general inform training. training session outline getting started– inform overview and navigation...

General InForm Training

Training Session Outline

Getting Started– InForm Overview and Navigation TipsGetting Started– InForm Overview and Navigation Tips

Entering Data and Editing Data Overview Entering Data and Editing Data Overview

InForm FeaturesInForm Features Add Entry FormsAdd Entry Forms Dynamic FormsDynamic Forms Repeating FormsRepeating Forms

Queries – Trial Details of Reviewing and ResolvingQueries – Trial Details of Reviewing and Resolving

Wrap Up– Helpful Hints and Admin DetailsWrap Up– Helpful Hints and Admin Details

22

InFormInForm……

InFormInForm is an is an EElectronic lectronic DData ata CCapture (EDC) apture (EDC) system which:system which: Enables site staff to enter Participant data into Enables site staff to enter Participant data into

an an Electronic Case Report FormElectronic Case Report Form (eCRF) (eCRF) Uses the power of internet technology to Uses the power of internet technology to

streamline the clinical trial data collection streamline the clinical trial data collection process. process.

Enables real-time access to all aspects of the Enables real-time access to all aspects of the management of clinical trial data.management of clinical trial data.

33

InFormInForm… How?… 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

44

Password RequirementsPassword 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.

55

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.

66

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.

1.Respond to your question and click Reset Password

Automatic Password Reset“Forgot Password, continued”

77

Changing your PasswordChanging your Password

‘As Needed’‘As Needed’

To change your password at anytime, select the trial logo box located here

88

EDC Help DeskEDC Help Desk

For password questions or any other questions about For password questions or any other questions about the InForm system, please contact the the InForm system, please contact the EDCEDC SSite ite SSupport upport HHelp elp DDesk at esk at 1-866-999-32741-866-999-3274

OR e-mail:OR e-mail:

edchelp@mc.duke.eduedchelp@mc.duke.edu

Hours 8:00am-8:00pm ESTHours 8:00am-8:00pm EST

Monday – FridayMonday – Friday

99

System SecuritySystem 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

1010

System SecuritySystem SecurityYour InFormYour InForm™™ Account Account

Training Database:Training Database:

You will be assigned a userID and password to the training You will be assigned a userID and password to the training databasedatabase

The training database and your access will remain The training database and your access will remain active throughout the trialactive throughout the trial

Production Database:Production Database:

After successful completion of training, each user will be After successful completion of training, each user will be notified via separate e-mails of their userID and temporary notified via separate e-mails of their userID and temporary password to the production databasepassword to the production database

For security reasons, your e-mail must not be a For security reasons, your e-mail must not be a shared account. This is so the temporary password shared account. This is so the temporary password will be secure until you receive it and change it.will be secure until you receive it and change it.

1111

System SecuritySystem SecuritySystem Operational Time LimitsSystem Operational Time Limits

The system will end a The system will end a session after a period of session after a period of inactivity of :inactivity of :

The system will end a The system will end a session after a period of session after a period of sustained activity:sustained activity:

15 minutes15 minutes

2 hours 2 hours

1212

Let’s Get Started…Let’s Get Started…

1313

The Home PageThe Home PageFirst screen to appearFirst screen to appear

after successfully logging into InForm after successfully logging into InForm

Screen Pane

Navigation PaneAlways Present

1414

Home Page Home Page Logging Out of InFormLogging Out of InForm

It is very important to always select the Logout button to end your InForm session securely.

1515

Home PageHome PageInForm PortalInForm Portal

The InForm Portal is a repository of study related The InForm Portal is a repository of study related documents to aid in the entry of data. Documents documents to aid in the entry of data. Documents included in the Portal are:included in the Portal are:

- Protocol- Protocol- Paper CRF, if applicable- Paper CRF, if applicable- eCRF Completion Guidelines- eCRF Completion Guidelines- Any other needed documents- Any other needed documents

These documents will be located under the These documents will be located under the appropriate tab.appropriate tab.

1616

Home Page Home Page Selecting a PatientSelecting 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 Select the Visit you want to view for a specific patientspecific patient Click the ‘GO’ buttonClick the ‘GO’ button

1717

Navigation Pane Navigation Pane Selecting a PatientSelecting a Patient

Clicking on the Patients button gives you a list of all Patients at your site

1818

Finding Your Enrolled Patients Finding Your Enrolled Patients High-Level view of all Patient CasebooksHigh-Level view of all Patient Casebooks

Click on an underlined patient number to view the details of all form for a Patient in the Patient’s ‘Time and Events Schedule’.

List of patient numbers in

your site

These buttons will allow you to view additional pages of participant casebooks.

*12 participants per page*

List of Visit for each patient

1919

Navigating in Patient ViewNavigating in Patient ViewHighlighting Forms - 1Highlighting Forms - 1

Can use highlight button to filter on which subjects you

wish to view

2020

Navigating in Patient ViewNavigating in Patient ViewHighlighting Forms - 2Highlighting Forms - 2

Click on incomplete box: Notice the yellow traffic lights are highlighted

2121

Subject StatusSubject StatusDefinitionsDefinitions

All All – All enrolled subjects.– All enrolled subjects. EnrolledEnrolled - InForm Enrollment must be complete and subject - InForm Enrollment must be complete and subject

has been enrolled in the study. has been enrolled in the study. RandomizedRandomized - Subject must be randomized in the InForm - Subject must be randomized in the InForm

software software (Not used)(Not used) Not CompleteNot Complete - Study Completion form (as designed per - Study Completion form (as designed per

InForm requirements) must be completed for the subject. The InForm requirements) must be completed for the subject. The form must indicate that the subject has dropped out of the form must indicate that the subject has dropped out of the study.study.

CompleteComplete - Study Completion form (as designed per InForm - Study Completion form (as designed per InForm requirements) must be completed for the subject. The form requirements) must be completed for the subject. The form must indicate that the subject has completed the study.must indicate that the subject has completed the study.

2222

Traffic LightsTraffic Lights

When viewing participants in InForm, the traffic light icons provide information on a visit or form level

Not Started

Missing Data Values

Completed and No Open Queries

Active OpenQueries

Active Open Queries & Missing Data Values

2323

Casebook ViewCasebook View Visit level view of all Participant Casebooks Visit level view of all Participant Casebooks

1 Traffic Light = 1 VISIT

Traffic Light Icons

Not Started

Missing Data Values

Completed and No Open Queries

Active OpenQueries

Active Open Queries & Missing Data Values

2424

Time and Event ScheduleTime and Event Schedule Form Level View of all eCRFs for a Form Level View of all eCRFs for a PatientPatient

List of all forms (eCRFs) for a patient

Click on traffic light to go to that

specific eCRF

Name of Each Visit

2525

Time and Events ScheduleTime and Events ScheduleForm Level View of all eCRFs for a Form Level View of all eCRFs for a PatientPatient

Patient Number

Not Started

Missing Data Values

Completed and No Open Queries

Active OpenQueries

Queries & Missing Data Values

1 Traffic Light = 1 eCRF

Traffic Light Icons

2626

Visit Ruler

Form Ruler

Form and Visit RulerForm and Visit RulerNavigation Through a VisitNavigation Through a Visit

Note: Visit Ruler – Current Visit is highlighted in Yellow Form Ruler – Current Form is highlighted in Yellow

2727

Form Ruler Form Ruler Identify Forms with ProblemsIdentify Forms with Problems

Exclamation Mark (!) next to form indicates one of the following:

- Missing Data- Query is present on that form

2828

Navigating within the VisitNavigating within the Visit

Click on the yellow arrow to

return to Time & Events

Schedule

Click on the Study Visit Ruler to navigate between

visits

Click on the eCRFTabs to navigate

between forms withina visit

2929

Navigating T & E ScheduleNavigating T & E ScheduleWhere are the forms?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

3030

Navigating in InFormNavigating in InFormSubmitting DataSubmitting Data

Click the Return button to return to the Time and

Events Schedule without saving your changesClick the Submit button to

save newly entered data

3131

InForm ICONSInForm ICONSWhat are these Symbols?What are these Symbols?

Icons

3232

Icon DefinitionsIcon Definitions

Comment Audit Trail Freeze

No comment entered for

item

No query exists for item

No changes to the item

Query exists for itemComment entered

for itemChanges have been

made to the item

Once these icons turn yellow, they will always be yellow. The

icons indicate activity has occurred

Form or Casebook frozen

(Seen at Casebook and Time and Events Schedule view)

Re-Set Icon (Eraser)

Used to clear data from a form item that has

previously been submitted

Query

Indicates there areno open queries

3333

Create a CommentCreate a Comment

Click on comment button

3434

A ‘Comment’A ‘Comment’

The Comment Bubble can be useful to describe specific The Comment Bubble can be useful to describe specific circumstances and explain data responses. circumstances and explain data responses.

The Comment Bubble allows for a selection of pre-set The Comment Bubble allows for a selection of pre-set reasons (Not Done, Not Applicable, Unknown), as well as reasons (Not Done, Not Applicable, Unknown), as well as free text entry describing the specific data value.free text entry describing the specific data value.

Comment Bubble free text is NOT stored in the ‘back end’ Comment Bubble free text is NOT stored in the ‘back end’ database, but is stored permanently in InForm. database, but is stored permanently in InForm.

Comments can not be analyzed.Comments can not be analyzed.

3535

Comment IconComment IconTakes you to the Comment TabTakes you to the Comment Tab

To enter Comment:-Make Comment-Indicate Reason-Click ‘Submit’

3636

Query IconQuery Icon

Click on query flag

3737

Query IconQuery Icon Takes you to the Queries TabTakes you to the Queries Tab

3838

Audit TrailAudit Trail

Click on audit trail icon

3939

Audit Trail Icon Audit Trail Icon Takes you to the Audit Trail TabTakes 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

4040

Navigating in InFormNavigating in InFormHow to Print an eCRF FormHow to Print an eCRF Form

To print a form – open form you want to print - 1 – Select Action ‘Print Preview’ - 2 – Click on Apply

4141

Navigating in InFormNavigating in InFormHow to Print an eCRF FormHow to Print an eCRF Form

This is the Print Preview. Click on ‘Print’ to print the page

4242

Navigation QuizNavigation Quiz

4343

Entering and Editing DataEntering and Editing Data

Entering Data in InFormEntering Data in InFormBefore Data is SubmittedBefore 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

4545

Data Entry Data Entry Changing Data After SubmittingChanging Data After Submitting

Any problems with the data will appear immediately after Submit

Missing values (Field turns yellow)

Open Query (Shows in Pink)

4646

Data EntryData EntryChanging Data (after Submit)Changing Data (after Submit)

Enter Missing Data Values and click 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

4747

Data EntryData EntryChanging Data (writes to Audit Trail)Changing Data (writes to Audit Trail)

2. Enter a reason for the change

3. Click the Submit button to save the

correction

1. Change the value

4848

Data Entry Data Entry Changing Data (Audit Trail Icon)Changing Data (Audit Trail Icon)

After the data value change, the Audit Trial Icon will turn yellow, indicating activity

4949

Data Entry Data Entry Types of CommentsTypes of Comments

You can enter a comment on the item level or form levelYou can enter a comment on the item level or form level Item-level comments – Comments that refer to one Item-level comments – Comments that refer to one

item on a formitem on a form Form-level comments – Comments that refer to all Form-level comments – Comments that refer to all

items on the for this studyitems on the for this study

Reminder: Do not use this unless necessary. This data will Reminder: Do not use this unless necessary. This data will not be in the analysis for this study.not be in the analysis for this study.

5050

Data EntryData EntryCreate a Comment - 1Create a Comment - 1

Form Level Comment

Item Level Comment

5151

Data EntryData EntryCreate a Comment - 2Create a Comment - 2

Click on the comment button – The following form Click on the comment button – The following form will appear:will appear:

1. Enter comment and reason

2. Click Submit

5252

Data EntryData EntryCreate a Comment - 3Create a Comment - 3

Not Done is entered and comment icon has turned

yellow

5353

Inform FeaturesInform FeaturesForm Types and FunctionalityForm Types and Functionality

There are different types of forms used in the InForm There are different types of forms used in the InForm databasesdatabases

Why do you need to know?Why do you need to know? Each form type has unique functionalityEach form type has unique functionality

Certain form types are best suited for certain types of data Certain form types are best suited for certain types of data collectioncollection

Each form type has unique navigation and data entry Each form type has unique navigation and data entry featuresfeatures

5454

Form TypesForm Types

Four types of forms are Four types of forms are routinely used:routinely used:

Standard FormStandard Form Dynamic FormDynamic Form Repeating FormRepeating Form Add Entry Add Entry

5555

Standard FormsStandard Forms

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

5656

Standard FormStandard FormEXAMPLEEXAMPLE

Vitals is a standard form – Data is entered and Vitals is a standard form – Data is entered and submittedsubmitted

5757

Dynamic FormsDynamic Forms

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

5858

Dynamic FormsDynamic FormsCreate New eCRFs based on a field on another formCreate 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

5959

Dynamic FormsDynamic FormsCreating these FormsCreating these Forms

MEDHX1, ALLRGYHX and LIVHX tabs appears

NOTE: SURGHX form did not appearBecause the response was NO.

6060

Repeating FormsRepeating Forms

Allow entry of unlimited rows of data on a form Allow entry of unlimited rows of data on a form within a visit. within a visit.

6161

Repeating Form Repeating Form Option 1Option 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

6262

Repeating FormRepeating FormOption 1Option 1

Click on the default Row 1Click on the default Row 1 Record 1 form appears for entryRecord 1 form appears for entry

6363

Repeating FormRepeating FormOption 2Option 2

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

6464

Repeating FormRepeating FormSummary ViewSummary View

Use drop down list to toggle between Summary View and Individual Forms.

In Summary view – one lineIn Summary view – one linefor each entryfor each entryNote: Summary is stated in boxNote: Summary is stated in box

Click on Traffic Light to Edit individual forms

6565

Repeating Forms Repeating Forms View by EntryView by Entry

Note: In the box – you can now select each entry or the

summary view

6666

Add EntryAdd Entry

Add entry rows allow you to enter an unlimited Add entry rows allow you to enter an unlimited amount of data within a form.amount of data within a form.

Add entry is a form function, not a form type.Add entry is a form function, not a form type.

6767

Add EntryAdd 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.

6868

Add EntryAdd EntryEditing DataEditing Data

Click on the underlined row number to Edit the Add Entry row

6969

Deleting eCRF DataDeleting eCRF Data

Occasionally it may be necessary to delete an Occasionally it may be necessary to delete an eCRF. eCRF.

This should This should onlyonly be done when necessary. be done when necessary.

Anything that has been Submitted to InForm, Anything that has been Submitted to InForm, stays in InForm - always!stays in InForm - always!

Deleted eCRFs can still appear in Listings and Deleted eCRFs can still appear in Listings and can make monitoring and reconciliation can make monitoring and reconciliation cumbersome.cumbersome.

7070

Select “Delete” from the menu at the bottom

Click “Apply”

Deleting eCRF DataDeleting eCRF DataStep 1Step 1

7171

Provide a reason for the deletion and click Delete

Deleting eCRF DataDeleting eCRF DataStep 2Step 2

7272

Deleted eCRFs remain in InForm with a line drawn through each of the fields.

Deleting eCRF DataDeleting eCRF DataStep 3Step 3

NOTE: Not all users/roles can delete eCRFs

7373

Add EntryAdd EntryDeleting a Row - 1Deleting a Row - 1

Click on the underlined row number to Delete the Add Entry row

7474

Add EntryAdd EntryDeleting a Row - 2Deleting a Row - 2

1. Enter a reason for deletion 2. Click Delete button to confirm the

deletion.

7575

Add EntryAdd EntryDeleting a Row - 3Deleting a Row - 3

NOTE: This box will appear and must Click on OK to verify the deletion of the item(s)

7676

Add EntryAdd EntryDeleting a Row - 4Deleting 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.

7777

Entry, Edit, Forms QuizEntry, Edit, Forms Quiz

7878

What are Queries?What are Queries?

QueriesQueries are questions about are questions about

the data!the data!

7979

Types of QueriesTypes of Queries

Automatic QueriesAutomatic Queries Based upon computer programmed checks.Based upon computer programmed checks. Auto-queries are created as soon as you Submit Auto-queries are created as soon as you Submit

(save) eCRF data(save) eCRF data

Manual Queries Manual Queries These are created by Monitors (during Source These are created by Monitors (during Source

Document Verification), and Data Management Document Verification), and Data Management (during Quality control and coding review) (during Quality control and coding review)

Manual queries will not instantly appear after you Manual queries will not instantly appear after you save newly entered data.save newly entered data.

8080

How to Resolve QueriesHow to Resolve Queries

Change the DataChange the Data Query autocloses when data is changed that Query autocloses when data is changed that

satisfies the querysatisfies the query Autoclosed queries are not reviewed by monitorsAutoclosed queries are not reviewed by monitors

Answer the QueryAnswer the Query Confirm information entered for the item is Confirm information entered for the item is

‘correct as is’‘correct as is’ Answered queries are reviewed by monitors\Answered queries are reviewed by monitors\

local QC staff before they can be closed. Site local QC staff before they can be closed. Site staff can not Close an Answered querystaff can not Close an Answered query

8181

Resolving AutoQueries –Resolving AutoQueries – Auto-Close a Query Auto-Close a Query

Change the data by clicking on the data value you want to change

8282

Auto-Queries Auto-Queries Auto-Close a QueryAuto-Close a Query

1. Change/Update the data

2. Provide a reason for change

3. Submit (save) 8383

Query is Auto-ClosedQuery 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

8484

Resolving a Query Resolving a Query byby AnsweringAnswering

(confirming data is correct as is)(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 Sometimes the data is correct as entered even though there is a querythough there is a query This data needs to be confirmedThis data needs to be confirmed To To AnswerAnswer the query, click on the red query text the query, click on the red query text

8585

Resolving a Query Resolving a Query Answering a QueryAnswering a Query

Select one of the reasons from the drop down menu or write your own reason.

Click submit (save)

8686

View and Sort QueriesView 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

8787

Questions?Questions?

8888

Thank You for your time and Thank You for your time and attention!attention!