Transcript New Approaches to SAE Reconciliation: An Integrated

New Approaches to SAE
Reconciliation for Paper and EDC
Studies: A Collaborative Perspective
Shannon Labout, CCDM
Senior Consultant
PSDM Meeting
22-May-2008
Weesp, The Netherlands
New Approaches to SAE
Reconciliation: Outline
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Introduction
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Background
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Example project
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Collaboration Opportunities (discussion points)
New Approaches to SAE Reconciliation: An Integrated Approach
Background
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Six Sigma methodology - DMAIC
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Define – process improvement goals / defects
Measure – how many? what does each one cost?
Analyze – how will making an improvement reduce
defects/costs?
Improve - implement the improvement
Control – control the defects so they don’t occur
New Approaches to SAE Reconciliation: An Integrated Approach
Project Background
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Project Assumptions and Scope
 Use existing technologies
 Limit project to evaluate
 SAE collection / reporting process
 SAE data query process
 Process for delivering safety data to statisticians
New Approaches to SAE Reconciliation: An Integrated Approach
What is our Current Approach?
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Collect SAEs using parallel processes - clinical and safety
 Separate entry process
 Separate data collection forms
 Separate query process
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Reconciliation process is required
 Differences between databases
 Potentially different responses to queries
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach to SAE Reconciliation
CDM
Query
Process
Site records
event
No
Serious?
Event entered
Into Clinical
database
Record on
CRF
Yes
Report to Sponsor
Within specified
Reporting period
Safety
Query
Process
Event entered
Into Safety
database
Expedited
Reporting
Safety
SOPs
New Approaches to SAE Reconciliation: An Integrated Approach
CDM
SOPs
Clinical data
Current Approach: Problems
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SAE Reconciliation must be done as a separate process
 Two databases with the same data
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Duplicate queries may be sent to the site
 Two organizations managing the same data
 Safety – for PV and reporting
 Clinical – for analysis and submission
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach: Problems

SOPs not aligned between clinical and safety
 They work in “silos”
 May not even know what the other group is doing
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Site is confused and frustrated
 Queries from two groups on same data
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach: Problems
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Possible for events to be unreported in one system
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Potential need for query responses to be reconciled
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Time is lost managing duplicate processes and then cleaning
up the mess
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Costs are higher than they need to be
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach to SAE Reconciliation
CDM
Query
Process
Site records
event
No
Serious?
Event entered
Into Clinical
database
Record on
CRF
CDM
SOPs
Clinical data
Yes
Report to Sponsor
Within specified
Reporting period
complex
Safety
Query
Process
Event entered
Into Safety
database
duplicate work
Expedited
Reporting
Safety
SOPs
New Approaches to SAE Reconciliation: An Integrated Approach
not aligned
Project Plan
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Identified that we have a problem
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What exactly is causing the problem, though?
How do we fix it?
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Need to gather some data and analyze
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Methodology chosen: DMAIC
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
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Defect
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An SAE term that must be manually reconciled
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Clearly defined
Measurable operational defect
Includes all reconciliation activities (including data
entry verification)
New Approaches to SAE Reconciliation: An Integrated Approach
Project –
Define/Measure/Analyze/Improve/Control
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How many defects (SAEs)?
 We can count them
 We can put a cost to each one
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1000 SAEs per year
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60 minutes to reconcile each one
 Data entry verification
 Query management
 Database reconciliation
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$5/minute to do this work
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
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Determine the cost to the organization
 N*T*C = cost to the organization
 N = Number of defects
 T = Time to reconcile each defect
 C = Cost per time unit
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1000 * 60 * 5 = $300,000 / year
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What can we change that will improve this?
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach to SAE Reconciliation
CDM
Query
Process
Site records
event
No
Serious?
Event entered
Into Clinical
database
Record on
CRF
CDM
SOPs
Clinical data
Yes
Report to Sponsor
Within specified
Reporting period
Safety
Query
Process
Event entered
Into Safety
database
WHY are we entering
this data twice?
Expedited
Reporting
Safety
SOPs
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
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Decision to simplify the process
 Single data collection process
 Eliminates duplicate query process
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What would the results be
 Number of defects potentially reduced
 Time to reconcile reduced (data entry verification, simple
verification, query resolution) to 15 minutes per SAE
 Single query process (data only queried once)
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
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How much improvement?
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N*T*C = cost to the organization
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1000 * 15 * 5 = $75,000
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$300,000 - $75,000 = $225,000 saved each year
Even if the number of defects remains the same
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
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Align SOPs and WPGs between clinical and safety
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Monitor the process with audits and documentation
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TRAINING!
New Approaches to SAE Reconciliation: An Integrated Approach
New Approach: Solutions
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Enter data into only one system
 Databases do not have to be reconciled with each other
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Safety manages SAE queries, clinical all others
 No duplicate queries are sent to the site
 Time is gained by managing a single query process
 Site has only one query process to deal with
 Reduces site frustration and confusion
New Approaches to SAE Reconciliation: An Integrated Approach
New Approach: Solutions
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SOPs aligned between clinical and safety
 Collaboration
 Cooperation
 Communication
 Shared responsibility
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High Quality – Lower ongoing costs – Better Timelines
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach to SAE Reconciliation
Site records
event
Serious?
Yes
simplified
Safety
SOPs
Report to Sponsor
Within specified
Reporting period
Clinical data
Safety
Query
Process
Event entered
Into Safety
database
CDM
SOPs
Expedited
Reporting
New Approaches to SAE Reconciliation: An Integrated Approach
aligned
Discussion Points
Other Opportunities for Collaboration
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Process mapping – find what is necessary, what is not:
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Align processes across other internal groups
 Different regulatory requirements –must meet all needs
 Different organizational goals
 PV – safety for all drug products
 Clinical – analysis and submission data
 Clinical – site, science, patient safety, informed consent
 Shared training / cross training
 Build understanding
 Build cooperation
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New technologies / EDC and eSource
New Approaches to SAE Reconciliation: An Integrated Approach
Thank you!
Contact information
[email protected]
www.cssinformatics.com
New Approaches to SAE Reconciliation: An Integrated Approach