1. Apple ResearchKit Krikor Krumlian CTO @ OpenClinica 1

2. © #OC15Europe What is it?  It is a framework that allows developers to create research apps on iOS  It is an open source framework developed by Apple  It aims to turn your phone into a medical research tool  A framework that provides UI element templates and a workflow(tasks & steps). 2

3. © #OC15Europe Modules?  The ResearchKit framework provides three customizable modules that address some of the most common elements of research:  Surveys  Consent  Active Tasks  You can use these modules as they are, build on them, and even create completely new modules of your own. 3

4. © #OC15Europe Surveys  Provides a pre-built user interface  Developers build the questions and specify the answer types  Support for localization is built in. 4

5. © #OC15Europe Consent  Provides a customizable interface  The module obtains the participant’s signature  Provides an option to generate PDF with the signature  Provides templates to choose from  Allows you to build a workflow 5

6. © #OC15Europe Active Tasks 6 CategoryTaskSensorData Collected Motor ActivitiesGait and BalanceAccelerometer Gyroscope Device motion Pedometer Tapping speedMulti-Touch display Accelerometer (optional) Touch activity Fitness AccelerometerDevice motion Pedometer Location Heart rate CognitionSpatial MemoryMulti-Touch displayTouch activity Correct and actual sequences VoiceSustained phonationMicrophoneUncompressed audio

7. © #OC15Europe Survey examples 7

8. © #OC15Europe Consent example 8

9. © #OC15Europe Active Task examples 9

10. © #OC15Europe Key concepts – Tasks & Steps 10

11. © #OC15Europe Key concepts – Tasks & Steps  Whether your app is giving instructions, presenting a form or survey, obtaining consent, or running an active task, everything in the ResearchKit framework is a collection of steps (ORKStep objects), which together form a task (an ORKTask object).  To present a task, attach the task to a task view controller object (ORKTaskViewController)  When the user completes a step in a task, the task view controller generates a step result object (ORKStepResult) that records the start and end time for that step, and any results from the step. 11

12. © #OC15Europe The Parkinson app  Presents consent form  Presents several surveys and questions  Activates phone sensors  Track health and symptoms of Parkinson’s Disease(PD) progression  Dexterity  Balance  Gait  Uploads data to server 12

13. © #OC15Europe Parkinson app demo 13

14. © #OC15Europe Parkinson app demo - eligibility 14

15. © #OC15Europe Parkinson app demo - eligibility 15

16. © #OC15Europe Parkinson app demo - consent 16

17. © #OC15Europe Parkinson app demo - consent 17

18. © #OC15Europe Parkinson app demo - activities 18

19. © #OC15Europe Parkinson app demo - dashboard 19

20. © #OC15Europe Why ResearchKit  Provide a framework for developers to easily create research Apps.  Large scale recruitment platform  Provides programmatic abstractions and UI elements to develop informed consent workflows 20

21. © #OC15Europe Current limitations of ResearchKit  Background sensor data collection. APIs like HealthKit and CoreMotion on iOS already support this.  Secure communication mechanisms between your app and your server, you will need to provide this.(There are some best practices)  The ability to schedule surveys and active tasks for your participants.  A defined data format for how the ResearchKit framework structured data is serialized. Sample code exists outside the framework for serializing objects to JSON. 21

22. © #OC15Europe Can your OC study become a ResearchKit App?  Group discussion  Describe anatomy of ResearchKit framework  Describe anatomy of OC  Discuss integration points  Strategies  Build a module that serializes data to the backend, what are the limitations?  Form serialization from OC to ResearchKit, what does this look like?  Scheduling surveys not supported, is this a major issue? 22

23. © #OC15Europe Thank you kkrumlian@openclinica.com 23