Clinical Research Management System

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CRMS
ClinicalResearchManagementSystem
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Introduction to mdlogix

• Developing clinical research technology since
  1997
• Conducts continuous requirements gathering and
  systems integration
• Delivers a product that is configured to the
  clients needs
• Performs as a biomedical informatics research
  partner

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Collaborators and Clients

• Johns Hopkins University (Baltimore, MD)
• School of Medicine
• School of Public Health
• Washington University (St. Louis, MO)
• School of Medicine
• BJC Healthcare (13 Hospitals)
• Childrens Hospital of Philadelphia
• Tennessee Oncology (Nashville, TN)
• Kennedy Krieger Institute (Baltimore, MD)

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Collaborative Efforts

• Developing best practices for clinical research
• Ongoing process re-engineering
• Integration with existing systems
• Cross-institutional development
• National Institutes of Health research grants
• Standards-based platform
• HL7, IHE, CDISC
• CRMS - caBIG Bronze Certified

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Clinical Research Management System Overview
IRB Integration
EPR, Labs Integration
Finance, Billing
Document Management
Institution Data
Subject Protocol Registry
Protocol Schema Subject Calendar
Financial Management
Case Report Forms
Subject Recruitment
Specimen Tracking
Data Warehouse
CRMS Modules
Web Based Application
Single Sign-on Web Access Management
Pharmacy Labs Core Facilities
Investigators Research Nurse Program Manager Data
manager
IRB Administration Management
Insurance Clearance Billing Compliance Dept.
Admin. Budget
User Community
Configurable to the clients workflows and systems
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CRMS Modules

• Subject Recruitment
• Subject Protocol Registry
• Protocol Schema Subject Calendar
• Financial Management
• Case Report Forms - Electronic Data Capture
• Specimen Tracking
• Data Warehouse

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The mdlogix CRMS gives you

• A scalable, configurable, enterprise level,
  Web-based solution to facilitate effective
  collaboration within and between institutions
• Dramatic time savings for all users
• Billing and regulatory compliance
• CTSA collaboration
• Breadth and depth in the functionality required
  across the research management process
• A powerful, user-friendly system that all
  research roles will want to use
• Unrivaled degree of scientific rigor and
  comprehensiveness

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Enterprise-wide Research Management

• Subject Recruitment
• Improve subject accrual actual/target percentage
• Easily identify potential subjects
• Broaden pool of potential subjects
• Reduce staff time needed for data collection and
  study management
• Easier access for subjects

• Specimen Tracking
• Configurable freezer layout and management
• Barcoding and audit trail
• Specimen requests and transfer management

• Financial Management
• Allows the study team to develop a protocols
  budget by mapping out the studys procedures over
  time
• Improve billing and regulatory compliance
• Prevent billing errors by separating standard of
  care and research procedures
• Determine study costs to increase profitability

• Subject Protocol Registry
• Decrease staff workload in managing and tracking
  subjects
• Accurately capture subject consent and
  eligibility
• Track subject progress through study
• Collaborate on study development
• Interface with eIRB systems
• Keep all important study documentation in single
  location

Clinical Research Management System

• Case Report Forms - EDC
• Design and deploy web-based forms
• Easily enter complex navigation and validation
  logic
• Safely version forms intra-study

• Protocol Schema Subject Calendar
• Specify simple and complicated protocols using
  common language rules
• View a test calendar to verify schedule accuracy
• Collaborate on resource and budget requirements
• Schedule visits based on schema-driven target
  dates
• View calendars across subjects, studies, and
  resources

• Data Warehouse
• Enterprise Systems Integration
• Ease of use to group and sub-group
• Enhanced querying functionality and analytical
  tools

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CRMS
Subject Recruitment
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Registration
Obtain self-report demographic contact
information to help match potential subjects to
research studies
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Consent
Increase potential subjects understanding by
providing full text of consent
Record a digital signature to ensure subject
agreement was captured
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Self-report Subject Data Entry

• One question per page format increases likelihood
  that forms will be completed
• Subjects can move forward and backward through
  questions
• Potential subjects can provide reasons for not
  answering
• Potential subjects can review all responses and
  correct before submitting final answers

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CRMS
Subject Protocol Registry
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Subject Protocol Registry
Subject Protocol Registry

• PI Home Page
• Shows PI protocols
• Ordered by status
• Then shows their Co-I protocols
• Ordered by status

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Protocol Information
Protocol Information Tabs Multiple Views
Role-based Access to Information

• Data migration/synchronization with other systems
• Legacy systems and databases
• eIRB
• External recruiting website
• Lay Abstract
• Keywords

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IRB Tracking and Integration
Link to ClickCommerce eIRB system to
automatically create an application for a new
study
Protocol dates and info updated nightly from
ClickCommerce eIRB system
Track IRB and other regulatory dates
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Multiple IRB Tracking
Manage approvals of multiple IRBs
Track consents and documents sent to IRBs
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Study Regulatory Log
Track all submissions to regulatory committees
Include submission tracking number and summary
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Protocol Enrollment

• One-click access to
• Subjects insurance clearance information
• Send request or review benefits
• Subjects consent forms
• Subjects eligibility checklists
• Subjects Calendar

Subject Enrollment Status Interested ? Insurance
Clearance ? Consented ? Eligible ? Registered
Consent Date
On/Off Study
On/Off Treatment
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Subject Information
Demographics
Tabbed sets of information
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Subject Contact Information
Open-ended list of contact information
Place for special instructions
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Subjects Study List
Indicates how subject is involved in the study
List of studies subject is involved in
Move subject through registration process
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Subject Eligibility Checklist

• Subject data can be pulled from existing systems
• EPR HL7 feeds
• External lab results may need to be manually
  entered

System checks subject data versus eligibility
criteria
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Subject Enrollment summary
Protocol information
Subject demographics
Enrollment summary
Subject consents
Subject eligibility
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One-Click Reports

• Enrollment Status Summary
• Summary report showing enrollment status by study
  or research program, including summary data on
  reason why subjects went off treatment and off
  study
• Demographic Report
• Definition Shows a summary of subjects
  demographic data. Can run report by study or
  program and search by enrollment status
• Study Consent Report
• Lists all consents signed by subject. Can run
  report by study or program and search by
  enrollment status
• Workload Report
• Shows study staff workload
• NCI Summary 4 Report

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CRMS
Protocol Schema Subject Calendar
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Protocol Schema Builder

• Drives trial activities
• Budgeting
• Medicare Coverage Analysis
• Scheduling
• Billing
• Data Collection (CRFs)

• PIs and Data Managers build protocol schema
• These procedures then are used to track subject
  progress through the study

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Protocol Schema Builder

• Protocol Procedure Attributes
• Billing information
• Standard of care vs. Research
• Including Pro, Facility, and Administrative fees
• Future
• Reviewed for Medicare Coverage Analysis
• Cost
• Processing place
• Notifications required
• Core labs
• Special instructions
• Scheduling restrictions
• Weekends, holidays, etc.

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Subject Calendar

• Subject Calendar
• Generated from protocol schema
• Using XSB (Prolog) logic engine
• Calendar events based on schema procedure
  definitions
• Procedure codes
• Allow integration with scheduling, billing
  systems
• Create data points for CRFs
• With lab values via HL7 message engine
• Billing status (Research, Standard of Care)
• Insurance Clearance and Billing staff can review
  subject calendar to ensure billing compliance
• Views
• Subject-study view
• Printable refrigerator view
• Subject all studies view
• If subject is on multiple protocols
• Nurse/Program Manager view
• Shows all subjects on a protocol
• Core lab calendar
• Shows procedures a core lab is involved in

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Calendar Ad Hoc Event
Ability to add unscheduled ad-hoc events
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Subject Calendar View
CRF status shown as In Progress or Complete on
event with symbol key
Subject Info shown with preferred method of
contact highlighted
CRF Link allows user to complete CRF through
calendar
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CRMS
Financial Management
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Set Base Costs in Schema Builder
Add / Remove Base Costs for a procedure
Costs managed by provider
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Generate a Study Budget
Study Charges Startup Fees
Per Procedure Charges
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Add Costs to a Procedure
Click to edit any cell
Select Cost Type to add to a procedure
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Change Costs Update Budget
Edit updates all cycles
All totals are updated
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Subject Billing Report
Billing status for auditing purposes
Based on procedures and dates from Subject
calendar
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CRMS
Case Report Forms -Electronic Data Capture
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Overview
Web-based, user-friendly, scientifically rigorous
tool that allows the creation of complex forms
for electronic data capture
Create sections and questions
Copy existing questions
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Validation Logic

• Apply validation logic to any question, comparing
  entered values to
• Static values
• Previously answered questions
• Subject demographics

What to compare to
how to compare
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Navigation Logic
Skip logic can be applied to any question
Set skip conditions
Set target question
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Associate Form with Study
Forms associated with study
Choose form from library to add to study
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Self-report Data Capture

• Single question per page
• Fully structured interview format
• Subject can save progress to complete the form at
  a later time

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Data Entry Audit Log

• Tracks
• Old value
• Date changed
• User who changed the data

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Data Issue Tracking

• Identify/flag form data requiring review
• Assignment of issue to user
• Data issue processing

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WYSIWYG Editor
Tool bar allows editing of form format
Add an existing item from item library to the form
Paste an existing form from another format (like
Word) or type in questions
Drop down list displays all items that are on the
current form
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WYSIWYG Item Attributes
Set attributes, define validations, define
navigation for items on the form
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WYSIWYG Validation Logic
Compare value of item to various other values
Set comparator
Set error message
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CRMS
Specimen Tracking
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Storage and Configuration Management
Configurable Freezer, Rack, and Box Types
Configurable Specimen Attributes
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Multi-Site Freezer Management
Bank and Freezer Management
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Specimen Tracking
Specimen and Relationships Tracking
Action Quicklinks for easy Editing, Processing,
and Exhausting
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Storage and Configuration Management
Virtual Freezer and Box Display
Quicklinks Available by Permission
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Specimen Shipping Log
Track shipped and pending specimens
Store collection details of each specimen
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CRMS
Data Warehouse
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Build a Query
Query-able fields
Resulting query
Existing systems and tables
Query field values
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Manipulate a Data Set
User-defined color coding
Drill down to specific subject
Groupings and sub-groupings
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GIS Analyses
One symbol per subject or one symbol for each ZIP
with a subject
Can use lasso tools to select sub-population
based on map location
Can customize map layers (ZIP, county, state,
topography, etc.)
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CRMS
Security in the CRMS
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System Roles
Roles provide access to various levels of system
information
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Role Permissions
Choose role and type
Set permissions for the role
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CRMS

• For more information and/or a product demo
• Call us at 410-828-8948
• Email us at info_at_mdlogix.com
• Visit our web site www.mdlogix.com