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Home » ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs)

ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs)

ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs) Certification Training

 
Rated 4.7 / 5
(3 reviews)

Program/Course ID:CP004a
Enrollment Period:12 months.
Average Learning Time:~60 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: ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs)
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

Specially designed for investigator site teams, this course covers the GCP essentials in ICH E6(R2) with a focus on the role of the investigator, clinical research coordinators, and other site personnel. Gain clarity on responsibilities, compliance requirements, and how your work fits into the bigger regulatory picture.

  • Meets TransCelerate BioPharma's mutual recognition criteria
  • Focuses on investigator and CRC responsibilities
  • Includes a brief overview of other stakeholder roles

With major ICH E6(R3) updates on the horizon, now is the time to reinforce your foundation and prepare for the changes.

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:


  • 1. GCP Overview
  • a. What is GCP
  • b. GCP Resources
  • c. What is ICH
  • d. What is E6
  • e. Purposes of GCP
  • f. Who Does GCP Affect?
  • g. ICH E6 Principles

  • 2. Sponsor Responsibilities
  • a. General Qualifications
  • b. Sponsor General Responsibilities
  • c. Investigator's Brochure
  • d. The Clinical Trials Protocol
  • e. Protocol Amendments vs Deviations
  • f. The Sponsor's Representative: The Monitor
  • g. GCP Noncompliance
  • h. Audit vs. Inspection
  • i. ICH E6(R2) and QRM
  • j. Implementation of a QRM

  • 3. Investigator Responsibilities
  • a. General Qualifications & Definitions
  • b. Investigator Agreements and Responsibilities
  • c. Pre-Study Responsibilities
  • d. Responsibilities During the Study Conduct
  • e. Randomization and Blinding
  • f. Source Documents and Source Data
  • g. Records and Reports
  • h. Investigational Product (IP) Responsibilities
  • i. Adverse Events
  • j. Safety Reporting
  • k. Termination or Suspension
  • l. Delegation and Oversight
  • m. Supervision of Trials
  • n. Examples of Inappropriate Delegation & Common Challenges
  • o. Factors that Compromise Adequate Supervision
  • p. Elements of a Plan for Adequate Supervision
  • q. Scenario

  • 4. Ethics Committee and ICF
  • a. What are IRBs/ECs?
  • b. IRB/EC Responsibilities
  • c. Types of Review and Decisions
  • d. What is Informed Consent?
  • e. Informed Consent Process
  • f. Vulnerable Subjects
  • g. Emergency Consent
  • h. Elements of Consent
  • i. Stakeholder Responsibilities
  • j. Informed Consent Tips from Regulators
  • k. Informed Consent Amendments
  • l. Common Informed Consent Deficiencies
  • m. Scenario

  • 5. Essential Documents and Good Documentation
  • a. Essential Documents Definition
  • b. Trial Master File (TMF)
  • c. Role of Essential Documentation
  • d. Investigator Regulatory Binders/TMF
  • e. Why are Good Documentation Practices Important?
  • f. ALCOA / ALCOA-C / ALCOACCEA?
  • g. 6 Key Elements of Quality Data
  • h. Certified Copies -Paper and Electronic
  • i. Scenario

  • 6. 10 Question Post Assessment

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.

Audience:
All clinical research personnel, such as a clinical research coordinator (CRC). This course has a focus on the responsibilities of the sponsor/CRO for oversight of the clinical research site.

Related Professional Certification Programs:


Professional Certification Program:

Clinical Research Coordinator (CRC) Professional Certification Program

Program ID: CRCPRO
Price: $995.00 (USD)

Certification Requirements: To earn a certificate, students must complete the entire course and pass an online, multiple-choice final assessment within 12 months of enrollment. Upon meeting these requirements, a certificate of completion is instantly available in PDF format.

Biopharma Institute's online training provides immediate access after enrollment. Students receive their username, password, and instructions via email directly after registering. The final assessment can be attempted as many times as necessary to achieve a passing score. Once the course is successfully completed, the certificate is generated instantly in an encrypted PDF format, featuring a watermark, unique validation code, and QR verification barcode.

Training achievements can be verified on our website using the certificate's unique ID or QR code. For professional certification programs, a digital badge is also issued, allowing students to showcase their accomplishment on platforms such as LinkedIn, Facebook, Twitter, and Badgr.

Certificates and digital badges include the completion date but do not display an expiration date. Compliance training is generally considered valid for up to three years, and many organizations schedule refresher training every one to three years to maintain alignment with evolving regulations, standards, and GxP expectations. Biopharma Institute does not assign a universal expiration date as it recognizes that the validity period or recertification interval for each individual worker should be determined by each individual organization's quality management team.

Benefits of Being Certified by Biopharma Institute Our training engages students in active learning through interactive eLearning modules that are validated by independent third-party organizations for relevance, compliance, and regulatory accuracy. Each course is developed by subject matter experts (SMEs) in collaboration with instructional design professionals to maximize knowledge retention. Programs include access to regulatory references, real-life case studies, and other essential resources to support learning.

Since 2003, Biopharma Institute has helped professionals and their employers meet training requirements. Our certifications are recognized by a wide range of industries, regulatory bodies, and organizations worldwide. Training solutions can be customized to meet the needs of any organization. We currently offer over 300 courses covering topics such as clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity, serving the clinical research, pharmaceutical, and medical device sectors.

Employee / Corporate Training For organizations seeking a cost-effective way to train employees without the need for travel, webinars, or in-person sessions, Biopharma Institute is a trusted partner. Our programs deliver effective, engaging, self-paced learning that fits seamlessly into employees' daily routines. All eLearning modules are SCORM-compliant and can be integrated into most corporate learning management systems (LMS).

We support both small- and large-scale training initiatives, always with the same goal- providing a positive, streamlined experience for everyone involved, from students to training managers.


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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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