End-User Procedures

The following list shows the tasks end users typically perform to manage site and contact information:

• Creating and Managing Site Visits. CRAs (clinical research associates) create site visits to evaluate, initiate, monitor, and close out sites.

• Managing Contacts for Sites. Users can associate sites with contacts, archive contact records for sites, and view the history of contacts at sites.

• Adding Address Types for Sites. Users can add a specific type of addresses for each site.

• Assigning Employees to Site Teams. Managers or CRAs add employees to the team associated with the site.

• Creating Activity Plans for Sites. CRAs use the clinical protocol site template that an administrator creates to plan a list of activities for each site.

• Applying Activity Templates to Sites. Users can simultaneously apply one or multiple activity templates to one or multiple sites for a study.

• Tracking and Adding Documents at Sites. CRAs and regional study managers post clinical trial and regulatory documentation for review at the site, region, and protocol levels.

• Creating Activities for Document Tracking. CRAs attach and track documents at the protocol, region, and site levels, or for accounts or contacts.

• Managing Tracking Activities for Case Report Forms. Users can create tracking activities for CRFs (case report forms).

• Tracking Case Report Forms. Users can create and track CRFs as part of a protocol, site, and region.

• Creating Correspondence Activities for Sites. Users can track all correspondence (phone, fax, email, and letters that the postal service delivers) between a site and a study team member as correspondence activities for the site.

• Adding Notes to Sites. Users can add notes to a site.

• Viewing the Status History for Sites. Users can view the changes to the Status field for a site.

• Assessing Contacts and Accounts. CRAs evaluate contacts and accounts by using the attributes in an assessment template.

• Generating Oracle BI Publisher Reports for Document Tracking. Users can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical.

• Generating Reports for Actual Visits. Users can generate a report for completed clinical subject visits.

• Generating Reports for Planned and Actual Dates of Subject Visits. Users can generate a report for completed clinical subject visit dates.