ICH GCP E6 R3 Good Clinical Practice training
This ICH GCP E6 (R3) training covers the full updated guideline, including Annex 1 and Annex 2. On completion, you'll receive a Good Clinical Practice certification that meets TransCelerate criteria and is accredited by the Faculty of Pharmaceutical Medicine (UK), offering participants the opportunity to earn 8 CPD points.
The objective of this ICH GCP Good Clinical Practice training is to train clinical research professionals and anyone involved in clinical research, providing individuals with an official Good Clinical Practice Certification that is widely accepted by all sponsors and CROs.
This ICH GCP training course covers all sections specified by the ICH GCP E6 R3 guideline and meets the training requirement for you to participate in international clinical trials. This ICH GCP training provides you with a practical review of good clinical practice guidelines, allowing you to retain and apply the information
You will learn how to apply good clinical practices in your daily work at your own pace, using interactive content and real-world case studies. You will obtain an ICH GCP Certification after passing the test with a score of 80%.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of ICH GCP training among trial sponsors. Additionally, it is accredited by the Faculty of Pharmaceutical Medicine (UK) and offers participants the opportunity to earn 6 CPD points.
KEY LEARNING OBJECTIVES
Upon completion of this course, you will be able to:
1. Summarize the purpose of the ICH GCP guidelines
2. List ICH GCP Principles
3. Comprehend the role of the IRB/IECs, Investigators, Sponsors/monitor, and appropriate data governance;
4. Understand what an Investigator Brochure is
5. List essential records required for the conduct of a clinical trial
6. Explain the purpose and scope of Annex 2 and its integration with Annex 1 and the core principles of GCP.
7. Implement Quality by Design (QbD) and proportionality principles to customize quality assurance measures based on trial design, risks, and critical-to-quality factors.
8. Adapt informed consent processes and investigational product (IP) management to suit remote, hybrid, and pragmatic trial settings while ensuring accountability and safety.
9. Evaluate investigator responsibilities in delegating tasks and overseeing data collection, ensuring reliability across both “usual clinical practice” (e.g., EHR) and DHTs acting as data acquisition tools.
10. Assess sponsor responsibilities in protocol design, vendor/service provider management, and the ethical use of diverse data sources, including RWD.
11. Identify and mitigate data-related risks, including variability, missing data, cybersecurity vulnerabilities, and confidentiality breaches, using a risk-based approach.
12. Develop the critical thinking skills necessary to interpret Annex 2 guidance and apply it proportionately to evolving trial technologies through interactive case studies and simulations
13. Supplementary Chapter: ICH GCP across the globe
Who should attend this ICH GCP Good Clinical Practice training?
- Persons expecting to start a career in clinical research within Pharmaceutical Companies or CROs, as CRAs / Monitors, Clinical Leads, Project Managers, etc.
- Experienced clinical research staff (Personnel from Pharmaceutical companies and CROs, as CRAs / Monitors, Clinical Leads, Project Managers, etc) requiring a documented Good Clinical Practice Certification.
- New or experienced physicians, investigators and clinical research staff requiring a documented Good Clinical Practice Certification.
- Staff from University Hospitals, Research institutes, research nurses
- Ehics committee members
METHODOLOGY
- it is Interactive with an attractive format
- You will be able to solve problems through the course to reinforce your learning.
- We cross reference to the ICH-GCP E6 document, to easily find the source material.
- The final exam is a multiple-choice questionnaire.
Learning Path
- What is ICH GCP?
- GCP Guideline Scope
- ICH-GCP E6 R3 Guideline Structure
- Important Definitions
- Summary
- Principles of ICH GCP
- Summary
- INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
- Submission and Communication
- Responsibilities
- Composition, Functions and Operations
- Procedures
- Records
- INVESTIGATOR
- Qualifications & Training
- Resources
- Communication with IRB/IEC
- Compliance with Protocol
- Premature Termination or Suspension of a Trial
- Participant Medical Care and Safety Reporting
- Informed Consent of Trial Participants
- End of Participation in a Clinical Trial
- Investigational Product Management
- Randomization Procedures and Unblinding
- Records
- Reports
- SPONSOR
- Trial Design
- Resources
- Allocation of Activities
- Qualification and Training
- Financing
- Agreements
- Investigator Selection
- Communication with IRB/IEC and Regulatory Authority(ies)
- Sponsor Oversight
- Quality management
- Quality Assurance and Quality Control
- Noncompliance
- Safety Assessment and Reporting
- Insurance / Indemnification / Compensation to Participants and Investigators
- Investigational product
- Data and Records
- Reports
- DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
- Data Governance
- Safeguard Blinding in Data Governance
- Data Life Cycle Elements
- Computerised Systems
- APPENDIX A: Investigator’s BROCHURE
- Introduction
- General Considerations
- Contents of the Investigator’s Brochure
- Summary
- APPENDIX B: CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENTS
- Clinical Trial Protocol and Protocol Amendments
- Summary
- Appendix C: ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
- Essential records
- Summary
- Advisory and regulatory bodies
- Important laws
- USA legislation
- EU legislation
- Japan legislation
- UK legislation
BENEFITS
- Study in your own time
- ICH GCP Good Clinical Practice online training, available 24/7
- Get instant, printable and recognised Good Clinical Practice Certification
- Obtain discounts for multiple purchases and corporate clients
- Keep track of your progress and continue where you left off.
- Affordable ICH GCP certification
Get your Good Clinical Practice certification here
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30-day money-back guarantee: If you’re not satisfied, request a refund with proof of purchase and issue details. Refunds apply only if the course is incomplete and no certificate has been printed. Contact us at contact@pharmaeducenter.com.
FAQ: Good Clinical Practice certification and Good Clinical Practice training program
Does this Good Clinical Practice certification cover the latest ICH E6 (R3) updates?
Yes, our Good Clinical Practice certification is fully updated to include ICH E6 (R3), ensuring you stay compliant with the latest regulatory changes.
Who is this Good clinical practice training designed for?
This Good clinical practice training is designed for life science professionals, including CRAs, Investigators, and Sponsors, who need a recognized certification that meets TransCelerate criteria.
Is the Good Clinical Practice certification accepted globally?
Absolutely. Our certification follows the harmonized ICH guidelines, making it globally accepted for clinical research professionals in the US, EU, and beyond.
How do I know which GCP training should I take?
- ICH GCP E6 R3 Good Clinical Practice training: is suitable to train clinical research professionals (those working in the Pharmaceutical Industry and CROs, as for example, CRAs/Monitors) that need a more comprehensive knowledge of ICH GCP. This GCP training is also ideal for people just starting or willing to start working in the Pharmaceutical industry, CROs or Clinical Sites, as it provides comprehensive and practical knowledge of the ICH GCP Guideline.
- ICH GCP E6 R3 Good Clinical Practice training for investigators and site personnel : is suitable to train clinical investigators and site personnel (in English and Spanish, respectively) on the fundamentals of GCP and how to apply them practically in the research setting. It is also ideal as a GCP refresher, as it meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training.
How long is the ICH GCP certification course?
This will depend on the course; nevertheless, learners may complete the modules at their own pace
GCP training for Investigators will approximately take around 2.5 hours to complete, as it is mainly focused on Investigator’s responsibilities.
Full GCP course will take around 6 hours to complete.
How long is the GCP certificate valid?
How long is GCP training valid? This is a recurring question. Nevertheless, there is no uniform standard regarding how frequently GCP training should occur. However, regulatory authorities and auditors/inspectors usually require Good Clinical Practice training to be refreshed every 3 years. Please check your country’s regulations.
A quiz is also required in order to obtain the Good Clinical Practice Certification. Usually, the passing score is greater than or equal to 80%.
Are PharmaEduCenter GCP courses mutually recognized by TransCelerate BioPharma?
Yes, our 3 GCP courses are mutually recognized by TransCelerate BioPharma. You could review each course in detail on the COURSE page.
Do I get a certificate?
Yes. When you complete a GCP training course with PharmaEduCenter, you will receive an electronic copy of the certificate, which you can print. This will include information about the course you took as well as the date you completed it. You can then save this for your records.
Is there an examination?
Yes, at the end of each GCP course there is a quiz you will need to pass in order to demonstrate you have acquired the knowledge and are appropriately trained. The passing score is greater than or equal to 80%.
Will your GCP training help me get a job?
Although we cannot guarantee you a job if you enroll in our GCP courses, we believe that by doing so, you are providing yourself with a great opportunity to advance in your career by expanding your knowledge and skill set and staying current with industry developments. Furthermore, upon course completion, you will have the option to print the GCP course certificate, which includes all the reviewed topics.
You should include your GCP training in your work portfolio to demonstrate your knowledge to prospective/current employers.
Do I get a discount if I buy more than one course?
If you sign up for our newsletter, you will see discounts being sent out periodically for single users.
We offer discounts for more than five accounts, so please get in touch with us to discuss a discount if you need to buy a course for multiple users.
Can I purchase a corporate license for a group of people?
Yes, please contact us to discuss your team needs.
How do I purchase a course?
When you select a GCP course, the system will allow you to start for free. Then, if you want to move forward with the course, you will need to create an account and purchase it. You can pay online via our secure Stripe’s payment gateway, using your preferred card, at no extra cost.
How do I use a discount code?
If you have a discount code, you must complete the course registration process as usual. Then, when you get to the screen where you have to enter your information and make payment, there will be a field where you can enter a discount code, if any. If the code worked, the course’s price will be updated to reflect the new discounted price.
Then, proceed to sign up as usual, entering all of your information.
What does it mean that I can take the course at my own pace?
It means that it is flexible enough to allow you to start and stop from any device whenever you like, and the system will automatically save your progress. You will have 3 months to complete your GCP certification.
What is the difference between medical reasearch and clinical research?
Although they are both vital to the development of medicine, clinical and medical research have different goals and purviews.
Any research that attempts to deepen our understanding of human health and disease is included under the broad category of medical research. Among other sorts of studies, it might include population-level research, epidemiological studies, or simple laboratory research. Identifying the underlying causes of disease, creating new diagnostic instruments, or investigating novel treatment approaches are all common goals of medical research.
Contrarily, clinical research is a branch of medical research that focuses on investigating novel medications, therapies, or interventions in human subjects. Clinical research can involve conducting clinical trials to test novel medications, medical devices, or procedures. It frequently entails conducting meticulously controlled studies to evaluate the side effects, efficacy, and safety of these interventions.
If a person is interested in investigating more general issues regarding human health and illness, such as comprehending the underlying mechanisms of a disease or determining risk factors for a specific condition, they may opt for medical research over clinical research. On the other hand, if a person is eager to test a novel intervention on humans in order to ascertain its efficacy and safety, they might opt for clinical research.
For the purpose of expanding our knowledge of human health and disease and enhancing medical treatment, both clinical and medical research are essential. Together, these complimentary methods enhance patient outcomes and progress medicine.
Will there be a record of my completion of your GCP course?
Yes, we keep track of all of our users and the dates on which they took our course. You, or your employer, may contact us at any time to confirm the validity of your certificate.
Do you have a refund policy?
We want you to be completely satisfied with your course; therefore, we offer a 14-day money-back guarantee if you are not 100% satisfied.
To request a refund, you should email us at contact@pharmaeducenter.com with proof of purchase and evidence of the course not being as advertised or any issues you have accessing or completing your course.
Please note you must not complete the course or print your certificate in order to make a valid refund claim.
