Are you ready to master the latest changes in the pharmaceutical industry? Our comprehensive online course is designed to guide you seamlessly through the transition from ICH-GCP E6(R2) to (R3). Whether you’re a professional in the pharmaceutical sector, a clinical researcher, or a regulatory affairs expert, this course is tailored to elevate your understanding and application of the new ICH guidelines.
Develop an in-depth understanding of the ICH GCP E6(R3) principles, focusing on the critical updates and revisions from E6(R2) to E6(R3).
Gain proficiency in the new regulatory requirements and ethical considerations for clinical trials, including changes to IRB/IEC compositions, investigator responsibilities, and data governance.
Master the nuances of the new appendices, including updates on the Investigator’s Brochure, clinical trial protocols, and essential records for clinical trials.
Equip yourself with the knowledge to implement the revised guidelines effectively in your professional role, ensuring compliance with the latest industry standards.
Dive into the intricacies of the ICH GCP E6(R3) principles with this comprehensive module. This course is designed to equip you with a thorough understanding of the latest updates and standards in Good Clinical Practice, crucial for ensuring the integrity and safety of clinical trials. You will explore the nuances of GCP, the significance of the Declaration of Helsinki, and the purpose behind the revisions from E6(R2) to E6(R3).
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Learn the nuances of GCP and their practical applications in clinical research.
✓ Understand the differences in the structure of E6(R2) and E6(R3).
✓ Explore the purpose of the E6(R3) revision and its impact on clinical trials.
✓ Comprehend the amendments to the principles as compared to E6(R2).
✓ Gain insights into the Declaration of Helsinki and its relevance to GCP.
KHILNA SAMAT
Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.
The “ICH GCP E6(R3) ANNEX I” module is essential for anyone involved in clinical research. This module provides a thorough understanding of the latest updates to Good Clinical Practice guidelines, focusing on the roles and responsibilities of IRBs/IECs, investigators, and sponsors. You will also gain insights into data governance and decentralized clinical trials, ensuring you are up-to-date with the latest industry standards and regulations.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the key changes in IRB composition.
✓ Learn the importance and execution of decentralized clinical trials.
✓ Master definitions, responsibilities, and key changes for investigators and sponsors.
✓ Gain insights into data governance and its critical role in clinical trials.
KHILNA SAMAT
Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.
This advanced module is designed to help you thoroughly understand the latest updates and key changes in the ICH GCP E6(R3) guidelines. Delve into the appendices that are critical for ensuring compliance and excellence in clinical trials. Equip yourself with the knowledge to effectively manage clinical trial documents and processes, ensuring patient safety and data integrity.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the definition, purpose, and key changes of the Investigator’s Brochure (IB).
✓ Learn about the Estimands and Bayesian design in the Clinical Trial Protocol.
✓ Explore the essential records required for conducting a clinical trial.
✓ Master the key changes and focus areas of E6(R3) guidelines.
✓ Ensure compliance with updated regulatory standards and improve your clinical research practices.
KHILNA SAMAT
Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.
This exam will help you apply your newly acquired knowledge and skills, covering a wide range of topics from the certificate program to ensure your readiness for a position in clinical research.
Explore the full curriculum in pdf and receive email reminders when enrollment closes:
Enrolment closes in
Online Self-paced
learn at your own schedule and pace
6 small monthly payments
one discounted payment
one payment – access forever
We pride ourselves on high-quality programs. That’s why we offer a 5-day no-questions-asked 100% money-back guarantee. If for any reason you are unhappy, you will get a full refund.
Your membership to VIARES includes everything you need to excel in your clinical research career.
Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.
Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.
Develop the latest and most in-demand clinical research skills with 100% online and globally recognized courses.
VIARES is known by the world’s leading organizations for for clinical reasearch providing you with the best training for your future dream job!
With VIARES you also get support with finding your clinical research dream job.
VIARES’ digital certificates are a proven way to showcase that you mastered a new skill and upgrade your resume to land your next dream job.
What You’ll Gain:
Course Highlights:
Elevate Your Professional Skills Today! Join a community of forward-thinking professionals adapting to the evolving pharmaceutical landscape. Enroll now and be at the forefront of the ICH-GCP (R3) transition!
Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:
We also show you how to best share your certificate on LinkedIn and other social media platforms.
There are several reasons why you might consider getting a CRA certification:
Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.
Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.
Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.
Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.
Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.
No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).
Navigating ICH GCP E6(R3)
| 5 star | 92% | |
| 4 star | 5% | |
| 3 star | 3% | |
| 2 star | 0% | |
| 1 star | 0% |
Verified ownerReally good work and presentations. I wish live also be a part of it. Otherwise the course is excellent
Verified ownerVIARES ACADEMY ALL-In-One Accelerator
Verified ownerClinical Research Associate Accelerator
Verified ownerClinical Research Associate
Verified ownerClinical Study Coordinator II
Verified ownerVIARES Micro Certificate DOUBLE-BLIND STUDY
Verified ownerCliniical Research associate Tutorials were very clear and tutors very friendly. Queries were responded to very promptly.
Verified ownerVIARES Micro Certificate PHASES OF CLINICAL TRIALS
Verified ownerVIARES Micro Certificate PHASES OF CLINICAL TRIALS
