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About this course
To comply with regulatory requirements pertinent to clinical trials, every organisation involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. These essential documents are stored in the trial master file (TMF). The TMF is created specifically for each clinical study.
The Trial Master File (TMF) maintenance short course provides students the
knowledge and skills essential for setting up and maintaining a TMF throughout the duration of a clinical trial for regulatory inspection-readiness. This course also includes the essential documents that make up the TMF and the requirements of the Clinical Trials Regulation for management and archiving of the TMF.
What you’ll learn
You will learn the following topics in this short course:
| MODULE NAME |
| Types of Trial Master File and its importance in clinical trials |
| TMF checklist and plan |
| TMF Reference Model |
| Essential documents required before/during/after a clinical trial |
| How To Perform TMF Review For A Clinical Trial |
| Final Quiz (1 hour) |
Who is this course for?
This program is ideal for individuals interested in a career in Clinical Research.
Requirements
Nil
Duration
The course, quizzes and supplemental materials are designed to be completed in approximately 20 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 Trial Master File maintenance 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
$928 inc. GST
