Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial >

Setting Up a Protocol

Multiple protocols and multiple versions of a protocol can be associated with a program. When you have created a protocol record, you may also add extra information about the protocol, such as financial information, central lab information, and so on.

To create a protocol record

1. Navigate to the Clinical Administration screen > Protocol List view.
2. In the Protocols list, create a new record and complete the necessary fields. (To access more fields, drill down on the name field of the protocol and move to the More Info tab view.)

   Some fields are described in the following table.

   Field	Comments
   # Planned Sites	Number of sites planned for the protocol.
   # Planned Subjects	Number of subjects planned for the protocol.
   Central Lab	The name of the laboratory associated with the study. This is entered through the Accounts screen.
   CRO	Name of the Clinical Research Organization that is sponsoring the trial.
   Design	Information about the type of study.
   Phase	Phase of clinical trial such as Phase II, or III.
   Product	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. For more information about creating a clinical program, see To create a new clinical program.
   Program	Name of the clinical trial program.
   Protocol #	Identifying number assigned to the protocol.
   Regions Required	Flag to indicate the sites for this protocol must belong to a region. For information on regions, see Setting Up Regions. 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.
   Status	Protocol status such as planned, in progress, completed.
   Team	Enter the names of those who need access to the protocol, the study manager and others who monitor the clinical trial.
   Title	Descriptive title for the protocol.
   Type	Purpose of the protocol.
   Withholding Amount	The amount to be withheld from each of the payments to the investigators until the trial is complete. This may be overwritten at the Region and Site levels.
   Withholding Percentage	The percentage to be withheld from each of the payments to the investigators until the trial is complete. This may be overwritten at the Region and Site levels.