Monitoring is one is the most important parts of the clinical research process. Without accurate and timely monitoring research studies can quickly fall into disarray. This is why it is important to have the necessary tools to facilitate, timely, accurate and cost effective monitoring practices. One way to do this is to utilize a CTMS with robust monitoring functionality. While this list is not exhaustive, it highlights some of the most critical tools needed to effectively use a CTMS for monitoring activities.
Dynamic Calendars and Scheduling
A CTMS that manages monitor scheduling well should be able to easily handle both sides of the monitor scheduling coin. It should be able to help the monitor schedule visits by providing information about scheduling windows and information about how long it has been since the last visit was performed. On the research site side, a good CTMS should be able to be able to manage both scheduled and unscheduled monitor visits.
Tracking AEs, SAEs and protocol deviations is a central part of the monitoring process. Without the proper CTMS tools, tracking and recording these events can be difficult and may not be accessible by all parties that need to see the data. By utilizing a CTMS with the ability to track AEs, SAEs and protocol deviations and incorporate them directly into the trip report it ensures that all of the necessary data is captured and that the data is available to all parties.
Enhanced Trip Reporting
Users should be able to quickly complete trip reports and be able to track all necessary information. In addition to having tracking all the right information, there should be printer friendly versions of the reports available as well. What’s more, a good CTMS provides greater functionality for visit report queries.
Visit Report Queries
Just as important as being able to accurately capture monitoring data in a CTMS, is the ability to quickly view the necessary data at a moment’s notice. It is essential that the CTMS you use for study monitoring has the ability to query monitor visit reports and extract data as it is needed. Users should be able to extract data on a particular trip report, on an individual site, a particular study or a number of other multi-variable searches.