1. Trust your Patient-Driven eData with PHT Boehringer Ingelheim 1230.14 Toronto 23 February 2013 Investigator’s Meeting

2. 22 Study Flow Chart Sites are responsible to administer the questionnaires to the patients: -PRIOR to seeing the investigator, -PRIOR to any clinical assessment, -PRIOR to any treatment at the clinic, -And PRIOR provision of any new information about their disease status so that the responses are not influenced (biased)

3. 33 Agenda 1 How it all works? 2 Start Using SitePad 3 Monitoring using StudyWorks 4 DCF on line

4. 44 PHT ePRO System: how it all works? StudyWorks Sites/Sponsors Nightly Data Backups and Three-Phase Commit Redundant Central Servers Hosted at two secure third-party co-location facilities Subjects Site Personnel SitePad

5. Confidential 5 START USING SITEPAD

6. What Sites will get from PHT Access to all study data through PHT StudyWorks™ Real-time data access and data summaries via online portal SitePad kits Active SitePad pre-defined for a specific Site (to use at site by Site Personnel and Subject) Site Support Guide Site guide for PHT’s electronic patient diaries in your study 3G Access Point only if needed Transmits data from the site

7. 77 SitePad device Screen can be reversed Ethernet transmission Stylus Enter the Security Password using Keyboard: myepro unlock code

8. 88 Log in to StudyWorks™ Internet Portal to review Data https://mystudy.phtstudy.com/ssa

9. 99 Sites Site User Access: Create account

10. 10 Site User Access: Follow instructions BI_1230_14 Your CML is alerted => approves your request => confirmation e-mail sent to user

11. 11 SitePad “Home” Screen

12. 12 Site User Management: Add Study Coordinator(s), Principal Investigator as users

13. 13 Site User Management: Set up pin and define permission

14. 14 SitePad “Home” Screen

15. 15 Subject Management: Add, Edit, Discontinue Subject

16. 16 Subject Management: Add, Edit, Discontinue Subject

17. 17 Subject Management: add a subject: Enter Subject Information

18. 18 SitePad “Home” Screen

19. 19 Visits and Questionnaires:

20. 20 Visits and Questionnaires: 1 st highlight the Subject ID and select Visits

21. 21 Visits and Questionnaires: then highlight the visit At least training module completed at cycle 1 Visit 1

22. 22 Visits and Questionnaires: 2 nd highlight the questionnaire

23. 23 EQ5D screenshots examples

24. 24 EQ5D screenshots examples

25. 25 FACT-Leu screenshots examples

26. 26 FACT-Leu screenshots examples

27. 27 Skip a Visit on the SitePad It is important to select the correct visit number on the SitePad. If a subject is not coming, cannot complete questionnaire, pay attention to select the next correct visit. When the next visit will be selected the previous skipped one will appear as skipped.

28. 28 End of Treatment: Scroll down to select the End of Treatment visit

29. 29 End of Treatment: Scroll down to select the End of Treatment visit

30. 30 Follow Up 1 Visit

31. 31 Subject Management: To Deactivate Subject

32. 32 Subject Management: 1 st highlight the subject

33. 33 Reason to discontinue a Subject Then enter the reason

34. 34 Study Flow Chart

35. Confidential 35 MONITORING USING STUDYWORKS

36. StudyWorks™ Data Summaries reports

37. Questionnaires completion per visit

38. Confidential 38 DCF ONLINE

39. 39  In StudyWorks, on My Study page, you can access DCF Management portal  Then with the arrow down, you can select the correct study from the drop down list DCF Creation Process

40. 40 A DCF is requested for one subject only. If the change impacts several subjects, you will need to repeat the steps for each subject. The Site user will be notified by email and the CRA has to approve the Data Clarification entries via electronic signature You can view all DCF that were issued for your site classified by status DCF “tips”

41. Confidential 41 ONLINE TRAINING

42. 42 1. Online Training Environment and Chapters Multiple course chapters will be customized based on final SitePad design

43. 43 Online Training Benefits There for you anytime you need a refresher  Short Spend… only ~20 minutes on the training  Flexible Watch… from start to finish or in chunks  Interactive Remember… with Checkup Questions  Simple Hear… simple, clear English language  Certified Take… a quiz at the end & get a certificate

44. 44 1. Request access to StudyWorks 2. Get approved 3. Start learning! How Sites Access Online Training

45. 45 You need help! Site Support Guide PHT Study Support Center 24x7x365 Video Training Videos On Web access via StudyWorks™ Welcome to video training

46. Confidential © Almac Group 2012 Questions