Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

Question: 1 / 400

According to the ICH Guideline on Good Clinical Practice, what is one of the primary considerations for clinical trial subjects?

Protection of clinical trial subjects

The primary consideration for clinical trial subjects, as outlined in the ICH Guideline on Good Clinical Practice (GCP), is the protection of their rights, safety, and well-being. This principle is fundamental to ensuring ethical standards in clinical research. Protecting subjects means that they must be adequately informed about the trial, its risks, and their rights, allowing them to make informed decisions about their participation.

The guideline emphasizes the necessity of obtaining informed consent, safeguarding confidentiality, and ensuring that subjects do not face undue risk. This responsibility falls on the researchers, who must continually monitor trials to protect participants' well-being throughout the study. By prioritizing subject protection, GCP establishes trust within the research framework, enhances participant recruitment and retention, and ensures that the data collected is ethically obtained, maintaining the integrity of the research process.

Get further explanation with Examzify DeepDiveBeta

Maximizing profits

Speeding up drug approval

Conducting trials with minimal oversight

Next Question

Report this question

Download Certified Clinical Research Associate (CCRA) Practice Exam PDF Study Guide
Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy