Fundamentals of Good Clinical Practice: Prep and Personnel

Novartis via Coursera

Go to Course: https://www.coursera.org/learn/fundamentals-of-gcp-prep-staffing

Syllabus

Preparing for a Clinical Trial

In Week One, you'll learn about the preparations and qualification criteria required for an Investigator and their site to participate in a Clinical Trial, and learn about Site Selection Visits.

Preparing for a Clinical Trial, part 2

In Week Two, you'll continue to learn about the preparations and qualification criteria required for an Investigator and their site to participate in a Clinical Trial. Topics include essential documents, the role of the Institutional Review Board / Independent Ethics Committee (IRB / IEC), and source data and ALCOA+.

Investigator and Site Staff

In Week Three, you'll learn about the role and responsibilities of a Primary Investigator, including practical advice and guidance on how to succeed in the role. You'll also learn about how site staff support a clinical trial.

Overview

Welcome to 'Fundamentals of Good Clinical Practice: Prep and Personnel'! This course is designed to introduce you to preparing for a clinical trial. This is Course Two in the Clinical Trial Teams series - the first course 'Introduction to Good Clinical Practice' provides background on what clinical trials are as well as the basic principles and practices of GCP. If you are new to the world of clinical research, we suggest starting your journey with Course One. In Course Two, we turn our atten

Skills

Reviews

The course was well designed, thorough, accurate and informative. The assessments were fair and thoughtful. Thanks Novartis.

This course was not only informative, but also provided questions throughout videos to ensure the retaining of correct information.

This course helped me a lot to have a better understanding of good clinical practice.

Amazing course with great examples throughout the course. Thanks for the training but it did not receive certificate even after completion.

Interesting course with a lot to learn. Much appreciated ?