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Process of Managing Clinical Trial Site and Contact Information

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.

NOTE:  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 site activity plan can be created.

Administrator Procedures

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

• Creating a Clinical Protocol Site Template. 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. The administrator or the study manager creates assessment templates that define weighted attributes for assessing a contact or account.
• Maintaining Contact and Account Information. An administrator maintains records of contact license numbers and deletes erroneous or obsolete account and contact data.
• Associating Contracts with a Clinical Trial Site. The administrator or a study manager enters details about the contracts for a site and the payment details for each contract.

End-User Procedures

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

• Creating and Managing Clinical Trial Site Visits. CRAs create site visits to evaluation, initiate, monitor, and close-out sites.
• Creating and Updating Site, Contact, and Account Records. CRAs record details about contacts, accounts, and sites.
• Assigning Employees to the Site Team. Managers or CRAs add employees to the team associated with the site.
• Creating Site Activity Plans. CRAs use the clinical protocol site template that has been created by an administrator to plan a list of activities for each site.
• 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 Documentation Tracking Activities. Documents can be attached and tracked at the protocol, region, and site levels, or for accounts or contacts.
• Assessing Investigators and Hospitals or Other Contacts and Accounts. CRAs score contacts and accounts, based on the attributes defined in an assessment template.