4.00
(6 Ratings)

Good Clinical Practice & Bioethics in Clinical Research (E‑Learning Course)

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About Course

No. of Sessions: 3
Max Duration of training: 3-4 Hours
Fee: ₹1500 + 18% GST as applicable

This self-paced e-learning course offers a comprehensive introduction to Good Clinical Practice (GCP), aligned with the ICH GCP E6(R3) guidelines, the ICMR Ethical Guidelines for Biomedical Research (2017), and India’s New Drugs and Clinical Trials (NDCT) Rules, 2019. Designed for researchers, investigators, and clinical trial professionals, the course provides clear, structured content on core GCP principles, ethical standards, regulatory requirements, and participant protection as outlined in these key frameworks. Through self-study modules, you will gain essential knowledge of international and Indian GCP standards, enabling you to understand and apply fundamental GCP principles in your clinical research activities with confidence and compliance.

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What Will You Learn?

  • NDCT Rules, 2019: Understand the regulatory framework governing clinical trials in India, including timelines, approval pathways, and obligations for sponsors and investigators
  • Compensation & Safety Reporting: Learn the requirements for adverse event reporting, timelines for submission, and the compensation mechanism for trial-related injuries under NDCT Rules
  • ICMR Ethical Guidelines (2017): Gain clarity on the composition, functions, and oversight responsibilities of Ethics Committees, along with key ethical principles for biomedical research, including informed consent processes and essential trial documentation requirements
  • ICH GCP E6(R3) Principles: Explore the updated GCP principles, including risk-based approaches, data integrity expectations, and participant rights and safety standards
  • Regulatory Compliance in India: Understand how ICH GCP, ICMR guidelines, and NDCT Rules intersect to shape compliant clinical trial conduct in the Indian context

Course Content

How to Access Learning Modules
🎓 How to Access Learning Modules and Sessions | Quick Step-by-Step Guide Welcome! In this tutorial, you’ll learn exactly how to access and navigate your learning modules and training sessions with ease. Whether you're accessing video lessons, downloadable materials, or live classes, this video will walk you through the entire process.

  • Quick Step-by-Step Guide
    07:29

Pre-Training Assessment

Session 1

Session 2

Session 3

Post-Training Assessment

Student Ratings & Reviews

4.0
Total 6 Ratings
5
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1 Rating
MG
1 month ago
good learning experience
good
AM
1 month ago
Good information and well structured content.
Great
DS
1 month ago
Good learning experience
Good learning experience
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