Frequently Asked Questions

2021-09-18

This topic contains the answers to some frequently asked questions about whether the COVID MyStudies app is right for your study?

Participant Interaction Questions

Consent Setup Questions


Participant Interaction Questions

What devices and operating system versions are supported?

  • Apple:
    • Devices: iPhone 5s,6,6s,6plus & 6splus, iPhone X, XS, XR.
    • Operating systems: iOS 11.x to 13.x.
  • Android:
    • Devices: Any Android device having the below OS
    • Operating systems: Lollipop to Pie

What accessibility features are supported?

Depending on the specifics of the individual device, the following features are supported:

  • iOS:
    • Voice over
    • Zoom in content
  • Android:
    • Font increase
    • Voice over
    • Zoom in content

How do study participants need to interact with the MyStudies app after granting consent?

They do not need to, and can completely delete the app after successfully granting eConsent. If they do not delete the app, participants will see this study as completed. They potentially have the opportunity to join other studies using it if/when appropriate.

A participant may receive an app notification if you later update the consent document for the study. These updated consent notifications cannot be disabled in the app.

How can participants leave the study?

If a participant wishes to leave the study and has not yet deleted the app, they can reopen the study page, click Resources and then click Leave Study.

If they have deleted the app, they can notify you by other means and be unenrolled by you.

Can a participant use the MyStudies app on an iPad?

No, the MyStudies app is not supported on the iPad.

Can a participant be forced to read the "Learn More" consent language before proceeding to the next screen?

No. If there is required information for the user to read and consent to, it must be included in the main consent page.


Consent Setup Questions

Can we ask participants to opt in or out of certain activities independent of consenting for the overall study?

No, there is no support for selecting sub activities within your study using the MyStudies app.

Are responses to eligibility questions stored?

No. You can have eligibility questions to screen participants prior to them granting eConsent, but the responses to these questions are not stored in the system.

Can we include a table or image on a consent screen?

Sometimes, but it is not recommended. Tables and images can be included under Learn More using HTML, but are not fully supported on Android devices.

  • A table can be added in HTML or by copy/paste from a spreadsheet source.
  • An image can be included if it is hosted on another server and referenced by direct URL. Images can't be uploaded from local storage/downloads, only via source URL.
Both will be shown as expected on iOS and Android devices for the main consent flow screens. However, after the participant grants consent, they can review the entire Consent Document in the Resources section. Here users on iOS devices will see the expected table/image, but Android users will not, and the stored Consent Document from an Android device user will be missing these components.

Workaround: You can host your table and/or image on your own server and let the consent user view it in the intended format there, but present a text translation of the information on your actual Consent Document.

Can the consent text be in Spanish (or another language)?|#localize]

The consent language can be entered in another language that uses the same character set, but the menus and direction steps within the app itself will still be in English.

Can more than 10 pages of consent language be included?

Yes, when there are very long consent documents, the material can be spread over more pages. 8 pages is the default and shown in the demonstration. 10 pages is a recommended number for longer documents, but if necessary, as many as 10 additional pages can be included. Please contact us to discuss this option.

Contact Us

More questions? We're happy to help you decide if the COVID MyStudies app is right for you.

  • Contact us at "FDAMyStudiesContact@harvardpilgrim.org".