Siebel Clinical Trial Management System Guide > Setting Up Clinical Trials >

Scenario for Clinical Trials

This topic gives one example of how clinical trials might be used. You might use clinical trials differently, depending on your business model.

The clinical director and the study manager, working for a CRO (clinical research organization), or pharmaceutical, biotech, or medical device company, have administrator responsibilities in Siebel Clinical to:

• Set up a new program for the treatment study.
• Create one or more protocols designed to assess the safety and efficacy of certain compounds in the treatment of the disease.
• Set up the geographic regions where the protocols are to be carried out.
• Compile a list of documents that are critical to the study and implement tracking at the protocol, region, and site levels, and for accounts and contacts.
• Create a subject visit template to facilitate consistent application of the protocol across sites and subjects. This template is used to set up subject visit schedules and activities according to the guidelines laid out in the protocol.

  When the program, protocol, and subject visit templates have been set up, the CRAs (clinical research associates) who are the end users of the Siebel Clinical product do the following:

  • Enter data about the:
    • Sites where the protocols are carried out.
    • Members to be assigned to the teams at the site, region, and protocol levels.
    • Accounts, institutions such as hospitals and clinics where the studies are conducted.
    • Contacts, site personnel such as investigators, site coordinators, and nurse practitioners who carry out the protocols.
    • Subjects recruited for the clinical trial.
  • Screen and enroll subjects and, if necessary, rescreen the subjects.
• Use the subject visit template to set up detailed schedules for the subjects' visits to the sites.
• Track required documents at the protocol, region, or site level, or for accounts or contacts.

NOTE:  The tasks of entering subject data, and setting up screening and enrollment schedules for subject visits, can also be performed by the site personnel using Siebel Site Portal. For more information about Siebel Site Portal, see Siebel Life Sciences Portals Guide.

At various times after subjects have been enrolled in the trial, the clinical director, study manager, or CRAs can use the charting features of Siebel Clinical to review the progress of the trial. Two informative metrics are the subject status and subject enrollment rate. These are plotted for an individual site, for a region, and for the protocol.