Integrating Oracle Clinical Studies with Siebel Clinical Protocols

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 Siebel Clinical and Oracle Clinical.

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 integrate an Oracle clinical study with a Siebel clinical protocol 

1. Navigate to the Administration - Clinical screen, then the Protocol List view.

2. In the Protocol list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments	Required
   Protocol #	Type an identifying number for the protocol. For integrating data with the study site code in Oracle Clinical, this field must not be more than ten characters in length.	Yes
   Title	Type a descriptive title for the protocol.	Yes
   Status	Select the status of the protocol, such as Planned, In Progress, Completed.	Yes
   Program	Select the name of the program for the clinical trial.	Yes
   Product	Select the name of the clinical product associated with the study. You can select only products that are associated with the clinical program, through the Application field in the Program List view, in the Clinical Product and Indication dialog box.	Yes
   Phase	Select the phase of the clinical trial, such as Phase I or II.	Yes
   Design	Select the type of study.	No
   Regions Required	Select this field to indicate the sites for this protocol must belong to a region. When you select this field, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions.	No
   Type	Select the purpose of the protocol.	Yes
   Team	Select the team members who need access to the protocol, such as the study manager and others who monitor the clinical trial.	No
   Currency Code	Select 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
   Exchange Date	Select the date that determines the exchange rate of the currency. By default, the exchange date for the protocol is the date that you create the protocol.	No
   Withholding Amount	Type the amount to withhold from each of the payments to the investigators until the trial is complete. You can overwrite this amount at the region and site levels.	No
   # Planned Sites	Type the number of planned sites for the protocol.	Yes
   # Planned Subjects	Type the number of planned subjects for the protocol.	Yes
   Withholding %	Type the percentage to withhold from each of the payments to the investigators until the trial is complete. You can overwrite this percentage at the region and site levels.	No

   
   

3. Drill down on the protocol number field.

4. Navigate to the More Info view and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments	Required
   Central Lab	Select the name of the laboratory associated with the study. You enter this name in the Accounts screen.	No
   CRO	Select the name of the clinical research organization that sponsors the trial. You enter this name in the Accounts screen.	No
   CDMS Study ID	Type 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
   Synchronize Active Study Sites	Select this field 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 More Info view for each protocol, and reviewing the integration section.	Yes