Siebel Clinical Trial Management System Guide > Setting Up and Configuring Clinical Data Management System Integration >

Overview of Integrating Siebel Clinical with a Clinical Data Management System

The following integration processes are provided for clinical trial integration:

• Protocol site integration. Protocol Site information can be sent to other systems, such as clinical data management systems (CDMS). A Process Integration Pack exists for integration with Oracle Clinical to take the information sent by Siebel Clinical and create investigators, sites and study sites in Oracle Clinical.
• Study subject integration. A Siebel Clinical Web service creates screening and enrollment subjects, and enables screening and enrolling against the active subject visit template. A Process Integration Pack exists for Siebel Clinical and Oracle Clinical that uses this Web service to create subjects in Siebel Clinical when screening or enrollment data is entered in Oracle Clinical.
• Activity completion data integration. The Process integration Pack for Siebel Clinical and Oracle Clinical uses a Siebel Clinical Web service to update the completion dates of visits and activities in the subject visit template. The Siebel Clinical visit and activity completion data is updated based on changes to the patient data that is entered in Oracle Clinical.

This integration enables the timely exchange of data between Siebel Clinical and the Clinical Data Management System (CDMS), such as Oracle Clinical. Data sent from Siebel Clinical to Oracle Clinical, including investigator details and site details, facilitates the automatic creation of a study site, and removes the necessity of creating site, investigator, and study site data manually. Data sent from Oracle Clinical to Siebel Clinical, including the number of patients and Oracle Clinical completion items such as visits, Data Collection Instruments (DCIs), Data Collection Modules (DCMs), and questions, facilitates more efficient and accurate tracking of patient numbers and activity completion in Siebel Clinical.

The automation of these processes enables the timely and accurate payments to investigators. It also provides a means to more accurately track and respond to issues relating to site performance and protocol adherence.