QQuestionOther Exams & Certifications
QuestionOther Exams & Certifications
A primary purpose of the ICH E^6 guideline is to:
A. Require registration of clinical trials
B. Require publication of negative trial results
C. Develop mandatory worldwide regulations for drug development
D. Minimize the need for redundant research
5 months agoReport content
Answer
Full Solution Locked
Sign in to view the complete step-by-step solution and unlock all study resources.
Step 1I'll solve this problem following the specified formatting guidelines:
Step 2: Understand the Context
The ICH E^6 guideline is part of the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline focuses on Good Clinical Practice (GCP) standards for clinical trials.
Final Answer
- Option A suggests trial registration - Option B addresses publication of trial results - Option C proposes worldwide drug development regulations - Option D discusses research redundancy Step 3: Evaluate the Primary Purpose The primary purpose of ICH E^6 is to establish a unified standard for conducting clinical trials that ensures: - Ethical and scientific quality of clinical trials - Protection of human subjects - Credibility of clinical trial data - Standardization of trial processes across different countries Step 4: Identify the Correct Answer Based on the comprehensive goal of ICH E^6, the most accurate answer is: C. Develop mandatory worldwide regulations for drug development Explanation: The ICH E^6 guideline aims to create a harmonized, international standard for clinical research that can be applied globally, ensuring consistent, ethical, and scientifically rigorous drug development processes across different countries and regulatory environments.
Need Help with Homework?
Stuck on a difficult problem? We've got you covered:
- Post your question or upload an image
- Get instant step-by-step solutions
- Learn from our AI and community of students