Mastering Clinical Research: SOCRA Exam Mastery Quiz
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Embark on a journey of clinical research mastery with the "Mastering Clinical Research: SOCRA Exam Mastery Quiz." This quiz is your key to unlocking the intricacies of the SOCRA (Society of Clinical Research Associates) Exam, designed to test your expertise in the field of clinical research. Challenge yourself with questions that delve into Good Clinical Practice (GCP) guidelines, regulatory compliance, and the ethical considerations crucial to conducting successful clinical trials.
Dive into the world of protocols, patient safety, and data integrity, gaining insights that will elevate your understanding of the clinical research landscape. Prepare for success and showcase your mastery Read moreof clinical research with the "Mastering Clinical Research: SOCRA Exam Mastery Quiz." Your path to certification excellence starts here!.
- 1.
The object of GCP is part of the ICH mission statement.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true because GCP, which stands for Good Clinical Practice, is a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. These standards ensure that the rights, safety, and well-being of trial participants are protected and that the data generated is reliable and credible. As part of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) mission statement, the organization aims to develop and promote harmonized guidelines and standards for the pharmaceutical industry, including GCP. Therefore, it can be concluded that the object of GCP is indeed part of the ICH mission statement.Rate this question:
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- 2.
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 InvestigatorsExplanation
The FDA form 3455 is used for the disclosure of financial interests and agreements of clinical investigators. This form is filled out to provide information about any financial interests or agreements that may create a conflict of interest for the clinical investigator. It helps ensure transparency and allows for the evaluation of potential biases that could influence the outcome of clinical trials.Rate this question:
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- 3.
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 ConsentExplanation
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 and procedures of the study, potential risks and benefits, and the right to withdraw from the study at any time. It also covers the requirement for participants to provide voluntary consent without coercion or undue influence. This regulation ensures that participants are fully informed about the study before making a decision to participate.Rate this question:
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- 4.
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 - childrenExplanation
21CFR50.53 Subpart D refers to the regulations governing clinical investigations involving children. The correct answer states that it involves clinical investigations that have greater than minimal risk but do not offer any direct benefit to individual subjects. However, these investigations are likely to generate generalizable knowledge about the disorder or condition of the subjects. This implies that the purpose of these investigations is to gather information that can be applied to a broader population rather than providing immediate benefits to the individual children involved.Rate this question:
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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. TrueExplanation
The objective of the ICH GCP Guideline is indeed to provide a unified standard for the European Union (EU), Japan, and the United States. This standard aims to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. By having a unified standard, it becomes easier for these regulatory authorities to evaluate and accept clinical data, which can ultimately expedite the approval process for new drugs and treatments. Therefore, the statement "True" is correct.Rate this question:
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- 6.
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 duties and functions?
- A.
CRO - Clinical Research Organization
- B.
CRO - Contract Research Organization
- C.
CRO - Center for Research Operations
- D.
Both A and B
Correct Answer
D. Both A and BExplanation
A Contract Research Organization, also called a Clinical Research Organization (CRO) is a person or organization contracted by the sponsor of a clinical trial to perform various trial-related duties and functions. These duties may include study design, data collection, data analysis, and regulatory compliance. CROs play a crucial role in ensuring the successful execution of clinical trials by providing expertise and resources to support the research process. They help to streamline the trial process, ensure data quality, and adhere to regulatory requirements.Rate this question:
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- 7.
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 ConsentExplanation
21CFR50.20 Subpart B refers to the general requirements for informed consent. Informed consent is a crucial aspect of conducting research involving human subjects. This regulation outlines the specific requirements and procedures that must be followed to ensure that participants are fully informed about the study, its risks and benefits, and have given their voluntary consent to participate. It covers aspects such as providing information in a language that the participant understands, ensuring that the participant has had the opportunity to ask questions and receive satisfactory answers, and documenting the informed consent process appropriately.Rate this question:
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- 8.
Which of the following is 21CFR56.106 Subpart B?
- A.
Registration
- B.
IRB Membership
- C.
IRB Functions and Operations
- D.
Option4
Correct Answer
A. RegistrationExplanation
21CFR56.106 Subpart B refers to the section of the Code of Federal Regulations that deals with the registration requirements for institutional review boards (IRBs). This section outlines the specific information that IRBs must provide when registering with the Food and Drug Administration (FDA), including the IRB's name, address, and contact information. It also specifies the need for IRBs to update their registration information within 90 days of any changes.Rate this question:
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- 9.
The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR_____
Correct Answer
312Explanation
The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR 312. This code outlines the regulations and requirements for conducting clinical trials and obtaining approval from the Food and Drug Administration (FDA) to test new drugs in humans. It covers various aspects such as the submission of the application, informed consent, reporting of adverse events, and the responsibilities of sponsors, investigators, and institutional review boards. Compliance with 21CFR 312 is essential for ensuring the safety and efficacy of new drugs before they can be marketed to the public.Rate this question:
- 10.
What is 21CFR56.109 Subpart C?
- A.
IRB documentation
- B.
IRB membership
- C.
IRB functions and operations
- D.
IRB review of research
Correct Answer
D. IRB review of researchExplanation
21 CFR 56.109 Subpart C refers to "IRB review of research." This section of the United States Code of Federal Regulations (21 CFR) outlines the responsibilities and functions of Institutional Review Boards (IRBs) in reviewing and overseeing research involving human subjects. So, the correct answer is:
IRB review of research.Rate this question:
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- 11.
A sponsor may transfer responsibility for any of all of the obligations to a ________.
Correct Answer
Contract Research Organization (CRO), CROExplanation
A sponsor may transfer responsibility for any or all of the obligations to a Contract Research Organization (CRO). This means that the sponsor can delegate certain tasks or responsibilities related to the research project to the CRO. The CRO will then take on these obligations and carry them out on behalf of the sponsor. This allows the sponsor to focus on other aspects of the project while ensuring that the necessary tasks are still being performed by a qualified organization.Rate this question:
- 12.
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
Correct Answer
B. Clinical Investigations not involving greater than minimal risk - childrenExplanation
21CFR50.51 Subpart D refers to the regulations that pertain to clinical investigations involving children. It specifically addresses clinical investigations that do not pose a risk greater than minimal to children. This subpart establishes additional safeguards to protect the rights, safety, and well-being of children participating in clinical trials. These safeguards ensure that the research is conducted ethically and that children are not exposed to unnecessary risks during the investigation.Rate this question:
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- 13.
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. 45CFR46Explanation
The correct answer is 45CFR46. This regulation is commonly known as the Common Rule and it provides guidelines for the protection of human subjects in research conducted or supported by the federal government. It sets forth the ethical principles and regulatory requirements for informed consent, IRB (Institutional Review Board) review, and the overall protection of human subjects involved in research. The other options, 21CFR11, 21CFR812, and 21CFR312, are regulations that pertain to other areas of research and do not specifically address the protection of human subjects.Rate this question:
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- 14.
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. FalseExplanation
must sign bothRate this question:
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- 15.
What is 45CFR46 Subpart B?
- A.
Additional Safeguards and Protection
- B.
Additional Protection for Prisoners and Vulnerable Subjects
- C.
Additional Protection for Children and Unborn Fetuses
- D.
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Correct Answer
D. Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in ResearchExplanation
45CFR46 Subpart B refers to the additional protections provided for pregnant women, human fetuses, and neonates involved in research. This subpart outlines specific guidelines and regulations to ensure the safety and well-being of these vulnerable populations during research studies. It aims to protect the rights and welfare of pregnant women, fetuses, and neonates, and to ensure that any potential risks are minimized and justified.Rate this question:
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- 16.
21CFR56 is IRB Functions and Operations
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
True. 21CFR56 refers to the regulations outlined in Title 21 of the Code of Federal Regulations (CFR) Part 56, which governs Institutional Review Boards (IRBs) and their functions and operations in the United States.Rate this question:
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- 17.
A ________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), CRFExplanation
A case report form is a document that is used to record all the necessary information about each trial subject and report it to the sponsor. This form can be in printed, optical, or electronic format and is designed to capture all the protocol-required information. It serves as a comprehensive record of the subject's participation in the trial and helps in documenting and analyzing the data collected during the study.Rate this question:
- 18.
The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized 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 normal required outside the research context.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The statement is false because the IRB may waive the requirement for written consent if the research presents minimal risk of harm to subjects, not more than minimal risk.Rate this question:
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- 19.
21CFR56 Subpart B is IRB Documentation.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The statement that 21CFR56 Subpart B is IRB Documentation is false. 21CFR56 Subpart B actually pertains to organization and operation of institutional review boards (IRBs). It outlines the requirements for the composition, functions, and responsibilities of IRBs, but it does not specifically address IRB documentation.Rate this question:
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- 20.
HHS stands for________
Correct Answer
Health and Human ServicesExplanation
HHS stands for Department of Health and Human Services. This government agency is responsible for protecting the health of all Americans and providing essential human services. They oversee various programs related to healthcare, public health, social services, and medical research. The Department of Health and Human Services plays a crucial role in promoting the well-being of individuals and communities, ensuring access to quality healthcare, and addressing public health emergencies.Rate this question:
- 21.
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 involving children, it is necessary to obtain permission from their parents or guardians and also obtain assent from the children themselves. This ensures that the children's rights and well-being are protected and that they are involved in the decision-making process to the extent that is appropriate for their age and maturity.Rate this question:
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- 22.
The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.
Correct Answer
1 year, one yearExplanation
The clinical investigator is required to update the financial disclosure information if any relevant changes occur during the investigation's course and for 1 year following the study's completion. This ensures that any potential conflicts of interest are properly disclosed and managed throughout the entire duration of the study and for a reasonable period afterwards.Rate this question:
- 23.
The contract research organization shall select a monitor that is _______.
- A.
Qualified by experience
- B.
Is located close to the sites
- C.
Qualified by training
- D.
Option4
Correct Answer(s)
A. Qualified by experience
C. Qualified by trainingExplanation
The contract research organization should select a monitor who is qualified by experience and training. This is important because an experienced monitor will have the necessary knowledge and skills to effectively oversee the research activities and ensure compliance with protocols and regulations. Similarly, a monitor who has received proper training will be equipped with the necessary tools and techniques to carry out their responsibilities effectively. Therefore, both experience and training are essential criteria for selecting a monitor in a contract research organization.Rate this question:
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- 24.
Before the investigation begins, the sponsor shall give each participation clinical investigator a/an _____.
Correct Answer(s)
Investigator brochure, investigator's brochure, investigatorial brochureExplanation
Before the investigation begins, the sponsor provides each participating clinical investigator with an investigator brochure. This document contains essential information about the investigational product, including its composition, properties, and potential risks and benefits. It helps the investigator understand the product and its intended use, enabling them to make informed decisions during the study. The investigator brochure also serves as a reference guide throughout the investigation, ensuring consistency in the understanding and handling of the investigational product among all investigators involved.Rate this question:
- 25.
A ________ lists the investigator’s education, training, and experience that qualifies the investigator as an expert in the clinical investigation of the drug for the use under investigation.
- A.
Curriculum vitae
- B.
Letter from a fellow investigator
- C.
Statement of qualifications of the investigator
- D.
A and C
Correct Answer
D. A and CExplanation
A curriculum vitae (CV) lists the investigator's education, training, and experience, providing a comprehensive overview of their qualifications. This document showcases the investigator's expertise in the clinical investigation of the drug for the specific use under investigation. Similarly, a statement of qualifications of the investigator serves the same purpose, highlighting the investigator's relevant background and expertise in the field. Therefore, both options A (curriculum vitae) and C (statement of qualifications of the investigator) are correct answers as they fulfill the requirement of listing the investigator's education, training, and experience that qualify them as an expert in the clinical investigation of the drug for the use under investigation.Rate this question:
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- 26.
The sponsor shall monitor investigations to identify when an IRB determines that it cannot approve the research because it does not meet the criteria for exception or because of other relevant ethical concerns.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
The statement is true. The sponsor of a research study is responsible for monitoring the investigations conducted by the Institutional Review Board (IRB). If the IRB determines that the research does not meet the criteria for exception or raises ethical concerns, the sponsor should be aware of this decision. This ensures that the sponsor is informed about any issues that may impact the approval and ethical conduct of the research.Rate this question:
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- 27.
The minimum number of Institutional Review board (IRB) members is:
- A.
3
- B.
12
- C.
5
- D.
7
Correct Answer
C. 5Explanation
The minimum number of Institutional Review Board (IRB) members is 5. This is because having a minimum of 5 members ensures diversity and representation of different perspectives, expertise, and backgrounds. It allows for a more comprehensive review and evaluation of research proposals, ensuring that ethical considerations are thoroughly examined. Additionally, having a larger number of members helps to prevent any potential conflicts of interest and promotes transparency in the review process.Rate this question:
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- 28.
Under 21CFR312, form___________ is the statement of the investigator of a clinical trial
Correct Answer
1572Explanation
Under 21CFR312, form 1572 is the statement of the investigator of a clinical trial. This form is required by the Food and Drug Administration (FDA) and serves as a commitment by the investigator to conduct the study in accordance with the regulations and to protect the rights, safety, and welfare of the study participants. The form includes information about the investigator's qualifications, experience, and training, as well as details about the study protocol, potential risks and benefits, and financial interests. By signing form 1572, the investigator acknowledges their responsibilities and obligations in conducting the clinical trial.Rate this question:
- 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 investigatorsExplanation
21CFR54 deals with the financial disclosure of clinical investigators. This regulation requires clinical investigators to disclose any financial interests or arrangements that could potentially create a conflict of interest in relation to the research they are conducting. This is important to ensure transparency and minimize any potential bias or influence on the research outcomes. By disclosing financial interests, it allows for a more thorough evaluation of the integrity and credibility of the research being conducted.Rate this question:
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- 30.
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
- A.
77
- B.
97
- C.
91
- D.
85
Correct Answer
A. 77Explanation
The initial drug dose is 110mg/m2. To decrease the dosage by 30%, we need to multiply the initial dose by 0.7 (1 - 0.3 = 0.7). Therefore, the new dosage would be 110mg/m2 * 0.7 = 77mg/m2.Rate this question:
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- 31.
The responsibility for ensuring that the investigator understands a clinical trial lies with:
- A.
The FDA
- B.
The IRB
- C.
The Sponsor
- D.
Option4
Correct Answer
C. The SponsorExplanation
The sponsor is responsible for ensuring that the investigator understands a clinical trial. This is because the sponsor is typically the organization or individual who initiates and supports the trial. They have the primary responsibility for the overall conduct of the trial and ensuring that it is conducted in accordance with applicable regulations and guidelines. As part of this responsibility, the sponsor must provide the necessary information and training to the investigator to ensure their understanding of the trial and their role in it.Rate this question:
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- 32.
A purpose of monitoring clinical trials is to verify that:
- A.
A. The rights, safety, and well-being of human subjects are protected
- B.
B. Investigators receive adequate payment for their participation in the clinical trial
- C.
C. The investigator has received annual reports from the sponsor
- D.
D. The regulatory agency has received all case history information of subjects enrolled on the clinical trial
Correct Answer
A. A. The rights, safety, and well-being of human subjects are protectedExplanation
The purpose of monitoring clinical trials is to ensure that the rights, safety, and well-being of human subjects are protected. Monitoring involves regularly reviewing and assessing the trial to identify any potential risks or issues that may arise during the study. This includes ensuring that the informed consent process is followed, that the trial protocol is being followed correctly, and that any adverse events or side effects are properly recorded and managed. By monitoring the trial, researchers can ensure that the subjects are being treated ethically and that their safety is a top priority.Rate this question:
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- 33.
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 -
- 34.
The "Doctor's Trial" prompted the Belmont Report.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The "Doctor's Trial" refers to the Nuremberg trials after World War II, where Nazi doctors were prosecuted for their unethical medical experiments. The Belmont Report, on the other hand, was a response to the unethical Tuskegee Syphilis Study conducted by the U.S. government. Therefore, the statement that the "Doctor's Trial" prompted the Belmont Report is false.Rate this question:
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- 35.
A significant risk device....
- 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.
- B.
Is intended as an implant and presents a potential for serious 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. 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.
B. Is intended as an implant and presents a potential for serious 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 includes three different criteria for a device to be considered a significant risk device. The first criterion is that the device is 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. The second criterion is that the device is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject. The third criterion is that the device is 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.Rate this question:
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- 36.
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 InvestigatorsExplanation
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 may create a conflict of interest for clinical investigators involved in FDA-regulated research. It ensures transparency and helps to maintain the integrity and impartiality of clinical trials. By requiring investigators to disclose any potential conflicts, the FDA can assess the impact of these conflicts on the reliability and validity of the research results.Rate this question:
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- 37.
A drug’s safety is determined by which of the following criteria?
- A.
C. The Food and Drug Administration’s (FDA) review of source documentation at a clinical site
- B.
B. The absence of harmful side effects on the individuals exposed so far
- C.
A. The dose at which no side effects are reported
- D.
Option4
Correct Answer
C. A. The dose at which no side effects are reportedExplanation
The correct answer is A. The dose at which no side effects are reported. This is because the safety of a drug is determined by the absence of harmful side effects. If a drug is administered at a dose where no side effects are reported, it indicates that the drug is safe for use. The FDA's review of source documentation at a clinical site is important for ensuring the integrity of the research, but it does not directly determine the safety of the drug. Similarly, the absence of harmful side effects on the individuals exposed so far is a consideration, but it does not provide a definitive assessment of the drug's safety.Rate this question:
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- 38.
The World Medical Association (WMA) ethical principles for medical research involving human subjects is called..
- A.
The Belmont Report
- B.
The National Research Act
- C.
The International Research Act
- D.
The Declaration of Helsinki
Correct Answer
D. The Declaration of HelsinkiExplanation
The Declaration of Helsinki is the correct answer because it is a set of ethical principles established by the World Medical Association (WMA) for medical research involving human subjects. It provides guidelines for researchers to ensure the protection of participants' rights, welfare, and well-being during the research process. The Declaration of Helsinki is widely recognized and followed by the global medical community as a standard for ethical conduct in human research.Rate this question:
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- 39.
Which of the following statements best defines the term “efficacy” in a clinical trial?
- A.
The best possible outcome of a clinical trial
- B.
The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease
- C.
C. A determination proving there is a statistically significant difference in the pharmacokinetic effect of the study drug versus placebo
- D.
Option4
Correct Answer
B. The capacity of a drug or treatment to produce beneficial effects on the course or duration of a diseaseExplanation
The term "efficacy" in a clinical trial refers to the capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease. It focuses on the effectiveness of the intervention in achieving positive outcomes and improving the health condition of the participants. This definition emphasizes the potential of the drug or treatment to provide therapeutic benefits and improve patient outcomes.Rate this question:
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- 40.
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 SponsorExplanation
The sponsor is responsible for monitoring the progress of all clinical trial investigations being conducted under its IND. They oversee the study and ensure that it is being conducted in compliance with the protocol, applicable regulations, and good clinical practice. The sponsor also provides the necessary resources and support for the study, including financial assistance, study drug supply, and data management. They play a crucial role in ensuring the safety and integrity of the clinical trial.Rate this question:
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- 41.
What is 21CFR50.54 Subpart D?
- 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.
- 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.
Requirements for permission by parents or guardians and for assent by children.
- D.
Option4
Correct Answer
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. -
- 42.
Which of the following terms is best defined as “a pharmaceutical preparation that contains no active agent”?
- A.
Blinded
- B.
Non Invasive
- C.
Placebo
Correct Answer
C. PlaceboExplanation
A placebo is a pharmaceutical preparation that contains no active agent. It is often used in clinical trials as a control group to compare the effects of a new drug against. Placebos are designed to look and feel like the active drug, but they do not actually contain any active ingredients. They are used to measure the psychological and physiological effects of the participant's belief in the treatment, as well as to account for the placebo effect.Rate this question:
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- 43.
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 ResearchExplanation
21CFR50.24 subpart B refers to the exception from informed consent requirements for emergency research. This means that under certain circumstances, such as in a life-threatening situation, researchers may be allowed to conduct research without obtaining informed consent from the participants. This exception is granted to ensure that potential participants can still benefit from the research in emergency situations where obtaining informed consent may not be feasible.Rate this question:
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- 44.
Which of the following design methods would best be used for a study interested in keeping both the subject and the investigator (or site staff) from knowing which treatment the subject was receiving?
- A.
Double Blinded
- B.
Interpretive Bias
- C.
Bias Reduction
- D.
Phase 1
Correct Answer
A. Double BlindedExplanation
Double Blinded design method would be best used for a study interested in keeping both the subject and the investigator (or site staff) from knowing which treatment the subject was receiving. In a double-blinded study, neither the subjects nor the investigators know which treatment is being administered. This helps to eliminate any potential bias or influence that knowledge of the treatment may have on the results. It ensures that the study is conducted in an objective and unbiased manner, increasing the validity and reliability of the findings.Rate this question:
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- 45.
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.
Health Canada
- C.
Canada Health
- D.
Federal Department of Canadian Health and Safety
Correct Answer
B. Health CanadaExplanation
Health Canada is the federal department responsible for helping people of Canada maintain and improve their health. This department is responsible for various health-related initiatives, including regulating and monitoring the safety of food and drugs, promoting healthy living, and providing information and resources to Canadians to support their well-being. Health Canada plays a crucial role in ensuring the health and safety of the Canadian population.Rate this question:
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- 46.
Which person(s) or agency would not be informed of the treatment assignment for a given subject in a study that was using a single blind method randomization?
- A.
The subject
- B.
Treating clinician/research team
- C.
FDA
Correct Answer
A. The subjectExplanation
In a study using a single blind method randomization, the subject would not be informed of the treatment assignment. This means that the subject would not know whether they are receiving the experimental treatment or the control treatment. The purpose of blinding the subject is to minimize any bias or influence that their knowledge of the treatment assignment could have on the study results. The treating clinician/research team and the FDA may be aware of the treatment assignment, but the subject would not be informed.Rate this question:
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- 47.
What is 45CFR46?
- A.
HHS - Protection of Human Subjects
- B.
DDS - Protection of Human Subjects
- C.
FDA - Protection of Research Participants
- D.
HHS - Protection of Research Participants
Correct Answer
A. HHS - Protection of Human SubjectsExplanation
45CFR46 refers to Title 45 of the Code of Federal Regulations, Section 46, which outlines the regulations and guidelines for the protection of human subjects in research. The HHS (Department of Health and Human Services) is responsible for enforcing these regulations. This answer correctly identifies the regulatory body (HHS) and the purpose of the regulations (protection of human subjects). The other options either have incorrect regulatory bodies or incorrect purposes, making them incorrect answers.Rate this question:
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- 48.
Which of the following responsibilities falls under the jurisdiction of the Food and Drug Administration (FDA)?
- A.
Approval of individual study sites in clinical trials
- B.
Direct management of clinical trials
- C.
Oversight of regulation adherence in clinical trials
- D.
Option4
Correct Answer
C. Oversight of regulation adherence in clinical trialsExplanation
The responsibility that falls under the jurisdiction of the Food and Drug Administration (FDA) is the oversight of regulation adherence in clinical trials. This means that the FDA is responsible for ensuring that clinical trials are conducted in accordance with the regulations and guidelines set forth by the agency. They monitor and evaluate the conduct of clinical trials to ensure that participants are protected and that the data generated is reliable. This oversight helps to maintain the integrity and safety of clinical trials and the products being tested.Rate this question:
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- 49.
Which of the following is IRB Functions and Operations?
- A.
21CFR56.108 Subpart D
- B.
21CFR56.108 Subpart C
- C.
21CFR56.106 Subpart B
Correct Answer
B. 21CFR56.108 Subpart CExplanation
In the context of research and Institutional Review Boards (IRBs), 21 CFR 56.108 Subpart C is a specific regulatory reference that pertains to IRB functions and operations. It outlines requirements related to the IRB's responsibility for ensuring that research conducted under its jurisdiction meets certain ethical and regulatory standards.Rate this question:
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- 50.
What is the formal designation for any board, committee, or group established by an institution to evaluate biomedical research that involves human subjects?
Correct Answer
Institutional Review Board (IRB), IRB, Institutional Review BoardExplanation
An Institutional Review Board (IRB) refers to any board, committee, or group that is officially designated by an institution to review biomedical research that involves human subjects. The purpose of an IRB is to ensure the protection of the rights and welfare of the research participants. The IRB reviews research protocols, informed consent documents, and other relevant materials to assess the ethical and scientific validity of the study. The IRB also monitors the ongoing research to ensure compliance with ethical guidelines and regulations.Rate this question:
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Mar 29, 2024Quiz Edited by
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Aug 18, 2016Quiz Created by
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