Viedoc Study Build Service – ViedocMe Considerations
The purpose of this document is to give a general high-level description of important things to consider when a customer is planning to use ViedocMe in a study and use Viedoc’s study build service.
Languages
System Language
ViedocMe has support for a long list of system languages, including languages written from right to left. This will ensure that all the system text, such as “log in”, “cancel”, “back”, “save”, and so on, are available in all these languages. Please see the list of supported languages here.
Additional system languages for ViedocMe can be added upon request.
Questionnaire/Form/Diary Language
The form/questionnaire/diary that is to be used in the study will need to be translated to the relevant languages. When Viedoc does the study build for a customer, the build team at Viedoc will also import the translations to the CRF design. It would be the customers responsibility to provide Viedoc with the actual translation of the form/questionnaire/diary. If validated questionnaires are planned to be used in the study, they are typically available in multiple languages already.
Questionnaire Adaptations
While many questionnaires can be used without any adaptations, there are sometimes minor modifications needed to fit an electronic version. It is typically isolated words that need to be replaced, for example “please circle the right option below” needs to be replaced with something like “please select the right option below”. Please note that these changes would also affect the translations.
Some copyright holders of validated questionnaires will require to see and approve screenshots of implemented modifications.
Data Entry Windows
Data entry windows can be set very exactly in ViedocMe. That means a diary, form, or questionnaire will only be available for entry for the subject in the window as specified in the study build. As an example, the design could allow for a window of ± 3 days from the proposed date on a 6-month questionnaire, while for a daily diary it could be stricter and allow the subject to enter data only during that day and within a specific time interval, as for instance a morning diary.
Generally, a narrow data entry window will lead to data of higher reliability and quality, and this is especially important if the subject is rating pain or symptoms and so on. A narrow data entry window could on the other hand increase the risk for missed assessments.
By default, the build team at Viedoc is using a data entry window of one day for daily diaries and for other scheduled ViedocMe forms the same data entry window is used as its corresponding clinic visit.
Forms can also be added in ViedocMe as “unscheduled events” to be available for ad-hoc reporting. Examples of this can be ad-hoc reporting of medications or adverse reactions, but also other types of assessments that do not have a given schedule.
Reminders
Reminders can be sent to the subjects via email and/or text messages. The reminder text can be customized, and the reminders can be configured to be sent multiple times for the same diary, form or questionnaire. As an example, reminders can be configured to be sent for a daily diary at 7PM, 8.30PM, and 9.45PM. For a 6-month questionnaire there could be a reminder in the evening on the proposed date and every remaining evening of the remainder of that data entry window.
Reminders are only sent to subjects who have not yet submitted the expected data.
UAT of ViedocMe
The forms to be used in ViedocMe are built at the same time as the forms to be used in the EDC. So in the first review round the customer would get access to review the EDC forms and workflow as well as the Viedoc Me forms and settings. So, the build of Viedoc Me is completely integrated part of the study build and ViedocMe forms and settings are reviewed as part of the CRF review process. The customer will be able to test how ViedocMe forms would appear for the subjects as well as test reminders and data entry windows during the UAT.
BYOD
ViedocMe is web-based and intended as a Bring Your Own Device (BYOD) solution. A subject is able to use their own device(s) and the device they are most comfortable with, whether it is a laptop, tablet, or a smartphone. Thus, under normal circumstances it is not recommended to provide subjects with devices since this is regarded as unnecessary and will increase costs and administration in the study significantly.
Since it is web-based, the subjects don't need to download any programs or applications to their device. It also means that no sensitive data will ever be stored on the device itself. You can read more information on this topic here.
If the subjects prefer, they can simply create a shortcut on their device to for example be able to access ViedocMe by clicking on an icon from the start page of their smartphone. You can find instructions on how to do this here.
ViedocMe Compliance
Key to ePRO/eCOA compliance is a system that is very easy for the subjects to use, the possibility to use the device they are comfortable with and always carry with them, and the multiple and customized reminders.
Any user, both site users and sponsor users, will also be able to view the ViedocMe compliance in an overview page when logged in to Viedoc.
Viedoc Connect – Video Calls through ViedocMe
Viedoc Connect is an application that enables meetings between Clinic and ViedocMe users through video calls. Site staff can conduct visits and make follow up calls with the subjects in a remote manner. The users are free to navigate in the Clinic tab to other pages (even other studies) during the call, and the subjects can navigate within ViedocMe and submit questionnaires during the call. Screensharing is also possible.
Viedoc Connect uses an encrypted peer-to-peer connection where no data passes through nor is stored on the servers.
The following is stored:
- the meeting id
- the IP addresses for the host and the participant
- the call duration
Note that Viedoc Connect must be included in the Work Order and study license to be used.
Drawing Pad
In addition to standard data collection item types, a drawing pad can be used to collect information that the subject is drawing in this item. Available backgrounds are:
- Signature background: the subject can draw a signature on a line.
- Full body background: the subject can indicate for example in what part of the body they feel pain.
- Empty background: for investigations/questions related to a subjects perception/cognitive state/understanding, for example drawing geometric figures or a clock with a time point.
File Upload
Just like the site users can upload files in the EDC, the subjects can upload files via ViedocMe. This can be any kind of report, image, or video, up to a size of 512MB per file, to support the conduct of the trial. For example it could be uploaded image of medication blisters, or adverse reactions like a skin rash.