AZ PETRA (D9720C00001)

This application is intended to support a clinical research trial by AstraZenica Users of this app will be trained health care providers working at research sites. They will use the application to invite participants and then perform remote visits via Medable's TeleVisit feature, and collect information using various Research Kit tasks. Your account is for a test site user. Site users receive training on how to use this application to conduct the study including the invitation of participants, how to conduct televisit calls, and how to view participant responses to certain tasks. Regarding our usage of HealthKit API: We use Apple's ResearchKit library to allow clinicians and researchers to gather information from participants as part of in person visits and remote televisits. We do not use any HealthKit functionality for this study, but it is not possible to remove the HealthKit APIs from Apple's ResearchKit library. Our application depends on Apple's open source ResearchKit project to operate. Apple's ResearchKit project includes components that reference HealthKit APIs, but are not utilized in our application. Unfortunately, we cannot remove these references without creating a fork of Apple's ResearchKit library, which is not in the best interest of the open source community that Apple is trying to foster. Additionally, the HealthKit APIs and the Health app is not available on iPadOS-- so this functionality is disabled, but again, it would require customization of the Apple library to completely remove it. For more information on the library, see https://developer.apple.com/researchkit/. Regarding our usage of VoIP services: For this study, site users will conduct encrypted video calls with participants using voip services. This is a necessity in a global pandemic. If you have any questions about our usage of these APIs, the study design, consent processes, etc-- please do not hesitate to call us using the contact info provided in the review submission.