Clinical OperationsGlossary Term
ICH E6(R3) Section 4.4
A potential participant who undergoes screening procedures but is determined to be ineligible for enrollment in the clinical trial based on the protocol-defined inclusion and exclusion criteria.
Screen failure occurs when an individual who has consented to screening procedures is subsequently determined not to meet the eligibility requirements for study participation. This determination may result from laboratory values outside specified ranges, disease characteristics not meeting inclusion criteria, concurrent medications or conditions specified as exclusions, or any other protocol-defined criterion that precludes enrollment. Screen failure represents a normal and expected aspect of the participant selection process.
Screen failure rates vary substantially depending on the therapeutic area, study design, and specificity of eligibility criteria. Complex protocols with numerous inclusion and exclusion criteria typically generate higher screen failure rates than simpler designs. Studies requiring specific disease stages, biomarker profiles, or prior treatment histories may screen many patients to identify eligible enrollees. Understanding expected screen failure rates is essential for enrollment planning, as sites must screen proportionally more patients to achieve enrollment targets when screen failure rates are high.
Analysis of screen failure reasons provides valuable operational intelligence. High screen failure rates due to a specific criterion may indicate that the criterion is more restrictive than anticipated, potentially warranting protocol amendment. Screen failures concentrated at particular sites may reveal differences in prescreening practices or patient population characteristics. Individual review of screen failures helps identify instances where eligible patients may have been inappropriately excluded and ensures that eligibility determinations are made consistently across sites.
Laboratory-based screen failure
"The potential participant completed all screening assessments but was a screen failure due to hepatic transaminase levels exceeding three times the upper limit of normal, which was specified as an exclusion criterion."
Screen failure analysis
"Monthly screen failure analysis revealed that 45% of screen failures were due to a single exclusion criterion related to prior treatment history, leading the sponsor to consider a protocol amendment broadening eligibility."
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 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.
ICH E6(R3) Section 4.4
A potential participant who undergoes screening procedures but is determined to be ineligible for enrollment in the clinical trial based on the protocol-defined inclusion and exclusion criteria.
Screen failure occurs when an individual who has consented to screening procedures is subsequently determined not to meet the eligibility requirements for study participation. This determination may result from laboratory values outside specified ranges, disease characteristics not meeting inclusion criteria, concurrent medications or conditions specified as exclusions, or any other protocol-defined criterion that precludes enrollment. Screen failure represents a normal and expected aspect of the participant selection process.
Screen failure rates vary substantially depending on the therapeutic area, study design, and specificity of eligibility criteria. Complex protocols with numerous inclusion and exclusion criteria typically generate higher screen failure rates than simpler designs. Studies requiring specific disease stages, biomarker profiles, or prior treatment histories may screen many patients to identify eligible enrollees. Understanding expected screen failure rates is essential for enrollment planning, as sites must screen proportionally more patients to achieve enrollment targets when screen failure rates are high.
Analysis of screen failure reasons provides valuable operational intelligence. High screen failure rates due to a specific criterion may indicate that the criterion is more restrictive than anticipated, potentially warranting protocol amendment. Screen failures concentrated at particular sites may reveal differences in prescreening practices or patient population characteristics. Individual review of screen failures helps identify instances where eligible patients may have been inappropriately excluded and ensures that eligibility determinations are made consistently across sites.
Laboratory-based screen failure
"The potential participant completed all screening assessments but was a screen failure due to hepatic transaminase levels exceeding three times the upper limit of normal, which was specified as an exclusion criterion."
Screen failure analysis
"Monthly screen failure analysis revealed that 45% of screen failures were due to a single exclusion criterion related to prior treatment history, leading the sponsor to consider a protocol amendment broadening eligibility."
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 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.