Study ConductGlossary Term
ICH E6(R3) Section 5.18
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Monitoring constitutes the primary mechanism by which sponsors maintain oversight of clinical trials and fulfill their regulatory obligation to ensure proper trial conduct. Through systematic evaluation of trial activities and documentation, monitoring aims to protect the rights and well-being of trial subjects, verify that reported data are accurate, complete, and verifiable against source documents, and confirm that the trial is conducted in compliance with the protocol, GCP, and applicable regulations.
Monitoring activities encompass both on-site and centralized approaches. On-site monitoring involves physical visits to investigational sites, where monitors review source documents, verify data accuracy, assess regulatory compliance, and evaluate site processes. Centralized monitoring involves remote review of accumulating data to identify patterns, trends, and inconsistencies that may indicate problems with data quality, site performance, or protocol compliance. Modern monitoring strategies typically combine both approaches, leveraging the complementary strengths of each.
The extent and nature of monitoring should be determined by the sponsor based on a risk assessment that considers factors such as the trial's objectives, complexity, and endpoints; the volume and complexity of data collected; the risks to participants; and the performance history of investigational sites. This risk-based approach, emphasized in ICH E6(R3), allocates monitoring resources to activities most likely to protect participants and ensure data quality, rather than applying uniform monitoring intensity regardless of risk.
Routine monitoring visit
"During the monitoring visit, the CRA reviewed new participant enrollments, verified informed consent documentation, performed source document verification on selected data points, and assessed investigational product accountability."
Remote monitoring
"The centralized monitoring team analyzed data patterns across all sites weekly, identifying one site with an unusually high screen failure rate that warranted further investigation during the next on-site visit."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.
ICH E6(R3) Section 5.18
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Monitoring constitutes the primary mechanism by which sponsors maintain oversight of clinical trials and fulfill their regulatory obligation to ensure proper trial conduct. Through systematic evaluation of trial activities and documentation, monitoring aims to protect the rights and well-being of trial subjects, verify that reported data are accurate, complete, and verifiable against source documents, and confirm that the trial is conducted in compliance with the protocol, GCP, and applicable regulations.
Monitoring activities encompass both on-site and centralized approaches. On-site monitoring involves physical visits to investigational sites, where monitors review source documents, verify data accuracy, assess regulatory compliance, and evaluate site processes. Centralized monitoring involves remote review of accumulating data to identify patterns, trends, and inconsistencies that may indicate problems with data quality, site performance, or protocol compliance. Modern monitoring strategies typically combine both approaches, leveraging the complementary strengths of each.
The extent and nature of monitoring should be determined by the sponsor based on a risk assessment that considers factors such as the trial's objectives, complexity, and endpoints; the volume and complexity of data collected; the risks to participants; and the performance history of investigational sites. This risk-based approach, emphasized in ICH E6(R3), allocates monitoring resources to activities most likely to protect participants and ensure data quality, rather than applying uniform monitoring intensity regardless of risk.
Routine monitoring visit
"During the monitoring visit, the CRA reviewed new participant enrollments, verified informed consent documentation, performed source document verification on selected data points, and assessed investigational product accountability."
Remote monitoring
"The centralized monitoring team analyzed data patterns across all sites weekly, identifying one site with an unusually high screen failure rate that warranted further investigation during the next on-site visit."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.