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Scenario for Clinical Trials

This scenario is an example process performed by the director of clinical trials, clinical study manager, and the clinical research associates (CRAs). Your company may follow a different process according to its business requirements.

In this scenario, the clinical director and the study manager, working for a clinical research organization, or pharmaceutical, biotech, or medical device company, have administrator responsibilities in Siebel Clinical to:

• Set up a new treatment study program.
• 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 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 visit schedules for subjects, may also be performed by the site personnel using Site Portal Web site. 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 enrollment rate. These are plotted for an individual site, for a region, and for the protocol.