What is an investigator primarily responsible for protecting during a study?

Prepare for the CITI Good Clinical Practice (GCP) Exam with comprehensive questions, hints, and explanations. Master the essential concepts to excel in your exam!

The primary responsibility of an investigator in a clinical study is to protect the rights and safety of the subjects participating in the research. This aligns with the ethical principles of conducting clinical trials, which emphasize the importance of prioritizing participant welfare. The investigator must ensure that informed consent is obtained, that participation is voluntary, and that participants are treated with respect and integrity throughout the study. This includes monitoring for any adverse effects, providing appropriate care, and ensuring that the study adheres to regulatory requirements and ethical standards.

While other factors such as financial interests, drug integrity, and study timelines are important in the context of clinical trials, they do not take precedence over the safety and rights of human subjects. The protection of participants is fundamentally central to Good Clinical Practice guidelines, highlighting the ethical obligation of researchers to prioritize participant well-being above all else. This ensures both the ethical conduct of research and the credibility of the data collected during the study.

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