Program Overview

The sponsor of a clinical trial must arrange for it to be monitored, throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents and the conduct of the trial complies with the study protocol, good clinical practice and regulatory requirements. Additional training and professional development required for those already working in the field as CRA.

Learning Outcomes

  • Describe how to prepare for and carry out regular monitoring visits to investigational sites
  • Describe how to review case report forms (CRFs) and verify consistency of data with source documents
  • Describe how to close out a trial at a site
  • Discuss the concept and implications of risk-based monitoring
  • Identify warning signs that raise suspicion of scientific misconduct or fraud

Career Options

A Clinical Study Monitor can work in a broad range of research settings, such as health centers, Federal Drug administration (FDA), and contract research Organizations (CRO), pharmaceutical, biotechnology and Medical device development companies.