principle investigator is not the only person allowed to transcribe data from the source document to the CRF. Other trained and authorized personnel, such as research assistants or data managers, may also be involved in this process. The principle investigator may oversee the data transcription, but it is not exclusively their responsibility.

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12.

When a short form is used for Informed Consent, the witness must sign either the short form or the summary.

True

False

Correct Answer

B. False

Explanation

According to regulations and best practices, the witness must sign both the short form and the summary when a short form is used for informed consent.

Here's a breakdown of the correct process:

Short Form: The short form is a translated document summarizing the essential elements of informed consent in the subject's preferred language.

Written Summary: This is a detailed document in English that outlines all aspects of the informed consent process.

Witness: An individual (over 18, fluent in both languages, not involved in the study) witnesses the researcher obtaining consent from the subject.

Signing: After the subject understands and agrees to participate, they sign the short form. The witness then signs both the short form and the written summary to confirm they witnessed the process and the subject's agreement.

Therefore, it's crucial for both the short form and the summary to be signed by the witness for proper documentation and ethical research practice.

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13.

Form___________ is the investigator statement.

1571

1572

3500

3500A

Correct Answer

B. 1572

Explanation

The correct form is Form FDA 1572. Form 1572, also known as the "Statement of Investigator," is a document that must be completed by clinical investigators participating in research studies involving investigational new drugs, biologics, or medical devices in the United States. The purpose of this form is to provide the Food and Drug Administration (FDA) with essential information about the investigator's qualifications, the study site, and the study itself. By signing Form 1572, investigators commit to conducting the study in accordance with the approved protocol, relevant regulations, and Good Clinical Practice (GCP) guidelines. This form plays a crucial role in ensuring the ethical conduct of clinical trials and the protection of human subjects.

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14.

What is 45 CFR Part 46?

HHS - Protection of Human Subjects

FDA - Protection of Human Subjects

HHS - Protection of Children

HHS - Protection of Research Participants

Correct Answer

A. HHS - Protection of Human Subjects

Explanation

45 CFR Part 46 refers to the Code of Federal Regulations (CFR) that outlines the protection of human subjects in research activities conducted or supported by the U.S. Department of Health and Human Services (HHS). Specifically, it is titled "Protection of Human Subjects." These regulations are based on the ethical principles outlined in the Belmont Report and provide a framework for the conduct of research involving human subjects. The regulations cover various aspects of research, including the requirement for Institutional Review Board (IRB) review and approval, informed consent procedures, and the protection of vulnerable populations, such as children, pregnant women, and prisoners. Compliance with 45 CFR Part 46 is essential for institutions and researchers involved in HHS-funded or conducted research to ensure the ethical treatment and safety of human subjects.

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15.

The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR812.

True

False

Correct Answer

B. False

Explanation

The statement is false. The Code of Federal Regulations that applies to Investigational New Drug (IND) Applications is 21 CFR Part 312, not 21 CFR 812. 21 CFR Part 312 provides the regulations and guidelines for obtaining and maintaining an IND, which is required for the study of investigational new drugs in the United States. This part covers the requirements for submitting an IND application, the responsibilities of sponsors and investigators, the protection of human subjects, and the monitoring and reporting of adverse events, among other topics. Compliance with these regulations is crucial for ensuring the ethical conduct of clinical trials and the safety of participants involved in the testing of new drug candidates.

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16.

Who monitors the progress of all clinical trial investigations being conducted under an IND?

Principal Investigator

IRB

Sponsor

CRO

Correct Answer

C. Sponsor

Explanation

The sponsor is responsible for monitoring the progress of all clinical trial investigations being conducted under an IND. They oversee the trial and ensure that it is being conducted according to the protocol, regulations, and ethical guidelines. The sponsor is typically a pharmaceutical company, government agency, or academic institution that initiates and funds the clinical trial. They play a crucial role in ensuring the safety and efficacy of the investigational product and have the ultimate responsibility for the trial's success.

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17.

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called...

The Belmont Report

The National Research Act

The Nuremberg Code

The Declaration of Helsinki

Correct Answer

D. The Declaration of Helsinki

Explanation

The Declaration of Helsinki is a set of ethical principles for medical research involving human subjects, established by the World Medical Association (WMA). It provides guidelines for researchers to ensure the protection and well-being of human participants in research studies. The Belmont Report, the National Research Act, and the Nuremberg Code are also important documents related to research ethics, but they are not specifically associated with the WMA or medical research involving human subjects.

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18.

The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as...

The ICH

Good Clinical Practices (GCP)

The Declaration of Helsinki

Fundamental Ethical Principles (FEP)

Correct Answer

B. Good Clinical Practices (GCP)

Explanation

Good Clinical Practices (GCP) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects. GCP ensures that the rights, safety, and well-being of the participants are protected and that the data generated from the trials are reliable and credible. It provides guidelines on the ethical considerations, study design, participant recruitment, informed consent process, data collection and management, safety monitoring, and reporting of results. GCP is widely recognized and followed by regulatory authorities, research institutions, and pharmaceutical companies to ensure the highest standards of research integrity and participant protection.

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19.

The Code of Federal Regulations that applies to Institutional Review Boards is:

45CFR46

21CFR312

21CFR50

21CFR56

Correct Answer

D. 21CFR56

Explanation

The correct answer is 21CFR56 because it refers to the Code of Federal Regulations that applies to Institutional Review Boards. The other options, 45CFR46, 21CFR312, and 21CFR50, do not specifically pertain to Institutional Review Boards.

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20.

This form is used for the voluntary reporting of adverse events and product problems:

1571

1572

3500

3500A

Correct Answer

C. 3500

Explanation

The correct form is Form FDA 3500. Form FDA 3500, also known as the "Voluntary Adverse Event Report," is used by healthcare professionals, consumers, and patients to voluntarily report adverse events and product problems related to drugs, biologics, medical devices, dietary supplements, and other FDA-regulated products. Reporting adverse events can help the FDA identify potential safety concerns, monitor product safety, and take appropriate actions to protect public health, such as issuing warnings or requiring label changes.

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21.

Each IRB that reviews studies involving children as subjects is covered by:

21CFR 56, Subpart A

21CFR 56, Subpart B

21CFR 50, Subpart D

21CFR 56, Subpart C

Correct Answer

C. 21CFR 50, Subpart D

Explanation

21 CFR 50, Subpart D- This section specifically provides "Additional Safeguards for Children in Clinical Investigations." It includes provisions that ensure extra protection for children involved in research, encompassing all necessary regulatory aspects to safeguard children’s welfare in clinical studies.

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22.

This form is used for the mandatory reporting of serious adverse events:

1571

1572

3500

3500A

Correct Answer

D. 3500A

Explanation

Form FDA 3500A is used for the mandatory reporting of serious adverse events, product problems, and medication errors associated with FDA-regulated products, such as drugs, biologics, and medical devices. This form is primarily intended for use by healthcare professionals, healthcare facilities, manufacturers, and importers to report serious events that occur during the use of these products. Reporting such events is essential to help the FDA monitor product safety, identify potential risks, and take appropriate actions to protect public health, including product label changes, safety warnings, or product recalls.

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23.

What is covered in 21CFR50 Subpart B?

Informed consent of Human Subjects

IRB Functions and Operations

Records and Reports

Additional Safeguards for Children in Clinical Investigations

Correct Answer

A. Informed consent of Human Subjects

Explanation

21CFR50 Subpart B covers the informed consent of human subjects. This means that it includes the regulations and guidelines related to obtaining informed consent from individuals who participate in clinical investigations. Informed consent ensures that participants are fully aware of the purpose, risks, and benefits of the study before they decide to participate. It also ensures that participants have the right to withdraw from the study at any time. This subpart outlines the specific requirements and procedures that must be followed to obtain informed consent from human subjects.

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24.

*The IRB must determine that requirements for permission by parents or guardians and assent by children are met.

True

False

Correct Answer

A. True

Explanation

True. The IRB ensures that parental/guardian permission and child assent requirements are met in pediatric research, as per federal regulations. These requirements vary based on the research risk level and the child's age, helping to protect children's rights, safety, and well-being while considering their developmental and emotional needs.

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25.

What topic is covered in 45CFR46 Subpart B?

Additional Safeguards and Protections

Additional Protection for Prisoners and Vulnerable Subjects

Additional Protection for Children and Unborn Fetuses

Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research

Correct Answer

D. Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research

Explanation

45 CFR 46 Subpart B, titled "Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research," specifically addresses the ethical guidelines and additional safeguards and protections for research involving pregnant women, human fetuses, and neonates. This subpart outlines the regulatory requirements and considerations to ensure the well-being and safety of these vulnerable populations when they participate in research studies. It includes detailed rules and procedures to protect the rights and welfare of pregnant women and their unborn fetuses, as well as neonates involved in research activities.

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26.

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

6 months

1 year

2 years

5 years

Correct Answer

B. 1 year

Explanation

The clinical investigator is required to update the financial disclosure information if any relevant changes occur during the investigation's course and for 1 year following the study's completion. This is important to ensure transparency and integrity in the research process and to identify any potential conflicts of interest that may arise. By updating the financial disclosure information for 1 year, it allows for a sufficient period of time to capture any changes that may occur after the study has ended.

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27.

The 3 fundamental ethical principles for human subjects' in research are:

Respect for persons, beneficence, justice

Respect for subjects, their safety and their time

Respect for sponsor, IRB and FDA guidelines

Respect for data, welfare and discovery

Correct Answer

A. Respect for persons, beneficence, justice

Explanation

The 3 fundamental ethical principles for human subjects in research are respect for persons, beneficence, and justice. These principles emphasize the importance of treating individuals with dignity and autonomy, ensuring their well-being and minimizing harm, and promoting fairness and equity in the distribution of research benefits and burdens. By adhering to these principles, researchers can ensure that their studies are conducted ethically and that the rights and welfare of the participants are protected.

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28.

*Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________.

45 CFR 46.110; CFR 56.110(c)

45 CFR 46.110(d); 21 CFR 56.110

45 CFR 46.110(c); 21 CFR 56.110(c)

45 CFR 46.110(b); 21 CFR 56.110(c)

Correct Answer

D. 45 CFR 46.110(b); 21 CFR 56.110(c)

Explanation

Both 45 CFR 46 and 21 CFR 56 are regulations that govern Institutional Review Boards (IRBs) — 45 CFR 46 applies to research conducted or supported by the U.S. Department of Health and Human Services (HHS), while 21 CFR 56 pertains to research regulated by the Food and Drug Administration (FDA). The cited subsections require that an IRB using expedited review procedures adopt a method for keeping all members advised of research proposals that have been approved under these procedures.

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29.

*In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________.

Expected

Serious

Would have implications for the conduct of the study

B & C

A, B & C

Correct Answer

D. B & C

Explanation

An adverse event (AE) observed during a study should be considered an unanticipated problem involving risk to human subjects and reported to the IRB if it is serious and would have implications for the conduct of the study. This means that if the AE is both serious and would affect the study, it should be reported to the IRB. The answer B & C correctly identifies these criteria.

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30.

Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects; the sponsor has _____________ to discontinue the study.

24 hours

48 hours

3 WD

5 WD

Correct Answer

D. 5 WD

Explanation

Although the specific regulations may vary by country and regulatory body, a common timeframe for a sponsor to report significant safety issues and make necessary changes to a clinical trial, including discontinuation, is within 5 working days (WD). In the event that a drug presents an immeasurable and significant risk to the subjects, the sponsor should work expeditiously to gather the necessary information and notify the appropriate parties, such as ethics committees and regulatory authorities, within this timeframe. The sponsor should also take prompt action to protect the safety and well-being of the subjects, which may include discontinuing the study or making significant modifications to the protocol.

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31.

A Short Form informed consent is a written summary of the ICF that is not to exceed one page.

True

False

Correct Answer

B. False

Explanation

The statement is false. Although a Short Form informed consent is indeed a written summary of the full informed consent form (ICF), it is not necessarily limited to one page. The purpose of a Short Form informed consent is to provide a simplified, easily understandable version of the full ICF, focusing on the key information that potential research subjects need to make an informed decision about participating

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