In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements of the Institutional Review Board (IRB) / Ethics Committee (EC), and all applicable regulations.
In addition, the goals of monitoring should include:
- identifying and addressing non-compliance
- improving quality and promoting high standards
- identifying research misconduct or fraud
What steps can be taken to ensure monitoring goals are achieved? Please take time to download our guide.