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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) 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. Once you have viewed the required parts, 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:

  • Describe quality management.
  • Describe the purposes, regulations, and guidances related to monitoring of clinical trials. 
  • Discuss the difference between monitoring and auditing.
  • Describe three types of sponsored study visits.
  • Describe the preparation required for and what is reviewed during a monitoring visit.
  • Describe three types of audits conducted for clinical trials



 Part 1

Quality Management in Clinical Research (57 minutes)Part 1 Handout Resources  Evaluation
 Part 2FDA Clinical Investigator Inspection:
Part 1(28 minutes)
Part II (30 minutes)

Part 2, Part 1 Handout
 Data and Safety Monitoring Committees (92 minutes)





Last updated by Ness, Elizabeth (NIH/NCI) [E] on Jul 24, 2016