The ICH-GCP Training Series is a practical, industry-oriented training program designed for students, healthcare professionals, researchers, and aspiring clinical research professionals. The course provides a strong foundation in Clinical Research and International Council for Harmonisation – Good Clinical Practice (ICH-GCP) guidelines, helping participants understand how clinical trials are conducted ethically, safely, and in compliance with global standards.

Through interactive sessions, real-world examples, case discussions, and industry insights, participants will gain practical knowledge of clinical trial operations, documentation, data integrity, safety reporting, monitoring, regulatory compliance, and career opportunities in Clinical Research.

Basic Plan

Duration: 5 Weeks (1 Session per Week)
Fee: ₹2,999

Designed for beginners, this program covers the core concepts of Clinical Research and ICH-GCP through 5 comprehensive modules.

Modules Covered

Module 1: Introduction to Clinical Research & ICH-GCP Foundations

Module 2: Informed Consent, Roles & Responsibilities

Module 3: Protocol, Documentation & Data Integrity

Module 4: Safety Reporting, Monitoring & Inspection Readiness

Module 5: Practical Application, Case Studies & Career Readiness

Ideal For

• MBBS, BDS, AYUSH, Pharmacy and Nursing Students
• Life Sciences Graduates
• Healthcare Professionals
• Clinical Research Beginners
• Research Enthusiasts

Advanced Plan

Duration: 8 Weeks (7–8 Sessions)
Fee: ₹5,999

The Advanced Program offers in-depth training in clinical research operations, regulatory compliance, pharmacovigilance, quality management, and industry readiness. It is designed for participants seeking specialized knowledge and career advancement in Clinical Research.

Modules Covered

Module 1: Foundations of Clinical Research & ICH-GCP

Module 2: Informed Consent & Participant Protection

Module 3: Clinical Trial Design & Protocol Development

Module 4: Documentation, Data Management & Data Integrity

Module 5: Indian GCP, Regulations & the Bigger Picture  

Module 6: How a Clinical Trial Works: From Start to Finish 

Module 7: Mock Documents: Reading, Filling & Critiquing Real Clinical Trial Paperwork 

Ideal For

• Clinical Research Aspirants
• Medical, Dental, Pharmacy & Nursing Professionals
• Life Sciences Graduates
• Clinical Trial Coordinators
• Medical Writers
• Professionals Transitioning into Clinical Research

About the Instructor

Dr. Shafali Nagpal, BDS (Double Gold Medalist), is a healthcare professional with over 7 years of clinical experience and a Diploma in Clinical Research and Pharmacovigilance. With extensive experience in medical writing and healthcare education, she is passionate about simplifying complex concepts and helping learners build a strong foundation in clinical research.

Her practical, learner-focused approach combines clinical expertise with industry knowledge, enabling participants to understand both the regulatory requirements and real-world applications of Clinical Research.

Learning Outcomes

By the end of the program, participants will be able to:

✔ Understand Clinical Research and ICH-GCP Guidelines

✔ Apply ethical principles and informed consent practices

✔ Understand stakeholder roles and responsibilities in clinical trials

✔ Maintain proper documentation and data integrity standards

✔ Understand safety reporting and pharmacovigilance requirements

✔ Prepare for monitoring visits, audits, and inspections

✔ Analyze real-world clinical research case studies

✔ Explore career opportunities in the Clinical Research industry

Whether you are starting your Clinical Research journey or looking to enhance your professional expertise, this program will equip you with the knowledge, practical skills, and industry insights needed to succeed in this rapidly growing field.