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.
Automatic reports
Online contracts
Protocol deviation log
Data query
MedDRA dictionary

Frequently asked questions.

Why is the presence of an audit trail module so important?
It is a fundamental feature in clinical trials, ensuring the credibility of data in the eCRF system. The presence of this module indicates a high standard and compliance with international guidelines.
What information does the audit trail record?
It records every change made in the questionnaire between subsequent events by each user.
Can I review the history of changes made in the system?
Yes, the system allows for reviewing the change history for each question with a precise timestamp and the author of the changes made.
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