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About this course
Translating medical discoveries into life-saving biologics or medical devices is a cornerstone of modern medicine through improving the treatment of and/or preventing human diseases. This enterprise is a multi-step process requiring in-depth knowledge and know-how of drug development, regulatory requirements, clinical monitoring, operation and management, market intelligence, and a strong understanding of research methods and medicine. All these aspects constitute the field of Clinical Research.
Knowledge of international “gold standard” for good clinical practice is “mandatory” in Clinical Research.
The International Council for Harmonisation Good Clinical Practice (ICH-GCP) short course provides students the knowledge essential for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, safety, and confidentiality of trial patients are protected.
What you’ll learn
You will learn the following topics in this short course:
| MODULE NAME |
| What is Good Clinical Practice in clinical trials? |
| History of ICH-GCP |
| Why ICH-GCP is important in clinical research? |
| Principles of ICH-GCP |
| Roles and Responsibilities Of The Investigator and Site Personnel Per ICH-GCP |
| Roles and Responsibilities Of Trial Sponsor Per ICH-GCP |
| Final Quiz (1 hour) |
Who is this course for?
This short course is the minimum requirement for any individuals interested in a career in Clinical Research.
Requirements
Nil
Duration
The course, quizzes and supplemental materials are designed to be completed in approximately 30 hours at your own pace. You have up to 365 days from purchase date to complete the course.
Course Delivery
The course is delivered online through our Member’s Portal.
Certification
- To obtain the completion certificate for ICH-GCP course, you will need a score of ≥ 80% to pass all your assessments.
- You can retake a single module mini quiz as many time as you wish
- You are allowed 2 attempts to pass the final quiz. Failing both attempts requires you to contact us at info@clueoclinical.com.
If you meet these criteria, your certificate of successful completion will be emailed to you within 48 hours after you finish the course.
Course Fee
$1,071 (inc. GST)
