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
- 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.
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
- Data Use
- Time Commitment
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.
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.