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Scenario for Managing Sites and Clinical Contacts

This scenario provides an example of a process performed by the administrator and the clinical research associates (CRAs). Your company may follow a different process according to its business requirements.

In preparation for the clinical trial, the administrator sets up templates to generate site activity plans for site initiation and to track documents. The administrator also creates templates that the CRA uses towards the end of the trial to assess contacts and accounts associated with the trial. Contact and account information may need to be updated by the administrator before the CRA can begin work on the site. Another important task that the administrator may have to carry out is to associate contracts with a site. Often, multiple contracts may need to be associated with individual sites.

When the CRAs begin work on a new clinical trial, they must set up a number of site visits that will dictate whether the site can be used to carry out the trial. After this, 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 a new contact is entered, the CRAs request that the administrator enter the contact's primary specialty. Data cannot be entered to this fields from the CRAs' views. After this, the CRAs must appoint a team of employees that is to be assigned to that site. This allows the study manager to keep track of the members of each site team.

CRAs need to plan how the protocol will be carried out at the site. This is done by creating a site activity plan, which determines how the trial is conducted. The CRAs use the clinical protocol site template that has been created by the administrator. CRAs may also track any number of extra documents that are associated with a site. This may include regulatory or clinical trial documentation.

From time to time, CRAs enter account or contact records incorrectly or they discover that some account or contact records have become obsolete. The CRA then puts in a request to the administrator to have those accounts and contacts deleted. CRAs do not have the permissions needed 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. Please obtain legal advice before using the contact assessment feature in Siebel Clinical.