Contents

Introduction

From the registration up to the end of study of a subject, all data entries, every deletion of it, each initiation of an activity, all data related actions in Vista Trials are recorded in the audit trail. Users of Vista Trials with access rights to a particular subject can access the audit trail of that subject at any given time. Just click the audit trail icon on the desired level.

Audit trail principles

Secure, computer-generated, time-stamped audit trails independently record the date and time of operator entries and actions that create, modify, or delete electronic records. This means that all user data entry, edits, or deletions that modify data are tracked in the audit trail.

The above example shows the columns that make up an audit trail. Audit trails are logged chronologically (most recent action on top).

Column	Reflects
Operation	The operation (change to the data)
Done By	By whom the change was made (account and role)
Changed	When (date and time) the operation was done
SS	Site of the subject
S-ID	Sequential ID of the subject
Location (from EventGroup to Item)	Identifier of the element on which the operation was done
Loc PR	Activity ID
Loc PR V	Version of the Activity
Old Value
New Value
Reason	The reason why the operation was done
Other	Contains additional information, depending on the type of operation

You can search within the audit trail and if you click the edit icon in the right upper corner you can select the columns to be shown.

Levels of audit trail

The audit trail can be accessed at different levels. On the level of the subject, the entire audit trail of that subject is available. The other levels will just show that part of the audit trail relevant to that specific element.

Subject level

To view the entire audit trail on subject level, select the audit trail via the subject menu.

EventGroup level

An EventGroup audit trail will only reflect that part of the audit trail relating to that particular EventGroup, thus the audit trail of all actions on that EventGroup and of all Events, Forms and Item(Groups) that are part of that EventGroup. The audit trail of an EventGroup can be found next to its name.

Event level

An Event audit trail will only reflect the audit trail relating to that particular Event, thus the audit trail of all actions on that Event and of any Forms and Item(Groups) that are part of it. The audit trail of an Event can be found to the right of its name.

Form level

The audit trail of a Form only shows the audit trail of that particular Form, thus the audit trail of that Form and Item(Groups) that are part of it. The audit trail of a Form can be found below its tab.

ItemGroup level

On the level of an ItemGroup, the audit trail of that ItemGroup and its Items are shown. The audit trail of an ItemGroup can be found in the menu, accessible under its edit icon.

Item level

An Item audit trail will show the audit trail specific to that Item. It can be found in the menu under its edit icon.

Activities

The audit trail of an activity will reflect the audit trail of any action relating to that particular activity. You can access it via the audit trail button next to the activity name in the study flow.

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