BeautiFi for Pc

1. Users will also have the opportunity to connect with a member of the mock study team to ask questions prior to signing the informed consent form.

2. ObvioHealth’s IRB of record, Advarra, has reviewed the project and made the determination that the proct does not meet the DHHS definition of human subjects research under 45 CFR 46, so does not require IRB oversight.

3. Users who are identified for this project by the Sponsor will complete the registration form via the web and be invited to download BeautiFi.

4. The POC will simulate a study, following the normal process of a clinical trial (consent, screening, active trial), but the participants will not be standard participants and will instead be employees of the Sponsor.

5. Upon download, the user will create an account and complete the simulated Informed Consent process.

6. NOTE: Because this is a POC, the user responses may be generated for testing purposes rather than being accurate responses from the user.

7. Instead, the experience of the Sponsor team will be used to determine if they would like to proceed with ObvioHealth and initiate a real research project.

8. Because this is a POC, the responses may be generated for testing purposes rather than being accurate responses from the user.

9. The BeautiFi app is a proprietary platform of ObvioHealth being used to carry out a proof-of-concept (POC) project with a potential client (Sponsor).

10. Because this is not a research project, this will be a simulation, not a true informed consent proces.

11. Once the simulated consent process is completed, the users will be presented with a screening questionnaire task.

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