Datacapt records each action on study data: who, what, when, the old value, the new value and the reason. Nobody can edit or delete an entry. You read this log at three levels.
Level | Where | Answers |
One question | The question menu in a subject's eCRF | "Who changed this blood pressure?" |
One study | Study › Audit Trails | "What did this user do last week?" "Who unblinded subject 03-012?" |
The platform | Settings › Audit trails | Logins, role changes, templates, dictionaries. See Read the platform audit trail |
🔑 Prerequisite: Audit trails (Access) on the study. Audit trails (Export) to download the log.
See the history of one answer
🛠️ Step by step guide
Open the subject's eCRF and go to the form
Open the menu of the question (3 dots)
Select Audit trails
The window lists each value the question held, with the Variable, the Value, and the change date and author. A question never answered shows "No audit trails for this question".
Search the whole study
🛠️ Step by step guide
Open the study and navigate to Audit Trails
Filter by user, by action, by event or by question variable
Select a row to open its details
Events: the area of the study
eCRF (the design), eCRF data (the answers), ePRO, eConsent, queries, randomization, subjects, users, documents, settings, exports.
Actions: what happened
The most useful in a review:
Action | Meaning |
Created / Updated / Deleted | On data: an answer. On the event eCRF: a question, a form or a visit of the design |
Signed | An investigator signed a visit |
Locked / Unlocked | A form, a visit or a record was frozen or released |
SDV | A monitor verified or unverified an answer |
Randomised | A subject received an arm |
Emergency unblind | A user revealed an arm, with their reason |
Viewed/Exported | A user downloaded data |
Excluded | A subject left the eCRF, with the reason |
What an entry contains
User name, date and time in your time zone, event type, action, subject ID, Datacapt ID, center, section, sub-section, question, variable, old value, new value, reason, comment, signature ID, and for exports the file name and format.
The Reason column fills when Enable GCP is on for the study, or when the action asks for a reason by design: exclusion, unblinding, reopening an ended study.
Export the log
🛠️ Step by step guide
Apply your filters first. The export follows them
To export some rows, tick them
Select Export data
💡 Tip: Datacapt has no separate audit page per subject. For one subject's complete history, export the log and filter the Subject ID column in Excel.
Questions this log answers
A site says it never changed that value. Filter on the variable, read the user and the time.
You suspect a user works under a colleague's login. The platform audit trail lists logins with their time; compare with the data entry times here.
The sponsor asks who exported data before the interim analysis. Filter action Viewed/Exported.
An inspector asks when the eCRF changed. Filter event eCRF, and match the dates with your version records.