By: Shree Kalluri
Clinical trials are more complex than ever and it’s important to make sure a study is being conducted in the same manner across sites. However, ensuring consistency across multiple sites for any aspect of a clinical trial can be more difficult than one would expect. Some inconsistencies at the site-level are unknown to many sponsors, resulting in both efficiency and quality problems in the industry.
One example of this industry challenge stems from having each research site transform the schedule of events, also known as the time and event schedule, into their local clinical trial management system (CTMS). This transcription requires sites to review and interpret the protocol document and build it out as a protocol calendar in their CTMS. The protocol calendar, a schedule of treatments and tests to be completed by a participant on a study, is one of the most important aspects of a clinical trial, and any deviations from the calendar can have detrimental consequences. The calendar is connected and tied to other downstream activities and uses within the site’s CTMS, making it more powerful than a static spreadsheet or PDF.
This process can be replicated from ten to a hundred times based on the size of the trial and the number of participating sites. With so much duplicated effort, this method is unnecessarily complicated, administratively expensive, and fraught with the potential for costly errors.
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