Using protocol calendars can significantly influence the performance of your entire clinical trial management system (CTMS), since the fundamental features offered within a CTMS are often dependent on the calendar. Forte’s Business Operations Services team has built more than 5,000 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), which can be imported directly into customers’ Forte CTMS.
In our vast experience building protocol calendars for our customers, we’ve learned a lot and would like to share what we believe are the best practices to follow when creating calendars in a CTMS. While a robust understanding of your CTMS is certainly vital, what is even more imperative is a thorough review of the protocol document to make sure you fully understand what the calendar-build entails. Below we outline several elements that go into deciphering a protocol document and transforming it into a protocol calendar that research sites can use in their CTMS.
Key areas to review in the protocol document
Title: The title assists in identifying the study type as oncology or non-oncology. The presence of words such as blinded, randomized or open-label help to swiftly determine how the treatment arms need to be set up for the calendar.
Schema/Study Design: The schema/study design section of the protocol document provides details about the precise manner in which the study will be carried out. Any initial questions you may have while reading the study title will typically be answered when reading this section. It will provide additional clarity on the treatment arm creation process.
Schedule of Events (SOE): The SOE grid is extremely useful when building the calendar, as it lists out the subject visit schedule and the procedures that need to be performed on every visit. When there are multiple treatment arms or cohorts involved, there may be separate grids provided, detailing the specific requirements for each arm. In this scenario, you will need to carefully compare and contrast the grids to first identify what attributes are shared across all arms, and to then sift out what is unique to each treatment cohort.
Section References: Section references in the SOE point to important details like tables in the protocol, such as the pharmacokinetic (PK) sample collection schedule, biomarker schedule, etc. It is essential to pay attention to these references, as they can greatly impact your calendar in terms of additional visit days being added to the calendar, apart from those listed in the SOE.
Drug Administration: This section should be reviewed thoroughly to understand the drug administration schedule. Any drug (irrespective of the route) that requires a subject to visit the study site for administration should be added to the list of procedures along with the indicated schedule – even if it is not listed in the SOE – as long as it’s described in another section of the protocol.
Study Duration: Reviewing the study duration helps clarify details such as the cycle duration for oncology studies. Additionally, this component of the protocol document provides information on the actual duration of the screening, treatment and follow-up period of the study, which may not always be clearly indicated in the SOE.
Visits & Tolerances: While the SOE provides visit information, this section defines specific visit window/tolerance allowed. In some cases, the SOE will display only a single visit for screening. However, if there are multiple procedures that need to be performed within a specified duration of the screening period, additional visits should be created. If a single procedure has to be performed at a different duration, we recommend that it remains part of the main screening visit created.
Procedures & Occurrences: In a straightforward protocol, associating procedures is typically not a challenge. For protocols with multiple SOEs, comparing and contrasting the various SOEs will show that some procedures are unique to one arm. It’s important to make sure these procedures are not blindly associated to all arms, as that could lead to an incorrect projection of subject visits. Occurrences will need to be added for certain procedures based on whether or not they need to be performed at additional times throughout the protocol.
Follow Up: While most protocols display a follow up visit in the SOE, in some cases the SOE will end at the off-treatment visit. In these situations it becomes especially essential to review the follow up section of the protocol document to identify if a follow up has been defined, including the procedures necessary as part of that follow up visit.
Footnotes: These provide additional information about each visit and procedure that may not be obvious upon first glance. For example, a protocol may have a common SOE, even though there are multiple treatment arms in the study, but the footnotes may contain text that could result in certain visits or procedures being unique to one arm.
There are many considerations and details to pay close attention to when it comes to building protocol calendars. 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. Following these best practices can help ensure you have an accurate representation of the protocol in calendar format for your CTMS in a way that best reflects the sponsor’s intent.
Have protocols that need calendars built in your CTMS?
If you have a backlog of calendars to be built and would like to utilize our services, please fill out this form to get started and we will be in touch with you at your earliest convenience. We can also let you know which protocols of yours are already built and are available for you to download from the Protocol Calendar Exchange. For more information, fill out this form and a member of our Customer Relationships Team will be in touch shortly.