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Navigating ICH GCP E6(R3)

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.

What you will learn

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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).

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Gain proficiency in the new regulatory requirements and ethical considerations for clinical trials, including changes to IRB/IEC compositions, investigator responsibilities, and data governance.

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Master the nuances of the new appendices, including updates on the Investigator’s Brochure, clinical trial protocols, and essential records for clinical trials.

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Equip yourself with the knowledge to implement the revised guidelines effectively in your professional role, ensuring compliance with the latest industry standards.

Why VIARES?

✓ Globally accredited & industry recognized
✓ Join 9,000+ members worldwide
✓ Making you the best candidate for the job
✓ All the tools you need to level up your career

Program structure

ICH GCP E6(R3) PrinciplesBEGINNER
1 lessons • 1 knowledge check • 10 hours
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MASTER THE LATEST GCP 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.

Your instructor:

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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.

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Master the Latest Updates in Clinical Research Standards

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.

Your instructor:

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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.

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MASTER THE NEW STANDARDS IN CLINICAL RESEARCH

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.

Your instructor:

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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:

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Online Self-paced
learn at your own schedule and pace

Duration: 30 hours
Study 3 hours a week to finish in 3 months
3 modules + official certificate
testing through quizzes + exams

Get free access to our learning portal and experience it yourself

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You can test your knowledge with our free micro-certificates, that cover some of the most important topics in clinical research.
This way you can test the learning environment before buying!

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3 months access to the Navigating ICH GCP E6(R3) course
Original price was: € 39,90.Current price is: € 19,90.

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1 Certificate Program

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Original price was: € 399,90.Current price is: € 199,90.

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All in One

Life-time access to all of our courses to elevate your clinical research career.

Original price was: € 499,90.Current price is: € 299,90.

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4.89 based on 257 reviews

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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.

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What VIARES members get

Your membership to VIARES includes everything you need to excel in your clinical research career.

Worldwide LinkedIn community

Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.

Comprehensive Resource Library

Access a vast collection of templates, tools, and playbooks to enhance your clinical research work.
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Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.

Easy Learning Portal

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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!

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With VIARES you also get support with finding your clinical research dream job.

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Grow your career

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.

Study Start Up Specialist online course clinical research
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What You’ll Gain:

  • Get ready for (R3) implementation: Get the latest changes from (R2) to (R3) and get ready to implement the new elements of the revised guideline.
  • In-Depth Understanding: Dive into the nuances of the (R3) update and grasp its impact on clinical trials and pharmaceutical practices.
  • Practical Insights: Learn how to implement these changes in your work environment with real-world examples and case studies.
  • Flexible Learning: Access the course anytime, anywhere, fitting your busy schedule without compromising on quality learning.
 

Course Highlights:

  • Detailed Breakdown of (R3) Changes: Understand every aspect of the new guidelines, from patient safety to data integrity.
  • Interactive Learning Modules: Engage with interactive content designed to reinforce your learning experience.
  • Certification of Completion: Receive a certificate upon completion, validating your expertise in the ICH-GCP (R3) guidelines.
 

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:

  • course title
  • contact hours
  • continuing education units (CEU)
  • your overall course score
  • date of completion
  • personal certificate verification code
 

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).

What alumni say about this program

Based on 257 reviews
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VIARES ACADEMY ALL-In-One

Excellent

Clinical Research Associate

The course is amazing journey into clinical research career attainment with deep insights of course units that are enriching ,from which knowledge and skills are drawn from , the course contents so far are rich and contributive to career progress.

very informative

very user friendly and lots of information to gather. Thank you

Clinical Study Coordinator Academy

Course content

Very rich course content.

Excellent

I want to say a big thank you to all VIARES Coordinators, for a well packaged program. It is so easy to understand a well-organized. I have just completed the Clinical Research Associate, it was awesome. I will recommend it to friends.

C
VIARES ACADEMY ALL-In-One
Ciprian Matcovici

VIARES ACADEMY ALL-In-One

Fabulous and super powered

The CTA was very informative and had a wide topics covered. I am a fresher to the field but now with the knowledge imparted by all the professionals, I feel empowered, Thank you all. Looking forward to complete the other courses in the All in One Academy, Thank you Viares Team

A
Clinical Research Associate Academy
Anthony Abudu
VIARES ASSESSMENT REVIEW

So far my journey here to become a CRA has been so insightful and impactful. I look forward to more exciting topics and lectures as far as the CRA program is concerned.

V
VIARES ACADEMY ALL-In-One
Vincent Alushula
Straight forward course

Very informative yet user friendly

Great information

My only critique is with the navigation. When you finish one module it should have an arrow to go to menu of next module The course content is great and informative

N
Clinical Trials Assistant Academy
Nhlamulo Wendy Baloyi

Clinical Trials Assistant Academy

Trial Master File Specialist

I want to say a big thank you to all the instructors and VIARES Academy for the great privilege to this unique ,easy to understand and accessible program. You'll have contributed immensely to my life. Good job

M
VIARES ACADEMY ALL-In-One
Maria Vilas Eiroa

VIARES ACADEMY ALL-In-One

Insightful

Alot of content relevant to my area of work.

R
Clinical Research Associate Academy
Regina Akise

Clinical Research Associate Academy

Excellent

This is awesome experience for me, the course outline is so easy to understand. Thank you Viares and all the lecturers, you all did a fantastic job. The course is 100% relevant.

N
Clinical Research Associate Academy
Nasson Chibwana
Very informative

The course structure is very simple to follow and above all the topics are taught by experts in the field.

Clinical Trials Assistant Academy

V
Clinical Research Associate Academy
Vincent Alushula
Mr Vincent

Awesome Self explanatory course. User friendly and easy to navigate and work it out. A love the fact that it keeps tabs with previous topic location.

Excellent

Excellent value for money

So far this has been a great purchase. I have completed two of the courses and am working on a third.

K
VIARES ACADEMY ALL-In-One
Karima Oumalk

VIARES ACADEMY ALL-In-One

Excellent CRA course

It is well explained and easy to understand , It opened my eyes to the highly new research world.

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