Consent Preferences

Fundamentals of Clinical Trials

Essential course covering the fundamentals of clinical trials: clinical drug discovery, clinical drug development, and the clinical trial design process. The perfect base for your ICH GCP training and certification. Ideal for people new to clinical trials, those from non-clinical backgrounds, or those embarking on a new career in clinical research.

1h 40m

Average study time

€97

Price

English

LANGUAGE

This comprehensive course provides the fundamentals of clinical trials, covering the essential phases, clinical drug discovery, clinical drug development, and the clinical trial design process required for successful study execution. Start your journey into clinical research with a deep understanding of core ethical and regulatory requirements.

This course is designed for people who are new to clinical trials or come from non-clinical backgrounds. It will benefit those starting a Study Coordinator or Sub-Investigator role in a multi-centre trial, as well as staff at contract research organisations and sponsoring pharma companies who will be involved in clinical trials for the first time. It is also ideal for staff who need a grounding in the clinical trial process without the need to do the entire ICH GCP course. It focuses on the practical aspects of conducting phase II or III clinical trials at a site.

This course covers the history of the ICH GCP Guidelines, ethical considerations, a brief review of the GCP Guidelines’ key points, the drug development process and its phases, and clinical trial design concepts. Participants will gain important knowledge about how Good Clinical Practice (GCP) is applied in real-world settings.

This course is designed to be international in scope. To learn more about specific guidelines for your location, please refer to the regulatory body that oversees drug and device development in your country.

KEY LEARNING OBJECTIVES

Upon completion of this course, you will be able to:

  1. Understand what GxP means in the pharma industry
  2. Analyze the principles of ethical research
  3. Know what ICH GCP is and why it was developed
  4. Describe key roles involved in the clinical research process
  5. Explain what a clinical trial protocol, an Investigator’s brochure, and essential records are
  6. Explain why clinical trials are performed
  7. Distinguish the different phases in the drug discovery and development
  8. List key elements to maintain the scientific integrity
  9. Understand the reasons to conduct clinical trials
  10. Understand the rationale of the different types of study designs
  11. Understand what pharmacokinetics and pharmacodynamics are
  12. Comprehend what study endpoints are and why they are necessary

Who should attend this training?

METHODOLOGY

Learning Path

  • Chapter Objectives

  • What is GxP in pharma industry?

  • What is ICH GCP E6?

  • The origin and history of ICH GCP

  • Summary

  • Chapter Objectives

  • Definition and purpose of ICH GCP

  • The Principles of ICH GCP

  • The clinical research team

  • The Clinical Trial Protocol

  • The Investigator Brochure

  • The Essential Documents

  • Summary

  • Chapter Objectives

  • A brief overview of clinical research

  • Drug Discovery and Development

  • Composition, Functions, Operations, Procedures 

  • Summary

  • Chapter Objectives

  • Reasons for Conducting Trials

  • Clinical Trials Design

  • Pharmacokinetics and Pharmacodynamics

  • Study Endpoints

  • Scientific integrity of clinical trials

  • Summary

BENEFITS

Ready to start your training?

Guarantee Good Clinical practice training and 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.

Check out our testimonials

FAQs about Good Clinical Practices Certification

This Fundamentals of Clinical Trials course provides a certificate of completion. While it is a crucial prerequisite, it is not the official ICH GCP certification. We recommend completing this course first, followed by our dedicated ICH GCP training course to earn the specific official certification.

Good Clinical Practice training (GCP) focuses primarily on the ethical and quality standards for conducting trials. Our Fundamentals of Clinical Trials course offers a broader scope, covering the entire lifecycle: drug discovery, drug development and clinical trial design understanding before specializing in GCP.

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.

📍163 essential terms that every clinical research professional should know!

Glossary of clinical research terminology

DOWNLOAD FOR FREE

📢Includes ICH GCP E6 R3 Updates! 🚀