Oracle's Siebel Clinical Trial Management System (CTMS)

The CTMS integration offering consists of four separate integrations; they are Study Version Template (SVT) Integration, Site Integration, Subject Visit (SV) Integration, and Source Data Verification (SDV) Integration. You only need to implement what is necessary for your study.

In the sections below, you will find details for each of the two-way data integrations between Oracle Clinical One Platform and CTMS. These include study design, site information, subject visit data, and subject verification details.

• Site Integration
  This cumulative integration runs on a schedule to retrieve a list of sites from CTMS based on their status. The integration then creates the sites in Oracle Clinical One Platform if they do not already exist or applies updates if they do.
• Subject Visit (SV) Integration
  This incremental integration based on the subject number runs on a schedule to identify events that occurred in a study since the last run. The integration then sends completed visit, form, and item data, subject status transitions for any subject event, and information for planned visits to CTMS.
• 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.