A clinical trial management system (CTMS) has numerous benefits. It streamlines the workflow of coordinators, provides a central place to house all trial-related information, and ultimately equips staff with the time-saving tools necessary to increase productivity. With benefits like this, it’s no wonder more and more investigator sites are making the decision to purchase a comprehensive CTMS solution. However, a great CTMS is only efficient when its end users are on board. Sites that obtain buy-in from their staff, develop a strategic rollout plan, and integrate the system with daily workflows are most successful in a CTMS adoption.
The key to successful user adoption lies in the very early stages of implementation. Some might even say it begins in the decision making process before the CTMS is purchased.
The extent to which users are involved in the decision-making process can impact how users adopt the CTMS and how quickly they begin using it. Too often, higher-level management makes a CTMS purchase without involving those who will actually operate the system on a daily basis. Successful sites communicate their plans and get feedback from the end users as stakeholders in the purchase. They take the time to understand the users’ workflows, learn where a CTMS can improve operations, and apply a solution-based approach to assessing the application. By inviting staff members to participate in the evaluation and selection of the appropriate CTMS, they become more likely to fully utilize the system and reap the benefits.
Creating buy-in comes down to clearly explaining the reasons for the system, what the organization hopes to gain from it, and what the benefits are to each user group. Sharing this information with everyone who will be using the system — not just those involved in the decision-making process — is essential. By doing so, the organization is able to create excitement among the users even before they get trained and begin using it.
Roles and Responsibilities
Once a CTMS decision has been made, outlining clear objectives and a course of action prior to the implementation is crucial. Jumping in and randomly importing information should be avoided and will only lead to confusion later on. In fact, the larger the scale of the implementation, the more consideration should be given to what data to move to the new system.
Involve input from multiple users across functional areas and agree on a rollout plan, answering questions such as:
- Who will make setup and data-import decisions?
- Will we roll out to users in phases or will all users adopt the system at once?
- Who should participate in trainings?
- How will the CTMS be used in site operations?
- What is the time frame to be fully implemented?
Consider all users of the system and how they will utilize the various functions in their daily workflows. Clinical research coordinators and principal investigators as well as regulatory, finance, physicians, nurses, and pharmacy staff might become users of the application. Discuss with your CTMS provider the different training needs of each group.
Your CTMS provider can help recommend a training plan to fit your needs. An ideal training session will familiarize users with the functionality of the system to teach them the tools they need to start using the application right away. Training should focus on navigating the application and knowing its features. Once users learn how to use the tools available to them, they are often able to apply that knowledge in a variety of real-life scenarios.
In addition, resources should be made available for users after training is complete. Consider designating core staff from your site to act as subject matter experts (SMEs), or project coordinators, for the CTMS. These core users can collaborate with staff to maximize the system for their workflows. The SMEs can also compile questions to ask your support team and stay up to date with new features and functionality available in the CTMS. Other suggestions for successful, ongoing adoption include:
- Ask your CTMS provider if they have startup guides, visual aids or help text.
- Develop an internal “cheat sheet” or tip sheet to outline workflows that include SOPs.
- Demonstrate positivity about the transition and highlight the solutions the CTMS provides.
- Encourage questions and feedback from the end users.
Maintain a relationship with your training or support team and know how to contact them. They can help answer any questions that come up as you move forward.
Perhaps one of the easiest aspects of the rollout plan is to provide the users an open environment where they can ask questions and provide feedback. When learning a new system, questions will undoubtedly arise. Encouraging staff to ask these questions empowers them to further their knowledge of the CTMS and ensures processes are being met by everyone. Taking a little extra time in the beginning to confirm everyone is on the same page can save sites time in the long run.
The amount of time devoted to implementation varies from one site to the next based on the number of users, number of trials, and any previous experience using a CTMS. Sites should consider the scope and sequence of rolling out a new system and set attainable deadlines. For example, decide when each department will begin using the system, what studies to implement first, and who will put each study into the system. Setting these priorities in advance is a significant time-saving tool.
According to Lauren Morrow, Clinical Trials Specialist at Vanderbilt University, “a good strategic plan makes things move faster and allows for standardization across protocols.” Their recent purchase of Allegro® CTMS and the resulting implementation proved to have a successful user adoption and continues to be a welcomed learning experience.
Vanderbilt Case Study
Vanderbilt’s approach to purchasing and implementing a CTMS was very calculated and they made sure to involve all users throughout the process. Morrow explains, “There were only a few people who technically got the system up and running for standardization purposes. However, everyone has been involved in giving feedback for changes they think should be made.” Additionally prior to the purchase, “all staff were invited to watch the demos and provide feedback. Everyone helped select and compare the system and recognized the benefits of having one.”
Upon implementation, the leadership team, which included representatives from both regulatory and finance, met to set their priorities and deadlines. They categorized each trial into one of three groups, based on priority.
- First Priority – Studies that were almost ready to open
- Second Priority – Studies that had been open for a while
- Third Priority – Studies that would likely open several months out
By putting each study into one of these three categories, they were able to make better use of the system and staff time.
Vanderbilt had an internal team specifically devoted to the rollout and training of coordinators. This team worked to enter study basics and reviews, as well as open the trials to enrollment within Allegro® CTMS. One person built the calendars for each protocol and then the financial group entered the budgeting pieces. The team tracked when each step was completed in order to provide handoff to the next person, and weekly meetings were held along the way to discuss progress. Once all the groundwork had been laid for the trial, the coordinators were responsible for managing only subject visit information. This way, coordinators were introduced to the system at a point that added immediate value to their workflows and creates a good foundation for later adopting further use of the system.
The same team that laid this foundation also took leadership on training sessions for the staff. In addition to the initial instruction that was provided for the Allegro system by Forte Research Systems staff, the team at Vanderbilt conducted small group training sessions with coordinators, which allowed them time and hands-on experience to learn how to navigate the system. To ease any fears of the unknown and to create buy-in among the coordinators, Morrow says they, “did multiple trainings, created step-by-step manuals, and even sat down with individuals and walked them through each step. They also were encouraged to ask questions as they arise.”
If giving advice to future CTMS adopters, Morrow would recommend they have a plan, prioritize, conduct internal staff training, identify key users, and set deadlines.