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.
You also learned that the reason we use Inform 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: 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.
No one but you should know your password and user name is your electronic signature which is kept in inform. 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.
If you attempt to login 3 times with the wrong password your account will be locked and you won’t be able to reset it. In this situation you have to call the helpdesk. So, it is a good idea to set the password to something short and easy to remember.
The majority of the Helpdesk calls are for resetting passwords.
This is especially important to remember if you are a west coast site or working after EST, after Helpdesk hours. 6

7. Automatic Password Reset “Forgot Password, continued”
1.Respond to your question and click Reset Password
2. A new, temporary password will be ed 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 Monday – Friday
For password questions or any other questions about the InForm system, please contact the EDC Site Support Help Desk at OR
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:
OMB A-130*, Appendix III:
DHHS AISSP** Handbook:
Privacy Act of 1974, Public Law , December 31, 1974 (5 U.S.C. 552a)
NOTICE: The applicable Privacy Act System of Records for this project is Number , as published in the Federal Register Vol. 60, No. 13 on January 20, 1995.
InForm is in compliance with all the laws.
*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 Services Automated Information Systems Security Program 10

11. System Security Your 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 s of their userID and temporary password to the production database
For security reasons, your must not be a shared account. This is so the temporary password will be secure until you receive it and change it.
The training database will be available prior to enrollment. This is not a live database. Make sure you are in the correct URL link when entering real participant data (in production and not training). 11

12. System Security System Operational Time Limits
15 minutes
2 hours
The system will end a session after a period of inactivity of :
The system will end a session after a period of sustained activity:
The 2 hr timeout is there to prevent any unauthorized entry. The longer you keep the port open, the more time you will allow a hacker to access the database. Keep track of your time and log-out and back-in before 2 hrs are up. 12

13. Let’s Get Started… 13

14. The Home Page First 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.
(If using eSignature closing out with X will leave the signature open) 15

16. Home Page InForm 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
Inform has multiple ways to do many tasks. Once you receive the training database practice to find out which works best for you. Remember in most cases you have a live participant in from of you-so you will need to be comfortable navigating by patient through visits.
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
This is an alternate way to navigate from previous slide. 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 View Highlighting Forms - 1
Can use highlight button to filter on which subjects you wish to view 20

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

22. Subject Status Definitions
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. Traffic Lights
Not Started
Missing Data Values
Completed and No Open Queries
Active Open
Queries
Active Open Queries & Missing Data Values
When viewing participants in InForm, the traffic light icons provide information on a visit or form level
You you had a preview of the traffic lights yesterday, now we will get into the details. 23

24. Casebook View Visit level view of all Participant Casebooks
Traffic Light Icons
1 Traffic Light = 1 VISIT
Not Started
Missing Data Values
Completed and No Open Queries
Active Open
Queries
Active Open Queries & Missing Data Values
Casebook view allows for a visual (traffic lights) look at the overall status of the entire visit.
Note: each page has 12 participants 24

25. Time and Event Schedule Form 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. Time and Events Schedule Form Level View of all eCRFs for a Patient
Traffic Light Icons
Patient Number
1 Traffic Light = 1 eCRF
Not Started
Missing Data Values
Completed and No Open Queries
Active Open
Queries
Queries & Missing Data Values
T and E view allows visual ( traffic lights) look at the status of a particular/specific form (eCRF) – which is similar to the overall visit view using the Casebook shown on slide 22 26

27. Form and Visit Ruler Navigation Through a Visit
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
Use pointer here – show submit and return buttons. 29

30. Navigating T & E Schedule Where 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 InForm Submitting Data
Click the Return button to return to the Time and Events Schedule without saving your changes
Use pointer – talk to stress the point that you need to be careful with entry and then submit. Don’t submit in middle of completing the form.
If fields are required, and data is not entered, they will turn yellow once submit button is hit.
Click the Submit button to
save newly entered data 31

32. InForm ICONS What are these Symbols?32

33. Icon Definitions 33 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
Query will not be displayed in the audit trail-only changes to data
Freeze and lock button are not used often, and may only see it toward the end of the trial.
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. Click on comment button
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 Icon Takes 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 Icon Takes you to the Queries Tab
To get to the query update click on the query. 38

39. Click on audit trail icon39

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 InForm How 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 InForm How 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 InForm Before 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 Entry Changing 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 Entry Changing 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

51. Data Entry Create a Comment - 1
Form Level Comment
Item Level Comment 51

52. Data Entry Create a Comment - 2
Click on the comment button – The following form will appear:
1. Enter comment and reason
2. Click Submit 52

53. Data Entry Create a Comment - 3
Not Done is entered and comment icon has turned yellow 53

54. Inform Features Form Types and Functionality
There are different types of forms used in the InForm databases
Why do you need to know?
Each form type has unique functionality
Certain form types are best suited for certain types of data collection
Each form type has unique navigation and data entry features 54

55. Form Types Four types of forms are routinely used: Standard Form
Dynamic Form
Repeating Form
Add Entry 55

56. Standard Forms
A Standard form is a form that contains data that is specific to the visit in which the form occurs. 56

57. Standard Form EXAMPLE
Vitals is a standard form – Data is entered and submitted 57

58. Dynamic Forms
Dynamic Forms are created based on the entry of a field(s) on one form (and submission of the form) 58

59. Dynamic Forms Create New eCRFs based on a field on another form
Answer YES to Question 1,2,3 and NO to Question 4
Notice there are no tabs for MEDHX1, LIVHX, ALLRGHX, SURGHX
Click Submit 59

60. Dynamic Forms Creating these Forms
MEDHX1, ALLRGYHX and LIVHX tabs appears
NOTE: SURGHX form did not appear
Because the response was NO. 60

61. Repeating Forms
Allow entry of unlimited rows of data on a form within a visit.
Some of these forms are both Dynamic and repeating. Refer to T and Events schedule. 61

62. Repeating Form Option 1
1. Forms that are both Dynamic and Repeating will have a blank row 1 already created. Click on the 1 or blank traffic light to add the first record.
2. Click on the New button to add additional records thereafter
Talk about process – easy to make mistake here. If you do not click on the first default row, but instead select new –row #1 is blank and items are out of order. 62

63. Repeating Form Option 1 63 Click on the default Row 1
Record 1 form appears for entry
Switch to a demo? 63

64. Repeating Form Option 2
Forms that are repeating only will not have row 1 already created.
Click ‘New’ to start entry on the form 64

65. Repeating Form Summary View
Click on Traffic Light to Edit individual forms
Use drop down list to toggle between Summary View and Individual Forms.
In Summary view – one line
for each entry
Note: Summary is stated in box 65

66. Repeating Forms View by Entry
Note: In the box – you can now select each entry or the summary view 66

67. Add Entry
Add entry rows allow you to enter an unlimited amount of data within a form.
Add entry is a form function, not a form type. 67

68. Add Entry
Click the Add Entry button to add new rows within the form
Note: Each entry has created a new row a,b,c etc. 68

69. Add Entry Editing Data
Click on the underlined row number to Edit the Add Entry row 69

70. Deleting eCRF Data OOPS
Occasionally it may be necessary to delete an eCRF.
This should only be done when necessary.
Anything that has been Submitted to InForm, stays in InForm - always!
Deleted eCRFs can still appear in Listings and can make monitoring and reconciliation cumbersome.
Stress-make sure entering data for the correct participant. Only repeating forms can be deleted. 70

71. Deleting eCRF Data Step 1
Select “Delete” from the menu at the bottom
Click “Apply” 71

72. Deleting eCRF Data Step 2
Provide a reason for the deletion and click Delete 72

73. Deleting eCRF Data Step 3
Deleted eCRFs remain in InForm with a line drawn through each of the fields.
NOTE: Not all users/roles can delete eCRFs 73

74. Add Entry Deleting a Row - 1
Click on the underlined row number to Delete the Add Entry row 74

75. Add Entry Deleting a Row - 2
2. Click Delete button to confirm the deletion.
1. Enter a reason for deletion 75

76. Add Entry Deleting a Row - 3
NOTE: This box will appear and must Click on OK to verify the deletion of the item(s) 76

77. Add Entry Deleting a Row - 4
The item(s) deleted have a line drawn through them.
If there is no line, then the item hasn’t been deleted. 77

78. Entry, Edit, Forms Quiz 78

79. Queries are questions about
What are Queries?
Queries are questions about
the data! 79

80. Types of Queries Automatic Queries
Based upon computer programmed checks.
Auto-queries are created as soon as you Submit (save) eCRF data
Manual Queries
These are created by Monitors (during Source Document Verification), and Data Management (during Quality control and coding review)
Manual queries will not instantly appear after you save newly entered data.
Manual queries don’t automatically appear. Therefore all your traffic lights could be green, and then the next day on the same form could be red because a manual query has been created. 80

81. How to Resolve Queries Change the Data Answer the Query
Query autocloses when data is changed that satisfies the query
Autoclosed queries are not reviewed by monitors
Answer the Query
Confirm information entered for the item is ‘correct as is’
Answered queries are reviewed by monitors\local QC staff before they can be closed. Site staff can not Close an Answered query 81

82. Resolving AutoQueries – Auto-Close a Query
Change the data by clicking on the data value you want to change
Don’t click on query text to close query entered. Change the data!!! This is the difference between closed and answered queries. 82

83. Auto-Queries Auto-Close a Query
1. Change/Update the data
2. Provide a reason for change
3. Submit (save) 83

84. Query is Auto-Closed
Query is auto-closed now that the data has been corrected
Autoclosed queries do not require a monitor\DCRI staff to close them 84

85. Resolving a Query by Answering (confirming data is correct as is)
TIP: You may choose to enter details in the comment bubble to assist the monitor(s) with their review of the data
Sometimes the data is correct as entered even though there is a query
This data needs to be confirmed
To Answer the query, click on the red query text 85

86. Resolving a Query Answering a Query
Select one of the reasons from the drop down menu or write your own reason.
Click submit (save) 86

87. View and Sort Queries
You can view and sort queries at your site by selecting the Queries button from the Navigation pane
All underlined items are hyperlinks
Click on any column heading to sort
Stress filters- by end of the study these lists will be huge so will need to know how to use filters. 87

88. Questions? 88

89. Thank You for your time and attention!