YouTube video by EkasCloud Online Courses

Understand Safety Reporting and Pharmacovigilance in Clinical Trials—from AEs, SAEs, and SUSARs to DSMBs, timelines, and reporting responsibilities. Essential for Medical Affairs and investigators. In this tutorial, you’ll learn: ✅ What qualifies as an Adverse Event (AE) vs Serious Adverse Event (SAE) ✅ How and when to report SUSARs ✅ The different safety reporting roles for Investigators and Sponsors ✅ Safety Reporting Timelines and Regulatory Expectations ✅ The role of Data Safety Monitoring Boards (DSMBs) ✅ Real-world implications of failing to report properly Whether you’re in Medical Affairs, Clinical Operations, or serving as an Investigator—this tutorial offers a clear, concise breakdown of what’s required to stay compliant and protect patients. 📌 Watch now and enhance your clinical trial safety skills. 👉 Subscribe for more free tutorials 👉 ICH- GCP Certification 👉 https://shorturl.at/5ULTO 👉 Visit our website for more resources: https://www.skyhealthacademy.net #SafetyReporting #Pharmacovigilance #ClinicalTrials #MedicalAffairs #SAE #AE #SUSAR #DSMB #ClinicalResearchTraining #SkyHealthAcademy...

What Responsibilities of the IRB/IEC in Clinical Trials ? Institutional Review Board (IRB) or Independent Ethics Committee (IEC) In this tutorial, you’ll discover the critical responsibilities of IRBs/IECs—from safeguarding human subjects to reviewing protocols and monitoring ongoing ethical compliance. We’ll break it down into 3 key sections: 🔹 Structure and Function of IRBs/IECs – How they’re formed and what they are accountable for 🔹 Relationship with Investigators – Oversight, communication, and continuing review 🔹 Relationship with Sponsors – Submissions, ethical obligations, and transparency This tutorial is essential for investigators, Medical Affairs professionals, and clinical research teams who need to understand the ethical foundation of every clinical study. 📅 Stay compliant. Stay informed. 🎯 Start mastering IRB/IEC requirements today. #IRB #IEC #ClinicalTrials #EthicsInResearch #ClinicalResearchTraining #MedicalAffairs #GCP #HumanSubjectProtection #IRBResponsibilities #SkyHealthAcademy

Imagine a future where every medical decision is informed by real-time data from millions of patients. In this tutorial, we explore the Future of Real-World Evidence Generation and how it’s revolutionizing clinical decision-making, patient care, and drug development. In the related tutorial, you can learn how traditional clinical trials are no longer enough to answer today’s complex healthcare questions — and why real-world evidence is becoming essential for regulators, payers, and clinicians. You’ll discover: Why real-world evidence is moving from “nice to have” to a critical part of healthcare decision-making How technology — including wearables, AI, machine learning, and blockchain — is powering continuous, large-scale data collection How clinicians and Medical Affairs professionals can use real-world data to improve patient outcomes The future of predictive modeling, digital twins, and real-time evidence feedback loops Practical recommendations for healthcare professionals to adopt and thrive in this evolving ecosystem By the end, you’ll...