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GCP Refresher Training for the Experienced Professional

GCP Refresher Training for the Experienced Professional Certification Training

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(1 reviews)

Program/Course ID:CP003a
Enrollment Period:12 months.
Average Learning Time:~35 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.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

Training Program: GCP Refresher Training for the Experienced Professional
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Biopharma Institute Reviews

This Good Clinical Practice (GCP) Refresher course reviews the major requirements of GCP for clinical trials according to the global guideline ICH E6(R2) related to roles and responsibilities. The course uses industry case scenarios to support applications and critical thinking.

This ICH E6 (R2) GCP Training meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Recommended for clinical research professionals with 5 or more years experience with GCP at sponsor, CRO, and/or clinical site.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.


GCP Overview
  • Purposes of GCP
  • Thirteen Principles of GCP
  • Elements in a Protocol
  • Protocol Amendments vs Deviations
  • Protocol Changes
  • Investigator's Brochure
  • GCP Resources

Stakeholders' Roles and Responsibilities
  • How GCP Stakeholders Interact
  • Responsibilities During the Study Conduct
  • Risk Based Approach Guidance
  • The Sponsor's Representative: The Monitor
  • Monitoring Plan
  • Quality Management
  • Implementation of a Quality System
  • General Qualifications for Investigator
  • Guidance for Investigator Responsibilities
  • Adequate Supervision of Trials
  • Examples of Inappropriate Delegation
  • Common Challenges
  • IRB/EC Responsibilities

Challenges and Opportunities in Implementing GCP
  • Essential Documents
  • Electronic Records & Computerized Systems
  • Trial Master Files (TMFs)
  • Sponsor & Investigator Regulatory Binders/TMF
  • Informed Consent Process
  • Vulnerable Subjects
  • Elements of Consent
  • Informed Consent Stakeholder Responsibilities
  • Common Informed Consent Deficiencies
  • Safety Reporting
  • Good Documentation Practices
  • Certified Copies
  • Managing Non-compliance
  • Managing Significant GCP Issues

Post Assessment


  • Review major GCP requirements and identify practical applications of the Guideline, including identifying methods to assess quality systems and documentation.
  • Relate GCP concepts during interactive activities to support application during a clinical trial.
  • Reflect on challenges and opportunities in the current state of the industry for implementing the GCP Guideline.

Recommended for clinical research professionals with 5 or more years experience with GCP at sponsor, CRO, and/or clinical site.

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.