What is InForm

1
What is InForm?
2
Current Paper Process
3
Internet-Based InForm Process
4
User-Friendly Features

• Sponsor
• Real-time access to data
• Up-to-date project management reports
• Centralized version control

• Site
• No special software or computer
• Minimal training required
• Integrated help, and communications
• Immediate response upon data entry

5
Password Rules

• Password allows InForm to track your activity on
  the CRF
• InForm automatically logs you out after a 30
  minutes of inactivity
• You may be required to re-login throughout the
  day every 90 minutes
• Your password will expire every 90 days

6
Rights

• Permission to perform a specific activity
• Each InForm user has a set of rights
• Appearance of InForm depends on the rights
  assigned to you and the site(s) you are
  associated with

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Navigation in InForm
Navigation Panel
Content Panel
Content-Specific Panel
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Icons
Freeze
Lock
Form or book has been locked
Form or book has been frozen
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Case Books List
10
Time and Events Schedule
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Queries

• Two types
• Automatic generated by InForm
• Manual issued by CRA
• For sites the process for responding to automatic
  or manual queries is the same

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Autoquery

• Generated when entered data violates edit checks
• Autoquery generates a query visible to site users
• Site users review Opened Queries and respond to
  them
• If data change meets rules, InForm closes
  autoquery

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Query Process Automatic Queries
Automatic Query data entry violates item rule
Site user responds to Open Query
Query status changes to Closed
14
Manual Queries

• Manual queries are created by CRAs or sponsor
  staff.
• Sites respond to manual queries just as they
  would automatic queries
• When a site user responds to a query, the query
  enters Answered status and is ready for review by
  the CRA.
• The CRA reviews Answered queries and either
  closes or reopens them.

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Query Process Manual Queries
Manual Queryquery opened by CRA or other Sponsor
Staff
Site user responds to Open Query
Query status changes to Answered
CDM/CRA reviews answered query
Close or Reissue Query?
Manual Query CDM/CRA closes
Reissue
Close
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Signing a Case Book

• You attest to the accuracy and completeness of
  data
• Normally signed after all data is complete and
  commented and all queries resolved
• Data or comments entered in a signed CRF or Case
  Book require a new signature
• New data in a signed CRF requires new signature
  on CRF
• New data in a signed CRF in a signed Case Book
  requires new signatures for both CRF and Case
  Book
• New data in an unsigned CRF in a signed Case Book
  requires new signatures for Case Book

17
Database Locking

• At end of study
• Prevent changes to forms
• Lock a CRF or Case Book
• No further data entry, edits, comments, or
  queries
• Lock icon appears
• Unlock CRF or Case Book to edit data

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Monitoring

• Review Screening/Enrollment Log
• Review Case Books
• Freeze CRFs

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Source Verification

• Freeze CRFs
• Online Monitoring
• Use SV screens
• Check for data requiring repeat SV
• Offline Monitoring
• Print CRFs and Case Books

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Freezing versus Locking

• Freeze during trial
• Conduct interim analysis
• Prepare for source verification
• No new data can be entered, but queries can be
  resolved
• Freeze CRF or Case Record Book
• Snowflake appears when frozen disappears
  when unfrozen
• Lock at end of study
• No further data entry, edits, comments, or
  queries
• Lock a CRF or Case Book
• Lock icon appears when locked appears as
  unlocked when CRF or CRB is unlocked

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Reports

• Patient Reports
• Patient Status Report
• Dropout Report
• Case Record Reports
• CRF/Case Book Status
• CRF Performance Reports
• Query Reports
• Query Status
• Query Performance
• Query Metrics

• Source Verification Reports
• Source Verification Status
• Source Verification Performance
• Hot Spot Report

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Listings

• Selected data items to a spreadsheet
• Download and save to a local directory
• Be sensitive to distribution of this file--trial
  data
• Manipulate data tables using Microsoft Excel
• Filtering, Sorting
• Scatter Charts
• Identify outliers
• Hyperlink back to InForm--to selected data item
  on CRF
• Re-enter password