TEST BANK :SOCRA Exam Questions and Answers |100% Correct| 2024/2025 Latest Version!!
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Course
SOCRA
Institution
SOCRA
TEST BANK :SOCRA Exam Questions
and Answers |100% Correct| 2024/2025
Latest Version!!
What is the primary purpose of Good Clinical Practice (GCP) guidelines?
A) To ensure the accuracy of data
B) To protect the rights and safety of participants
C) To minimize costs in clinical trials
D)...
TEST BANK :SOCRA Exam Questions
and Answers |100% Correct| 2024/2025
Latest Version!!
What is the primary purpose of Good Clinical Practice (GCP) guidelines?
A) To ensure the accuracy of data
B) To protect the rights and safety of participants
C) To minimize costs in clinical trials
D) To standardize drug approval processes
B) To protect the rights and safety of participants
Which document outlines the objectives, design, and methodology of a clinical trial?
A) Informed Consent Form
B) Clinical Trial Protocol
C) Case Report Form
D) Investigator’s Brochure
B) Clinical Trial Protocol
What is the role of an Institutional Review Board (IRB) in clinical research?
A) To manage clinical trial sites
B) To approve and monitor clinical trials for ethical compliance
C) To recruit participants for studies
D) To conduct statistical analyses
1
, B) To approve and monitor clinical trials for ethical compliance
In clinical trials, what is the significance of randomization?
A) To eliminate the need for informed consent
B) To ensure that participants are assigned to groups in a non-biased manner
C) To reduce the duration of the study
D) To guarantee a specific outcome
B) To ensure that participants are assigned to groups in a non-biased manner
Which of the following is a requirement for informed consent?
A) Participants must be paid for their involvement
B) Participants must be informed of their right to withdraw at any time
C) Participants must sign the consent form before any discussion of the study
D) Participants must provide consent in writing only
B) Participants must be informed of their right to withdraw at any time
What is a serious adverse event (SAE) in clinical research?
A) Any minor side effect
B) Any adverse event that does not require medical intervention
C) Any event that results in death, hospitalization, or significant disability
D) Any event reported by participants
C) Any event that results in death, hospitalization, or significant disability
2
,Which phase of clinical trials primarily assesses the safety and dosage of a new drug?
A) Phase I
B) Phase II
C) Phase III
D) Phase IV
A) Phase I
What is the main purpose of the Investigator's Brochure?
A) To summarize the study design
B) To provide information on the investigational product to investigators
C) To serve as the informed consent document
D) To detail participant recruitment strategies
B) To provide information on the investigational product to investigators
What is the purpose of monitoring in clinical trials?
A) To speed up the trial process
B) To ensure compliance with the protocol and GCP
C) To analyze the data collected
D) To recruit additional participants
B) To ensure compliance with the protocol and GCP
When must serious adverse events be reported to the IRB?
A) Within 30 days
3
, B) Immediately, or within 24 to 48 hours
C) Only if they result in hospitalization
D) Only at the end of the study
B) Immediately, or within 24 to 48 hours
What is the function of the Data Monitoring Committee (DMC) in a clinical trial?
A) To approve study budgets
B) To monitor trial data for safety and efficacy
C) To manage participant recruitment
D) To conduct statistical analyses
B) To monitor trial data for safety and efficacy
What should be included in a clinical trial protocol amendment?
A) A list of enrolled participants
B) Justification for the changes and updated procedures
C) The original protocol only
D) Data from previous studies
B) Justification for the changes and updated procedures
What is the primary focus of Phase III clinical trials?
A) To assess safety in a small group
B) To evaluate the efficacy of a drug in a large population
C) To gather information for the Investigator's Brochure
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