Scenario for Managing Sites and Contacts for Clinical Trials

This topic gives one example of how to manage sites and contacts for clinical trials. You might manage sites and contacts for clinical trials differently, depending on your business model.

To prepare for the clinical trial, the administrator sets up templates to generate activity plans for site initiation and to track documents. The administrator also creates templates that the CRA (clinical research associate) uses near the end of the trial to assess contacts and accounts associated with the trial. The administrator might have to update contact and account information before the CRA can begin work on the site. Another important task that the administrator might have to complete is to associate contracts with a site. Often, the administrator might have to associate multiple contracts with individual sites.

When the CRAs begin work on a new clinical trial, they must set up a number of site visits that dictate whether the site can carry out the trial. Then they add new information and update existing information about accounts, contacts, and sites, and about the affiliations and associations among them. Maintaining accurate data is critical to successful clinical trials.

When creating a new contact record, the CRAs request that the administrator enter the contact's primary specialty. The CRAs cannot enter data in this field. Then the CRAs must appoint a team of employees to assign to that site so that the study manager can keep track of the members of each site team.

The CRAs plan how to carry out the protocol at the site by creating an activity plan for the site. This plan determines how to conduct the trial. The CRAs use the clinical protocol site template that the administrator creates. They also track any number of extra documents that are associated with a site. These documents can include regulatory or clinical trial documentation.

From time to time, the CRAs enter account or contact records incorrectly, or they discover that some account or contact records are obsolete. The CRA then puts in a request to the administrator to delete those accounts and contacts. The CRAs do not have the permissions to delete these records.

Before the clinical trial ends, the administrator or the study manager creates a contact assessment template that each CRA can use to evaluate the performance of the investigators at the conclusion of the trial.

Caution: In some countries, it is not permitted to evaluate the performance of site personnel. Obtain legal advice before using the contact assessment feature in Siebel Clinical.