audit trail

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audit trail

A software-tracking system used for data security, which is attached to a file each time it is opened so an operator can identify who and when a file has been accessed.

(1) A sequential printed or electronic record of individual audits, which can be used to assess the successful completion and maintenance of performance improvements.
(2) A permanent record of claims and/or payments stored on the database.

The entire written record of documents, correspondence and reports that document study conduct; a secure, time-stamped record that allows reconstruction of the course of events relating to the creation, modification and deletion of an electronic study record.

Study files, changes to CRFs, drug accountability records.

audit trail

Informatics A software tracking system used for data security, which is attached to a file each time it is opened so an operator can identify who and when a file has been accessed. See Internal audit.

doc·u·men·ta·tion trail

(dok'yū-mĕn-ta'shŭn trāl)
A detailed sequential record of events pertaining to a particular matter; used as a risk management technique.
Synonym(s): audit trail.


a well-defined information pathway that leads from data point to data point and sequentially from analysis to conclusion.

audit trail
as for accounting trail but designed for audit purposes.
diagnostic trail
a diagnostic decision tree.
References in periodicals archive ?
Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
Therefore, the audit trail applies not only to events recorded in the electronic record, but events associated with electronic signatures that are applied to the electronic record in the appropriate sequence (review, approval, signature, time/date).
the audit trail can be enabled or disabled for individual transactions (functions) and associated data tables, by customizing the software configuration.
Item 7: Annex 11 refers to keeping the audit trails for as long as required by the predicate rule requirements for record retention, but there is no explicit statement in Annex 11.
This category describes the use of an individual's audit trail data to provide users with information that may assist them with decision making or further actions.
Unlike the majority of audit trail implementations involving directive support and individual feedbackkasee of data, group feedback requires a means of storing and retrieving audit trail data generated by multiple users.
It should be noted that these three difficulties are not inherent weaknesses of audit trail systems per se.
Yet, many companies still attempt to implement Part 11 audit trails using plug in database tools that aggregate ALL database changes into large, unstructured data files.
These audit trails can be printed by clicking on File, Print and selecting Summary Information in the Print What box.
IN ADDITION, USERS can apply audit trails to determine whether inadvertent or unauthorized changes have occurred.