A critical component of any clinical trial is the protocol calendar, the schedule of treatments and tests a patient completes on a research study. In order to manage this effectively at the site-level, a protocol calendar is built in each participating site’s clinical trial management system (CTMS) for every trial. This process requires sites to decipher the sponsor’s protocol document–including unstructured representations of the schedule of events and procedures, instructions buried in the footnotes and modifications found elsewhere in the PDF–and transforming it into a format sites can use throughout the trial.
The protocol calendar may be the most important aspect of a clinical trial, as any errors or misinterpretation from it can result in missed visits and inaccurate treatments. Deviations can create non-trivial safety concerns for participants and regulatory compliance challenges for the site and sponsor. Setting up a single protocol calendar can significantly influence the performance of the entire CTMS, as the fundamental features within it are interdependent on the calendar.
Given how critical this process is, you would expect a calendar to be created with scientific rigor, checks, balances and best practices to ensure it carefully reflects the sponsor’s intent. However, this is not always the case.
Building protocol calendars can be subjective
Most study coordinators and site staff will tell you that calendar creation is more of an art than a science. Any two people can interpret the same protocol very differently. Based on this interpretation, the calendar builder at each site makes judgment calls on how to set up a calendar in their CTMS. Since the protocol details can radically change how you build the calendar, it’s important to understand what you are doing in order to make the best decisions for the trial. There may be more than one way to set up a calendar correctly – which can either simplify the process or create more work. These options vary depending on the CTMS you use, but may include:
- Configuration choices for how dates are set up (e.g., visits starting on Day -1, 0, or 1 or for oncology calendars that need to structure cycle visits)
- The best way to break out treatments, visits and segments
- The use of either footnotes to differentiate procedures on different arms, or to build them out separately
- The use of either additional or custom fields on a protocol, or putting them within the calendar
- How to group treatment arms
- Whether you will share segments or separate out arms
- If you will set up one large protocol with several treatment arms or several individual protocols
With calendar creation comes some freedom and flexibility to determine how to set up a protocol. It will always require some subjectivity and can never be fully automated by the software, making it an art form.
Consequences of misinterpreting the protocol document
While there is an art to calendar creation, it’s also very systematic in nature with applied knowledge and rules. The calendar functionality alone within the site CTMS is a robust tool that requires an in-depth technical understanding. In addition to having a vast CTMS know-how, you also need extensive clinical research knowledge. There are key areas to review in the protocol document and best practices that should be followed to ensure you have an accurate representation of the protocol calendar that best reflects the sponsor’s intent. The slightest misinterpretation or translation error from the protocol document to the protocol calendar in the CTMS can result in clinical trial participants receiving the wrong care.
Furthermore, science assumes a consistency that art does not. Making sure you know what you’re doing and following the best practice guidelines will help ensure the protocol calendar represents the sponsor’s intent.
Standardization is the answer
Even if everyone who builds calendars does it full-time, the sponsors’ intentions can get lost in translation. Having individual staff at each site make judgment calls on the protocol independently leads to misinterpretation, confusion and human error. The likelihood of error is amplified, since this re-interpretation can happen from ten to a hundred times based on the size of the trial and the number of participating sites. Ultimately, this process needs to be standardized to get all sites on a trial on the same page and using the same protocol calendar–one that acts as a single source of truth.
That’s why Forte created the Protocol Calendar Exchange, a technology platform that enables the building and distribution of standardized protocol calendars developed in-line with established guidelines. These standardized protocol calendars can be downloaded directly into OnCore Enterprise Research system and Allegro. Creating a calendar once so that it can be used multiple times removes the guesswork for site staff, prevents duplicate, manual effort and makes the protocol less open to interpretation. The more sites that conform to a single standard protocol calendar, the greater the impact on study conduct across sites.
Forte’s Protocol Calendar Exchange can save sites time and effort spent interpreting protocol calendars into a CTMS. Find out how one Allegro CTMS user leverages this calendar-building service to increase the accuracy of her site’s protocol calendars.