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About this course
Clinical trial monitoring is the oversight and administrative efforts to ensure that a clinical trial is conducted, recorded, and reported according to the study protocol and the International Council for Harmonisation of Good Clinical Practice (ICH-GCP). This is performed based on the guidance of the monitoring plan laid out by the sponsors and investigators of a clinical trial.
The Introduction to Clinical Trial Monitoring short course provides students the essential knowledge of clinical trial monitoring and expert’s tips on how to perform different types of monitoring visits (initiation, interim, close-out) and various skills required for effective oversight for each visit including source data verification (SDV), drug accountability, Investigator Site File (ISF) review. You will also be introduced to risk-based clinical trial monitoring and management.
What you’ll learn
You will learn the following topics in this short course:
| MODULE NAME |
| Introduction to Clinical Trial Monitoring |
| Types of Monitoring Visits |
| How to perform a Qualification Visit |
| How to perform a Site Initiation Visit |
| How to perform an Interim Monitoring Visit |
| How to perform a Close-Out Visit |
| Clinical Trial Monitoring Plan |
| Role and Responsibilities of a Clinical Research Associate |
| Source Document Verification |
| Risk-Based Monitoring |
| Final Quiz (1 hour) |
Who is this course for?
This course is ideal for individuals interested in a career as a Clinical Research Associate (CRA). No prior clinical research experience is necessary.
Please note, this course does not cover everything you need to know to be a CRA. It only covers the Clinical Trial Monitoring aspect of the role. For the comprehensive program, please refer to our signature CRA Industry-Bridging program.
Requirements
Nil
Duration
The course, quizzes and supplemental materials are designed to be completed in approximately 50 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 Clinical Trial Monitoring 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
$1556 inc. GST
