QualityGlossary Term
ICH E6(R3) Section 5.18.3
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.
Risk-based monitoring represents a fundamental shift in how sponsors approach clinical trial oversight, moving from traditional approaches emphasizing uniform, comprehensive on-site verification toward strategic allocation of monitoring resources based on identified risks. This approach, explicitly endorsed by ICH E6(R3), recognizes that not all data, sites, and processes carry equal risk to participant safety and data integrity, and that monitoring resources should be concentrated where they can have the greatest impact.
The foundation of risk-based monitoring is systematic risk assessment and management. Before the trial begins, sponsors identify and evaluate risks associated with the trial design, data collection processes, investigational product, and trial conduct activities. Critical data and processes are identified based on their importance to participant safety and primary endpoint evaluation. This assessment informs the monitoring plan, which specifies the monitoring methods, intensity, and frequency appropriate for each risk category.
Implementation of risk-based monitoring integrates multiple oversight approaches. Centralized monitoring analyzes accumulating data to detect patterns indicative of potential issues, such as unusual data distributions, unexpected missing data patterns, or protocol deviations concentrated at particular sites. On-site monitoring is targeted based on centralized findings and risk assessment, focusing verification activities on critical data and processes. This integrated approach enables more efficient use of monitoring resources while maintaining or improving the protection of participant safety and data quality.
Monitoring plan development
"The risk-based monitoring plan identified participant eligibility verification and primary endpoint data as critical processes requiring intensive oversight, while demographic data collection was classified as lower risk requiring only sampling-based verification."
Triggered monitoring
"When centralized statistical monitoring detected an unusually narrow distribution of blood pressure measurements at one site compared to others, an unscheduled on-site visit was triggered to investigate potential measurement or recording issues."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.
ICH E6(R3) Section 5.18.3
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.
Risk-based monitoring represents a fundamental shift in how sponsors approach clinical trial oversight, moving from traditional approaches emphasizing uniform, comprehensive on-site verification toward strategic allocation of monitoring resources based on identified risks. This approach, explicitly endorsed by ICH E6(R3), recognizes that not all data, sites, and processes carry equal risk to participant safety and data integrity, and that monitoring resources should be concentrated where they can have the greatest impact.
The foundation of risk-based monitoring is systematic risk assessment and management. Before the trial begins, sponsors identify and evaluate risks associated with the trial design, data collection processes, investigational product, and trial conduct activities. Critical data and processes are identified based on their importance to participant safety and primary endpoint evaluation. This assessment informs the monitoring plan, which specifies the monitoring methods, intensity, and frequency appropriate for each risk category.
Implementation of risk-based monitoring integrates multiple oversight approaches. Centralized monitoring analyzes accumulating data to detect patterns indicative of potential issues, such as unusual data distributions, unexpected missing data patterns, or protocol deviations concentrated at particular sites. On-site monitoring is targeted based on centralized findings and risk assessment, focusing verification activities on critical data and processes. This integrated approach enables more efficient use of monitoring resources while maintaining or improving the protection of participant safety and data quality.
Monitoring plan development
"The risk-based monitoring plan identified participant eligibility verification and primary endpoint data as critical processes requiring intensive oversight, while demographic data collection was classified as lower risk requiring only sampling-based verification."
Triggered monitoring
"When centralized statistical monitoring detected an unusually narrow distribution of blood pressure measurements at one site compared to others, an unscheduled on-site visit was triggered to investigate potential measurement or recording issues."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.