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

Adding a Protocol

Multiple protocols and multiple versions of a protocol can be associated with a program.

To add a new protocol

  1. From the application-level menu, choose View > Site Map > Clinical Administration > Protocols.
  2. In the Protocols list, add a record, and complete the necessary fields. (To access more fields, click the show more button in the form.)

    3. Some of the fields in the Protocol record 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.
    Abbreviated Title
    Short descriptive title for the protocol.
    Central Lab
    The name of the laboratory associated with the study. This is entered through the Accounts screen.
    Currency Code
    The currency that is used to display the payments, costs, and budgets in the Protocols screen. The default value is USD (United States dollars).
    Design
    Information about the type of study.
    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.
    This date may be changed in response to changes in currency rates. However, changes made to the exchange date at the protocol level take effect only when the exchange date also changes at the system level. For more information, see Applications Administration Guide.
    Lab Contact Last Name
    Contact person associated with the central lab.
    Paid to Date
    The sum of the payments associated with the protocol.
    Phase
    Phase of clinical trial such as Phase II, or III.
    The choices in this drop-down list are configured by using the LS_PTCL_PHASE type in the List of Values.
    # Planned Sites
    Number of sites planned for the region.
    # Planned Subjects
    Number of subjects planned for the region.
    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. See To add 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.
    The choices in this drop-down list are configured by using the LS_PTCL_STAT_CD type in the List of Values.
    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.
    The choices in this drop-down list are configured by using the LS_PTCL_TYPE_CD type in the List of Values.

  3. Optional: Add files associated with the clinical protocol as attachments.

 Siebel Life Sciences Guide 
 Published: 18 April 2003