Source Data Verification (SDV) Integration

This integration runs on a schedule to generate a cumulative list of subjects that have been selected for Source Data Verification (SDV) in a study. The integration also sends incremental information on the SDV status changes at the visit level.

This integration runs fourth if all four (4) CTMS integrations have been implemented.

Table 2-10 Details

Type of integration	Data flow	Frequency
Multiple file	One-way, from Oracle Clinical One Platform to CTMS.	Scheduled

Overview

• The integration sends only the first SDV performed for a visit to CTMS.
• Once the integration process completes.
  • The subject data from Oracle Clinical One Platform is displayed in CTMS under each site in the Site Management/{Target Site}/Subjects/SDV Required column.
  • Subject visit verification data is displayed in CTMS under Site Management/{Target Site}/CRF Tracking tab in the columns marked Source Verified and Source Verified Date.

Pre-requisites: the following should be confirmed before running the integration

• Study versions for sites in CTMS and in Oracle Clinical One Platform match.
• The Source Data Verification setting in Oracle Clinical One Platform is configured to allow for source data verification in a study.

Integration user and roles

An integration user needs to be created and assigned to a custom role that includes the following permissions.

• Answer Queries
• Integrate Subject Data
• Perform Source Data Verification and Reconcile Inventory

For more information on permissions, see Descriptions of permissions in Clinical One

Exceptions

• Subject Data Verification information for Adverse Events is not sent.

Configuration

Working with the customer, the Oracle integration team creates a Configuration Setup Details Document (CSDD), which details the configuration specifications defined for integrations between Oracle Clinical One Platform and CTMS.