Siebel Clinical Trial Management System Guide > Administering and Using Clinical Trip Reports >

Scenario for Managing Clinical Trip Reports

This topic gives one example of how to manage clinical trip reports. You might manage clinical trip reports differently, depending on your business model.

This topic includes the following information:

• Preparing Trip Report Templates
• Preparing Trip Reports

Preparing Trip Report Templates

A clinical administrator prepares a set of trip report templates for the CRAs (clinical research associates) to use when preparing for and writing up their visits to clinical sites. For more information about site visits, see Creating and Managing Site Visits.

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

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

Preparing Trip Reports

The CRA (clinical research associate) is the end user of the Siebel Clinical product. Before visiting a site, the CRA uses the trip report to prepare for the visit. The follow-up items list reminds the CRA of the open activities arising from previous visits that the CRA can close.

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, then it is then locked to prevent the CRA from making any further changes. If the trip report is not satisfactory, then the manager can reject the report and return it to the CRA for further attention.