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Tuesday, May 19, 2026
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GCP Training: ICH E6(R2)

GCP Training: ICH E6(R2) Certification Training

 
Rated 4.3 / 5
(3 reviews)

Program/Course ID:CP002a
Enrollment Period:12 months.
Average Learning Time:~75 minutes.
Additional Resources:Supplemental materials & activities.
Credit Hours:2 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Catalog:Clinical Trials Management and Monitoring.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote or invoice.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with QR validation code.
  Price: $199.00 USD  

Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.

Training Program: GCP Training: ICH E6(R2)
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment.
Description:
Biopharma Institute Reviews

This comprehensive GCP training covers the essentials of ICH E6(R2) for clinical trials, including investigator, sponsor, and stakeholder responsibilities. You'll explore major regulatory agencies, essential documentation methods, and good documentation practices (GDocP) with ALCOA-C principles.

  • Ideal for professionals new to GCP
  • Meets TransCelerate BioPharma's minimum criteria for mutual recognition of training
  • Prepares you for evolving regulations with ICH E6(R3) content coming in 2025

Gain the knowledge and confidence to excel in your clinical trial role and stay compliant in a rapidly changing regulatory landscape.

Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products.

These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry.


Outline:


GCP Overview
  • What is GCP
  • GCP Resources
  • What is ICH
  • What is E6
  • Purposes of GCP
  • Who Does GCP Affect?
  • ICH E6 Principles
Major Regulatory Authorities
  • Global Health Authorities
  • The EU and GCP
  • Transition between Directive and Regulation
  • The Corpus of GCP in the EU
  • The US and GCP
  • The Role of the FDA
  • Applicable Regulations in the US
  • Japan and GCP
GCP Essential Documentation
  • The Clinical Trials Protocol
  • Protocol Amendments vs Deviations
  • Investigator's Brochure
  • Essential Documents Definition
  • Trial Master File (TMF)
  • Sponsor & Investigator Regulatory Binders/TMF
  • A Note about Sponsors and Records
Sponsor Responsibilities
  • General Qualifications
  • Sponsor General Responsibilities
  • The Sponsor's Representative: The Monitor
  • Audit vs. Inspection
  • ICH E6(R2) and QRM
  • Implementation of a QRM Good Clinical Practice
Investigator Responsibilities
  • General Qualifications
  • Investigator Agreements and Responsibilities
  • Pre-Study Responsibilities
  • Responsibilities During the Study Conduct
  • Records and Reports
  • Termination or Suspension
  • Lack of Oversight
Ethics Committee and ICF
  • What are IRBs/ECs?
  • IRB/EC Responsibilities
  • Types of Review and Decisions
  • What is Informed Consent?
  • Informed Consent Process
  • Vulnerable Subjects
  • Emergency Consent
  • Elements of Consent
  • Stakeholder Responsibilities
  • Informed Consent Tips from Regulators
  • Informed Consent Amendments
  • Common Informed Consent Deficiencies
ALCOA-C and Good Documentation Practices
  • Why are Good Documentation Practices Important?
  • ALCOA / ALCOA-C / ALCOACCEA?
  • A is for Attributable
  • L is for Legible
  • C is for Contemporaneous
  • O is for Original
  • Certified Copies, Paper and Electronic
  • A is for Accurate
  • C is for Complete
Question Post Assessment

Objectives:


Learning Objectives:
  • Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6(R2).
  • Discover how the ICH global guideline affects your role.
  • Reflect on challenges and opportunities in implementing the guideline.
  • Identify practical applications of the guideline in your work processes including identifying methods to assess quality systems and documentation.

Length: 75 minutes run time plus additional time to complete activities and post assessment.

Audience: All clinical research professionals, particularly those with less experience, who have previously trained on GCP, but desire or require a refresher training providing more detail for the individual roles responsibilities as required by GCP. It is a perfect course for renewal training.

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Benefits of Training with Biopharma Institute

Immediate Course Access: Login details, instructions, and payment confirmation are emailed immediately upon online enrollment.
Self-Paced eLearning: Enjoy 24/7 access to all course materials and assessments for 12 months.
Open Enrollment: No prerequisites or prior work experience required to start.
Expert-Developed Content: Courses are designed by subject matter experts (SMEs) in their respective fields.
Up-to-Date & Validated: Training is regularly updated to meet current regulations and is third-party validated or accredited.
Optimized for Learning: Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention.
Secure Access: Encrypted connections, firewalls, and daily malware scans ensure security and system performance.
Flexible Assessments: Multiple-choice exams can be retaken until a passing score is achieved.
Instant Certificates: Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification.
Training Verification: Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications.
Manager Access: A secure portal allows managers to view and download enrollment reports, training records, account balances, and more.
SCORM-Compliant: Courses can be integrated directly into most corporate Learning Management Systems (LMS).
Purchase Orders: We accept POs from all companies. Request an invoice to start the procurement process.
Employer Reimbursement: Some employers may cover training costs -check your company's reimbursement policy.
Financial Assistance: Payment plans are available for eligible learners, or purchase courses individually as needed.
Career Advancement: Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills.


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