Announcing eConsent!
Prelude’s unique eConsent functionality is the latest in a long line of enhancements aimed at eliminating paper from clinical trials. Up until now, most clinicians have obtained owner and subject consent on paper forms that are then uploaded into the system. Now sites can obtain owner and subject consent electronically the same as for any other user signature for the study.
Animal Studies
For animal studies, the process for obtaining owner signatures begins with an owner profile added by the site. The owner then logs on and immediately signs an electronic signature agreement. After the generic agreement is signed the owner is able to electronically sign any study-specific consent forms. Once the subject is enrolled the owner is free to fill in their own demographic information as well as any forms that are required for the study such as a dosing schedule or owner diary.
Human Studies
For human studies, brand-new technology has been implemented to attach the signed consent form directly to the appropriate PDF document. No personal data will be collected about the subject until the informed consent is signed electronically by the subject.
Notifications
The eConsent feature of VISION includes the ability to send (and re-send) notifications to the subject to remind them to sign relevant forms. A notification can also be sent to site personnel to alert them when a form has been signed. The forms can also be provided with multiple language options for studies enrolling non-English-speaking subjects.
Electronic Signature
An electronic signature is a distinctive mark appended to a document for verification. It offers the same validity as an ink signature yet with an even higher degree of contemporaneousness as it also includes the time/date stamp and logged-on user information. It is a safer, faster, and more cost-effective approach for capturing signatures.
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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.
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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!
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Animal Studies