Data Manager s Role in Data Quality
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1 Data Manager s Role in Data Quality and KPI for Data Management Process May 17 th, 2011 Beijing, China Joyce Lai MSD (Shanghai) Pharmaceutical Consultancy Co, Ltd.
2 Agenda Why is the Data Manager So Important for Data Quality? Roles of Data Manager Core Elements for Quality Data Management Key Performance Indicators (KPI) for Data Management Process 2
3 Why is Data Quality So Important for Society? Reliable Data for Drug Approval Fit for Use for Meaningful Analysis Drug Safety 3
4 Why is Data Quality So Important for Society? ICH GCP Section 2 Principles of GCP: 2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification Systems with procedures that assure the quality of every aspect of the trial should be implemented. Section 5 Sponsor: Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. 4
5 Data Manager is the Key Person to Unlock the Value of Clinical Data in Clinical Research CRA Site Data Manager Clinical Statistician Reaching the Goal of Quality Data is a Shared Process! 5
6 Why is the Data Manager So Important for Data Quality? Provides accurate, complete and fit for use data for medical review and statistical analysis, which is critical for final report and clinical data submission to FDA or other agencies Reduces or eliminates critical changes after Database Lock (DBL) Enables analyses to be conducted during the study that may drive key program decisions (e.g. Interim Analysis drives Go/ No Go decisions) Provides accurate data for updates to Data Safety Monitoring Boards Allows for timely drug/vaccine approval Provides accurate data for publications 6
7 Roles of Data Manager Data Management Plan Preparation Design and Data Review Specifications CRF/Collector/DHG/DEG/Time&Event Schedule/Coding Edit Check/Data Validation Plan External Data Specification & UAT Mapping Specification Collector UAT & Deployment Data Review Tool UAT & Deployment Data Repository Dataflow UAT Achieving Complete & Clean Data Completion of Coding Quality Check Resolution of Statistical Findings External Data Verification PI Signature Database Lock Data Repository Dataflow Study Setup Study Conduct Study Closeout Data Integrity Review Missing Visit Management Query Management Coding Site DM Performance Management External Data Processing & Loading Post Production Change Management CRF/Collector/DHG/DEG/Time&Event Schedule/Coding Edit Check/Data Validation Plan Acronyms: CRF=Case Report Form; DHG=Data Handling Guideline; DEG=Data Entry Guideline; UAT=User Acceptance Test 7
8 Core Elements for Quality Data Management Data Completeness Data Accuracy Data Consistency Data Manager Technology & Resources Standard Template / Library Check List / Job Aid Training & Mentoring Effective Tool Development Operational Excellence DMP, DHG, DEG, DVP Cycle Time & Quality Metrics Good Project Management Communication & Collaboration Industry & Company Standards ICH E6 (GCP) / 21 CRF Part 11 / MedDRA Company SOP, Procedure & Guidance Documents Control System Access Control/Audit Trail System UAT QA / QC Audit / Inspection 8
9 Key Performance Indicators for Data Management Operational Quality and Data Quality CRF Design Cycle Time Collector Development Cycle Time Data Review Tool Development Cycle Time Rounds of Changes in Specifications Rounds of UAT for Collector, Data Review tool No. of Post Production Changes CRF/ Collector/ DHG/ DEG Edit Check/ Data Validation Plan LPLV Database Lock Cycle Time No. of Critical Deviation from DMP* No. of Critical Changes post DBL Mapping and Dataflow Error Study Setup Study Conduct Study Closeout Data Entry and Review Cycle Time Query Resolution Cycle Time % Re-issue Queries (Poorly Written Queries) % Queries without Data Changes (Non-value added Queries) Coding Cycle Time Data Entry Error No. of Queries per Visit Coding Accuracy Data Review Quality Assurance* External Data Loading Error *Also a KPI in Process Compliance Critical Findings from Inspection, Internal Audit 9
10 KPI Example: Study Setup Report Specification/User Acceptance Test (UAT) Quality Request from Clinical/Statistics Draft Report Specifications Draft Report Specifications Draft Report Specifications Final Report Specifications Test Data Preparation UAT Round 1 UAT Round 2 UAT Round 3 UAT Passed Report ID Tester Name Protocol Number UAT Round No. UAT Result No. of Findings result in Test Data Changes No. of Findings result in Specification Changes Report 01 Amy Pass 0 0 Report 02 Amy Pass 0 0 Report 03 Amy Fail 2 1 Report 03 Amy Pass 0 0 Report 04 Amy Pass 0 0 Report 05 Amy Fail 5 2 Report 05 Amy Fail 1 0 Report 05 Amy Pass 0 0 Report 06 Peter Fail 4 2 Report 06 Peter Fail 2 1 Report 06 Peter Pass 0 0 Report 07 Peter Fail 3 1 Report 07 Peter Pass 0 0 Report 08 Peter Pass 0 0 Report 09 Peter Fail 6 3 Report 09 Peter Fail 2 1 Report 09 Peter Fail 1 0 Report 09 Peter Pass 0 0 Report 10 Peter Pass 0 0 Release to Production Behind Drug Information Operational Association Quality, Poor Specifications/ Software Build Leads to Poor Data Quality! 10
11 KPI Example: Study Conduct Data Review Quality Assurance (DRQA) DRQA is an activity to understand the quality of data review according to Data Validation Plan (DVP) Base on the objective, it can be conducted at portfolio or protocol level Qualified reviewer could select a sample of data to perform the followings: Review if data review is executed according to DVP Review all review report outputs Review all queries issued and handled Identify missing datapoints Any findings result in critical data change Data Review Quality Assessment Cycle: May-Jun 2010 Protocol Number of errors (Review reports) Number of errors (Missing data) Number of errors (Queries) Overall error rate (per 1000) Number of errors resulting in critical datapoint changes Number of data points Number of patients Number of visits Total Errors A B C D E F Total Average Error rate (/ 1000 datapoints) Jan-Feb Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-Dec Combined (6 cycles) Drug Information Not Only Association Data Entry Quality is Critical, Data Review Quality is Equally Important! 11
12 KPI Example: Study Closeout Database Lock Cycle Time (LPLV to DBL) 120 (Median Time for LPLV to DBL for Participating Pharmaceutical Companies) Large Midsized Other 100 n (days).. Interval duratio A B C D E F G H I J K L M N O P Q R S T U V W X Y Z I Company Last patient last visit to Database lock. Source from CMR International. Data are shown for Phase Ib, Phase II and Phase III studies that were completed between 2007 and Extensions and terminated studies or studies associated with terminated projects have been excluded. Benchmark Data Can Help You to Understand How Well You Perform in the Industry! 12
13 Summary Data Management is a critical step in Clinical Research Data Manager has important role in data quality from study setup until study closeout Key Performances Indicators (KPI) are effective measurements of timeliness, quality & compliance in Data Management Process Site CRA Data Manager Statistician Clinical 13
14 Thank You! 14
15 Reference: Roles of Data Manager Study Setup Accountable for timely and quality delivery of Data Management deliverables that meet the requirements of the protocol and specifications set by Clinical/Statistics Finalize Design & Data Review Specifications Design: CRF/Collector/DHG/DEG/Time& Events Schedule/Coding Data Review: Edit Check/Data Validation Plan Finalize Data Management Plan Collector UAT & Deployment Data Review tool UAT & Deployment External data specifications and UAT Mapping programming and Data Repository dataflow UAT 15 Acronyms: CRF=Case Report Form; DHG=Data Handling Guideline; DEG=Data Entry Guideline; UAT=User Acceptance Test
16 Reference: Roles of Data Manager Study Conduct Accountable for timely and quality management of Clinical Data Data Integrity Review & Query Management Coding Routine follow-up on outstanding issues with sites External data processing & communication with vendors Liaise with Clinical/Statistics for Protocol Level Data Management Concerns (Found during Medical Review, Interim Analysis and Database Lock) Assessment and follow up on needs for Post Production Changes 16
17 Reference: Roles of Data Manager Study Closeout Accountable for timely, quality and complete delivery of Clinical Data Close communication with CRA and Sites Clearance of missing data and outstanding queries Complete coding and finish i coding quality check Clean all critical data points and resolution of statistical findings External data verification Obtaining PI Signature Lock database 17
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Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data