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 you carry out the protocols.

• 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. End users can use this template to set up subject visit schedules and activities according to the guidelines laid out in the protocol.

  After the program, protocol, and subject visit templates are 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 you carry out the protocols.

    • Members to assign to the teams at the site, region, and protocol levels.

    • Accounts or institutions, such as hospitals and clinics where the studies are conducted.

    • Contacts or site personnel, such as investigators, site coordinators, and nurse practitioners who carry out the protocols.

    • Recruited subjects 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 subject visits to the sites.

• Track required documents at the protocol, region, or site level, or for accounts or contacts.

  
  

  Note: Site personnel can use Siebel Site Portal to enter subject data and set up screening and enrollment schedules for subject visits. For more information about Siebel Site Portal, see Siebel Life Sciences Portals Guide.

  
  

After subjects are 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 metrics are plotted for an individual site, for a region, and for a protocol.