ICH GCP E6 R3 Good Clinical Practice Training
for investigators and site personnel
The goal of this short ICH GCP E6 R3 Good Clinical Practice training online for investigators is to provide you with a practical review of ICH GCP guidelines, allowing you to retain and apply the information. It is also ideal as a GCP refresher, as it meets TransCelerate criteria.
The goal of this ICH GCP training is to train investigators and site personnel on all of the specific topics that TransCelerate BioPharma, Inc. has identified as necessary to enable mutual recognition of GCP training.
This online ICH GCP course is ideal for clinical trial staff with ICH GCP experience who are taking the course as a GCP refresher. You will receive an official Good Clinical Practice certification that is widely recognized by all sponsors and CROs.
You will learn how to apply good clinical practices in your daily work, at your own pace, with interactive content and real-life case studies. Successful completion (pass mark is 80%) of the exam will earn you a Good Clinical Practice Certification.
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. Recognize the investigator’s obligations
4. Recognize Data Governance requirements for Investigator and Sponsor
5. List the Essential records required for the conduct of a clinical trial
6. ICH GCP E6 R3 Glossary
7. Key takeaways
8. Final Exam
9. Supplementary Chapter: ICH GCP Across the globe
Who should attend this ICH GCP training online?
- Physicians and staff working in health institutions (e.g., nurses, etc.) expecting to start a career in clinical research and requiring a documented Good Clinical Practice Certification.
- Experienced physicians, investigators and clinical research staff (e.g. nurses, study coordinators, etc) requiring a documented Good Clinical Practice Certification.
- Investigators 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 the ICH-GCP E6 guideline to easily find the source material.
- The final exam is a multiple-choice questionnaire.
Learning Path
- What is ICH GCP
- Guideline Scope
- Guideline Structure
- The need for the ICH E6 R3 guideline
- The Principles of ICH GCP
- Summary
- General considerations
- Qualifications & Training
- Responsibilities and 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
- Record keeping
- Documentation and Reporting
- The investigator’s role in risk management
- Data processing and storage (GDPR)
- Data Governance and Data Integrity
- Safeguard Blinding in Data Governance
- Data Life Cycle Elements
- Computerised Systems
- Essential records
- New Glossary
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 training
Ready to get your good clinical practice certification?
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.
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FAQs about Good Clinical Practices Certification
GCP training is required for research teams involved in clinical trials of drugs, biologics, and devices research studies.
- 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.
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 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%.
Yes, our 3 GCP courses are mutually recognized by TransCelerate BioPharma. You could review each course in detail on the COURSE page.
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.
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%.
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.
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.
Yes, please contact us to discuss your team needs.
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.
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.
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.
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.
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.
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.