Test Your Knowledge About SOCRA

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SOCRA Quizzes & Trivia

Questions and Answers
  • 1. 

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

    • A.

      Autonomy of Patients

    • B.

      Respect for Persons

    • C.

      Informed Consent for Participation in Research

    • D.

      Beneficence

    • E.

      Justice

    • F.

      Fair Distribution of Cost/Benefit Ratio

    • G.

      Non-Exploitative and Well-Considered procedures

    • H.

      Maximizing Benefits, Minimizing Risks

    Correct Answer(s)
    B. Respect for Persons
    D. Beneficence
    E. 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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  • 2. 

    The FDA form 483 is used for ...

    Correct Answer(s)
    Inspectional Observations
    Explanation
    The FDA form 483 is used for documenting inspectional observations made during an inspection of a regulated facility. It is a tool used by the FDA to communicate to the facility the observations made during the inspection, which may include deviations from regulations or non-compliance with good manufacturing practices. The form allows the FDA to inform the facility of the issues found and gives the facility an opportunity to respond and provide corrective actions.

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  • 3. 

    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?

    • A.

      CRO - Clinical Research Organization

    • B.

      CRO - Contracted Research Organization

    • C.

      CRO - Center for Research Operations

    • D.

      CRO - Contracted Research Operations

    Correct Answer
    B. 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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  • 4. 

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

    • A.

      The ICH

    • B.

      Good Clinical Practice (GCP)

    • C.

      The Declaration of Helsinki

    • D.

      Fundamental Ethical Principles (FEP)

    Correct Answer
    B. 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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  • 5. 

    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 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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  • 6. 

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

    • A.

      21CFR11

    • B.

      21CFR812

    • C.

      45CFR46

    • D.

      21CFR312

    Correct Answer
    D. 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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  • 7. 

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

    • A.

      True

    • B.

      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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  • 8. 

    What is the minimum number of IRB members?

    • A.

      2

    • B.

      10

    • C.

      15

    • D.

      5

    Correct Answer
    D. 5
    Explanation
    The minimum number of IRB members is 5. This is because the IRB (Institutional Review Board) is responsible for reviewing and approving research involving human subjects. To ensure a comprehensive and diverse review, a minimum number of members is required. Having at least 5 members allows for a range of perspectives and expertise to be represented, enhancing the quality and fairness of the review process.

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  • 9. 

    Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the...

    • A.

      Mission statement of the ICH

    • B.

      Mission statement of the GCP Guidelines

    • C.

      Mission statement of the Declaration of Helsinki

    • D.

      Mission statement of Canada Health

    Correct Answer
    B. Mission statement of the GCP Guidelines
    Explanation
    The GCP Guidelines aim to provide a unified standard for Europe, US, and Japan in order to facilitate the acceptance of clinical trials. This means that the guidelines outline the requirements and best practices that should be followed in conducting clinical trials in these regions, ensuring that the trials are conducted ethically, with participant safety as a priority, and with reliable and valid results. The mission statement of the GCP Guidelines reflects their purpose and goals in harmonizing clinical trial practices across different countries.

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  • 10. 

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

    • A.

      21CFR11

    • B.

      21CFR812

    • C.

      21CFR312

    • D.

      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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  • 11. 

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

    • A.

      Federal Department of Food and Drug Administration

    • B.

      Canada Health

    • C.

      Health Canada

    • D.

      Federal Department of Canadian Health and Safety

    Correct Answer
    C. 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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  • 12. 

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

    • A.

      21CFR11

    • B.

      45CFR46

    • C.

      21CFR812

    • D.

      21CFR312

    Correct Answer
    B. 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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  • 13. 

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

    • A.

      The Principle Investigator

    • B.

      The Institutional Review Board

    • C.

      The Sponsor

    • D.

      The CRO

    Correct Answer
    C. 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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  • 14. 

    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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  • 15. 

    What is the FDA form 482 for?

    • A.

      Notice of Inspection

    • B.

      Findings of Inspection

    • C.

      Declaration of Financial Interests and Arrangements

    • D.

      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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  • 16. 

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

    • A.

      45CFR46

    • B.

      21CFR312

    • C.

      21CFR56

    • D.

      21CFR50

    Correct Answer
    C. 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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  • 17. 

    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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  • 18. 

    In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapuyetic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered __________________.

    Correct Answer
    adverse drug reaction, ADR
    Explanation
    In the pre-approval clinical experience with a new medicinal product or its new usages, all noxious and unintended responses to the medicinal product related to any dose should be considered as adverse drug reactions (ADRs). This means that any negative or unintended effects that occur as a result of taking the medication, regardless of the dose, should be taken into account and reported as ADRs. This is important because it helps to gather information about the safety profile of the medication and identify any potential risks or side effects.

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  • 19. 

    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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  • 20. 

    A significant risk device....

    • A.

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

    • B.

      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.

    • C.

      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.
    B. 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.
    C. 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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  • 21. 

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

    • A.

      The Bellmont Report

    • B.

      The National Research Act

    • C.

      The International Research Act

    • D.

      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 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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  • 22. 

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

    Correct Answer
    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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  • 23. 

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

    Correct Answer
    1571
  • 24. 

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

    • A.

      1572

    • B.

      1571

    • C.

      3454

    • D.

      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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  • 25. 

    What is the FDA form 3454?

    • A.

      Certification - Disclosure of Conflict of Interest

    • B.

      Declaration of Conflict of Interest

    • C.

      Certification - Financial Interests and Arrangements of Clinical Investigators

    • D.

      Declaration - Financial Interests and Arrangements of Clinical Investigators

    Correct Answer
    C. 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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  • 26. 

    What is the FDA form 3455?

    • A.

      Certification - Disclosure of Conflict of Interest

    • B.

      Declaration of Conflict of Interest

    • C.

      Certification - Financial Interests and Arrangements of Clinical Investigators

    • D.

      Disclosure - Financial Interests and Agreements of Clinical Investigators

    Correct Answer
    D. 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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  • 27. 

    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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  • 28. 

    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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  • 29. 

    What does 21CFR54 deal with?

    • A.

      IRB regulations

    • B.

      Exemptions of Informed Consent for emergency use

    • C.

      Financial disclosure of clinical investigators

    • D.

      Protection of human subjects: prisoners

    Correct Answer
    C. 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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  • 30. 

    What is 21CFR50 Subpart B?

    • A.

      Protection of Human Subjects

    • B.

      Additional Safeguards for Children in Clinical Investigations

    • C.

      IRB Functions and Operations

    • D.

      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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  • 31. 

    What is 21CFR50 Subpart D?

    • A.

      Records and Reports

    • B.

      Protection of Human Subjects

    • C.

      IRB Functions and Operations

    • D.

      Additional Safeguards for Children in Clinical Investigations

    Correct Answer
    D. 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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  • 32. 

    What is 21CFR50.20 Subpart B?

    • A.

      Exception from General Requirements

    • B.

      General Requirements for Informed Consent

    • C.

      Exception from Informed Consent Requirements for Emergency Research

    • D.

      Documentation of Informed Consent

    Correct Answer
    B. 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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  • 33. 

    What is 21CFR50.23 Subpart B?

    • A.

      Documentation of Informed Consent

    • B.

      Exception from Informed Consent Requirements for Emergency Research

    • C.

      Exception from General Requirements

    • D.

      General Requirements for Informed Consent

    Correct Answer
    C. Exception from General Requirements
    Explanation
    21CFR50.23 Subpart B refers to the exception from general requirements for informed consent. In certain situations, such as when obtaining informed consent is not feasible or would compromise the validity of the research, this exception allows researchers to conduct studies without obtaining informed consent from the participants. This exception is typically applied in emergency research situations where immediate intervention is required and obtaining consent would delay or hinder the research process.

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  • 34. 

    Which of the following are necessary to satisfy 21CFR50.23 Subpart B?

    • A.

      There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject

    • B.

      Subjects are not able to give consent due to their medical condition

    • C.

      Time is not sufficient to obtain consent from the subject's legal representative

    • D.

      Participation in the research holds out the prospect of direct benefit to the subject

    • E.

      The clinical investigation could not be carried out without the waiving of informed consent

    • F.

      Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject

    • G.

      There is no reasonable way to prospectively deem patients eligible

    • H.

      The human subject is confronted by a life-threatening situation necessitating the use of the test article

    • I.

      The subject is in a life threatening situation and no alternative treatments are available

    Correct Answer(s)
    A. There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject
    C. Time is not sufficient to obtain consent from the subject's legal representative
    F. Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject
    H. The human subject is confronted by a life-threatening situation necessitating the use of the test article
    Explanation
    The necessary conditions to satisfy 21CFR50.23 Subpart B include: the absence of alternative therapies with a higher likelihood of saving the subject's life, insufficient time to obtain consent from the subject's legal representative, inability to obtain informed consent from the subject due to communication barriers or legal constraints, and the presence of a life-threatening situation that requires the use of the test article.

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  • 35. 

    What is 21CFR50.24 subpart B?

    • A.

      Documentation of Informed Consent

    • B.

      Exception from General Requirements

    • C.

      General Requirements for Informed Consent

    • D.

      Exception from Informed Consent Requirements for Emergency Research

    Correct Answer
    D. 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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  • 36. 

    Which of the following are necessary to satisy 21CFR50.24 Subpart B?

    • A.

      The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness particular interventions.

    • B.

      Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.

    • C.

      Obtaining informed consentis not feasible - as described in 21CFR50.24 (a)

    • D.

      Participation in the research holds out the prospect of direct benefit to the subjects - as described in 21CFR50.24 (a)

    • E.

      There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

    • F.

      The human subject is confronted by a life-threatening situation necessitating the use of the test article.

    • G.

      The clinical investigation could not practicably be carried out without the waiver.

    • H.

      Subjects are not able to give consent due to their medical condition.

    • I.

      The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.

    • J.

      Oompa Loompas say it's okay!

    Correct Answer(s)
    A. The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness particular interventions.
    C. Obtaining informed consentis not feasible - as described in 21CFR50.24 (a)
    D. Participation in the research holds out the prospect of direct benefit to the subjects - as described in 21CFR50.24 (a)
    G. The clinical investigation could not practicably be carried out without the waiver.
    I. The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.
    Explanation
    Oompa Loompas don't even exist silly

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  • 37. 

    What is 21CFR50.25 Subpart B?

    • A.

      Elements of Informed Consent

    • B.

      Documentation of Informed Consent

    • C.

      Exemptions of Informed Consent

    • D.

      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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  • 38. 

    Which of the following are considered BASIC elements of informed consent under section 21CFR50.25 Subpart B?

    • A.

      A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

    • B.

      A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

    • C.

      Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.

    • D.

      Any additional costs to the subject that may result from participation in the research.

    • E.

      A description of any reasonably foreseeable risks or discomforts to the subject.

    • F.

      The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

    • G.

      A description of any benefits to the subject or to others which may reasonably be expected from the research.

    • H.

      A statement that significant new findings develped during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

    • I.

      A disclosure of appropriate alternative procedures or courses of treatment , if any, that might be advantageous to the subject.

    • J.

      Disclosing that a description of the clinical trial will be available on www.clinicaltrials.gov.

    • K.

      A statement describing the extent, if any, to whicch confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records.

    • L.

      For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained.

    • M.

      An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

    • N.

      A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is othewise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

    Correct Answer(s)
    A. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
    E. A description of any reasonably foreseeable risks or discomforts to the subject.
    G. A description of any benefits to the subject or to others which may reasonably be expected from the research.
    I. A disclosure of appropriate alternative procedures or courses of treatment , if any, that might be advantageous to the subject.
    K. A statement describing the extent, if any, to whicch confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records.
    L. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and if so, what they consist of, or where further information may be obtained.
    M. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
    N. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is othewise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
    Explanation
    The given answer includes the basic elements of informed consent under section 21CFR50.25 Subpart B. These elements include: a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; a description of any reasonably foreseeable risks or discomforts to the subject; a description of any benefits to the subject or to others which may reasonably be expected from the research; a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and noting the possibility of FDA inspection; for research involving more than minimal risk, an explanation of compensation and availability of medical treatments in case of injury; an explanation of whom to contact for questions about the research and research subjects' rights, and in case of research-related injury; and a statement that participation is voluntary without penalty or loss of benefits.

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  • 39. 

    What is 21CFR50.27 Subpart B?

    • A.

      Documentation of informed consent

    • B.

      Exemptions of Informed Consent

    • C.

      Exception from Informed Consent Requirements for Emergency Research

    • D.

      General Requirements for Informed Consent

    Correct Answer
    A. Documentation of informed consent
    Explanation
    21CFR50.27 Subpart B refers to the section of the US Code of Federal Regulations that pertains to the documentation of informed consent in research studies. This means that it outlines the specific requirements and guidelines for documenting the process of obtaining informed consent from participants in research studies. It likely includes information on what should be included in the consent form, how it should be presented to participants, and how the consent process should be documented and maintained.

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  • 40. 

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

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    When a short form is used for Informed Consent, it means that the patient signs only the short form, which contains a summary of the information about the procedure or treatment. Along with signing the short form, the patient also receives a copy of both the summary and the short form. This ensures that the patient is aware of the key points and has a record of the information provided to them.

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  • 41. 

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

    • A.

      True

    • B.

      False

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

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  • 42. 

    What is 21CFR50.50 Subpart D?

    • A.

      IRB Documentation

    • B.

      IRB Exemptions

    • C.

      IRB Duties

    • D.

      IRB Membership Guidelines

    Correct Answer
    C. 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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  • 43. 

    What is 21CFR50.51 Subpart D?

    • A.

      Clinical Investigations involving minimal risk - prisoners

    • B.

      Clinical Investigations not involving greater than minimal risk - children

    • C.

      Clinical Investigations involving greater than minimal risk - children

    • D.

      Additional Safeguards for Children in Clinical Investigations

    • E.

      None of these

    Correct Answer
    B. Clinical Investigations not involving greater than minimal risk - children
    Explanation
    Remember - all sections under subpart D of 21CFR50 deal with children - the heading for all of subpart D is Additional Safeguards for Children in Clinical Investigations

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  • 44. 

    What is 21CFR50.52 Subpart D?

    • A.

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

    • B.

      Clinical Investigations not involving greater than minimal risk - children

    • C.

      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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  • 45. 

    What is 21CFR50.53 Subpart D?

    • A.

      Clinical Investigations not involving greater than minimal risk - children

    • B.

      Clinical Investigations involving greater than minimal risk - children

    • C.

      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

    • D.

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

    Correct Answer
    C. 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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  • 46. 

    What is 21CFR50.54 Subpart D?

    • A.

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

    • B.

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

    • C.

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

    • D.

      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. Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
    Explanation
    21CFR50.54 Subpart D refers to clinical investigations that are not otherwise approvable but provide an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. This means that even though these investigations may not meet the usual approval criteria, they are allowed because they address a significant issue related to children's health and well-being. The focus is on finding solutions or improving the situation for children who are facing serious health problems.

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  • 47. 

    What is 21CFR50.55 Subpart D?

    • A.

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

    • B.

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

    • C.

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

    • D.

      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
    B. 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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  • 48. 

    What is 21CFR50.56 Subpart D?

    • A.

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

    • B.

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

    • C.

      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.

    • D.

      Wards.

    Correct Answer
    D. 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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  • 49. 

    21CFR56 Subpart B is IRB Documentation.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    21CFR56 Subpart B is Organization and Personnel

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  • 50. 

    21CFR56.107 Subpart B is IRB Membership.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    Thats right mofo

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