Monitoring in clinical trials

Monitoring in clinical trials is a critical activity that ensures the rights, safety, and well-being of trial subjects are protected, and that the trial data are accurate, complete, and verifiable from source documents.

Purpose

The main purpose of monitoring in clinical trials is to verify that:

• The rights and well-being of human subjects are protected.
• The reported trial data are accurate, complete, and verifiable from source documents.
• The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with Good Clinical Practice (GCP), and with the applicable regulatory requirement(s).

Methods

Monitoring in clinical trials can be done in various ways:

• On-site monitoring: This is the traditional method of monitoring. It involves the monitor visiting the site where the clinical trial is being conducted.
• Centralized monitoring: This is a remote evaluation of accumulated data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians).
• Risk-based monitoring: This is a method that uses a combination of centralized and on-site monitoring practices to oversee a clinical trial effectively.

Responsibilities

The sponsor is responsible for ensuring proper monitoring of the clinical trial. The sponsor may delegate this task to a Contract Research Organization (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.

Regulations

Monitoring in clinical trials is regulated by various international guidelines and regulations, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) E6(R2).

See also

• Clinical trial
• Good Clinical Practice
• Contract Research Organization
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use