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Coursera

Fundamentals of Good Clinical Practice: Recruitment & Trial

Novartis via Coursera

Overview

Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'! This is the third course in the Clinical Trial GCP series. It is designed to introduce you to the processes, procedures and documentation needed prior, during and after a clinical trial according to Good Clinical Practice (GCP). In Courses One and Two, we explored the foundations of clinical research, including the preparations and documentation needed to begin a trial as well as the role of the investigator, site staff and the IRB/IEC. We conclude our GCP studies with this final course. The course is divided into several modules, each covering specific stages of a clinical trial. The modules include a variety of videos, a fictional case study and interactive quizzes to reinforce your learning. Enroll now and start building a strong foundation in the conduct of clinical research!

Syllabus

  • Recruitment & Enrollment of Patients
    • In Week One, you'll learn about the processes for recruiting and enrolling patients, including how to build a recruitment plan.
  • Patient consent and working with vulnerable subjects
    • In Week Two, we’ll focus on the consent process, and also discuss what to consider when working with vulnerable patient groups.
  • Conducting a Clinical Trial
    • In Week Three, you'll learn about key documentation, and processes and procedures that occur when conducting a clinical trial which help to ensure protocol compliance. We also cover the steps involved in closing out and archiving a trial.

Taught by

Novartis Learning

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4.9 rating at Coursera based on 16 ratings

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