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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.
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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 |