General InForm Training
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
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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.
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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
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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.
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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.
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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”
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Changing your PasswordChanging your Password
‘As Needed’‘As Needed’
To change your password at anytime, select the trial logo box located here
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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:
[email protected]@mc.duke.edu
Hours 8:00am-8:00pm ESTHours 8:00am-8:00pm EST
Monday – FridayMonday – Friday
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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
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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.
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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
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Let’s Get Started…Let’s Get Started…
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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
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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.
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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.
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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
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Navigation Pane Navigation Pane Selecting a PatientSelecting a Patient
Clicking on the Patients button gives you a list of all Patients at your site
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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
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Navigating in Patient ViewNavigating in Patient ViewHighlighting Forms - 1Highlighting Forms - 1
Can use highlight button to filter on which subjects you
wish to view
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Navigating in Patient ViewNavigating in Patient ViewHighlighting Forms - 2Highlighting Forms - 2
Click on incomplete box: Notice the yellow traffic lights are highlighted
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
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InForm ICONSInForm ICONSWhat are these Symbols?What are these Symbols?
Icons
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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
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Create a CommentCreate a Comment
Click on comment button
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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.
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Comment IconComment IconTakes you to the Comment TabTakes you to the Comment Tab
To enter Comment:-Make Comment-Indicate Reason-Click ‘Submit’
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Query IconQuery Icon
Click on query flag
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Query IconQuery Icon Takes you to the Queries TabTakes you to the Queries Tab
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Audit TrailAudit Trail
Click on audit trail icon
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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
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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
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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
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Navigation QuizNavigation Quiz
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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
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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)
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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
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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
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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
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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.
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Data EntryData EntryCreate a Comment - 1Create a Comment - 1
Form Level Comment
Item Level Comment
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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
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Data EntryData EntryCreate a Comment - 3Create a Comment - 3
Not Done is entered and comment icon has turned
yellow
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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
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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
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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.
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Standard FormStandard FormEXAMPLEEXAMPLE
Vitals is a standard form – Data is entered and Vitals is a standard form – Data is entered and submittedsubmitted
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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)
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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
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Dynamic FormsDynamic FormsCreating these FormsCreating these Forms
MEDHX1, ALLRGYHX and LIVHX tabs appears
NOTE: SURGHX form did not appearBecause the response was NO.
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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.
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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
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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
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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
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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
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Repeating Forms Repeating Forms View by EntryView by Entry
Note: In the box – you can now select each entry or the
summary view
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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.
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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.
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Add EntryAdd EntryEditing DataEditing Data
Click on the underlined row number to Edit the Add Entry row
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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.
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Select “Delete” from the menu at the bottom
Click “Apply”
Deleting eCRF DataDeleting eCRF DataStep 1Step 1
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Provide a reason for the deletion and click Delete
Deleting eCRF DataDeleting eCRF DataStep 2Step 2
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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
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Add EntryAdd EntryDeleting a Row - 1Deleting a Row - 1
Click on the underlined row number to Delete the Add Entry row
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Add EntryAdd EntryDeleting a Row - 2Deleting a Row - 2
1. Enter a reason for deletion 2. Click Delete button to confirm the
deletion.
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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)
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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.
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Entry, Edit, Forms QuizEntry, Edit, Forms Quiz
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What are Queries?What are Queries?
QueriesQueries are questions about are questions about
the data!the data!
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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.
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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
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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
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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
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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
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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)
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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
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Questions?Questions?
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Thank You for your time and Thank You for your time and attention!attention!