| Siebel CRM Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2017, Rev. A E52416-01 |
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| Siebel CRM Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2017, Rev. A E52416-01 |
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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:
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 typically must perform:
Site evaluation
Site initiation
Site monitoring
Site close-out
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 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. He can use the report as a reference to help keep track of the activities he completes while at the site.
After returning from a site visit, the CRA completes the trip report and generates a final report. He then submits this report 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.
