Based on Good Clinical Practice (GCP) guidelines, the research site investigator has the primary responsibility for selecting study monitors.A. TRUEB. FALSE
Question
Based on Good Clinical Practice (GCP) guidelines, the research site investigator has the primary responsibility for selecting study monitors.
A. TRUE
B. FALSE
Solution
Break Down the Problem
- Understanding the context of Good Clinical Practice (GCP) guidelines.
- Identifying the role of the research site investigator.
- Evaluating the responsibilities related to selecting study monitors.
Relevant Concepts
- Good Clinical Practice (GCP): These are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials.
- Research Site Investigator: This individual is responsible for ensuring the safety and welfare of participants and overseeing study conduct.
Analysis and Detail
- In GCP, the investigator has several responsibilities concerning the conduct of clinical trials, including overseeing the trial’s integrity and ensuring compliance with the protocol.
- The selection of study monitors, however, is typically the responsibility of the sponsor of the clinical trial rather than the investigator.
Verify and Summarize
Given the role of the sponsor to ensure that monitors are qualified and capable of executing monitoring activities, it is accurate to conclude that the statement regarding the investigator's responsibility to select study monitors is FALSE.
Final Answer
B. FALSE
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