Audit trail.

Secure recording of study details in eCRF system.

Audit trail a fundamental function in clinical trials that every eCRF system should have. The presence of this module ensures data traceability and reliability. The audit trail module has been prepared following the FDA (21 CFR Part 11) guidelines. It allows reconstruction of the history of such events relating to the record regardless of its medium, including the “who", "what", "when" and "why” of the action. This module tracks changes and activities in the system, and helps to maintain transparency and accountability.

Every change in the questionnaire between two events made by each user is recorded.

Przegląd historii zmian
Review of the change history is possible for each question - time of change and change's author.
The audit trial mechanism allows to collect the following information:
type of changes (new entry, edited, deleted, etc.)
Rodzaj zmian
date of change
Data zmiany
time of change
Godzina zmiany
current and previous entries.
Wartości wpisu
Other eCRF system functions.
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