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

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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

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

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Building sustainable organizational capability of quality assurance

Check

12Pfizer Confidential

Building sustainable organizational capability of quality assurance

Check

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Building sustainable organizational capability of quality assurance

TMF

DHC

Check

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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