Building a protocol calendar in a clinical trial management system (CTMS) is a time-intensive activity for research sites to carry out. This process can take 8-20 hours per protocol for people who do it full-time and follow best practices for building calendars. For those who aren’t as experienced or proficient in calendar building, it can take up to a week. Furthermore, the protocol calendar is often considered the source of truth for a trial and is used for many downstream purposes, making accuracy a top priority.
Before you build your next calendar, ask these six questions and consider the signs that it might be better to seek external help for calendar building.
1. Would time be better spent on other activities?
With too much to do and too little time, many site staff juggle a number of priorities. While building the protocol calendar is an important step in setting up a trial at a site, it’s very time-consuming and is often not the primary focus of a single employee. A site can operate more efficiently by reexamining the workload of those who are spread too thin and reassigning resources to other value-add projects. This freed up time allows employees to accomplish other important job duties and trial-related activities that need to be completed at your site.
2. Do you have a backlog of protocol calendars that need to be built?
Whether your site just implemented a CTMS and you need to add calendars into your system from scratch, or this task simply keeps getting postponed due to other pressing activities at your site, it may be nearly impossible to get all calendars prepared in a timely manner. For some sites, it would require hiring several new full-time equivalents (FTEs) just to build calendars for all of their protocols. Getting the protocol calendar up is the cornerstone of a trial and the first step some take to get a trial activated at their site. Given the importance of the calendar to the protocol, it’s something sites should never neglect.
3. How difficult is it to train new staff on building calendars?
It can be hard for large institutions to get an FTE that’s dedicated to building calendars, often making it a task that is completed by people who already have a variety of other tasks. Regardless of who is building the calendars, figuring out what to do when someone leaves presents additional challenges. The painful and costly realities of managing staff turnover, hiring and training presents a lot of burden for sites. Because it takes so long to get up to speed on how to properly build protocol calendars, training new employees requires a lot of time.
4. How many people are responsible for building calendars?
As mentioned above, it’s common for employees to be the jack-of-all-trades, master of none. However, this role won’t cut it when it comes to building protocol calendars. Calendar building is a very specific skill set and takes a lot of practice to become adequate. If a person doesn’t have these specialized skills, costly mistakes will happen. Any two staff may interpret the same protocol very differently and build different calendars for the same protocol. When people are making judgment calls independently, misinterpretation, confusion and human error are bound to occur. Similarly, if a person has to relearn how to build a protocol calendar from scratch each time, it will take much longer than someone who does it everyday. This doesn’t help sites operate in an efficient manner.
5. Is the protocol complicated?
Depending on the type of trial, the schedule of events can be more complicated, making a protocol calendar more complicated to build. For example, with the rise of precision medicine, newer types of trial designs in oncology, such as umbrella and bucket or basket trials are becoming more common. These trials cover multiple smaller trials or sub-studies, which may be the equivalent of building out many studies within one calendar. Thus, building protocol calendars for these trials requires even more work than usual.
6. Is the calendar already built and being used by other sites on the trial?
Why create something from scratch if it already exists? The Protocol Calendar Exchange is an ever-expanding library of pre-built protocol calendars available for sites participating on a trial to download directly into their CTMS when using OnCore Enterprise Research system or Allegro CTMS. Built by Forte’s dedicated team of experts, the calendars are pre-approved, reviewed and are being used by other sites participating on the trial. There’s no need for each site to reinvent the wheel, because others have already taken the time to interpret the protocol document and build the calendar.
These are just some of the telltale signs that it’s time for your site to consider outside help for calendar builds (at least for some of your protocols). With all the time, effort and know-how required for calendar creation, it may be best to leave it up to experts to get it done quickly and accurately.
If any of the above signs sound all too familiar to your site, there’s a solution that can help you save time and resources by downloading high quality, cost-effective calendars. Every new Allegro CTMS subscription now includes one free calendar-build. Register for an Allegro demo today to learn more.