Test Your Knowledge About SOCRA

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  • 1/62 Questions

    What is the minimum number of IRB members?

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About This Quiz

This quiz assesses knowledge of SOCRA guidelines, focusing on ethical principles, regulatory compliance, and standards in clinical trials. It prepares learners for effective participation and oversight in human subjects research.

Test Your Knowledge About SOCRA - Quiz

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  • 2. 

    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 among the EU, Japan, and the US regulatory authorities. This unified standard facilitates the mutual recognition and acceptance of clinical data, reducing the need for duplicative studies and streamlining the drug development process. By adhering to this guideline, sponsors can ensure that their clinical trials meet the regulatory requirements of multiple jurisdictions, saving time and resources. Therefore, the statement is true.

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  • 3. 

    The object of GCP is part of the ICH mission statement.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The statement is true because the object of GCP (Good Clinical Practice) is indeed part of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) mission statement. GCP is a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. The ICH is a global organization that develops guidelines and standards for the pharmaceutical industry, and ensuring the use of GCP is one of their objectives. Therefore, the statement is correct.

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  • 4. 

    What are the three fundamental ethical principals for human subjects research?

    • Autonomy of Patients

    • Respect for Persons

    • Informed Consent for Participation in Research

    • Beneficence

    • Justice

    • Fair Distribution of Cost/Benefit Ratio

    • Non-Exploitative and Well-Considered procedures

    • Maximizing Benefits, Minimizing Risks

    Correct Answer(s)
    A. Respect for Persons
    A. Beneficence
    A. Justice
    Explanation
    The three fundamental ethical principles for human subjects research are respect for persons, beneficence, and justice. Respect for persons refers to treating individuals as autonomous agents and protecting those with diminished autonomy. Beneficence involves maximizing benefits and minimizing risks to participants, ensuring their well-being. Justice entails fair distribution of the costs and benefits of research, avoiding exploitation and considering the needs of vulnerable populations.

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  • 5. 

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

    • True

    • False

    Correct Answer
    A. False
    Explanation
    False - the witness must sign BOTH the short form and the summary

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  • 6. 

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

    • The Principle Investigator

    • The Institutional Review Board

    • The Sponsor

    • The CRO

    Correct Answer
    A. The Sponsor
    Explanation
    The sponsor is responsible for monitoring the progress of all clinical trial investigations being conducted under its IND. The sponsor is typically a pharmaceutical company or organization that initiates and funds the clinical trial. They have the ultimate responsibility for ensuring the safety and efficacy of the investigational product. This includes monitoring the progress of the trial, ensuring compliance with regulations and protocols, and overseeing the collection and analysis of data. The sponsor also plays a crucial role in reporting adverse events and ensuring the overall integrity of the trial.

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  • 7. 

    The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is..

    • 21CFR11

    • 21CFR812

    • 21CFR312

    • 21CFR56

    Correct Answer
    A. 21CFR11
    Explanation
    The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is 21CFR11. This regulation sets forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It establishes the requirements for the use of electronic records and signatures in FDA-regulated industries, ensuring the integrity, authenticity, and confidentiality of electronic records and signatures.

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  • 8. 

    The Code of Federal Regulations that applies to the Protection of Human Subjects is..

    • 21CFR11

    • 45CFR46

    • 21CFR812

    • 21CFR312

    Correct Answer
    A. 45CFR46
    Explanation
    The correct answer is 45CFR46. This code refers to the regulations that apply to the Protection of Human Subjects. It outlines the ethical standards and guidelines for conducting research involving human participants. These regulations aim to ensure the safety, rights, and well-being of individuals involved in research studies.

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  • 9. 

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

    • The Bellmont Report

    • The National Research Act

    • The International Research Act

    • The Declaration of Helsinki

    Correct Answer
    A. 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 of human subjects' rights and welfare during the research process. The Bellmont Report and the National Research Act are both related to ethical guidelines for human subjects research in the United States, but they are not specific to the WMA. The International Research Act does not exist, making it an incorrect option.

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  • 10. 

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

    • 21CFR11

    • 21CFR812

    • 45CFR46

    • 21CFR312

    Correct Answer
    A. 21CFR312
    Explanation
    The correct answer is 21CFR312. This is the specific section of the Code of Federal Regulations that applies to Investigational New Drug Applications (INDs). It outlines the requirements and procedures for conducting clinical trials with investigational drugs in humans. This section covers topics such as the submission of INDs, the responsibilities of sponsors and investigators, informed consent, and reporting of adverse events.

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  • 11. 

    What is the FDA form 482 for?

    • Notice of Inspection

    • Findings of Inspection

    • Declaration of Financial Interests and Arrangements

    • Certification of Financial Interests and Arrangments

    Correct Answer
    A. Notice of Inspection
    Explanation
    FDA form 482 is used for the purpose of issuing a Notice of Inspection. This form is typically used by the U.S. Food and Drug Administration (FDA) to inform regulated establishments that they will be subject to an inspection. The Notice of Inspection provides details about the scope and purpose of the inspection, as well as the date and time it will take place. This form serves as an official notification to the establishment, ensuring that they are aware of the upcoming inspection and can prepare accordingly.

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  • 12. 

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

    Correct Answer
    3500, FDA form 3500
    Explanation
    The given correct answer is "3500, FDA form 3500". This answer suggests that the form mentioned, which is FDA form 3500, is used for the voluntary reporting of adverse events and product problems. The number "3500" is likely used as a reference to the specific form, while "FDA form 3500" indicates that it is an official form of the Food and Drug Administration (FDA) in the United States.

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  • 13. 

    A(n) ___________________ can be any unfavorable and unintended sign )including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 

    Correct Answer
    adverse event, AE
    Explanation
    An adverse event refers to any negative and unintended sign, symptom, or disease that occurs after the use of a medicinal or investigational product. This can include abnormal laboratory findings as well. The term AE is commonly used as an abbreviation for adverse event.

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  • 14. 

    What is 45CFR46?

    • HHS - Protection of Human Subjects

    • DDS - Protection of Human Subjects

    • FDA - Protection of Research Participants

    • HHS - Protection of Research Participants

    Correct Answer
    A. HHS - Protection of Human Subjects
    Explanation
    45CFR46 refers to Title 45 of the Code of Federal Regulations, Section 46, which is a set of regulations established by the U.S. Department of Health and Human Services (HHS). These regulations provide guidelines and protections for human subjects involved in research studies. The HHS is responsible for ensuring that research involving human subjects is conducted ethically and with the utmost consideration for the safety and well-being of the participants. This includes obtaining informed consent, protecting privacy and confidentiality, and minimizing any potential risks to the participants.

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  • 15. 

    Under 21CFR312, this form is the statement of the investigator of a clinical trial

    • 1572

    • 1571

    • 3454

    • 483

    Correct Answer
    A. 1572
    Explanation
    Under 21CFR312, the correct form that serves as the statement of the investigator of a clinical trial is 1572. This form is used to document the investigator's commitment to conduct the study in compliance with the applicable regulations and to protect the rights, safety, and welfare of the study participants. It includes information about the investigator's qualifications, the protocol, the investigational product, and any previous or ongoing clinical trials. The completion and submission of form 1572 is a crucial step in ensuring the integrity and ethical conduct of clinical trials.

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  • 16. 

    The "Doctor's Trial" prompted the Belmont Report.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The "Doctor's Trial" refers to the Nuremberg Trials, which were a series of military tribunals held after World War II to prosecute prominent leaders of Nazi Germany. The Belmont Report, on the other hand, was a response to the unethical experiments conducted by the U.S. Public Health Service on African American men in the Tuskegee Study. Therefore, there is no direct connection between the "Doctor's Trial" and the Belmont Report, making the answer false.

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  • 17. 

    A(n) _______________ is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

    Correct Answer
    case report form, CRF
    Explanation
    A case report form (CRF) is a document, whether printed, optical or electronic, that is specifically created to collect and record all the necessary information about each trial subject. This information is then reported to the sponsor. The CRF serves as a standardized tool for capturing and documenting data related to the study, ensuring consistency and accuracy in the reporting process.

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  • 18. 

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

    Correct Answer
    3500A, FDA form 3500A
    Explanation
    This answer states that the form used for the mandatory reporting of serious adverse events is the 3500A, FDA form 3500A.

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  • 19. 

    What is the FDA form 3455?

    • Certification - Disclosure of Conflict of Interest

    • Declaration of Conflict of Interest

    • Certification - Financial Interests and Arrangements of Clinical Investigators

    • Disclosure - Financial Interests and Agreements of Clinical Investigators

    Correct Answer
    A. Disclosure - Financial Interests and Agreements of Clinical Investigators
    Explanation
    The FDA form 3455 is the form used for the disclosure of financial interests and agreements of clinical investigators. This form is used to report any financial interests or arrangements that may create a conflict of interest for the clinical investigator. It is important for the FDA to have this information in order to ensure the integrity and impartiality of clinical trials.

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  • 20. 

    What is 21CFR50 Subpart D?

    • Records and Reports

    • Protection of Human Subjects

    • IRB Functions and Operations

    • Additional Safeguards for Children in Clinical Investigations

    Correct Answer
    A. Additional Safeguards for Children in Clinical Investigations
    Explanation
    21CFR50 Subpart D refers to the additional safeguards that are put in place for children participating in clinical investigations. This subpart outlines specific requirements and protections that must be followed when conducting research involving children. It ensures that children are not subjected to unnecessary risks and that their rights and welfare are protected throughout the study. This includes obtaining informed consent from both the child and their parent or guardian, ensuring the study is scientifically valid and ethical, and monitoring the child's safety and well-being during the research.

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  • 21. 

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

    • 45CFR46

    • 21CFR312

    • 21CFR56

    • 21CFR50

    Correct Answer
    A. 21CFR56
    Explanation
    The correct answer is 21CFR56. This is because 21CFR56 refers to the specific section of the Code of Federal Regulations that applies to Institutional Review Boards (IRBs). IRBs are responsible for reviewing and approving research involving human subjects to ensure ethical standards are met. Therefore, it is important for IRBs to adhere to the regulations outlined in 21CFR56 to protect the rights and welfare of research participants.

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  • 22. 

    21CFR56.107 Subpart B is IRB Membership.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Thats right mofo

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  • 23. 

    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 Practice (GCP)

    • The Declaration of Helsinki

    • Fundamental Ethical Principles (FEP)

    Correct Answer
    A. Good Clinical Practice (GCP)
    Explanation
    Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve 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 for the conduct of clinical trials, including the ethical principles that should be followed, the responsibilities of the investigators and sponsors, and the procedures for data collection and analysis. GCP is widely recognized and accepted by regulatory authorities and research organizations worldwide as the gold standard for clinical trial conduct.

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  • 24. 

    What is 45CFR46 Subpart B?

    • Additional Safeguards and Protection

    • 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
    A. Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
    Explanation
    45CFR46 Subpart B provides additional protections for pregnant women, human fetuses, and neonates involved in research. This subpart ensures that these vulnerable populations are given special consideration and safeguards in research studies to protect their rights, welfare, and well-being. It includes specific guidelines and requirements for informed consent, risk assessment, and monitoring of research involving pregnant women, human fetuses, and neonates. These additional protections aim to ensure that the potential benefits of the research outweigh any potential risks and that the rights and welfare of these individuals are protected throughout the study.

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  • 25. 

    What is 21CFR50.56 Subpart D?

    • Requirements for permission by parents or guardians and for assent by children.

    • Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

    • Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.

    • Wards.

    Correct Answer
    A. Wards.
    Explanation
    21CFR50.56 Subpart D refers to the requirements for permission by parents or guardians and for assent by children. It specifically pertains to clinical investigations involving children where there may be greater than minimal risk and no prospect of direct benefit to the individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition. The term "wards" is used to describe children who are under the legal guardianship of someone else, such as a foster parent or legal guardian.

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  • 26. 

    What is the federal department responsible for helping people of Canada maintain and improve their health?

    • Federal Department of Food and Drug Administration

    • Canada Health

    • Health Canada

    • Federal Department of Canadian Health and Safety

    Correct Answer
    A. Health Canada
    Explanation
    Health Canada is the federal department responsible for helping people of Canada maintain and improve their health. This department is responsible for a wide range of health-related activities, including regulating and ensuring the safety of food, drugs, and medical devices, promoting healthy living and disease prevention, and providing health information and resources to the public. Health Canada plays a crucial role in protecting and promoting the health and well-being of Canadians.

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  • 27. 

    The IRB may, for some or all subjects, waive the requirement hat the subject, or the subject's legally authroized representative, sign a written consent form if it finds that the research presents more than minimal risk of harm to subjects and involves no procedures for which written consent is normall required outside the research context.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The IRB may, for some or all subjects, waive the requirement hat the subject, or the subject's legally authroized representative, sign a written consent form if it finds that the research presents NO more than minimal risk. The IRB may not do this for research that is more than minimal risk.

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  • 28. 

    What is a person or an organization (commercial, academic, or other) contracted by the sponsor of a clinical trial to perform one or more trial-related duty and function?

    • CRO - Clinical Research Organization

    • CRO - Contracted Research Organization

    • CRO - Center for Research Operations

    • CRO - Contracted Research Operations

    Correct Answer
    A. CRO - Contracted Research Organization
    Explanation
    A person or organization contracted by the sponsor of a clinical trial to perform trial-related duties and functions is referred to as a CRO, which stands for Contracted Research Organization. The CRO is responsible for various tasks such as conducting the trial, recruiting participants, collecting and analyzing data, and ensuring compliance with regulatory requirements. They play a crucial role in the successful execution of clinical trials by providing expertise and resources to support the sponsor's research objectives.

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  • 29. 

    What is the FDA form 3454?

    • Certification - Disclosure of Conflict of Interest

    • Declaration of Conflict of Interest

    • Certification - Financial Interests and Arrangements of Clinical Investigators

    • Declaration - Financial Interests and Arrangements of Clinical Investigators

    Correct Answer
    A. Certification - Financial Interests and Arrangements of Clinical Investigators
    Explanation
    FDA form 3454 is the Certification - Financial Interests and Arrangements of Clinical Investigators. This form is used to disclose any financial interests or arrangements that clinical investigators may have that could potentially create a conflict of interest. It is important for the FDA to be aware of any potential conflicts of interest to ensure the integrity and impartiality of the clinical investigation process. By completing this form, clinical investigators are certifying that they have disclosed all relevant financial interests and arrangements.

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  • 30. 

    What does 21CFR54 deal with?

    • IRB regulations

    • Exemptions of Informed Consent for emergency use

    • Financial disclosure of clinical investigators

    • Protection of human subjects: prisoners

    Correct Answer
    A. Financial disclosure of clinical investigators
    Explanation
    21CFR54 deals with the financial disclosure of clinical investigators. This means that it focuses on the requirements and regulations regarding the disclosure of financial interests and relationships of clinical investigators involved in research studies. This is important to ensure transparency and prevent any potential conflicts of interest that could bias the results or compromise the integrity of the research.

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  • 31. 

    A(n) _______________ is an investigational or marketed product, or placebo, used as a reference in a clinical trial.

    Correct Answer
    comparator, product
    Explanation
    In a clinical trial, a comparator is a reference product or placebo that is used to compare the effectiveness and safety of an investigational or marketed product. It serves as a standard against which the new product is measured, allowing researchers to determine if the new product provides any additional benefits or improvements compared to the comparator. This helps in evaluating the efficacy and safety of the new product and making informed decisions about its use in medical practice.

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  • 32. 

    A significant risk device....

    • Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.

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

    • For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.

    Correct Answer(s)
    A. Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject.
    A. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject.
    A. For use of the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents potential risk to health, safety, or well-fare of the subject.
    Explanation
    The correct answer is a combination of all three options. A significant risk device is one that is intended as an implant and presents a potential for serious risk to health, safety, or the well-being of the subject. It is also purported or represented to be for a use in supporting or sustaining human life, which also presents a potential risk to health, safety, or well-being. Additionally, it is used for the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health, which again presents potential risk to health, safety, or well-being.

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  • 33. 

    ________________ is permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

    Correct Answer(s)
    direct access
    Explanation
    Direct access refers to the permission granted to individuals or organizations to have unrestricted and immediate access to examine, analyze, verify, and reproduce any records and reports that are crucial for evaluating a clinical trial. This access allows for a comprehensive evaluation of the trial's processes, data, and outcomes, ensuring transparency and accuracy in the evaluation process.

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  • 34. 

    Which of the following is IRB Functions and Regulations?

    • 21CFR56.108 Subpart D

    • 21CFR56.108 Subpart C

    • 21CFR56.106 Subpart B

    • I seriously can't believe this is a question

    Correct Answer
    A. 21CFR56.108 Subpart C
    Explanation
    The correct answer is 21CFR56.108 Subpart C. This regulation specifically addresses the functions and operations of Institutional Review Boards (IRBs). It outlines the requirements and responsibilities of IRBs, including the review and approval of research protocols, the informed consent process, and the ongoing monitoring of research studies. Subpart C also covers the composition and membership requirements of IRBs, as well as the procedures for conducting IRB meetings and maintaining records.

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  • 35. 

    What is 21CFR50.53 Subpart D?

    • Clinical Investigations not involving greater than minimal risk - children

    • Clinical Investigations involving greater than minimal risk - children

    • Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition - children

    • Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children

    Correct Answer
    A. Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition - children
    Explanation
    21CFR50.53 Subpart D refers to clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition in children. This means that the clinical investigations being conducted on children carry a higher level of risk, but there is no immediate benefit for the individual subjects. However, the information gathered from these investigations is expected to contribute to a better understanding of the disorder or condition being studied in children.

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  • 36. 

    What is 21CFR50.52 Subpart D?

    • Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children

    • Clinical Investigations not involving greater than minimal risk - children

    • Clinical Investigations involving greater than minimal risk - children

    Correct Answer
    A. Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children
    Explanation
    21CFR50.52 Subpart D refers to a specific section of the Code of Federal Regulations (CFR) that pertains to clinical investigations involving children. The correct answer states that it pertains to clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children. This means that the regulations outlined in this subpart apply to studies conducted on children where there is a possibility of potential harm, but also a potential for direct benefit to the individual child participating in the study.

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  • 37. 

    What is 45CFR46 Subpart A?

    • HHS Definitions of Human Subject Protection

    • Basic HHS policy for Protection of Human Research Subjects

    • HHS Definitions for Protection of Human Research Subjects

    • HHS Policy for Human Subjects Protection

    Correct Answer
    A. Basic HHS policy for Protection of Human Research Subjects
    Explanation
    The correct answer is "Basic HHS policy for Protection of Human Research Subjects." 45CFR46 Subpart A refers to the basic policy of the Department of Health and Human Services (HHS) for the protection of human subjects in research. This policy outlines the ethical principles and guidelines that researchers must follow when conducting research involving human subjects. It ensures the protection of participants' rights, welfare, and well-being during the research process.

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  • 38. 

    What is 21CFR50.20 Subpart B?

    • Exception from General Requirements

    • General Requirements for Informed Consent

    • Exception from Informed Consent Requirements for Emergency Research

    • Documentation of Informed Consent

    Correct Answer
    A. General Requirements for Informed Consent
    Explanation
    21CFR50.20 Subpart B refers to the section of the Code of Federal Regulations that outlines the general requirements for informed consent in research studies. This subpart specifies the necessary elements and information that must be provided to participants before they can give their informed consent to participate in a study. It ensures that participants are fully aware of the purpose, risks, benefits, and alternatives of the study before making a decision to participate. This subpart also emphasizes the importance of voluntary participation and the right of participants to withdraw from the study at any time.

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  • 39. 

    What is 21CFR50.25 Subpart B?

    • Elements of Informed Consent

    • Documentation of Informed Consent

    • Exemptions of Informed Consent

    • Documentation of Emergency Use of Experimental Treatments

    Correct Answer
    A. Elements of Informed Consent
    Explanation
    21CFR50.25 Subpart B refers to the section of the Code of Federal Regulations that outlines the elements of informed consent in clinical trials. This includes the information that must be provided to participants, such as the purpose of the study, potential risks and benefits, alternative treatments, and the voluntary nature of participation. It also specifies that informed consent must be obtained in writing and that the participant should have the opportunity to ask questions and have them answered satisfactorily. This regulation ensures that participants are fully informed and able to make an educated decision about their participation in clinical trials.

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  • 40. 

    What is 21CFR50.50 Subpart D?

    • IRB Documentation

    • IRB Exemptions

    • IRB Duties

    • IRB Membership Guidelines

    Correct Answer
    A. IRB Duties
    Explanation
    21CFR50.50 Subpart D refers to the section of the Code of Federal Regulations that outlines the specific duties and responsibilities of an Institutional Review Board (IRB). This section provides guidelines and requirements for IRBs in order to protect the rights and welfare of human subjects involved in research studies. It includes duties such as reviewing and approving research protocols, ensuring informed consent is obtained, monitoring ongoing studies, and ensuring compliance with ethical standards and regulations.

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  • 41. 

    What is 21CFR50.55 Subpart D?

    • Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

    • Requirements for permission by parents or guardians and for assent by children.

    • Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

    • Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.

    Correct Answer
    A. Requirements for permission by parents or guardians and for assent by children.
    Explanation
    21CFR50.55 Subpart D refers to the requirements for permission by parents or guardians and for assent by children in clinical investigations. This means that when conducting clinical investigations that involve children, the parents or guardians must give their permission for the child to participate, and the child must also provide their assent or agreement to participate. This ensures that the rights and well-being of children are protected in research studies.

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  • 42. 

    When a short form is used for Informed Consent, the patient signs the short form ONLY and the receives a copy of both the summary and the short form.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    True. When a short form is used for informed consent, the patient typically signs only the short form, indicating their consent to participate in the study. However, they should also receive a copy of both the short form and the summary of the study, ensuring that they have access to the necessary information about the study before making their decision.

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  • 43. 

    What is 21CFR50.24 subpart B?

    • Documentation of Informed Consent

    • Exception from General Requirements

    • General Requirements for Informed Consent

    • Exception from Informed Consent Requirements for Emergency Research

    Correct Answer
    A. Exception from Informed Consent Requirements for Emergency Research
    Explanation
    21CFR50.24 subpart B refers to the exception from informed consent requirements for emergency research. This means that in certain situations where obtaining informed consent from participants is not feasible due to the nature of the emergency, such as in life-threatening situations, the research can be conducted without obtaining consent. This exception allows researchers to proceed with urgent studies that aim to save lives or improve health outcomes without the delay of obtaining informed consent.

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  • 44. 

    What is 21CFR56.110 Subpart C?

    • IRB review of research

    • IRB functions and operations

    • Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research

    • IRB registration

    Correct Answer
    A. Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research
    Explanation
    Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research refers to the process by which an Institutional Review Board (IRB) can review and approve research studies that involve minimal risk and minor changes to previously approved research protocols. This allows for a more streamlined and efficient review process for studies that pose minimal risk to participants and require only minor modifications to the original research plan.

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  • 45. 

    21CFR56 is IRB Functions and Operations.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    21 CFR 56 is a section of the Code of Federal Regulations (CFR) in the United States that specifically addresses Institutional Review Boards (IRBs). This section outlines the functions and operations of IRBs, including their responsibilities for protecting the rights and welfare of human subjects in research. It provides guidelines for IRB membership, review procedures, record keeping, and other aspects of IRB management.

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  • 46. 

    What do the HHS stand for?

    Correct Answer
    Health and Human Services, health and human services
    Explanation
    HHS, which stands for "Health and Human Services," denotes the U.S. Department of Health and Human Services. This federal agency strives to enhance the well-being of all Americans by offering a range of health-related initiatives and programs aimed at fostering improved health and providing essential human services.

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  • 47. 

    What is 45CFR46 Subpart C?

    • Additional Protection for Children and Unborn Fetuses

    • Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

    • Additional Protection for Prisoners and Vulnerable Subjects

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

    Correct Answer
    A. Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
    Explanation
    45 CFR 46 is a section of the Code of Federal Regulations (CFR) in the United States that provides regulations for the protection of human subjects in research. Subpart C of 45 CFR 46 specifically addresses additional protections for prisoners involved in research. This subpart outlines specific requirements for IRB review, informed consent, and research design when conducting research with prisoners. It aims to ensure that prisoners are not coerced or unduly influenced to participate in research and that their rights and welfare are protected.

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  • 48. 

    The form _____________ is used for investigational new drugs (or IND).

    Correct Answer
    1571
  • 49. 

    What is 21CFR50 Subpart B?

    • Protection of Human Subjects

    • Additional Safeguards for Children in Clinical Investigations

    • IRB Functions and Operations

    • Records and Reports

    Correct Answer
    A. Protection of Human Subjects
    Explanation
    21CFR50 Subpart B refers to the regulations that outline the protection of human subjects in clinical investigations. These regulations ensure that individuals participating in clinical trials are treated ethically and their rights and well-being are safeguarded. The regulations cover aspects such as informed consent, assessment of risks and benefits, and the responsibilities of Institutional Review Boards (IRBs) in reviewing and approving research protocols. This subpart is crucial in maintaining the ethical conduct of clinical investigations and ensuring the safety and welfare of human subjects involved.

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Quiz Review Timeline (Updated): Nov 4, 2024 +

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  • Nov 04, 2024
    Quiz Edited by
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  • Sep 21, 2017
    Quiz Created by
    Bseko
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