Mastering Clinical Research: SOCRA Exam Mastery Quiz

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1/81 Questions

The object of GCP is part of the ICH mission statement.
- True
- False

About This Quiz

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, See moreand 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 of clinical research with the "Mastering Clinical Research: SOCRA Exam Mastery Quiz." Your path to certification excellence starts here!.

Mastering Clinical Research: SOCRA Exam Mastery Quiz - Quiz

Questions and Answers

2.

What is the FDA form 3455?
- Certification - Disclosure of Conflict of Interest
- Declaration of Conflict of Interest
- Certification - Financial Interests and Arrangements of Clinical Investigators
- Disclosure - Financial Interests and Agreements of Clinical Investigators
Correct Answer

A. Disclosure - Financial Interests and Agreements of Clinical Investigators

Explanation

The FDA form 3455 is 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.

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6
3.

What is 21CFR50.25 Subpart B?
- Elements of Informed Consent
- Documentation of Informed Consent
- Exemptions of Informed Consent
- Documentation of Emergency Use of Experimental Treatments
Correct Answer

A. Elements of Informed Consent

Explanation

21CFR50.25 Subpart B refers to the section of the Code of Federal Regulations that outlines the elements of informed consent in clinical trials. This includes the information that must be provided to participants, such as the purpose 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.

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1
4.

What is 21CFR50.53 Subpart D?
- Clinical Investigations not involving greater than minimal risk - children
- Clinical Investigations involving greater than minimal risk - children
- Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition - children
- Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects – children
Correct Answer

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

Explanation

21CFR50.53 Subpart D refers to 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.

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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.
- True
- False
Correct Answer

A. True

Explanation

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.

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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?
- CRO - Clinical Research Organization
- CRO - Contract Research Organization
- CRO - Center for Research Operations
- Both A and B
Correct Answer

A. Both A and B

Explanation

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.

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3
7.

What is 21CFR50.20 Subpart B?
- Exception from General Requirements
- General Requirements for Informed Consent
- Exception from Informed Consent Requirements for Emergency Research
- Documentation of Informed Consent
Correct Answer

A. General Requirements for Informed Consent

Explanation

21CFR50.20 Subpart B refers to the 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.

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0
8.

Which of the following is 21CFR56.106 Subpart B?
- Registration
- IRB Membership
- IRB Functions and Operations
Correct Answer

A. Registration

Explanation

21 CFR 56.106 Subpart B pertains to the registration of Institutional Review Boards (IRBs). This section requires IRBs to be registered with the Food and Drug Administration (FDA), ensuring that they meet specific regulatory requirements for overseeing research involving human subjects. It does not cover IRB membership, functions, or operations, which are addressed in other subparts.

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0
9.

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

Correct Answer
312

Explanation
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.

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1
10.

Which phase of a clinical trial is primarily focused on assessing the safety, tolerability, and optimal dosage of a new drug in a small group of healthy volunteers?
- Phase I
- Phase II
- Phase III
- Phase IV
Correct Answer

A. Phase I

Explanation

Phase I clinical trials are the first step in testing a new drug in humans. This phase typically involves a small group of healthy volunteers and focuses on evaluating the safety, tolerability, and pharmacokinetics of the drug, as well as determining the optimal dosage. Unlike later phases, which assess efficacy, Phase I trials are crucial for ensuring that the drug does not pose significant risks before moving on to larger populations and more complex evaluations.

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0
11.

A sponsor may transfer responsibility for any of all of the obligations to a ________.

Correct Answer
Contract Research Organization (CRO), CRO

Explanation
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.

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1
12.

What is 21CFR50.51 Subpart D?
- Clinical Investigations involving minimal risk - prisoners
- Clinical Investigations not involving greater than minimal risk - children
- Clinical Investigations involving greater than minimal risk - children
- Additional Safeguards for Children in Clinical Investigations
Correct Answer

A. Clinical Investigations not involving greater than minimal risk - children

Explanation

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.

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1
13.

The Code of Federal Regulations that applies to the Protection of Human Subjects is..
- 21CFR11
- 45CFR46
- 21CFR812
- 21CFR312
Correct Answer

A. 45CFR46

Explanation

The correct answer is 45CFR46. This 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.

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3
14.

When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
- True
- False
Correct Answer

A. False

Explanation

must sign both

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15.

What is 45CFR46 Subpart B?
- Additional Safeguards and Protection
- Additional Protection for Prisoners and Vulnerable Subjects
- Additional Protection for Children and Unborn Fetuses
- Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Correct Answer

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

Explanation

45CFR46 Subpart B 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.

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16.

21CFR56 is IRB Functions and Operations
- True
- False
Correct Answer

A. True

Explanation

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.

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5
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), CRF

Explanation
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.

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1
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.
- True
- False
Correct Answer

A. False

Explanation

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.

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2
19.

21CFR56 Subpart B is IRB Documentation.
- True
- False
Correct Answer

A. False

Explanation

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.

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20.

HHS stands for________

Correct Answer
Health and Human Services, health and human services

Explanation
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.

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0
21.

What is 21CFR50.55 Subpart D?
- Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
- Requirements for permission by parents or guardians and for assent by children.
- Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
Correct Answer

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

Explanation

21CFR50.55 Subpart D refers to the requirements for permission by parents or guardians and for assent by children in clinical investigations. This means that when conducting clinical investigations 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.

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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 year

Explanation
The clinical investigator is required to update the financial disclosure information if any relevant changes occur during the investigation's course and for 1 year following the study's completion. This 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.

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2
23.

Which phase of clinical research focuses primarily on assessing a drug’s effectiveness and side effects in a larger group of patients who have the condition the drug is meant to treat?
- Phase 1
- Phase 2
- Phase 3
- Phase 4
Correct Answer

A. Phase 2

Explanation

Phase 2 trials involve testing the drug on a larger group of participants (several hundred) who have the condition the drug is designed to treat. The focus is on determining the drug's effectiveness, assessing short-term side effects, and finding the optimal dose. This phase follows Phase 1, which focuses on safety, and precedes Phase 3, where larger-scale efficacy and monitoring occur.

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1
24.

In clinical research, ensuring the statistical power of a study is critical for producing reliable results. To achieve adequate statistical power, researchers must carefully calculate the required sample size based on the expected effect size, significance level, and power. The term _____ refers to the likelihood that a study will detect an effect if there is, in fact, an actual effect.

Correct Answer
statistical power

Explanation
Statistical power in clinical research is a fundamental concept that relates to the ability of a study to detect an effect when one exists. It is influenced by the sample size, effect size, significance level, and the variability in the data. High statistical power reduces the risk of Type II errors, which occur when a study fails to detect an effect that actually exists. Ensuring adequate statistical power is essential for the ethical conduct of research, as it respects the investment of resources and the participation of human subjects by maximizing the likelihood of meaningful results.

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1
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.
- Curriculum vitae
- Letter from a fellow investigator
- Statement of qualifications of the investigator
- A and C
Correct Answer

A. A and C

Explanation

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.

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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.
- True
- False
Correct Answer

A. True

Explanation

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.

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27.

The minimum number of Institutional Review board (IRB) members is:
- 3
- 12
- 5
- 7
Correct Answer

A. 5

Explanation

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.

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1
28.

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

Correct Answer
1572

Explanation
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.

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0
29.

What does 21CFR54 deal with?
- IRB regulations
- Exemptions of Informed Consent for emergency use
- Financial disclosure of clinical investigators
- Protection of human subjects: prisoners
Correct Answer

A. Financial disclosure of clinical investigators

Explanation

21CFR54 deals with the financial disclosure of clinical investigators. This 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.

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0
30.

The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
- 77
- 97
- 91
- 85
Correct Answer

A. 77

Explanation

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.

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31.

The responsibility for ensuring that the investigator understands a clinical trial lies with:
- The FDA
- The IRB
- The Sponsor
- Option4
Correct Answer

A. The Sponsor

Explanation

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.

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32.

A purpose of monitoring clinical trials is to verify that:
- A. The rights, safety, and well-being of human subjects are protected
- B. Investigators receive adequate payment for their participation in the clinical trial
- C. The investigator has received annual reports from the sponsor
- 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 protected

Explanation

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.

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33.

What is 21CFR50.56 Subpart D?
- Requirements for permission by parents or guardians and for assent by children.
- Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
- Wards
Correct Answer

A. Wards
34.

The "Doctor's Trial" prompted the Belmont Report.
- True
- False
Correct Answer

A. False

Explanation

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.

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2
35.

Which ethical principle in clinical research emphasizes the obligation of researchers to maximize benefits and minimize harms to participants?
- Beneficence
- Nonmaleficence
- Justice
- Informed Consent
Correct Answer

A. Beneficence

Explanation

The ethical principle of beneficence is crucial in clinical research. It compels researchers to take proactive steps to ensure the well-being of the participants by maximizing potential benefits and minimizing potential harms. This principle is central to the ethical guidelines in clinical studies, aiming to protect participants from unnecessary risks and ensure that the research is conducted with their best interests in mind. While nonmaleficence is closely related, focusing more on "do no harm," beneficence requires a more proactive role in promoting good and beneficial outcomes. Justice relates to the fair distribution of benefits and burdens, and informed consent ensures participants are fully aware of what they are agreeing to participate in, including all potential risks and benefits.

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1
36.

What is the FDA form 3454?
- Certification - Disclosure of Conflict of Interest
- Declaration of Conflict of Interest
- Certification - Financial Interests and Arrangements of Clinical Investigators
- Declaration - Financial Interests and Arrangements of Clinical Investigators
Correct Answer

A. Certification - Financial Interests and Arrangements of Clinical Investigators

Explanation

FDA form 3454 is the Certification - Financial Interests and Arrangements of Clinical Investigators. This form is used to disclose any financial interests or arrangements that 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.

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2
37.

Which of the following is a common reason for a drug to be withdrawn from the market after its initial approval?
- Unexpected and severe adverse effects
- Minor changes in manufacturing processes
- Increased competition from similar drugs
- Expiry of the patent protection period
Correct Answer

A. Unexpected and severe adverse effects

Explanation

Post-marketing surveillance of approved drugs sometimes reveals rare but serious side effects that were not detected during clinical trials. If these adverse effects outweigh the drug's benefits, regulatory authorities may decide to withdraw the drug from the market to protect public safety.

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0
38.

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called..
- The Belmont Report
- The National Research Act
- The International Research Act
- The Declaration of Helsinki
Correct Answer

A. The Declaration of Helsinki

Explanation

The Declaration of Helsinki is 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.

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39.

Which of the following statements best defines the term “efficacy” in a clinical trial?
- The best possible outcome of a clinical trial
- The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease
- C. A determination proving there is a statistically significant difference in the pharmacokinetic effect of the study drug versus placebo
- Option4
Correct Answer

A. The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease

Explanation

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.

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40.

Who monitors the progress of all clinical trial investigations being conducted under its IND?
- The Principle Investigator
- The Institutional Review Board
- The Sponsor
- The CRO
Correct Answer

A. The Sponsor

Explanation

The sponsor is responsible for monitoring the progress of all clinical trial investigations being conducted under its IND. 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.

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41.

What is 21CFR50.54 Subpart 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.
- Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- Requirements for permission by parents or guardians and for assent by children.
- Option4
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.
42.

Which of the following terms is best defined as “a pharmaceutical preparation that contains no active agent”?
- Blinded
- Non Invasive
- Placebo
Correct Answer

A. Placebo

Explanation

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.

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43.

What is 21CFR50.24 subpart B?
- Documentation of Informed Consent
- Exception from General Requirements
- General Requirements for Informed Consent
- Exception from Informed Consent Requirements for Emergency Research
Correct Answer

A. Exception from Informed Consent Requirements for Emergency Research

Explanation

21CFR50.24 subpart B refers to the exception from informed consent requirements for emergency research. This means that 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.

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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?
- Double Blinded
- Interpretive Bias
- Bias Reduction
- Phase 1
Correct Answer

A. Double Blinded

Explanation

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.

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0
45.

What is the federal department responsible for helping people of Canada maintain and improve their health?
- Federal Department of Food and Drug Administration
- Health Canada
- Canada Health
- Federal Department of Canadian Health and Safety
Correct Answer

A. Health Canada

Explanation

Health Canada is the federal department responsible for helping people of Canada maintain and improve their health. This department is responsible for 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.

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2
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?
- The subject
- Treating clinician/research team
- FDA
Correct Answer

A. The subject

Explanation

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.

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47.

What is 45CFR46?
- HHS - Protection of Human Subjects
- DDS - Protection of Human Subjects
- FDA - Protection of Research Participants
- HHS - Protection of Research Participants
Correct Answer

A. HHS - Protection of Human Subjects

Explanation

45CFR46 refers to Title 45 of the Code of Federal Regulations, Section 46, which 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.

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1
48.

Which of the following responsibilities falls under the jurisdiction of the Food and Drug Administration (FDA)?
- Approval of individual study sites in clinical trials
- Direct management of clinical trials
- Oversight of regulation adherence in clinical trials
- Option4
Correct Answer

A. Oversight of regulation adherence in clinical trials

Explanation

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.

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49.

Which of the following is IRB Functions and Operations?
- 21CFR56.108 Subpart D
- 21CFR56.108 Subpart C
- 21CFR56.106 Subpart B
Correct Answer

A. 21CFR56.108 Subpart C

Explanation

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.

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Mastering Clinical Research: SOCRA Exam Mastery Quiz

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