A Winning Strategy On Data Quality-Putting the Right Pieces Together
May 17th, 2011 | Beijing, China
Highlights
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• The quality control system on data management in clinical trials• What are the challenges• Building sustainable organizational capability of quality assurance
Quality Control System on Data Management
Data Quality in
Clinical Trials
Environment: • Regulations• ICH E6/E2A/E8• 21 CFR Part
11/50/312• European Union
Clinical Trial Directive
Infrastructure: • Quality standard• Implementation
guidelines• Administrative
structure and resource
Control System: • SOPs and Processes• QC / QA• Audit• Inspection
People: • Knowledge• Experience• Competency• Capacity• Compliance
Technology: • Systems• Applications• Software / Hardware• Methodology• Media
Metrics: • Key Performance
Indicators• Evaluations• Report of metrics
Design of Protocol, CRF, and
Database
Data Flow
Data Collection
Data Management
Data QC
Access Control& Audit Trail
Pre-defined templates to ensure what data to be collected and consistent format of data, such as CDISC, 21CFR11, ICH E6, and company used Data Standards to ensure the consistency of data quality standard.
A series of processes, such as CRF Completion Requirement; Data Entry Guidelines, Source Document Verification Procedures; and Personal Data Protection Guidelines, etc.to ensure data completeness & accuracy
Data Flow Activities Document is to define where data is located; how data is transferred; time frame for actions; and Task Owners Metrics, etc. to ensure the timeliness of data
- Discrepancies management: Data Handling Conventions (Self-evident Corrections); Data Quality Specifications for edit checks- Coding conventions: using international implemented dictionaries to categorize medical or treatment terms- e-data reconciliation process: for batch loaded data from other databases, such as central lab data, PK/PD data, etc. - SAE Reconciliation guideline: to ensure SAE information are consistent in both safety and project data bases- Manual reviews by defining templates of data listings document to ensure complete, accuracy and reliable dataData Quality Control Plan is to define the process of how the in-progress data quality control is conducted, such as which system/database is compared, when, how, by whom, etc.
Access control and audit trail for each change of patient data to ensure the reliability.
Regulations, Industry G
uidance, SOPs &
ProcessesQuality Control System on Data Management
Highlights
5www.diahome.orgDrug Information Association
• The quality control system on data management in clinical trials
• What are the challenges• Building sustainable organizational capability of quality assurance
Some statistics
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QUALITY
Some statistics
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TYPES OF ERRORS
Errors of Ignorance
Errors of Ineptitude
The challenges
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• Do we have the right persons in place? • Do we have a good system in place?• Do we have right metrics to make the data quality become visible and
comparable?
• How to build a sustainable capability of quality assurance in a new and fast expanding organization?
• What are the key success factors of high quality data delivery?
Highlights
9www.diahome.orgDrug Information Association
• The quality control system on data management in clinical trials• What are the challenges
• Building sustainable organizational capability of quality assurance
Building sustainable organizational capability of quality assurance
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Manage BEHAVIORS
in addition to
manage RESULTS
Plan
DoCheck
Act
“Closed Loop System”
1. Plan. Identify the factors critical to quality with metrics to measure them. Identify the high-risk processes with quality management plans to mitigate these risks
2. Conduct. Conduct Data Management
3. Check. Use tools and risk metrics to monitor performance
4. Act. Perform root cause analysis, take corrective and preventitive actions, and modify mitigating factors, if necessary
Learning Cycle
11Pfizer Confidential
Building sustainable organizational capability of quality assurance
Check
12Pfizer Confidential
Building sustainable organizational capability of quality assurance
Check
13Pfizer Confidential
Building sustainable organizational capability of quality assurance
TMF
DHC
Check
14Pfizer Confidential
Building sustainable organizational capability of quality assurance
The little things make all the differences.
Summary
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• Quality control system are essential to ensuring data quality in clinical trials
• Quality assurance is a capability both to individuals and organizations, which is trainable, manageable, and sustainable
• Build the organizational behavior of continuous improvement on data quality is the key success factor for a new data center in China
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Thank You