Data ManagementGlossary Term
ICH E6(R3) Section 4.9
A secure, computer-generated, time-stamped electronic record that automatically captures the creation, modification, or deletion of data, including the identity of the operator and the date and time of the action.
The audit trail provides the documentary evidence that enables reconstruction of the sequence of events related to clinical trial data, serving as a fundamental mechanism for ensuring data integrity in electronic systems. Every entry, change, and deletion in the database is automatically recorded with information identifying who performed the action, when it occurred, what the original value was, and what the new value is. This immutable record protects against undetected data manipulation and supports regulatory inspection by demonstrating the chain of custody for all data throughout the trial.
Regulatory requirements for electronic records, including FDA 21 CFR Part 11 and EU Annex 11, mandate that clinical trial systems maintain audit trails meeting specific criteria. The audit trail must be automatically generated by the system rather than manually created by users. It must capture sufficient information to enable reconstruction of the data history, including the previous value, new value, user identity, date and time, and reason for change where required. The audit trail itself must be protected from modification or deletion, ensuring that the historical record cannot be tampered with. Users must be unable to disable or modify audit trail functionality.
Review of audit trails serves multiple purposes in clinical trial quality management. During routine data cleaning, audit trail review can identify patterns of corrections that may indicate training needs or systemic issues with data collection. During monitoring and auditing, audit trail review enables verification that data changes are legitimate and appropriately documented. During regulatory inspections, audit trails demonstrate that data integrity has been maintained and that any modifications followed appropriate procedures. Systems must provide functionality for audit trail review that is practical for users while maintaining the integrity of the underlying records.
Data correction verification
"During the monitoring visit, the CRA reviewed the audit trail for a corrected laboratory value and confirmed that the change was made by an authorized user, was dated appropriately, and included a reason for change indicating that the original entry had been a transcription error."
Regulatory inspection
"The FDA inspector requested audit trail reports for a sample of participants with efficacy endpoint corrections, verifying that all changes were performed by authorized personnel, timestamped appropriately, and accompanied by documented reasons for the corrections."
A CDISC standard that defines the structure and content of analysis-ready datasets derived from SDTM data, supporting efficient generation of statistical analyses and displays for regulatory submissions.
An international nonprofit organization that develops and supports global data standards for clinical research, enabling consistent and efficient exchange of clinical trial information.
The process of detecting, correcting, and resolving inaccurate, incomplete, or inconsistent data in the clinical trial database to ensure data quality and reliability for analysis.
The degree to which data are complete, consistent, accurate, trustworthy, and reliable throughout the data lifecycle.
The formal process of making the clinical trial database unmodifiable once all data have been entered, reviewed, cleaned, and verified, marking the transition from data collection to statistical analysis.
ICH E6(R3) Section 4.9
A secure, computer-generated, time-stamped electronic record that automatically captures the creation, modification, or deletion of data, including the identity of the operator and the date and time of the action.
The audit trail provides the documentary evidence that enables reconstruction of the sequence of events related to clinical trial data, serving as a fundamental mechanism for ensuring data integrity in electronic systems. Every entry, change, and deletion in the database is automatically recorded with information identifying who performed the action, when it occurred, what the original value was, and what the new value is. This immutable record protects against undetected data manipulation and supports regulatory inspection by demonstrating the chain of custody for all data throughout the trial.
Regulatory requirements for electronic records, including FDA 21 CFR Part 11 and EU Annex 11, mandate that clinical trial systems maintain audit trails meeting specific criteria. The audit trail must be automatically generated by the system rather than manually created by users. It must capture sufficient information to enable reconstruction of the data history, including the previous value, new value, user identity, date and time, and reason for change where required. The audit trail itself must be protected from modification or deletion, ensuring that the historical record cannot be tampered with. Users must be unable to disable or modify audit trail functionality.
Review of audit trails serves multiple purposes in clinical trial quality management. During routine data cleaning, audit trail review can identify patterns of corrections that may indicate training needs or systemic issues with data collection. During monitoring and auditing, audit trail review enables verification that data changes are legitimate and appropriately documented. During regulatory inspections, audit trails demonstrate that data integrity has been maintained and that any modifications followed appropriate procedures. Systems must provide functionality for audit trail review that is practical for users while maintaining the integrity of the underlying records.
Data correction verification
"During the monitoring visit, the CRA reviewed the audit trail for a corrected laboratory value and confirmed that the change was made by an authorized user, was dated appropriately, and included a reason for change indicating that the original entry had been a transcription error."
Regulatory inspection
"The FDA inspector requested audit trail reports for a sample of participants with efficacy endpoint corrections, verifying that all changes were performed by authorized personnel, timestamped appropriately, and accompanied by documented reasons for the corrections."
A CDISC standard that defines the structure and content of analysis-ready datasets derived from SDTM data, supporting efficient generation of statistical analyses and displays for regulatory submissions.
An international nonprofit organization that develops and supports global data standards for clinical research, enabling consistent and efficient exchange of clinical trial information.
The process of detecting, correcting, and resolving inaccurate, incomplete, or inconsistent data in the clinical trial database to ensure data quality and reliability for analysis.
The degree to which data are complete, consistent, accurate, trustworthy, and reliable throughout the data lifecycle.
The formal process of making the clinical trial database unmodifiable once all data have been entered, reviewed, cleaned, and verified, marking the transition from data collection to statistical analysis.