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.
VISION’s user-friendly tools for customizing forms includes a handy tool known as the dynamic drop-down. This deceivingly simple field packs a lot of punch. While you can leave the drop-down menu as just that, a menu and nothing more, did you know that you can also use this menu to populate other fields or even populate it from other fields?
A great place to use this tool is on the Adverse Events and Concomitant Medications forms, so that the two can communicate with each other. If a con med gets administered to a subject due to an adverse event, both need to be documented. Using a dynamic drop-down menu on each form for the relevant subject saves a great deal of time and streamlines documentation. Once it is noted on the con med form that a medication was administered after an adverse event, then a menu appears with all previously entered adverse events for that subject. Simply select the correct event, and now the medication and adverse event are linked. Vice versa, If an adverse event required the administration of a medication in a subject, then you can select from a drop-down menu on the adverse events form all previously entered con meds.
This tool opens the door to many more opportunities for customization and, therefore, simplification of data-entry. Signature drop-down menus can either be populated from another field, i.e., from a list of names, or be role-based, meaning the names of every user who has been assigned a specified role will appear as an option. The menu for the reason a subject was withdrawn can be pre-populated conditionally, e.g., only if the subject was euthanized. This would save the investigator time as there would be no need to answer a slew of unnecessary questions to close out a patient. The transcribed CRF form features a drop-down menu that can be based on all forms or form groups, or it can include or exclude specific forms or form groups. Dynamic drop-downs can even communicate between subjects and sites, e.g., when updating con med and adverse event dictionaries.
Do you have a need for any other dynamic features? Let us know!
The importance of testing all aspects and features of a study before Go-Live cannot be over-emphasized. That being said, testing can be a very messy process. If not undertaken with a great deal of planning and documentation, the whole process of testing a study can be rendered not only ineffective but counterproductive. In comes User Acceptance Testing (UAT) to the rescue!
First, you might ask, what is UAT and how is it different from other forms of testing? Think of UAT as a dress rehearsal before a play. The actors all know their lines, the lighting director knows all their queues, and the sets have all been built and tested for safety. But you need to see it all together before you fill the seats with spectators. What if those perfectly built sets don’t line up with the spotlights or what if the bulky costumes get in the way of the actors’ performances? All the parts are there and accounted for, but the picture as a whole has yet to be validated.
The study-build process is similar. After each form has been tested separately, and all of the summaries and reports have been set up to your satisfaction, there is still the issue of unforeseen scenarios. You won’t be able to find or fix all the potential conflicts until you test the entire study as one. Set up a new site, enroll several patients, take each one through the entire screening/dosing/withdrawal/etc., process. Then do it again with another patient and another, until you have ironed out as many eventualities as possible. Even then, there may still be unforeseen problematic scenarios, but the purpose of UAT is to mitigate the number of issues that might come up during the Live study as thoroughly as possible. UAT is also a good way to provide you and your team with a finalized, succinct idea of what, exactly, you are signing off on before your sites begin entering patients. Once you complete your final run-through of the study, you can rest assured that you have done everything you can to make your study run smoothly.
The study build is the most volatile and, therefore, the most important part of the study’s life cycle. Keeping a good record of the build gives the rest of the study a fighting chance at success. It’s a time for testing, training, re-testing, amending, testing and retesting again. Did we mention it’s a time for testing? Changes get added and reverted then added back in, the final protocol may not be ready, there are usually multiple people requesting updates to study forms, sometimes conflicting with each other. It is important to be able to see exactly when requests were made and by whom.
This “story” of the study build has a major impact on the study once it goes Live and after it has been completed. It even affects future studies. Being able to see all in one place where the build went right and where there is room for improvement makes site-training easier, it provides a starting point for future study builds, and it streamlines the development of future protocols.
The Prelude field spec and feedback features are the most powerful tools for telling this story. The field spec allows the team to see in a nutshell how every form and field is set up. If they are unsure the effects of a calculation or constraint on a specific field, they can go directly to the form in question and test it. Then they can add feedback directly into the system if they feel a change is needed. From there the request goes through the feedback cycle until it is resolved. Then it is tested again. Prelude provides more feedback categories than any other EDC provider for added clarity and efficiency.
Each team member can use these tools to see exactly what changes have been requested, which changes have been approved, and the completion status of the approved changes. They can view at a glance all roles, permissions, constraints, calculations, etc., to find everything they need to know about the progress of the build, and they can view a succinct record of the Prelude team’s responses to each feedback item. Furthermore, the audit trail provides information about who left what feedback or query and when. In this way, Prelude offers a full package of features to streamline the build process and keep a thorough record each study’s build.
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!