There are so many ways to design electronic CRFs. Perhaps by looking at how NOT to design them, we can come up with some fresh ideas for how to make your next study a smashing success.
Fail to consider how well the forms will function on handheld devices.
The sun us setting on big screens and desktop workstations. Soon a new day will dawn, and the sun will shine solely on small screens. They provide mobility and greater access across the board. They are the key to conducting business in the information age.
Take, for example, form layout. Regardless of whether you are viewing it in landscape or portrait, a long list of fields is not conducive to the thought-processes of the human brain. Fields need to be grouped together in a way that makes sense to the person filling it out. And news flash: the person filling out the forms for your study is guaranteed to be relying on a human brain.
Put simply: don’t shortchange the design process of the study build in favor of a quick turnaround. You will thank yourself later when you are parsing through the raw data for usable statistics.
Require users to navigate extensively to do their jobs.
Do not bury important fields at the bottom of the form. Don’t force your sites to have to dig deep to get what you need. Cater the form configurations to quick and easy navigation.
Employ checkboxes instead of radios.
Simplify the investigators’ jobs before they even begin. Give them less options when possible. Dummy-proof your study to the point where the patients themselves could fill out their forms.
Don’t provide options for “Neither,” “N/A,” “Not Done,” or “Other.”
Bottlenecks happen when a field is lacking necessary options. The investigator will simply leave it blank if they do not see the option they need. Then the monitor goes in and queries the blank field. The investigator responds that they didn’t perform that particular test. The issue gets shunted up the line until it gets to Prelude and a mid-study update is requested to add the pertinent option to the field in question. This takes time, causes confusion, and costs extra support hours, depending on the complexity of the request. There will always be mid-study updates. It’s a normal part of the process, but some things can be prevented. Do your best to predict issues before they happen, and your study will run much more efficiently. Just don’t overthink it…
Assume that the data will be entered in a certain order.
After taking into account all of the above, we’ll leave you with this: You can’t predict everything. Put as much thought into your eCRF’s as you can, but first you have to learn the difference between what you can control and what you cannot. Providing a radio in place of a list of checkboxes is all well and god, but don’t assume they will fill out the first item on the form first. Don’t go overboard with field suppressions and calculations. Try to think the way a clinical would. That’s all you can do.
Streamline data-capture by using Vision’s built-in documents manager. You can keep all of your data and communications in one, easy-to-navigate place. Not only will assigned users have instant access to communications and updates, but you will be able to track who has viewed or edited what. No more unresponsive team members claiming, “No, I didn’t see that last update!” when really, they just forgot to respond to it (you know who you are).
Simply navigate to the applicable patient or site where you intend to upload a file or attach a note. Typically, the last or second-to-last form under each patient and site is labelled Notes/Comments/Errors or Comments/Errors. Under this file group will be a notes form. This can be used to append documents like medical histories or previous labs results to a specific patient or signed forms to a specific site. Team members can also add short comments as necessary throughout the study. Prelude offers this form group as part of every contract, but it can also be customized to suit your unique study’s needs.
There is also a form where users can upload transcribed CRF’s, making it easier than ever for sites to keep a thorough record of all essential documentation for their subjects. This basic form includes a place to record the date and time uploaded, the name of the electronic version of the form where the data was transcribed, as well as a link to that form within the system, the reason for transcription, and checkbox where the monitor can indicate that they reviewed the transcription. But don’t forget: this form can be customized to include any extra details your study requires.
Ask your Prelude Project Manager about even more ways to tailor your study’s forms to meet all your document management needs!
An EDC improves efficiency and reliability while conducting clinical research. Here are some ways it does that:
1. Efficient Communication
The efficiency of communication between team members is what determines the success or failure of a clinical trial. If a team does not have a streamlined process for disseminating information throughout the life of a project that deals with the staggering amount of data typically generated by a drug trial, everything else can fall apart. An Electronic Data Capture (EDC) system provides a platform for making sure information gets to the proper people in a timely manner in a way that paper will never be able to match.
With an EDC, there is a much lower risk of communications being lost or seen by the wrong people. Updates can be shared instantly to ensure that everyone who needs to know will have the pertinent information at their fingertips with no waiting. The only thing you will have to wait for is federal approval (sorry, can’t help you there).
2. Instant Documentation
Every time a user changes a field or makes an entry into the EDC system, the time, date, and user information is captured and recorded instantaneously. Indeed, as soon as a user logs onto the study, the EDC system records how much time they spent on each form even if they simply left their browser open while they played Solitaire in another window (disclaimer: we do not, as yet, have a way to track for you who on your team is playing games and who is actually working).
The EDC system can also record signatures on forms along with accurate date/time stamps. Say an investigator forgot to sign off on a form, and it goes unnoticed until the end of the trial. With paper, the monitor would have to track down who the investigator at that site was and mail them the form to sign. Then the offending investigator would have to mail the signed form back to the Monitor. If the investigator forgot to sign the form initially, who is to say they won’t also forget to send the signed form back? This process is time-consuming and susceptible to errors. With electronic data-capture, signatures are a given and no one has to wait by the mailbox for clerical corrections.
3. Intuitive Summaries
Most clinical trial personnel would agree the most time-consuming aspect of a drug trial is the extrapolation of useful information from the massive amounts of data generated throughout any given study. Where paper fails, an EDC system thrives. The EDC platform is designed specifically to make combing through data as efficient as possible (we won’t go so far as to say it’s enjoyable, but efficient, definitely). An EDC accomplishes this by providing user-friendly summaries directly within the system, which saves time and energy by doing all the work of combing through patient data for you.
Summaries can be set up to meet almost any parameters you can think of, and they can be set up in a matter of seconds. You can compare infinite pieces of data (provided you have infinite pieces of data) to help you come up with the most accurate results possible for your study without wasting man-hours (or woman-hours). Most importantly, EDC summaries can be saved, altered, and shared as fast as thought, so you can keep up with the continuously evolving business of producing safe drugs for people and animals.
4. Real-time monitoring
Monitors can review data entered into an EDC System as soon as the person entering the data hits ‘Save’. There are even features which allow monitors to view data-entry live from a remote location to ensure that patients are kept safe during difficult or potentially dangerous procedures. An EDC system keeps a study moving forward by removing lag-time between clinical observations of patients and safety monitoring of documentation.
5. Error Minimization
The biggest shortcoming with recording data on paper might be the amount of errors that go undetected. When using an EDC system, where every field utilizes automatic constraints and calculations, often in tandem, errors are not only much easier to detect but they are also much easier to prevent.
Constraints can be placed on fields to restrict an impossible value from ever being entered in the first place. If there are unforeseen types of errors that the constraints do not account for, then the monitors can easily attach a query directly onto the field in question. Then the system can be updated to catch any future errors of the same kind. More levels of validation lead to less mistakes.
6. Customizable Forms
Every clinical trial is unique, and, therefore, every clinical trial has unique requirements when it comes to forms and fields. An EDC system, being highly customizable, offers the ability to only show the fields necessary to be filled out for each patient and visit. This saves time for the investigators when recording their observations. They do not need to waste time filling out an entire stock form as they would on paper.
Forms in an EDC system can be set up so that the next field or form becomes visible or remains suppressed depending on the answer to a previous field or form. In this way, the system guides the data entry personnel through the appropriate process and prevents a lot of headaches. Plus, not having papers means no paperwork!
One of the most important aspects of the clinical trial process is making sure that the right people have the right access to view and edit study data. One could argue that the success or failure of a drug trial hinges on the proper assignation of permissions to each team member. Permissions are the barriers that prevent important data from falling into the wrong hands or, equally as problematic, not being received by the right hands. The key to managing the user permissions for your trial is understanding what the basic user permissions are. From there you can customize them depending upon the needs of your unique trial, with help from your EDC provider.
The first and most important thing to note before you begin assigning permissions is that one, and only one, member from your team should be assigned to manage all user permissions. This is typically the job of your Project Manager (PM), and it is important for that person to be trained on permissions, in general, and your team’s needs, specifically. Your Prelude PM can help you set up the initial users if you are unsure where to start, and they can offer guidance and support throughout the life of the trial. It is up to you and your team, however, to ensure that you have the necessary users set up with the proper permissions before your trial begins. There is no one set process for determining your user permissions, but it is important that no more than one person should have the ultimate power to edit and manage the users and permissions in the system. This measure is in place to prevent conflicting user assignments or improper access to data being given to users. Having a streamlined process for managing user permissions is a vital pillar of Good Clinical Practice (GCP). It also mitigates confusion and promotes communication.
The second thing to note is that the earlier you get your users and permissions set up, the better. The farther into a study you get, the more complicated and potentially problematic it becomes to change the permissions. For example, if you determine that the Investigator should not have been able to view the treatment assignments of their patients halfway through the study, your results from the first half of the study might be deemed unusable. That would be bad!
Finally, do not rely on your EDC provider to know what permissions you need for your trial. It’s your study and your neck on the FDA chopping block! This is where proper training comes in. Here are four basic user-access categories to keep in mind when setting up and managing your user permissions and remember: your Prelude team is here to help and guide you should you need further customizations.
1. Prelude personnel
This includes your Prelude PM and Prelude Quality Assurance (QA) team. The PM will have Administrator access-only to your Live study so that they can assist you with user access issues and mid-study updates. QA will also be able view all study forms so they can ensure they meet industry standards. Neither of these roles will be given data-entry access to patient forms.
2. Non data-entry personnel – This category includes two sub-categories, both of which are given view-only access to patient forms:
- Roles which can view and edit all user/site/project forms, e.g., Project Manager, Monitor.
- Roles which have limited access to view and edit user/site/project forms, e.g., Coordinator, Medical Monitor.
3. Data-entry personnel – This category includes two sub-categories:
- Roles which can view and edit all patient data, e.g., Investigator
- Roles which have limited access to view and edit patient data, e.g., Patient, Lab Technician.
4. View-only personnel
These are the roles which, like Prelude personnel, cannot edit any data and can only view the forms which are necessary for them to view (again, as determined by you and your team), e.g., Sponsor, Statistician, Data Manager.
Of course, there will always be exceptions to these basic permissions. Perhaps your Medical Monitor should be able to enter patient data, or your Lab Technicians shouldn’t be able to view site data. You can also, of course, add or remove roles according to your every whim (well, maybe not every whim, but we’ll do our best). This is the beauty of using a highly customizable system like the one provided by Prelude. The possibilities are endless! Whatever your study needs, Prelude delivers. Our system is designed to make your study run as efficiently as possible by catering to your unique needs. Customize away!
Prelude Dynamics Releases New Software Version: VISION 10.0 – Exceptional User Experience and Industry-Driven Enhancements
Prelude Dynamics, LLC, has recently announced the release of its latest software upgrade, VISION 10.0. The new version includes many new features in Composer, VISION’s do-it-yourself study builder, including enhanced usability, additional form logic and bulk editing capabilities for a more efficient study build experience. Monitors will enjoy the new risk-based-monitoring tools and streamlined report creation. As the #1 Electronic Data Capture (EDC) software in animal health, Prelude Dynamics offers a premium EDC solution for both human and animal clinical trials at affordable pricing. VISION 10.0 simplifies data monitoring practices, streamlines study cycles and accelerates approved submissions to the FDA and the Center of Veterinary Medicine (CVM). As quoted from Richard Tieken, the President of Prelude Dynamics,
Prelude has been advancing the conduct of clinical trials internationally with automation for 15 years. VISION 10.0 continues the excellence and has included significant improvements to fulfill the needs of our Full-service and DIY clients. We know what Data Managers find useful, because we also do that job! Our clients see results that ease building, managing, and submitting clinical data to FDA/CVM and EMA, and our clients should see even more successful submissions with VISION 10.0.
With this release, users can expect significant functionality enhancements to data capture, data analytics, and data exportation within an improved and friendlier user interface that is also more optimized for mobile-device and offline data capture. Some note-worthy enhancements include:
- Form libraries to save and re-use forms from past studies
- Automated invoicing functionality by site
- A new two-way lab interface with Marshfield Labs that enables automatic submission directly to the lab without manual intervention from the sites
- Improved AE and ConMed dictionary coding capabilities
- Enhanced export capabilities including CDISC export format and greater data format configurations
- A built-in risk-based monitoring tool that highlights the most critical fields in the study as it progresses (AI driven)
Tommy Jackson, COO at Prelude Dynamics, is excited for the release,
Efficiency and compliance are top of mind to every sponsor and CRO with whom we’ve interacted. The enhancements to VISION Composer were specifically designed to address these demands. We are excited for clinicians and data managers to be introduced to an affordable EDC alternative with the same or greater level of functionality and compliance than they are used to.
Focusing on a seamless user experience, Composer offers a fresh new look and reboot to its graphical user interface (GUI), now enabling form building and study schedule assembly all in one central place. Building, copying, and organizing study forms is now easier than ever with a form library that collects previously-built forms and stores them for use in future, per-client Composer studies. Site invoicing, a feature previously only available in the full-service version of VISION, is now configurable within the tool and a new standout feature that tracks site payments and study milestones within the DIY tool. This is just one of the multiple customizable features and functions to be expected in this year’s product release. Prelude Dynamics is focused on the future of animal and human health clinical trial advancement, leveraging industry-driven software updates to its EDC platform and enabling clients to build and configure faster, more complex study protocols in one encompassing product platform with greater data accuracy.
With the newest advancement of VISION’s Dashboard tool, monitoring your study or trial has never been easier or more adaptable! With more monitoring capability located in one place, you have the power to review what you need at a glance and dive deeper for further review.
Gone are the days of scattered summaries and reports. With the updated Dashboard you can now monitor what you want, when you want and all on one page with data summaries that you control. At Prelude Dynamics, we understand the importance of quick, convenient monitoring that you don’t have to dig for and in this article we’ll showcase some enhancements to the Dashboard that give you exactly that!
Similar to a news feed, VISION’s Dashboard enables you to decide what data criteria you want to see. No matter what your data monitoring preferences are, we give you full control to arrange and filter your data within the dashboard to your needs while also including fundamental tracking tools like a Quick Stat overview, messaging module, and a built-in study calendar. Real-time data reports and summaries are now all conveniently located in one place – the VISION™ Dashboard.
To access the Dashboard, simply click the dedicated Dashboard icon in the main navigation while logged into VISION™:
When you first arrive you’ll be prompted to take an automated tour of the new dashboard features. One new feature is that your dashboard is fully configurable to show you the data that you need to monitor. You can choose from a variety of summaries, graphs and charts, display the ones you want, hide those you don’t and sort them in any order. Just click the +/- icon to show a list of active and disabled summary modules. Any module you want to view, simply drag it into the “Active” column, click Save and you’re done! Your dashboard is customized and you are ready to monitor.
The Dashboard has 3 Main sections: Overview, Messages and Calendar…
In the Overview section, the Quick Stats module lets you select from important monitoring data counts, like: number of adverse events, serious adverse events, monthly enrollment, number of unresolved queries or total queries, form status data and more. You can then add numerous charts and graphs showing at-a glance visual representation of various data within the study.
Within Overview, you decide which data points to monitor and in what order they are displayed. For a more detailed breakdown on any of the summaries, simply click on the label to access additional information which will display within a table or chart.
In the Messages section, notifications are conveniently displayed in a list so you can quickly review sent or pending notifications, acknowledge them or even compose new ones. The list can also be filtered by category such as adverse event, new patients enrolled, queries, protocol deviations and more to show you only what you want to see.
In the Calendar section, you get a view of the current month showing personal, site and study created events that are color-coded to help keep track of each. You can navigate to view past, present and future months, add and schedule new events and filter them by type to focus on only those events that are relevant to you to help plan and schedule accordingly.
As a Monitoring tool, the Dashboard is a comprehensive one-stop shop. You can pull in any existing subject, site or user summary or any ad-hoc report that you created. This provides you with the ability to view all the important study data in one place, and eliminates the need to click through reports and summaries in separate locations.
It gets even better! You can now also filter the dashboard by a given site or view data for all the sites as a whole. Each report and summary can be filtered separately by any custom search you create. If you want to see only data for enrolled patients, select that filter. Create new reports and filters at any time and they become immediately available for use in the dashboard. You can even pull in shared reports and searches from other users.
That’s a quick dive into our enhanced Dashboard monitoring tool available for all studies with our newest version of VISION™. At Prelude, we believe in the power of convenience, configuration, and time-saving tools for you and your team. Welcome to VISION™ Dashboard!