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
🧾 Informed Consent in Clinical Research 🔍 1. What is Informed Consent? Informed Consent is a process by which a clinical trial participant voluntarily confirms their willingness to participate in a particular trial, after having been informed of all...
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 28, 2025
⚠️ Challenges Faced in Clinical Research 🔹 1. Participant Recruitment and Retention Difficulty in finding eligible and willing volunteers. High dropout rates affect trial integrity. Lack of diversity in participant populations. 🔹 2. Regulatory and...
