Clinical Research Operations

Monitoring and Auditing in Clinical Trials

Monitoring and auditing of clinical trials is necessary to assure the rights and safety of patients (i.e., human subjects, research participants) are protected, reported trial data are accurate, complete, and verifiable from source documents, and the conduct of trial is in compliance with protocol, good clinical practice (GCP) and applicable regulatory requirements. This module has one video to review which discusses quality management activities in clinical research, and 1 recommended video. Once you have viewed the required video, please link to the evaluation after which you will be directed to a certificate of completion for your education records. 

Module Objectives

At the conclusion of this module, learners will be able to:

• Define quality management.
• Describe the purposes, regulations, and guidances related to monitoring of clinical trials. 
• Explain the difference between monitoring and auditing.
• Describe the different types of monitoring plans.
• Describe the preparation required for and what is reviewed during a monitoring visit.