Transcript click here for slides

General InForm Training
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
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
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
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
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
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
Changing your Password
‘As Needed’
To change your password at anytime,
select the trial logo box located here
8
EDC Help Desk
For password questions or any other questions about
the InForm system, please contact the EDC Site
Support Help Desk at 1-866-999-3274
OR e-mail:
[email protected]
Hours 8:00am-8:00pm EST
Monday – Friday
9
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 Services Automated Information Systems Security Program
10
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 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
System Security
System Operational Time Limits


The system will end a
session after a period of
inactivity of :
The system will end a
session after a period of
sustained activity:
12

15 minutes

2 hours
Let’s Get Started…
13
The Home Page
Navigation Pane
Always Present
First screen to appear
after successfully logging into InForm
Screen Pane
14
Home Page
Logging Out of InForm
It is very important to always select
the Logout button to end your InForm
session securely.
15
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
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
17
 Select the Visit you want to view for a
specific patient
 Click the ‘GO’ button
Navigation Pane
Selecting a Patient
Clicking on the Patients button gives you a
list of all Patients at your site
18
Finding Your Enrolled Patients
High-Level view of all Patient Casebooks
List of Visit for each patien
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
Navigating in Patient View
Highlighting Forms - 1
Can use highlight button to
filter on which subjects you
wish to view
20
Navigating in Patient View
Highlighting Forms - 2
 Click on incomplete box:
 Notice the yellow traffic
lights are highlighted
21
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
Traffic Lights
Active Open
Queries
When viewing
participants in
InForm, the traffic
light icons
provide
information on a
visit or form level
Missing Data Values
Active Open Queries &
Missing Data Values
Completed and No
Open Queries
Not Started
23
Casebook View
Visit level view of all Participant Casebooks
Traffic Light
Icons
1 Traffic Light = 1 VISIT
Active Open
Queries
Missing Data Values
Active Open
Queries & Missing
Data Values
Completed and No
Open Queries
Not
Started
24
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
Time and Events Schedule
Form Level View of all eCRFs for a Patient
Traffic Light
Icons
Patient Number
1 Traffic Light = 1 eCRF
Active Open
Queries
Missing Data Values
Queries & Missing
Data Values
Completed and No
Open Queries
Not Started
26
Form and Visit Ruler
Navigation 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
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
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
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
Navigating in InForm
Submitting Data
Click the Submit button to
save newly entered data
31
Click the Return button to
return to the Time and
Events Schedule without
saving your changes
InForm ICONS
What are these Symbols?
Icons
32
Icon Definitions
Comment
No comment
entered for
item
Audit Trail
No changes
to the item
Query
Freeze
Form or Casebook frozen
No query exists
for item
(Seen at Casebook and Time
and Events Schedule view)
Re-Set Icon (Eraser)
Comment entered
for item
Changes have been
made to the item
Once these icons turn yellow,
they will always be yellow. The
icons indicate activity has
occurred
Query exists for
item
Used to clear data from a
form item that has
previously been submitted
Indicates there are
no open queries
33
Create a Comment
Click on comment button
34
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
Comment Icon
Takes you to the Comment Tab
 To enter Comment:
-Make Comment
-Indicate Reason
-Click ‘Submit’
36
Query Icon
Click on query flag
37
Query Icon
Takes you to the Queries Tab
38
Audit Trail
Click on audit trail icon
39
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
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
Navigating in InForm
How to Print an eCRF Form
 This is the Print Preview.
 Click on ‘Print’ to print the page
42
Navigation Quiz
43
Entering and Editing Data
Entering Data in InForm
Before Data is Submitted
Data can be entered and
changed without specifying a
Reason for change before
Submit (save)
45
Click the Submit
button to save newly
entered data
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
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
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
Data Entry
Changing Data (Audit Trail Icon)
 After the data value change, the Audit Trial
Icon will turn yellow, indicating activity
49
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
Data Entry
Create a Comment - 1
Form Level Comment
Item Level Comment
51
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
Data Entry
Create a Comment - 3
Not Done is entered and
comment icon has turned
yellow
53
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
Form Types
Four types of forms are
routinely used:




Standard Form
Dynamic Form
Repeating Form
Add Entry
55
Standard Forms

A Standard form is a form that contains data that is
specific to the visit in which the form occurs.
56
Standard Form
EXAMPLE

Vitals is a standard form – Data is entered and
submitted
57
Dynamic Forms

Dynamic Forms are created based on the
entry of a field(s) on one form (and
submission of the form)
58
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
Dynamic Forms
Creating these Forms
MEDHX1, ALLRGYHX and LIVHX
tabs appears
NOTE: SURGHX form did not appear
Because the response was NO.
60
Repeating Forms

Allow entry of unlimited rows of data on a form
within a visit.
61
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
62
Repeating Form
Option 1
 Click on the default Row 1
 Record 1 form appears for entry
63
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
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
Repeating Forms
View by Entry
Note: In the box – you can
now select each entry or the
summary view
66
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
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
Add Entry
Editing Data
Click on the underlined row number
to Edit the Add Entry row
69
Deleting eCRF Data

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.
70
Deleting eCRF Data
Step 1
Select “Delete” from the
menu at the bottom
Click
“Apply”
71
Deleting eCRF Data
Step 2
Provide a reason for the
deletion and click Delete
72
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
Add Entry
Deleting a Row - 1
Click on the underlined row
number to Delete the Add
Entry row
74
Add Entry
Deleting a Row - 2
1. Enter a reason for deletion
75
2. Click Delete button
to confirm the
deletion.
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
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
Entry, Edit, Forms Quiz
78
What are Queries?
Queries are questions about
the data!
79
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.
80
How to Resolve Queries

Change the Data



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
Resolving AutoQueries –
Auto-Close a Query
Change the data by
clicking on the data value
you want to change
82
Auto-Queries
Auto-Close a Query
1. Change/Update the
data
2. Provide a reason
for change
3. Submit (save)
83
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
Resolving a Query by Answering
(confirming data is correct as is)
 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
TIP: You may choose to enter
details in the comment bubble
to assist the monitor(s) with
their review of the data
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
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
87
Questions?
88
Thank You for your time and
attention!