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Scenario for Managing Clinical Trip Reports

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

The Clinical Administrator

In this scenario, a clinical administrator prepares a set of trip report templates for the CRAs to use when preparing for and writing up their visits to clinical sites.

The clinical administrator prepares four templates, one for each type of site visit the CRAs are typically required to perform:

• Site evaluation
• Site initiation
• Site monitoring
• Site close-out

For more information about site visits, see Creating a Subject and Setting Up Visits and Visit Activities (End User).

The CRAs

The CRA is the end user of the Siebel Clinical product. Before visiting a site, the CRA uses the trip report feature to prepare for the visit. The follow-up items list reminds the CRA of the open activities arising from previous visits that need to be closed.

After preparing a draft trip report, the CRA makes a hard copy of the report and takes this copy on the site visit. The report can be used as a reference to help keep track of the activities that are carried out while at the site.

Upon return from a site visit, the CRA completes the trip report and generates a final report. This report is then submitted to the study manager for approval. The manager reviews the report and approves it if it is satisfactory. If the manager approves the trip report, it is then locked to prevent the CRA from making any further changes. If the trip report is not satisfactory, the manager may reject the report and return it to the CRA for further attention.