by Dr. Yashashwini Reddy | Jun 30, 2025
🧪Evaluating the Potential Risks and Benefits of the Research for Participants 🔍 1. What is Risk-Benefit Assessment in Clinical Research? Risk-Benefit Assessment is a critical ethical and scientific evaluation process in which researchers, sponsors, and ethics...
by Dr. Yashashwini Reddy | Jun 30, 2025
📢 Reporting Complaints Related to FDA-Regulated Clinical Trials 🔍 1. Why Report a Complaint? Reporting complaints helps ensure: Protection of participant rights and safety Maintenance of ethical and regulatory standards Detection of misconduct, fraud, or GCP...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XVI – Addendum II: Methods for Evaluating the Effectiveness of Risk Minimization Measures (RMMs) 📘 Purpose This addendum to GVP Module XVI provides specific methodologies and practical guidance for evaluating the effectiveness of risk minimization...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module XVI – Risk Minimization Measures (RMMs) 📘 Purpose GVP Module XVI provides detailed guidance on the planning, implementation, evaluation, and effectiveness of risk minimization measures (RMMs) that are necessary to ensure safe use of medicinal products in...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting...