ICH E6(R2) - Introduction and Principles of Good Clinical Practices (GCP) (Chapter 1-2)
 | Enrollment Period: 12 months. Average Learning Time: ~30 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 0.1 CPD Credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Catalog: Clinical Trials Management and Monitoring.Demonstration: Five (5) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $199.00 USD |
Download Program DetailsDocument your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: ICH E6(R2) - Introduction and Principles of Good Clinical Practices (GCP) (Chapter 1-2)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  In this course, we discuss Sections 1-2 of ICH E6 R2 Good Clinical Practices (GCP), including an overview and the principles of GCP.This course is divided into two sections: - Introduction and E6 GCP Overview - Principles of GCP Upon completion of this course, students will be able to: - Explain how E6 is organized - Identify where to locate key GCP E6 terminology - Discuss GCP guidance and examples of their application 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 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. 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 instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
Outline:E6 Organization -ICH E6: 1 - Glossary of Key Terms -ICH E6: 2 - Principles of Good Clinical Practices -ICH E6 Principle 2.1 -ICH E6 Principle 2.2 -ICH E6 Principle 2.3 -ICH E6 Principle 2.4 -ICH E6 Principle 2.5 -ICH E6 Principle 2.6 -ICH E6 Principle 2.7 -ICH E6 Principle 2.8 -ICH E6 Principle 2.9 -Knowledge Check -ICH E6 Principle 2.10 -ICH E6 Principle 2.11 -ICH E6 Principle 2.13 Conclusion -What We Covered Test Your Knowledge -Results | Objectives:Upon completion of this course, students will be able to: -Explain how E6 is organized -Identify where to locate key GCP E6 terminology -Discuss GCP guidance and examples of their application | |
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. |
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| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Certificate of completion is instantly available once requirements have been fulfilled. |
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| 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. |
