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According to the Declaration of Helsinki, which of the following statements is true regarding the participation of vulnerable populations in research?
Vulnerable populations should not participate in research to avoid potential harm.
sive studies only.
dditional safeguards should be provided to protect the rights and welf erable populations.
ulnerable populations can participate in research without any addition iderations.
wer: C
anation: According to the Declaration of Helsinki, additional safeguar ld be provided to protect the rights and welfare of vulnerable populati cipating in research. Vulnerable populations include individuals who m limited autonomy, diminished decision-making capacity, or are at a h
f coercion or exploitation. Examples of vulnerable populations includ ren, prisoners, pregnant women, and individuals with mental impairm eclaration of Helsinki recognizes the importance of ensuring their ction and requires researchers to implement additional measures to guard their rights and well-being during the research process.
The participation of vulnerable populations should be limited to non- inva
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Which of the following regulations governs the protection of human subjects in non-FDA-regulated research conducted in the United States?
21 U.S. Code of Federal Regulations – Part 50
21 U.S. Code of Federal Regulations – Part 56
45 U.S. Code of Federal Regulations - Part 46
ICH GCP Guideline for Good Clinical Practice E6(R2) Answer: C
es to research involving human subjects conducted or supported by fe rtments and agencies. It establishes the ethical standards and requirem he protection of human subjects, including informed consent, instituti w boards (IRBs), and the minimization of risks. 21 U.S. Code of Fede ulations – Part 50 and Part 56 primarily pertain to FDA-regulated rese
the ICH GCP Guideline for Good Clinical Practice E6(R2) provides national standards for clinical trials.
ch document provided the ethical framework for the protection of hum ects in the United States?
he Nuremberg Code he Belmont Report
he Declaration of Helsinki
U.S. Code of Federal Regulations – Part 50
Explanation: The protection of human subjects in non-FDA-regulated research conducted in the United States is governed by 45 U.S. Code of Federal Regulations - Part 46. This regulation, often referred to as the Common Rule, appli deral
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Answer: B
Explanation: The Belmont Report, published in 1979, provided the ethical framework for the protection of human subjects in the United States. It was prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report outlines three core principles: respect for persons, beneficence, and justice. These principles form the basis for
Which international document provides guidelines for medical research involving human subjects?
he Belmont Report
he Declaration of Helsinki
CH GCP Guideline for Good Clinical Practice E6(R2) wer: C
anation: The Declaration of Helsinki is an international ethical guideli edical research involving human subjects. It was first adopted in 196 orld Medical Association and has been revised several times since th eclaration of Helsinki provides guidance on ethical principles, onsibilities of researchers, informed consent, participant protection, an
aspects related to the conduct of medical research. It serves as a glob gnized reference for ensuring the ethical conduct of research involving an subjects.
ch set of regulations governs the conduct of clinical trials in the Unite
The Nuremberg Code
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21 U.S. Code of Federal Regulations – Part 11
21 U.S. Code of Federal Regulations – Part 312
45 U.S. Code of Federal Regulations - Part 46
45 U.S. Code of Federal Regulations - Part 50
ch of the following is a requirement outlined in 21 U.S. Code of Feder ulations – Part 312?
eporting of serious adverse events to the sponsor btaining informed consent from research subjects stablishing an institutional review board (IRB)
onducting regular monitoring visits at investigational sites wer: A
anation: 21 U.S. Code of Federal Regulations – Part 312 outlines the rements for Investigational New Drug (IND) applications in the Unit
s. One of the requirements stated in this regulation is the reporting of us adverse events to the sponsor. Sponsors are responsible for prompt rting any serious adverse events that occur in connection with the use
Explanation: Clinical trials in the United States are governed by the 21 U.S. Code of Federal Regulations – Part 312. This regulation sets forth the requirements for the investigational new drug application (IND) process, including the submission of clinical trial protocols, informed consent, monitoring, reporting of adverse events, and other aspects related to the conduct of clinical trials involving investigational drugs.
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the investigational drug to the appropriate regulatory authorities, such as the FDA. Obtaining informed consent from research subjects is covered under 21
U.S. Code of Federal Regulations – Part 50, establishing an institutional review board (IRB) is addressed in Part 56, and conducting regular monitoring visits at investigational sites is a practice associated with Good Clinical Practice (GCP) guidelines.
According to ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), which of the following is considered an expedited reporting event?
Any adverse event occurring during the course of the clinical trial
uct
on-serious adverse events that are expected and consistent with the uct's labeling
dverse events that occur in a control group but not in the treatment gr wer: B
anation: According to ICH Clinical Safety Data Management: Definit tandards for Expedited Reporting (E2A), expedited reporting events r rious adverse events that are unexpected and related to the investigati uct. These events require immediate reporting to regulatory authoritie
committees. Expedited reporting ensures that potential safety concer romptly communicated and appropriate actions are taken to protect th being of study participants.
ording to the Nuremberg Code, which of the following is a fundament
Serious adverse events that are unexpected and related to the investigational prod
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ethical principle for human experimentation?
Voluntary informed consent of the subject
Maximizing benefits for society
Conducting experiments without regard to potential risks
Excluding vulnerable populations from participation
ent ensures respect for individual autonomy and protects the rights an are of research subjects.
ording to ICH GCP Guideline for Good Clinical Practice E6(R2), whi ollowing is a key responsibility of the sponsor in a clinical trial?
roviding medical care to study participants onducting the statistical analysis of study data
nsuring the trial is conducted in compliance with the protocol and cable regulations
nterpreting the study results and drawing conclusions wer: C
anation: According to the ICH GCP Guideline for Good Clinical Prac R2), the sponsor in a clinical trial has the key responsibility of ensurin
Explanation: The Nuremberg Code, formulated as a result of the Nuremberg trials after World War II, established ethical principles for human experimentation. One of its fundamental principles is the requirement of voluntary informed consent from the research subject. This means that individuals must be fully informed about the nature, purpose, risks, and benefits of the research study before they can voluntarily agree to participate. Informed cons d
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the trial is conducted in compliance with the protocol and applicable regulations. The sponsor is responsible for designing the study, obtaining regulatory approvals, providing investigational products, monitoring the trial, ensuring data quality, and taking overall accountability for the conduct of the trial. Compliance with the protocol and applicable regulations is crucial to protect the rights, safety, and well-being.
According to ICH GCP Guideline for Good Clinical Practice E6(R2), which of the following is a key responsibility of the investigator?
Reviewing and approving the study protocol
onducting statistical analysis of the study results reparing the Investigational New Drug (IND) application
wer: B
anation: According to ICH GCP Guideline for Good Clinical Practice R2), a key responsibility of the investigator is to monitor the study dat ty and accuracy. The investigator is responsible for ensuring that the d cted during the clinical trial is complete, accurate, and verifiable. This des conducting regular monitoring visits at the investigational site to
w and verify the source documents, case report forms, and other stud ed records. Reviewing and approving the study protocol is typically th onsibility of the sponsor and/or the institutional review board (IRB). stical analysis of the study results is usually performed by a biostatisti reparing the Investigational New Drug (IND) application is the onsibility of the sponsor.
Monitoring the study data for quality and accuracy
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According to the Belmont Report, which principle emphasizes the fair distribution of the benefits and burdens of research?
Respect for persons
Beneficence
Justice
Autonomy Answer: C
ding exploitation and ensuring that the potential benefits of research ar ed fairly among the population under study. This principle safeguards nst discrimination and promotes fairness in the conduct of research.
ch document provides guidelines for the management of safety data in cal trials?
he Nuremberg Code
he Declaration of Helsinki
CH GCP Guideline for Good Clinical Practice E6(R2)
CH Clinical Safety Data Management: Definitions and Standards for dited Reporting (E2A)
wer: D
Explanation: According to the Belmont Report, the principle of justice emphasizes the fair distribution of the benefits and burdens of research. Justice requires that the selection of research participants is equitable, without any unjustifiable exclusions or preferences. It also highlights the importance of avoi e
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Explanation: ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) provides guidelines for the management of safety data in clinical trials. This document outlines definitions and standards for the collection, processing, analysis, and reporting of safety data. It emphasizes the importance of timely and accurate reporting of adverse events, ensuring that the safety of study participants is a top priority throughout the course of the clinical trial.
Which set of regulations provides guidelines for the protection of human subjects in non-exempt research conducted or supported by the U.S. Department of Health and Human Services (HHS)?
U.S. Code of Federal Regulations – Part 46
U.S. Code of Federal Regulations - Part 50
U.S. Code of Federal Regulations - Part 312 wer: B
anation: The protection of human subjects in non-exempt research ucted or supported by the U.S. Department of Health and Human Ser
S) is governed by the 45 U.S. Code of Federal Regulations - Part 46. T ation, also known as the Common Rule, establishes the ethical standa he protection of human subjects in research. It applies to a wide range rch activities, including biomedical and behavioral studies, and cover
ederally funded and non-federally funded research.
ch of the following is a requirement stated in 21 U.S. Code of Federal ulations – Part 56?
21 U.S. Code of Federal Regulations – Part 11
21
45
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Obtaining informed consent from research subjects
Reporting of serious adverse events to the sponsor
Establishing an institutional review board (IRB)
Conducting regular monitoring visits at investigational sites Answer: C
us adverse events to the sponsor is addressed in Part 312, and conduct ar monitoring visits at investigational sites is a practice associated wit Clinical Practice (GCP) guidelines.
ording to ICH Clinical Safety Data Management: Definitions and Stan xpedited Reporting (E2A), which of the following is an example of a us adverse event (SAE)?
ild headache lasting for 30 minutes
ight skin irritation at the site of application
oderate nausea and vomiting after taking the study medication ife-threatening allergic reaction requiring hospitalization
wer: D
anation: According to ICH Clinical Safety Data Management: Definit
Explanation: 21 U.S. Code of Federal Regulations – Part 56 outlines the requirements for institutional review boards (IRBs) in the United States. One of the key requirements stated in this regulation is the establishment of an IRB. An IRB is an independent committee responsible for reviewing, approving, and monitoring research involving human subjects to ensure the protection of their rights and welfare. Obtaining informed consent from research subjects is covered under 21 U.S. Code of Federal Regulations – Part 50, reporting of
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and Standards for Expedited Reporting (E2A), a serious adverse event (SAE) is defined as any untoward medical occurrence that results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Among the options provided, a life-threatening allergic reaction requiring hospitalization is the only example that meets the criteria for an SAE. Mild headache, slight skin irritation, and moderate nausea
and vomiting, while adverse events, do not meet the criteria for seriousness as defined by E2A.