Clinical Research Assistant Interview Questions and Answers

Yes

• Yes, a recent sentinel event occurred during clinical research in India.

• The event involved a serious adverse reaction to a study drug in a participant.

• The participant experienced severe allergic symptoms and required immediate medical intervention.

• The event was reported to the ethics committee and regulatory authorities.

• Investigations were conducted to determine the cause of the event and prevent future occurrences.

GCP stands for Good Clinical Practice, a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

• GCP ensures the safety and well-being of trial participants

• GCP ensures the credibility and accuracy of trial data

• GCP is mandatory for all clinical trials involving human subjects

• GCP guidelines cover various aspects of clinical trial conduct, including trial design, informed consent, data management, and moni...read more