eCRF Source Data Verification (SDV) Audit Trail

All the monitor’s SDV activities are recorded in the Catchtrial database in order to generate a validated eCRF SDV Audit Trail.
The structure of the Audit Trail is described below:

• The Catchtrial SDV Audit Trail is documented in an excel report containing multiple tabs, one for each form in your study eCRF (Figure 1).
• The Audit Trail of a single SDV record is reported in one line of the excel. Any changes/updates of the record are tracked in the subsequent lines.
• Records are listed by site and patient (first two columns of the excel), and placed in chronological order based on date/time, with the most recent ones at the bottom of the page.

Each SDV record of the audit trail (single line of the excel report) contains the following information:

• Site ID
• Patient ID
• Form ID (unique identifier, applicable only to multiple-event forms, e.g. AE Form)
• Form Update (indication of form update, applicable only to multiple-event forms, e.g. AE Form)
• SDV status (Completed, Partial, To Be Completed)
• Date and time of SDV record insertion (expressed as UTC±00:00)
• User Name
• User Role
• SDV notes recorded by the Monitor

Regarding the SDV status, the options available are listed below:

SDV Status	Description
SDV Completed	Source Data Verification done (CRF Monitored): CRF complete and no pending queries
Partial	Source Data Verification done (CRF Monitored): CRF partially completed, open queries to be addressed, any values updated by the site after the previous SDV
SDV To Be Completed	Source Data Verification to be done (CRF not Monitored)

SDV Audit Trail button is a Catchtrial Add-on.

It can be requested via Helpdesk.

Please write in your ticket:

• Do you need a one-time export of the audit trail?
• Or
• Do you want the activation of the “unlimited” audit trail export button?

One-time report:	Catchtrial Add-On:
Create ticket: Request one-time data entry audit trail export	Create Ticket: SDV Audit Trail button (unlimited exports by Sponsor)
The Helpdesk will generate a one-time export of the audit trail for your study SDV records (Figure 1, Excel file) Fee applied for generating each export will be quoted in response to your ticket. Helpdesk will provide the audit trail export within 24-hours from cost acceptance. To request a new audit trail export, the Helpdesk should be contacted again by a separate ticket. A fee will be applied for each report generated and provided to the requester.	The SDV Audit Trail export button is available in the Catchtrial Data Report interface, section Data Export, tab Custom exports. This add-on allows the Sponsor to run unlimited SDV Audit Trail exports, which will be launched and sent to the requester’s email automatically upon clicking the button. See Figure 2 below.

Catchtrial Add-On: SDV Audit Trail Export

The SDV Audit Trail export button is available in the Catchtrial Data Report module.
To access, click on section Data Export, tab Custom exports.

This add-on allows the Sponsor to run unlimited SDV Audit Trail exports, which will be launched and sent to the requester’s email automatically upon clicking the button.