With the continuous improvement of electronic trip report functionality offered by certain clinical trial management systems (CTMS), companies can do a lot more in a shorter amount of time. And, with an increased focus on risk-based monitoring (RBM) techniques, designed to identify, resolve, and prevent issues relating to the execution of trials, trip reports are playing an ever-more critical role in clinical and safety departments.
Here are several ways you can leverage Oracle Siebel CTMS’ trip report functionality:
Track and monitor site-, subject-, and site visit-related issues and action items
- Records can be created directly in site visit reports
- Records can be imported from a site’s action list into a site visit trip report
- Records included in a trip report can be linked to specific checklist items, subjects, document tracking, communications, etc. outside of the trip report
- Records can be entered and closed by study team and/or monitoring team members
- Information about trip reports can be rolled up to the study level for cross-study review and comparison
Track operational metrics around adverse events, protocols, and other site violations
- Can include serious, unanticipated, major, and other types of adverse events
- Data can automatically be pulled in from an integrated EDC system
- Data can be imported into the site visit trip report as proof of source data verification (SDV)
- Information can be rolled up to the study level for cross-study review and comparison
For companies who are not planning to implement a new CTMS, adding a configurable trip report module to their existing solution can be a viable option. Alternatively, those who are evaluating a new system should consider a CTMS that offers comprehensive trip report functionality. If you are interested in either solution, contact us.
