GOOD CLINICAL PRACTICE (ICH-GCP) ESSENTIALS - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
3 Weeks / 80 Hours
 
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IGCP: Good Clinical Practice (ICH-GCP) Essentials

Introduction – Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects. Developed by the International Council for Harmonisation (ICH), GCP ensures that trial participants’ rights, safety, and well-being are protected, and that data generated is credible and accurate.

The IGCP program introduces learners to the core principles of ICH-GCP and their practical application in clinical research. It is a foundation course for anyone entering clinical research, clinical data management, or drug safety roles.

Course Name :  Good Clinical Practice (ICH-GCP) Essentials
Course Code :  IGCP
Experience Level :  Entry-Level
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Public Health, or related disciplines
Student Category :  Clinical Research Associates (CRA), Clinical Trial Assistants (CTA), Data Managers, CRCs, Career Changers

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  1. Understand the origin, purpose, and global importance of ICH-GCP.
  2. Learn the 13 principles of GCP and how they apply to clinical trials.
  3. Gain insights into ethical conduct, informed consent, and subject protection.
  4. Explore roles and responsibilities of sponsors, investigators, monitors, and ethics committees.
  5. Understand essential documents and their role in ensuring trial integrity.
  6. Learn how GCP links to regulatory compliance (FDA, EMA, Health Canada, MHRA).
  7. Review inspection readiness and audit requirements.
Who Should Take This Course
  1. Clinical Research Associates (CRA) and Clinical Research Coordinators (CRC).
  2. Clinical Data Managers (CDMs) learning regulatory foundations.
  3. Drug Safety / PV staff applying GCP in safety monitoring.
  4. Healthcare professionals transitioning into clinical research.
  5. Career changers pursuing roles in pharma/CRO environments.
Benefits & Outcomes
  1. Build a strong foundation in ICH-GCP compliance.
  2. Learn how to protect participants’ rights and data integrity.
  3. Be prepared for site audits, monitoring, and regulatory inspections.
  4. Gain credibility for roles across clinical research, CDM, and pharmacovigilance.

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Career Pathways: After completing this course
  1. Clinical Research Assistant (CRA/CTA)
  2. Clinical Trial Coordinator
  3. Clinical Data Management Associate
  4. Quality & Compliance Specialist (GCP focus)
  5. Regulatory Affairs Associate

Curriculum & Modules

Modules
1. Introduction to ICH-GCP and Clinical Research Ethics

2. The 13 Principles of GCP Explained

3. Roles & Responsibilities: Sponsor, Investigator, Monitor, IRB/IEC

4. Informed Consent – Ethical & Regulatory Requirements

5. Essential Documents & the Trial Master File (TMF)

6. GCP in Clinical Trial Conduct (Monitoring, Data Collection, Safety Reporting)

7. Regulatory Authorities & GCP Compliance (FDA, EMA, MHRA, Health Canada)

8. Audits, Inspections & GCP Readiness

9. Case Studies – Applying GCP in Real Trial Scenarios
Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.