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.
Out in the fields or inside the barns, sometimes a reliable Internet connection can be hard to come by, if there is one at all. In these cases, professionals often must rely on the error prone method of recording with a pen and paper. However, a lack of an Internet connection should not compromise or disrupt a study.
Digital Paper is an offline Electronic Data Capture (EDC) app developed to work with VISION™ tools and accommodate studies that may operate in a field environment.
Q: What is it?
A: Digital Paper is a unique feature of VISION which allows a user to enter data into the system when there is no internet service available.
Q: What makes it so special?
A: Once internet access is regained, all data entered onto Digital Paper will be automatically synced into the system, maintaining time stamps both for when the data was entered and when it was uploaded.
Q: How does it work?
A: Digital Paper can be customized to feature whichever forms and fields the client specifies. Keep in mind that it is for data-entry only and will not run any calculations or constraints. All of these edit checks will trigger in the system once the data has been synced. The main purpose of Digital Paper is to give investigators in the field a place to synchronously record their findings as they perform physical exams on animals in places where there is limited internet available (e.g., horses out in the country) without having to write it on physical paper then transcribe it later.
Q: Is there anything else to note?
A: Yes, a few things to keep in mind are:
1. The subject for whom data is being entered onto Digital Paper must already be randomized
2. Blinding DOES remain in effect when logged onto Digital Paper
3. Digital Paper currently only works on android devices
4. Digital Paper is a contracted item
5. It’s easy to learn and easy to use!
Have you ever worried about how a mid-study update to calculations or constraints might be implemented without affecting any previously entered data? Hopefully, this overview of batch edit checks will give you a good idea what options are available to you when considering mid-study updates. The batch edit check is a tool that your Prelude Project Manager (PM) in their administrator role utilizes in order to apply an updated edit check to all existing subjects so that you won’t have to waste time manually rendering each and every affected form.
Behind the scenes:
1. At the Project level, the administrator navigates to the Batch Edit Checks form.
2. The administrator has the option to run a past batch or start a new one.
3. If starting a new one, they set up the parameters. These include:
a. Choose either Subject or Site level forms.
b. Select whether or not to process new forms (i.e., blank forms). Note: Selecting this option will cause all constraints to fire for new forms, meaning they cannot be signed off on until the errors are resolved. Typically, this option is left blank so only In-Work forms are rendered.
c. Choose specific forms to be rendered or allow the system to process all forms. Note: The batch will run much faster if the PM knows which specific forms need to have their calculations and constraints processed.
4. Once a batch has been run, the administrator can:
a. Reset the form
b. Clear the form
c. Delete and renumber the forms
d. Lock the form
That’s it! Sit back and relax in the knowledge that VISION has got your data’s back (so to speak).
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!
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!