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New Approaches to SAE Reconciliation for Paper and EDC Studies: A Collaborative Perspective
Shannon Labout, CCDMSenior Consultant
PSDM Meeting22-May-2008Weesp, The Netherlands
New Approaches to SAE Reconciliation: An Integrated Approach
New Approaches to SAE Reconciliation: Outline Introduction
Background
Example project
Collaboration Opportunities (discussion points)
New Approaches to SAE Reconciliation: An Integrated Approach
Background
Six Sigma methodology - DMAIC
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
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?
Collect SAEs using parallel processes - clinical and safety Separate entry process Separate data collection forms Separate query process
Reconciliation process is required Differences between databases Potentially different responses to queries
New Approaches to SAE Reconciliation: An Integrated Approach
SafetySOPs
Serious?Record on
CRF
No
Yes
Report to SponsorWithin specifiedReporting period
Event enteredInto Safetydatabase
Event enteredInto Clinicaldatabase
Current Approach to SAE Reconciliation
ExpeditedReporting
Clinical data
CDMSOPs
Site recordsevent
Safety Query
Process
CDMQuery
Process
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach: Problems
SAE Reconciliation must be done as a separate process Two databases with the same data
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
Site is confused and frustrated Queries from two groups on same data
New Approaches to SAE Reconciliation: An Integrated Approach
Current Approach: Problems
Possible for events to be unreported in one system
Potential need for query responses to be reconciled
Time is lost managing duplicate processes and then cleaning up the mess
Costs are higher than they need to be
New Approaches to SAE Reconciliation: An Integrated Approach
SafetySOPs
Serious?Record on
CRF
No
Yes
Report to SponsorWithin specifiedReporting period
Event enteredInto Safetydatabase
Event enteredInto Clinicaldatabase
Current Approach to SAE Reconciliation
ExpeditedReporting
Clinical data
CDMSOPs
Site recordsevent
Safety Query
Process
CDMQuery
Process
complex
duplicate work
not aligned
New Approaches to SAE Reconciliation: An Integrated Approach
Project Plan
Identified that we have a problem
What exactly is causing the problem, though? How do we fix it?
Need to gather some data and analyze
Methodology chosen: DMAIC
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
Defect
An SAE term that must be manually reconciled
Clearly defined Measurable operational defect Includes all reconciliation activities (including
data entry verification)
New Approaches to SAE Reconciliation: An Integrated Approach
How many defects (SAEs)? We can count them We can put a cost to each one
1000 SAEs per year
60 minutes to reconcile each one Data entry verification Query management Database reconciliation
$5/minute to do this work
Project – Define/Measure/Analyze/Improve/Control
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
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
1000 * 60 * 5 = $300,000 / year
What can we change that will improve this?
New Approaches to SAE Reconciliation: An Integrated Approach
SafetySOPs
Serious?Record on
CRF
No
Yes
Report to SponsorWithin specifiedReporting period
Event enteredInto Safetydatabase
Event enteredInto Clinicaldatabase
Current Approach to SAE Reconciliation
ExpeditedReporting
Clinical data
CDMSOPs
Site recordsevent
Safety Query
Process
CDMQuery
Process
WHY are we enteringthis data twice?
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control
Decision to simplify the process Single data collection process Eliminates duplicate query process
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
How much improvement?
N*T*C = cost to the organization
1000 * 15 * 5 = $75,000
$300,000 - $75,000 = $225,000 saved each yearEven if the number of defects remains the same
New Approaches to SAE Reconciliation: An Integrated Approach
Project – Define/Measure/Analyze/Improve/Control Align SOPs and WPGs between clinical and safety
Monitor the process with audits and documentation
TRAINING!
New Approaches to SAE Reconciliation: An Integrated Approach
New Approach: Solutions
Enter data into only one system Databases do not have to be reconciled with each
other
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
SOPs aligned between clinical and safety Collaboration Cooperation Communication Shared responsibility
High Quality – Lower ongoing costs – Better Timelines
New Approaches to SAE Reconciliation: An Integrated Approach
Serious?
Yes
Report to SponsorWithin specifiedReporting period
Current Approach to SAE Reconciliation
ExpeditedReporting
Clinical data
CDMSOPs
Site recordsevent
Safety Query
ProcessEvent entered
Into Safetydatabase
SafetySOPs
simplified aligned
New Approaches to SAE Reconciliation: An Integrated Approach
Discussion PointsOther Opportunities for Collaboration
Process mapping – find what is necessary, what is not:
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
New technologies / EDC and eSource
New Approaches to SAE Reconciliation: An Integrated Approach
Thank you!
Contact [email protected]
www.cssinformatics.com
