Process of Managing Sites and Contacts for Clinical Trials

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

Perform the administrative tasks described in this topic before performing the related end-user tasks. For example, a clinical protocol site template must exist before you can create the corresponding activity plan for the site.

Administrator Procedures

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

• "Creating Clinical Protocol Site Templates". An administrator creates templates that detail the activities that users must perform at all sites that carry 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.

• "Associating Accounts with Sites". An administrator applies the accounts for protocols and regions to site records.

• "Associating Activities with Sites". An administrator applies the activities for protocols and regions to site records.

• "Associating Documents with Sites". An administrator applies the documents for protocols and regions to site records.

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.