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

Integrating an Oracle Clinical Study with a Siebel Clinical Protocol

The CDMS Study ID field in Siebel Clinical maps a Protocol in Siebel Clinical to a Study in Oracle Clinical. The Synchronize Active Study Sites field enables integration between the two applications.

Multiple protocols can be associated with a clinical program in Siebel Clinical. When you create a protocol record, you can also add extra information about the protocol, such as financial information, central laboratory information, and so on.

To create a Siebel Clinical protocol record and activate it for integration

1. Navigate to the Administration - Clinical screen, then the Protocol List view.
2. In the Protocols list, create a new record.
3. Complete the necessary fields (use the More Info tab to view hidden fields). Some fields are described in the following table.

   Field	Description	Required
   CDMS Study ID	The Oracle Clinical Study ID. This field is required for integration with Oracle Clinical and links a protocol in Siebel Clinical to a study in Oracle Clinical.	Yes
   Central Lab	The name of the laboratory associated with the study. You enter this name in the Accounts screen.	No
   CRO	The name of the clinical research organization (CRO) that is sponsoring the trial.	No
   Currency Code	The currency that is used to display the payments, costs, and budgets for the protocol. The default value is USD (United States dollars). NOTE:  You must specify the currency code for the protocol.	No
   Design	Information about the type of study.	No
   Exchange Date	The date that determines the exchange rate of the currency used. By default, the exchange date for the protocol is the date the protocol is created.	No
   Phase	The phase of the clinical trial, such as Phase I or II.	Yes
   Planned Sites Number	The number of sites planned for the protocol.	Yes
   Planned Subjects Number	The number of subjects planned for the protocol.	Yes
   Product	The name of the clinical product associated with the study. Only products that have been associated with the clinical program, through the Application field in the Clinical Programs view, can be selected from the Clinical Product and Indication dialog box.	Yes
   Program	The name of the clinical trial program.	Yes
   Protocol Number	The number assigned to the protocol. For integrating data with the Oracle Clinical study site code, this field must not be more than ten characters in length.	Yes
   Regions Required	The flag to indicate that the sites for this protocol must belong to a region. When this flag is selected, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions.	No
   Status	The protocol status, such as Planned, In Progress, Completed.	Yes
   Synchronize Active Study Sites	This flag must be checked to enable the protocol for integration with Oracle Clinical. You can review all protocols that are currently set up for synchronization by navigating to the Protocols tab, and reviewing the Integration section for each protocol.	Yes
   Team	Enter the names of those who require access to the protocol, the study manager, and others who monitor the clinical trial.	No
   Title	The descriptive title for the protocol.	Yes
   Type	The purpose of the protocol.	Yes
   Withholding Amount	The amount to be withheld from each of the payments to the investigators until the trial is complete. This amount can be overwritten at the region and site levels.	No
   Withholding Percentage	The percentage to be withheld from each of the payments to the investigators until the trial is complete. This percentage can be overwritten at the region and site levels.	No

4. Navigate to the Integration section in the More Info tab.
5. Enter the Oracle Clinical Study ID in the CDMS Study ID field.
6. Select Synchronize Active Study Sites.