Clinical OperationsGlossary Term
ICH E6(R3) Section 5.21
The series of activities conducted at the conclusion of a clinical trial or site participation to ensure all regulatory requirements are met, documentation is complete, investigational products are reconciled and returned, and the trial file is inspection-ready.
Study close-out represents the final phase of clinical trial conduct at either the site level when a site completes participation or the study level when the entire trial concludes. This phase ensures orderly completion of all outstanding activities, proper documentation and archival of trial records, appropriate disposition of investigational products and biological samples, and preparation for potential future inspections. Thorough close-out is essential for regulatory compliance and reflects the quality standards maintained throughout the trial.
Site close-out activities typically include resolution of all outstanding data queries, completion of all case report form pages, collection and reconciliation of all investigational product, preparation and archival of the investigator site file, notification to the IRB/IEC of study completion, and discussion of participant follow-up plans if applicable. A close-out monitoring visit verifies completion of these activities and documents the state of the site file at study conclusion. The investigator acknowledges responsibility for maintaining essential documents for the required retention period.
The transition from active conduct to archival requires careful attention to document preservation and accessibility. Essential documents must be organized, indexed, and stored in conditions that ensure their preservation for the regulatory-required retention period, typically at least two years following the last marketing approval or study termination. Storage arrangements must enable retrieval if documents are requested for inspection. Contact information for responsible parties must be maintained to enable communication even years after the trial concludes.
Close-out visit
"During the close-out visit, the monitor verified that all 47 enrolled participants had completed final assessments, all data queries were resolved, all unused study drug was reconciled and packaged for return, and the regulatory binder was complete and organized."
Document archival
"Following study close-out, the site transferred the complete investigator site file to secure long-term storage, maintaining an index of archived materials and contact information for the study records custodian."
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 5.21
The series of activities conducted at the conclusion of a clinical trial or site participation to ensure all regulatory requirements are met, documentation is complete, investigational products are reconciled and returned, and the trial file is inspection-ready.
Study close-out represents the final phase of clinical trial conduct at either the site level when a site completes participation or the study level when the entire trial concludes. This phase ensures orderly completion of all outstanding activities, proper documentation and archival of trial records, appropriate disposition of investigational products and biological samples, and preparation for potential future inspections. Thorough close-out is essential for regulatory compliance and reflects the quality standards maintained throughout the trial.
Site close-out activities typically include resolution of all outstanding data queries, completion of all case report form pages, collection and reconciliation of all investigational product, preparation and archival of the investigator site file, notification to the IRB/IEC of study completion, and discussion of participant follow-up plans if applicable. A close-out monitoring visit verifies completion of these activities and documents the state of the site file at study conclusion. The investigator acknowledges responsibility for maintaining essential documents for the required retention period.
The transition from active conduct to archival requires careful attention to document preservation and accessibility. Essential documents must be organized, indexed, and stored in conditions that ensure their preservation for the regulatory-required retention period, typically at least two years following the last marketing approval or study termination. Storage arrangements must enable retrieval if documents are requested for inspection. Contact information for responsible parties must be maintained to enable communication even years after the trial concludes.
Close-out visit
"During the close-out visit, the monitor verified that all 47 enrolled participants had completed final assessments, all data queries were resolved, all unused study drug was reconciled and packaged for return, and the regulatory binder was complete and organized."
Document archival
"Following study close-out, the site transferred the complete investigator site file to secure long-term storage, maintaining an index of archived materials and contact information for the study records custodian."
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.