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!
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!
Prelude Dynamics is thrilled to be returning as the premiere EDC exhibitor at this year’s 2019 Annual Society of Quality Assurance Conference in Atlanta. We are excited to exhibit and engage with SQA members on the increasing demands of electronic data capture in conducting human and animal clinical trials.
Make sure to drop by our booth #’s: 319 & 320 on 4/30-5/01, Tuesday through Wednesday, to get a first-hand sneak-peek of our most exciting software upgrade yet, VISION 10.0™! We will have Prelude members on-hand to give demos and answer any questions you may have.
We are also pleased to announce three of our executive members, Dr. Alicia Browner, Ph.D. (CTO); Richard Tieken (President); and Dr. Karina Loyo, Ph.D. (Director of Clinical Research Services), will be featured on panels and roundtable discussions over the course of the conference.
They will be speaking on the following topics:
- Audit Trails: “Over the River and Through the Woods: Following the Audit Trail” with Alicia Browner
- EDC Challenges and Opportunities: “Challenges and Opportunities Using Electronic Data Capture Systems in Animal Health Studies” with Richard Tieken
- Best Practices to Build a Study: “The Secrets of a Good Study Build: What You Wish You Knew” roundtable discussion with Karina Loyo
- IT Compliance: 90-minute Session “Open Microphone with CVIC” with Richard Tieken
[Note: Make sure to check the SQA program schedule for their exact speaking sessions and times]
As the only attending EDC provider at SQA, we are honored to be given the opportunity to contribute to meaningful conversations on compliance and data quality as more clinical trials are integrating with EDC platforms. So, make sure to visit us at our booth, or attend one of our speaking sessions during the conference and see the #1 EDC platform for human and animal health in action!
We hope to see you in Atlanta!!