Table of Contents

guest
2021-02-28
FDA COVID MyStudies Support
Explore the Example
Getting Started with COVID MyStudies
Completing the Intake Form
Frequently Asked Questions
Review Consent Forms
Support Resources

FDA COVID MyStudies Support


Welcome to the Support Portal for the FDA COVID-19 MyStudies mobile app. Studies using the app can obtain informed consent from participants directly from the participant's own mobile device, eliminating contact but ensuring security and privacy.

The resources here will help you explore how the FDA COVID-19 MyStudies app works, how to complete your enrollment Intake Form to get your study added to the app, and ultimately how to retrieve the secured electronic consent forms. Your actual research data collection will be performed via another mechanism.


Using COVID MyStudies for eConsent

Contact FDA by emailing CDERMedicalPolicy-RealWorldEvidence@fda.gov.

Coordinate with the COVID MyStudies app team via the resources in this portal.

Use the app to send informed consent documents and receive completed digital documents.




Explore the Example


As a researcher interested in using the FDA COVID MyStudies app for recording participant consent for your study, you can follow these steps to explore our Demo Study and understand what your users' experience would be like. The app is used for requesting and granting informed consent. Your study will collect the actual study data associated with the participant via some other mechanism.

Download the App

Locate and download the COVID MyStudies from your device's app store. Searching for "MyStudies" may be helpful.

User Consent Process

When you (or your users) download the app to your device, the welcome screen will look like the following.

Click New User? to create an account, agree to the terms of use and privacy policy and click Submit. You'll complete a verification step after receiving an email. You can opt to use a passcode, touch verification, and receive notifications as with other apps for your device.

Select a Study

The first step is to select the study of interest. To explore, click the "Example COVID-19 Consent Form Study".

You'll see the description of the "Covid-19 Consent Form Demo" along with a button to Join Study. Click it to continue.

  • Two other optional links are available for this screen. Either or both may be hidden in your study:
    • A "Visit Website" link to your own content (it will open your page in the user's default browser).
    • A "Visit Consent" link to view the full text of the consent form. This link lets the user review it prior to deciding whether to walk through the process.

Eligibility

On the Eligibility page, you will enter the enrollment token that was provided to you and click Submit.

  • In practice, you as the study administrator will provide a token like this to your candidate subjects.
  • Delivery of the token to the subject can be done in a variety of ways. Learn more about your options in this TBD resource about delivering tokens
  • You will need to remember the tokens you provide because for security purposes, there is no way for us to recall them on your behalf.

Consent Pages

Next, you will see one or more Consent Components. These are pages (screens) of details about the study and what you would be granting consent to participate in.

  • When you design your own study to use the app, you can customize these panels, including links to expand and show additional information if necessary.
  • You can include up to 10 custom consent panels.
  • Learn more in this topic: Completing the Intake Form.
The consent panels you will see in the example have the following titles and demonstration text. On each page, if you scroll to the bottom, you will see a link to Learn More opening another page of even more text.
  • What is this study about?
  • Will there be any costs to me?
  • What will happen if I take part?
  • Will being in this study help me?
  • How does HIPAA apply to this study?
  • How will you protect my confidentiality?
  • Do I have to be in this study?
  • What happens if I say yes, but change my mind later?

Review and Sign

After reviewing all screens, you will see the Review panel that will look something like this. The entire consent document is available to scroll through.

Once the user clicks Agree, they will sign the consent itself, then have the option to email themselves a copy of the form they signed.

What Happens Next?

Within the app, you will see a single "Study Activity". Clicking Start opens a thank you page and gives a contact email. If you are interested in using this app for your own study, please get in touch to get started.

  • Contact the support team at "FDAMyStudiesContact@harvardpilgrim.org".
  • Contact FDA at "CDERMedicalPolicy-RealWorldEvidence@fda.gov".
You can customize the content of this final page to provide your own contact information to your own study participants. After the consent process has been completed, the user can delete the app.

As you evaluate using this application, learn more about the support and troubleshooting assistance that will be available to you.




Getting Started with COVID MyStudies


To be eligible to use the COVID MyStudies app, your study must comply with all applicable requirements for IRB review and approval. When you contact the FDA to get started, you will reference your pre-IND or IND number if applicable.

To set up your own study to obtain consent via the FDA COVID MyStudies app, there are a few decisions to make. When you enroll, you fill out and submit an Intake Form where you present the answers to many of these questions. For details about completing the Intake Form, see the topic: Completing the Intake Form.

How Will Participants Find the App and Your Study?

Decide how you will be promoting the work and what mechanism you will use to tell your own users how to download and use the app. You will need a unique title for your study. Note that within the app, all users will be able to see the titles and branding of all studies participating.

You will provide the title, image, and brief description on the Intake Form. A few examples are shown here.

For instance, this topic shows how to use our Example Study that you may have tried when evaluating this program: Explore the Example

Creating something similar, but customized to your own study language and branding can help users get started.

What Background Information Will You Present?

The app can present up to 10 pages of background information prior to requesting conset, including descriptions of the planned study, links to outside resources, etc. It should provide everything the study participant should know to make an informed consent decision. The sequence of panels in the example includes:

  • What is this study about?
  • Will there be any costs to me?
  • What will happen if I take part?
  • Will being in this study help me?
  • How does HIPAA apply to this study?
  • How will you protect my confidentiality?
  • Do I have to be in this study?
  • What happens if I say yes, but change my mind later?
You will provide the panels your study should present on the Intake Form.

How Will You Distribute Tokens to Participants?

You will obtain batches of tokens and need to manage them yourself. Decide how you will keep track of which ones have been used and what mechanism you will use to deliver them. Options include:

  • Securely emailing or texting a token to each candidate participant.
  • Printing a paper 'ticket' with each token and handing batches to data collectors.

Register With Us

When you adopt the application, your intake form will provide the names and email addresses for your staff. Each staff member will be invited to create an account on our LabKey Support site, www.labkey.org, and given access to the shared support portal where you will find more detailed usage information, training materials, and troubleshooting tips.

Learn more about support resources here:

Learn More First

  • Frequently Asked Questions
  • Contact us at "FDAMyStudiesContact@harvardpilgrim.org" to learn more and find out how to enroll your study.



Completing the Intake Form


Once you have decided to use the COVID MyStudies app for obtaining informed consent to participate in your research, you will complete the Intake Form. This topic reviews the sections and how to gather the information you need to complete it.

Study and Investigative Team Information

Provide:

  • Study title: Your study title as it should appear in the app.
  • Principal investigator: Name of the principal investigator.
  • Main point of contact for all communications regarding your study on the COVID MyStudies app: Provide both name and email address for this point of contact.
  • Please provide a list of team members who will require access to the signed consent forms.

Study Level Components and Branding

Study level components will be visible to logged in users of the app prior to enrolling in and consenting for the study. Screen shots of these elements can be provided to the study team for submission to the IRB of record.

Please note that documentation of IRB approval is required before a study can be active in the COVID MyStudies app.
  • Study Name (Required): The name of the study as it will appear in the app.
    • Study name can be a maximum of 50 characters (including spaces)
    • Study long name (if applicable) can be a maximum of 150 characters (including spaces)
    • Research sponsor can be a maximum of 50 characters (including spaces)
  • Study Tagline (Required): A brief description of the study, up to 100 characters (including spaces).
  • Thumbnail for Study (Required): A small image that will appear in the list of studies. Must be 225px square.
  • Study home screen primary image (Required): The first image a participant will see. Vertically oriented: 750px x 1334px.
  • Study home screen text and button (Required): The text and buttons for the home screen for your study. You provide a title up to 50 characters, page text up to 200, and text for up to 3 buttons, only one of which is required.
  • Eligibility Language: The text for the page where the user would enter their unique "enrollment token". This text can be up to 230 characters including spaces and should explain the token and why it is required.

Consent Components

Once the participant has successfully entered an enrollment token, they are presented with up to 10 screens of content. When you receive the intake form, you will receive an accompanying PDF file that gives examples of these screens. Templated section titles include:

  • Overview: What is this study about?
  • Data gathering
  • Privacy
  • Data Use
  • Time Commitment
  • Tasks
  • Withdrawal
Each consent component page has a title (up to 75 characters), summary text (up to 500 characters) and an option to include up to 15,000 characters of additional text available by clicking "Learn more about the study first". All text provided in all the components will be compiled into the final consent document for the participant to sign.

Final Components

The final pages of the consent process are Review which are not customized by you but provide the user with include a chance to scroll the entire compiled consent document before clicking either Agree or Disagree. You provide up to 250 characters of text for the review confirmation popup. "By agreeing, you confirm that you have read...," for example.

You also provide a title and text for a "Thank you" page that offers the participant the option to email or save a copy of the consent document they have just agreed to.

Submitting the Form

Once you have completed the form, save it and all necessary image files in a single folder. Zip this folder into a single archive and email it to the address provided at the top of the form. Be sure your contact information is correct and complete, and keep a copy of all information you submit.

You will be contacted when it is time to take the next steps.




Frequently Asked Questions


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".



Review Consent Forms


This topic describes how the investigator will retrieve the consent forms after users have submitted them. While you cannot explore this feature with the example study, this topic shows what you will do.

Note: Access to this information is strictly controlled and available only to authorized persons.

Access Registration Server

The authorized user can access the submitted consent forms on the Registration Server. Each study is housed in a distinct location and the investigator will only be able to access their own study's information.

Obtain authorization and the individual link as part of the onboarding process.

Review Consent Forms

Once your study is in use on the COVID MyStudies app, you will be able to access the downloadable consent records in the file browser.

The filenames and dates are shown. Click the column header menus to sort.

Download Consent Forms

To download one or more forms, use the checkboxes on the left to select them. You can multi-select by selecting the first one in the set you want, then shift-clicking the name (not the checkbox) for the last form you want. Click the download link. If you select multiple forms, they will be downloaded as a zip file.

Related Topics

The COVID MyStudies app only collects informed consent from your study participants. If you are interested in exploring an expanded solution for collecting more of your study data, explore the options available with the FDA MyStudies app:




Support Resources


This topic describes the additional support resources available to participating study researchers using the FDA COVID MyStudies app.

Support Portal

Once you have been approved and enrolled in the COVID MyStudies app, the team members you listed on the Intake Form will be granted access to an additional folder:

Here you will find additional resources, including troubleshooting and answers to frequently asked questions from other users.