Subject Logs

Subject Logs are used by a site to track subject information such as adverse events and concomitant medications that is not associated to a specific visit.

Creating a Log Entry

1. To create a new log entry for a subject, select the Subject Logs tab within the appropriate subject.
   
2. Select the Subject Log
   
3. Select “New Event”
4. Follow the Data Entry fields to enter information and upload source necessary. Subject Logs can continue to be modified until they’ve been submitted for CRA Review.  Similar to Visit procedures (CRFs), Subject logs are automatically saved.
   

Notes

Subject log entries can go through the same processes outlined in the Procedure Review workflow and the Procedure Queries workflow. The Review Status button and the Query Status button are all located within each entry and can be used by monitors, data managers and safety users. (screenshot)

It is important to note that site users should not submit log entries via the Review Status button until the entry is complete. Submitting will render the entry not editable by the site user. However, if the site user needs unlock the subject log entry for editing, they can still do so while the log entry is in Submitted status by clicking on the Review Status button, choose Unlock Procedure and provide a reason for unlocking. Monitors and data managers can enter review comments and queries respectively, regardless of the submission status of the log entry.

If a subject log needs to be crossed out the Review Status needs to be Open. All open review comments or open queries need to be closed or marked as Reviewed in order for the subject log row to be crossed out.

Crossing Out Log Entries

If a subject log entry is entered by mistake and needs to be removed it can be crossed out. Data entered in the crossed-out log entry will be removed from Clinical Listings, Dashboard Report and SDTM export. Unresolved queries in crossed-out log entries will still be visible in the Queries tab and the downloadable Query Listing.

A subject log entry cannot be crossed out if:

• it is in Submitted state
• it is locked by Data Manager
• it is associated with a visit or visit procedure

If there are unresolved queries in the log row, the queries will be automatically addressed by the Vessel system as follows:

• Manual queries issued by Data Management / Clinical Monitor / Safety User will be set to answered state with the message This subject log row has been crossed out by <User, Organization> and the data has been removed from the subject record. The original user who issued the query will be able to mark it as closed in the Queries tab.
• Automated queries issued by Vessel API will be set to closed state with the message This subject log row has been crossed out by <User, Organization> and the data has been removed from the subject record.

To cross out a subject log entry, go to the Log row you wish to cross out and click on the blue X button.

Give a reason why this row should be crossed out.

The log row will show it has been crossed out. A audit trail of crossing/uncrossing actions in a log row is accessible by clicking on the clock icon next to the Open button.

Uncrossing out Log rows

If you need to use a log row that is crossed out select the blue check mark button

Give a reason as to why the cross out row is being removed and click Confirm.

Timezones

In the audit trail of data entry fields, accessible by clicking on the clock icon next to the field label, the timezones of timestamps are as follows:

• When column: timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.
• Value column: as entered by the site user and there is no timezone conversion for different viewers in different timezones.

The date and time entered for any data entry field on a subject log row are displayed as-is as entered by the site user. This datetime value is displayed the same for all viewers, regardless of the timezone setting on their device.