Clinical OperationsGlossary Term
ICH E6(R3) Section 5.0
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The CAPA system represents a cornerstone of quality management in clinical trials, providing a structured methodology for addressing problems identified through monitoring, audits, inspections, or other means. Rather than simply fixing immediate symptoms, CAPA requires investigation of underlying causes and implementation of sustainable solutions. This approach transforms individual problems into opportunities for systematic improvement, strengthening overall trial quality and compliance.
Corrective actions address the immediate problem and its root causes after an issue has been identified. The process begins with accurate documentation of the non-conformance, including what happened, when, where, and the potential impact. Investigation seeks to identify not just the immediate cause but the underlying systemic factors that allowed the problem to occur. Solutions must address these root causes rather than merely correcting the surface manifestation. Implementation includes verification that corrections were effective in resolving the issue.
Preventive actions extend beyond the immediate problem to reduce the likelihood of similar issues occurring elsewhere. Analysis of trends across multiple events may reveal systemic vulnerabilities not apparent from individual incidents. Preventive measures may include process modifications, enhanced training, additional controls, or resource adjustments. The effectiveness of preventive actions must be monitored over time to confirm that anticipated improvements are realized. Documentation throughout the CAPA process creates an audit trail demonstrating appropriate response to identified issues.
Deviation response
"Following identification of repeated informed consent documentation errors at a site, the CAPA investigation revealed inadequate coordinator training; corrective actions included immediate retraining, and preventive actions established a quarterly competency assessment program."
Systemic improvement
"Analysis of protocol deviations across all sites revealed that 30% involved missed laboratory assessments, prompting implementation of automated visit reminder systems at all sites as a preventive action."
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.
ICH E6(R3) Section 5.0
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The CAPA system represents a cornerstone of quality management in clinical trials, providing a structured methodology for addressing problems identified through monitoring, audits, inspections, or other means. Rather than simply fixing immediate symptoms, CAPA requires investigation of underlying causes and implementation of sustainable solutions. This approach transforms individual problems into opportunities for systematic improvement, strengthening overall trial quality and compliance.
Corrective actions address the immediate problem and its root causes after an issue has been identified. The process begins with accurate documentation of the non-conformance, including what happened, when, where, and the potential impact. Investigation seeks to identify not just the immediate cause but the underlying systemic factors that allowed the problem to occur. Solutions must address these root causes rather than merely correcting the surface manifestation. Implementation includes verification that corrections were effective in resolving the issue.
Preventive actions extend beyond the immediate problem to reduce the likelihood of similar issues occurring elsewhere. Analysis of trends across multiple events may reveal systemic vulnerabilities not apparent from individual incidents. Preventive measures may include process modifications, enhanced training, additional controls, or resource adjustments. The effectiveness of preventive actions must be monitored over time to confirm that anticipated improvements are realized. Documentation throughout the CAPA process creates an audit trail demonstrating appropriate response to identified issues.
Deviation response
"Following identification of repeated informed consent documentation errors at a site, the CAPA investigation revealed inadequate coordinator training; corrective actions included immediate retraining, and preventive actions established a quarterly competency assessment program."
Systemic improvement
"Analysis of protocol deviations across all sites revealed that 30% involved missed laboratory assessments, prompting implementation of automated visit reminder systems at all sites as a preventive action."
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.