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Fundamentals of Clinical Trials

Build a strong foundation in clinical trials and prepare for your ICH GCP certification. Ideal for beginners and non-clinical professionals.

⭐⭐⭐⭐⭐  4.8 — 94 verified reviews      6,000+ certified professionals

Expert author: Adam Williams

1h 40m

Average study time

€97

Price

English

LANGUAGE

Yes

Final Exam

Professionals from these organisations have completed our training

Certification

Upon completion, you will receive an official certification, downloadable and shareable on LinkedIn, and fully qualifying you to work on international clinical trials globally.

Description

Get a solid foundation in clinical research and trial execution.

Designed for newcomers, non-clinical professionals, new Study Coordinators, Sub-Investigators, and CRO/pharma staff, this course walks you through drug development phases, trial design, ethical standards, and ICH GCP principles.

This course is ideal if you work on Phase II/III sites and need practical, real-world knowledge without taking a full, lengthy GCP certification course.

What you will learn?

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

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

Who should enrol?

  • Persons expecting to start a career in clinical research
  • Persons starting a Study Coordinator or
  • Sub-Investigator role in a multi-centre trial
  • Persons starting a career as staff at contract research organisations (CRO) and/or pharmaceutical companies who will be involved in clinical trials for the first time
    Staff from University Hospitals, Research institutes, and research nurses

Curriculum

  • What is GxP in pharma industry?
  • What is ICH GCP E6?
  • The origin and history of ICH GCP
  • 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
  • A brief overview of clinical research
  • Drug Discovery and Development
  • Composition, Functions, Operations,
  • Procedures 
  • Reasons for Conducting Trials
  • Clinical Trials Design
  • Pharmacokinetics and Pharmacodynamics
  • Study Endpoints
  • Scientific integrity of clinical trials

Reviews

⭐⭐⭐⭐⭐ What 6,000+ certified professionals say

FAQ: Fundamentals of Clinical Trials

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.

Select a course and purchase it. You can pay online via our secure Stripe payment gateway, using your preferred card, at no extra cost. The system will automatically create you an account, and you will be able to start your training. 

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. To support the lifelong learning of our researchers, we provide lifetime access to our course resources.

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 30-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.

Fundamentals of Clinical Trials online course — introduction to clinical research, drug discovery, and GCP basics

This course includes:

  • 🎓 Downloadable certification
  • ♾️  Lifetime access
  • 📊 Automated progress tracking
  • 💰 Discounts for teams

🛡️30-day money-back guarantee 

100% Secure Payment 🔒

KEY LEARNING OBJECTIVES

Guarantee Good Clinical practice training and Certification

 

30-day money-back guarantee: Try the full course risk-free. If you’re not satisfied before completing it, we’ll refund you, no questions asked.

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