Dena Hughes, Senior Implementation Specialist, PROMETRIKA, LLC.
PROMETRIKA is pleased to announce that we have successfully implemented RaveX in our Data Management department. RaveX is the latest version of Medidata’s popular Electronic Data Capture (EDC) solution for collecting clinical trial data. Its predecessor, “classic” Rave, has been in use in the industry since 2001. With our first configuration and release (June 2018) of a clinical trial database utilizing RaveX, PROMETRIKA has navigated the waters of this new Rave user interface (UI) and its Cloud Administration component. In so doing, we have developed a standard set of re-usable processes and procedures around implementation of Cloud Administration, approaches that take advantage of new features and thereby reduce the time and effort required for managing this component of a database using RaveX.
But what, exactly, is RaveX? With classic Rave performing as a tried and true solution, why should you consider switching to RaveX? What benefits would you gain? What pitfalls might you encounter? And who can help you navigate these new waters?
What is RaveX?
RaveX is primarily an updated UI, replacing the current classic look with a dynamic display and more efficient navigational controls. In addition, behind the scenes, access to RaveX is managed through Cloud Administration, bringing both a new look and a more streamlined process to granting user access to EDC and other integrated Medidata products such as Coder and Safety Gateway. And RaveX, unlike classic Rave, is automatically upgraded, meaning you will always be running the most current version.
What RaveX is not? A complete overhaul of the entire Rave EDC system. Although it has a new look and feel, the RaveX UI is supported by the same outward-facing architecture when it comes to building databases and managing system features. For database builders, Architect remains the same, only now some of the dynamic-design programming surfaces immediately in the RaveX UI, rather than requiring additional action on the part of the end-user. For system administrators, the core configuration settings are as they were, so no need to re-think your entire URL configuration.
Why RaveX over Classic Rave?
After more than 15 years of designing and building study databases in classic Rave, it admittedly was not an easy transition for me to the new RaveX UI. Features to which I’ve previously been able to navigate with my eyes closed are no longer in the same places. Log forms look foreign, yet oddly intriguing. And where did the eyeball icon go? For that matter, what happened to all of my icons, they all look so different now. What is this colored badge? And how do I find my tasks? Is this new UI and its associated Cloud Administration requirements making my work simpler and more efficient or is the change management process required to get there not worth the effort?
These are the types of questions you may ask when first navigating the RaveX and Cloud Administration waters, but there are a number of advantages to staying the course and adopting these newer products for your organization.
Efficiencies in Account Management
Cloud Administration, required for RaveX databases, introduces the concept of “Platform Roles,” which are not just the EDC roles to which we are accustomed but comprehensive roles that bring together multiple components, simplifying access-granting activities and reducing the possibility of granting inconsistent access to the same types of end-users.
Implementing these umbrella roles requires a slight shift in thinking and there are a few manageable pitfalls that must be avoided around component assignments when creating your Platform Roles. For many of us, updates to our account management processes and request forms will also be required. But the simplification of requesting access for a single role, rather than multiple components, eases the burden on end-users and system administrators alike. Additionally, as Medidata integrates more products into Cloud Administration, the ability to manage the currently-multiple access points through a single entryway will bring added value.
Improved Role-Based Testing and Navigation
Data Managers spend a considerable amount of time performing user acceptance testing (UAT) of EDC builds. In many cases, this includes logging into Rave EDC with several different roles, confirming configurations such as view- and entry-restrictions or signature requirements. In classic Rave, this requires numerous open browser tabs or, worse yet, for core configurations that don’t allow for multiple logins, the use and maintenance of multiple separate test accounts, one for every testing role required.
In RaveX, this process is streamlined by the new ability for the user to switch to a different role, on the fly, within the same browser window. Need to test as a data manager? Select data manager from your profile dropdown list of roles. Now need to view as a clinical research coordinator (CRC)? No need to open another browser tab or log in with a separate CRC account – just pick the CRC role from your profile dropdown list and your view is shifted to that role. The benefits in time savings during testing activities are obvious.
Similar efficiencies are available to database builders and system administrators, with new dropdown navigation menus allowing the user to switch environments on the fly or go from working in EDC to accessing the system administration screens with a single click.
Simplified Visual Cues
How do you reduce your overview status icons from a whopping 16 to a more manageable 8? Switch from classic Rave to RaveX. I admit to missing the eyeball icon, but there is beauty in simplicity and greater ease for end-users when the eyeball is not staring blankly back.
For long-term Rave EDC users such as myself, the change in icons may be one of the more difficult new features to manage. But by simplifying the visual indicators of what needs to be done – entering data, addressing queries, taking some sort of action, signing a form – the need for constantly referencing the icon key fades and the ability to quickly see where action is needed rises to the surface. See a Flag? Click on it and the colored badges at the top of the form will tell you – in words, not pictures – what action is required. It’s a new look but more directly informative to the end-user.
Faster and Cleaner Data Entry
The switch from classic Rave to RaveX isn’t just about the efficiencies we can gain as EDC builders, system administrators, and people that monitor and review the clinical data from within the platform. More importantly, it’s also about the quality of the data as it is being entered by the clinical sites. Easing the ability for sites to correctly enter dates by providing a calendar control, firing real-time queries for missing or non-conformant data as soon as the clinician navigates away from a field, prompting immediate data correction rather than the save-and-come-back later approach, making a field dynamically visible as soon as the triggering data is entered, thereby eliminating that same save-and-come-back later architecture; these are the new RaveX UI features that can contribute to cleaner and more efficiently entered data, with the resultant downstream effects of fewer outstanding queries and missing results.
Automatic Upgrades and Bug Fixes
In addition to improved data quality, perhaps one of the most pragmatic reasons for switching from classic Rave to RaveX is that RaveX is always automatically upgraded, allowing you to take instant advantage of new features and bug fixes. Furthermore, if you are using other integrated Medidata products, such as Coder, the full features of these integrated products are also immediately available to your RaveX databases.
What We Can Do To Help
PROMETRIKA’s Data Management and Database Programming teams are now well-versed in navigating the new RaveX UI and understand how differences in study and form design will render in the interface. We are familiar with the classic Rave features that are no longer supported or that now require a new way of navigating, and we can provide consultation and/or train sponsors in these areas. The knowledge we have gained through direct experience in implementing RaveX and Cloud Administration can be leveraged to facilitate a smoother start-up for your adoption of this new UI. It’s a leap worth taking.