General InForm  Training

1. General InForm Training

2. Training Session Outline • Getting Started– InForm Overview and Navigation Tips • Entering Data and Editing Data Overview • InForm Features • Add Entry Forms • Dynamic Forms • Repeating Forms • Queries – Trial Details of Reviewing and Resolving • Wrap Up– Helpful Hints and Admin Details 2

3. InForm… • InFormis an Electronic Data Capture (EDC) system which: • Enables site staff to enter Participant data into an Electronic Case Report Form (eCRF) • Uses the power of internet technology to streamline the clinical trial data collection process. • Enables real-time access to all aspects of the management of clinical trial data. 3

4. InForm… How? 1. After training, each user will receive the trial URL, a username and temporary password. 2. Log in and change temporary password to a private one 4

5. Password Requirements • Passwords can be changed at any time. • Password length Requirements: 6 - 32 characters. • Passwords are case sensitive, c is different from C. • Passwords are automatically set to expire every 120 days • You will have to re- log in with your username and password after a pre-determined time while working in InForm or after a period of inactivity. 5

6. Automatic Password Reset “Forgot Password” • After activation, if you’ve forgotten your password, enter your User Name and click ‘Forgot Your Password?’ • Be sure to do this as soon as you realize you don’t remember your password. Three unsuccessful login attempts will cause your account to become inactive. 6

7. Automatic Password Reset “Forgot Password, continued” 1.Respond to your question and click Reset Password 2. A new, temporary password will be emailed to you. 3. You will be prompted to change your password again when you log-in with the temporary password. 7

8. Changing your Password‘As Needed’ To change your password at anytime, select the trial logo box located here 8

9. EDC Help Desk For password questions or any other questions about the InForm system, please contact the EDCSite Support Help Desk at 1-866-999-3274 OR e-mail: edchelp@mc.duke.edu Hours 8:00am-8:00pm EST Monday – Friday 9

10. System Security • The systems used for processing data on the PROMISE trial is required to meet the security and privacy specifications set forth in: • Computer Security Act of 1987: http://csrc.ncsl.nist.gov/secplcy/csa_87.txt • OMB A-130*, Appendix III: http://csrc.ncsl.nist.gov/secplcy/a130app3.txt • DHHS AISSP** Handbook: http://irm.cit.nih.gov/policy/aissp.html • Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) *OMB A-130: Office of Management and Budget (OMB) Circular A-130 also called ‘Security of Federal Automated Information Systems,’ ** DHHS AISSP: Dept. of Health and Human ServicesAutomated Information Systems Security Program 10

11. System SecurityYour InForm™ Account Training Database: • You will be assigned a userID and password to the training database • The training database and your access will remain active throughout the trial Production Database: • After successful completion of training, each user will be notified via separate e-mails of their userID and temporary password to the production database • For security reasons, your e-mail must not be a shared account. This is so the temporary password will be secure until you receive it and change it. 11

12. The system will end a session after a period of inactivity of : The system will end a session after a period of sustained activity: 15 minutes 2 hours System SecuritySystem Operational Time Limits 12

13. Let’s Get Started… 13

14. The Home PageFirst screen to appear after successfully logging into InForm Navigation Pane Always Present Screen Pane 14

15. Home Page Logging Out of InForm It is very important to always select the Logout button to end your InForm session securely. 15

16. Home PageInForm Portal • The InForm Portal is a repository of study related documents to aid in the entry of data. Documents included in the Portal are: • - Protocol • - Paper CRF, if applicable • - eCRF Completion Guidelines • - Any other needed documents • These documents will be located under the appropriate tab. 16

17. Home Page Selecting a Patient • Select the Patient number from the drop down menu. • This takes you to the individual Patients Time and Events Schedule • Select the Visit you want to view for a specific patient • Click the ‘GO’ button 17

18. Navigation Pane Selecting a Patient Clicking on the Patients button gives you a list of all Patients at your site 18

19. Finding Your Enrolled Patients High-Level view of all Patient Casebooks List of Visit for each patient List of patient numbers in your site Click on an underlined patient number to view the details of all form for a Patient in the Patient’s ‘Time and Events Schedule’. These buttons will allow you to view additional pages of participant casebooks. *12 participants per page* 19

20. Navigating in Patient ViewHighlighting Forms - 1 Can use highlight button to filter on which subjects you wish to view 20

21. Navigating in Patient ViewHighlighting Forms - 2 • Click on incomplete box: • Notice the yellow traffic lights are highlighted 21

22. Subject StatusDefinitions • All – All enrolled subjects. • Enrolled - InForm Enrollment must be complete and subject has been enrolled in the study. • Randomized - Subject must be randomized in the InForm software (Not used) • Not Complete - Study Completion form (as designed per InForm requirements) must be completed for the subject. The form must indicate that the subject has dropped out of the study. • Complete - Study Completion form (as designed per InForm requirements) must be completed for the subject. The form must indicate that the subject has completed the study. 22

23. Active Open Queries Missing Data Values Active Open Queries & Missing Data Values Completed and No Open Queries Not Started Traffic Lights When viewing participants in InForm, the traffic light icons provide information on a visit or form level 23

24. Active Open Queries Missing Data Values Active Open Queries & Missing Data Values Completed and No Open Queries Not Started Casebook View Visit level view of all Participant Casebooks Traffic Light Icons 1 Traffic Light = 1 VISIT 24

25. Time and Event ScheduleForm Level View of all eCRFs for a Patient Name of Each Visit List of all forms (eCRFs) for a patient Click on traffic light to go to that specific eCRF 25

26. Active Open Queries Missing Data Values Queries & Missing Data Values Completed and No Open Queries Not Started Time and Events ScheduleForm Level View of all eCRFs for a Patient Traffic Light Icons Patient Number 1 Traffic Light = 1 eCRF 26

27. Form and Visit RulerNavigation Through a Visit Visit Ruler Form Ruler • Note: • Visit Ruler – Current Visit is highlighted in Yellow • Form Ruler – Current Form is highlighted in Yellow 27

28. Form Ruler Identify Forms with Problems • Exclamation Mark (!) next to form indicates one of the following: • Missing Data • Query is present on that form 28

29. Navigating within the Visit Click on the Study Visit Ruler to navigate between visits Click on the yellow arrow to return to Time & Events Schedule Click on the eCRF Tabs to navigate between forms within a visit 29

30. Navigating T & E ScheduleWhere are the forms? • Click on the traffic light for form needed • Scroll bar on right hand side to move down this page for remaining forms 30

31. Navigating in InFormSubmitting Data Click the Return button to return to the Time and Events Schedule without saving your changes Click the Submit button to save newly entered data 31

32. InForm ICONSWhat are these Symbols? Icons 32

33. Icon Definitions Comment Audit Trail Query Freeze Form or Casebook frozen (Seen at Casebook and Time and Events Schedule view) No comment entered for item No changes to the item No query exists for item Re-Set Icon (Eraser) Query exists for item Comment entered for item Changes have been made to the item Used to clear data from a form item that has previously been submitted Once these icons turn yellow, they will always be yellow. The icons indicate activity has occurred Indicates there are no open queries 33

34. Create a Comment Click on comment button 34

35. A ‘Comment’ • The Comment Bubble can be useful to describe specific circumstances and explain data responses. • The Comment Bubble allows for a selection of pre-set reasons (Not Done, Not Applicable, Unknown), as well as free text entry describing the specific data value. • Comment Bubble free text is NOT stored in the ‘back end’ database, but is stored permanently in InForm. • Comments can not be analyzed. 35

36. Comment IconTakes you to the Comment Tab • To enter Comment: • Make Comment • Indicate Reason • Click ‘Submit’ 36

37. Query Icon Click on query flag 37

38. Query IconTakes you to the Queries Tab 38

39. Audit Trail Click on audit trail icon 39

40. Audit Trail Icon Takes you to the Audit Trail Tab The most recent action is listed at the top. • As you edit data, your changes are saved in the Audit Trail • This Audit trail includes date/time/editor’s username stamp • This information helps ensure data integrity as required by Regulatory Guidelines for clinical data • Audit trails can be viewed by clicking on the icon associated with each data item 40

41. Navigating in InFormHow to Print an eCRF Form To print a form – open form you want to print - 1 – Select Action ‘Print Preview’ - 2 – Click on Apply 41

42. Navigating in InFormHow to Print an eCRF Form • This is the Print Preview. • Click on ‘Print’ to print the page 42

43. Navigation Quiz 43

44. Entering and Editing Data

45. Entering Data in InFormBefore Data is Submitted Data can be entered and changed without specifying a Reason for change before Submit (save) Click the Submit button to save newly entered data 45

46. Data Entry Changing Data After Submitting Any problems with the data will appear immediately after Submit Open Query (Shows in Pink) Missing values (Field turns yellow) 46

47. Data EntryChanging Data (after Submit) To close Query, click in the field – update the value and enter reason for change. Data changes after Submit will remain in the audit trail Enter Missing Data Values and click Submit 47

48. Data EntryChanging Data (writes to Audit Trail) 1. Change the value 2. Enter a reason for the change 3. Click the Submit button to save the correction 48

49. Data Entry Changing Data (Audit Trail Icon) • After the data value change, the Audit Trial Icon will turn yellow, indicating activity 49

50. Data Entry Types of Comments • You can enter a comment on the item level or form level • Item-level comments – Comments that refer to one item on a form • Form-level comments – Comments that refer to all items on the for this study Reminder: Do not use this unless necessary. This data will not be in the analysis for this study. 50