Building protocol calendars in a clinical trial management system (CTMS) can seem like a daunting task for many research sites. A calendar can significantly influence the protocol workflows and performance of the entire CTMS, as the fundamental features offered within a CTMS are interdependent on the calendar. Serving as the source of truth for a trial and used for many downstream purposes, a protocol calendar must be built accurately.
Luckily, not all sites have to start from scratch or build calendars themselves. Calendar building services offer protocol calendars used by other sites on the same protocol. These services also offer custom calendars built specifically to the guidelines of the institution for those protocols without a pre-built calendar.
Saving time and effort
There can be a lot of wasted time and effort when a site has to sift through a protocol document and build a protocol calendar within their CTMS. Often, this process includes interpreting unstructured representations of the schedule of events and procedures, instructions buried in the footnotes, as well as modifications reflected elsewhere in the document. It’s a time-intensive activity that can take 8-20 hours per protocol. Based on the size of the trial and the number of participating sites, this process can happen from ten to a hundred times. This redundancy is extremely inefficient, especially across protocols, costing the industry significant time and money.
By limiting duplication of a time-consuming step and increasing reuse, clinical trials can become more efficient and systematic. In addition to delays in study startup, having each site build calendars from scratch is unnecessarily complicated, administratively expensive, and fraught with the potential for errors–costly errors.
Boosting accuracy and quality
Calendar building is a very specific skill set that takes a lot of practice to master. Given the subtle intricacies of any protocol, a calendar may be created differently by any two inexperienced staff. When people are making judgment calls independently, misinterpretation, confusion and human error are bound to occur. Without the specialized skills of an experienced calendar builder, the manual protocol interpretation and building process may hinder the accuracy and efficiency of study conduct, while potentially posing a risk to patient safety.
Some institutions, especially large academic sites, use a custom process for calendar building. These guidelines are required to adhere to best practices and follow specific processes common to all trials within the institution. These guidelines add another layer of complexity to the task of building the protocol calendar, reinforcing the need for an experienced, knowledgeable builder.
From a timing perspective, having a quality protocol calendar delivered early in the protocol timeline helps reduce risks associated with the downstream activities a calendar is used to complete, such as budgeting, coverage analysis, invoicing/payment reconciliation and forecasting participant visits. Consistent calendar use across sites is an essential way to ensure patients are getting the right treatment at the right time. Using a shared or custom-built protocol calendar removes the guesswork for sites and improves the quality and safety of study conduct.
Making the best use of your resources
There’s no need for each site to devote time and effort to interpret the protocol document and build the calendar. With limited staff time and budgets, and the increasing complexity of protocols, the ability to rely on high quality, existing calendars can help deliver a consistent and accurate representation of the protocol.
Forte Protocol Calendar services provide an ever-expanding library of pre-built protocol calendars available for sites to download directly into their OnCore Enterprise Research system or Allegro CTMS. Built by Forte’s dedicated team of experts, the calendars are already being used by other sites participating on the trial. For calendars not-yet built, Forte can quickly build it for you, adhering to your custom guidelines if necessary.
Forte follows best practices, defined guidelines and has experience building thousands of protocol calendars of various types, including NCTN, non-NCTN and umbrella/bucket trials across various therapeutic areas (cardiac, ophthalmology, AIDS, diabetes/endocrinology, transplant and more).