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Process of Managing Sites and Contacts for Clinical Trials

This topic details sample tasks often performed by administrators and end users when managing site and contact information. Your company might follow a different process according to its business requirements.

The administrative tasks described in this topic must be performed before the related end-user task can be performed. For example, a clinical protocol site template must exist before the corresponding activity plan for the site can be created.

Administrator Procedures

The following list shows tasks administrators typically perform to manage site and contact information:

• Creating Clinical Protocol Site Templates. An administrator creates templates that detail the activities that must be performed at all sites that are carrying out the same protocol.
• Creating Contact and Account Assessment Templates. An administrator or the study manager creates assessment templates that define weighted attributes for assessing a contact or account.
• Maintaining Contacts and Accounts. An administrator maintains records of contact license numbers and deletes erroneous or obsolete account and contact data.
• Associating Contracts with Sites. An administrator or a study manager enters details about the contracts for a site and the payment details for each contract.
• Associating Accounts with Contracts. An administrator or a study manager enters details about the accounts for a site.

End-User Procedures

The following list shows tasks end users typically perform when managing site and contact information:

• Creating and Managing Site Visits. CRAs (clinical research associates) create site visits to evaluate, initiate, monitor, and close out sites.
• Creating and Updating Sites, Contacts, and Accounts. CRAs record details about contacts, accounts, and 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 has been created by an administrator to plan a list of activities for each site.
• Applying Activity Templates to Sites. Users can simultaneously apply one or multiple activity templates across 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 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.
• Creating 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 delivered by the postal service) 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.
• Assessing Contacts and Accounts. CRAs evaluate contacts and accounts, using the attributes defined 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.