Introduction Of Clinical Data Management
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Introduction to CDM
Why CDM
Review & approval of new drugs by Regulatory Agencies is dependent upon a trust that clinical trials data presented are of sufficient integrity to ensure confidence in results & conclusions presented by pharma company Important to obtaining that trust is adherence to quality standards & practices Hence companies must assure that all staff involved in the clinical research are trained & qualified to perform data management tasks
The Scenario
Drug development is becoming more & more global Parallel multi-centric trials in US & Europe across continents is now common which leads to simultaneous regulatory submission With increase in globalization & consequent need for increased data management expertise needed for global submissions, data management organizations are being set up all over the globe
Global CDM Market All figures in USD Bn. 2.50
2.33 2.07
Global % DM Outsou rced Market 2 004 2 005
2.00
35%
1.00
1.61
40%
0.50
2003
2004
1.86
1.50
1.3
2002
1.29
1.34
1.39
0.00 US
Europe
Global Data Management spend
CDM is a significantly under leveraged outsourced opportunity for India Source: Own estimates based on Industry R&D numbers reported by PhRMA & European Commission. Clinical estimated as 35% of the total R&D exp. DM estimated to be 15% of clinical. Extent of outsourcing is assumed to be 35% in 2004, increasing to 40% 21 Jan 2006 in 2005.
Crux of the problem
Clinical Data Management positions are hard to fill, partly because many potentially good candidates do not have necessary training & experience Companies don’t have resources or time to train inexperienced people from scratch
India Advantage High
Ireland
•180,000 Engineering graduates per annum!
Australia
Singapore U.K.
Location Attractiveness Infrastructure Country-specific risks Time zone attractiveness
India
China
•70% of CMM level 5 companies are in India Philippines
Mexico
•185 of Fortune 500 outsource IT services to India
Low Low Note: Size of circle indicates resource availability
High People Strength Skills quality Resource costs Language abilities and other skills
Source: NASSCOM – McKinsey. 2002 21 Jan 2006
CDM Process STUDY CENTERS
DATA PAPER CRF FROM SITES/HOSPITALS SENT TO SCAN
DATA ENTERED INTO ORACLE DATABASE
ENTERED DATA CLEANED/VALIDATED
LOGICAL CHECKS IN ORACLE RUN
BOTH AUTOMATED VALIDATIONS AND MANUAL DISCREPANCY RESOLVED
INVESTIGATOR ANSWERS QUERY FAXED TO HIM
FREEZING OF DATABASE AFTER ALL DATA IS CLEAN
AFTER FREEZING BIOSTATICIANS DO ANALYSIS
FINAL ANALYSIS DONE FOR SAFETY AND EFFICACY
CDM Process Subject
CRF DCF Investigator
Monitor
Sample
CRF
DCF
Lab Results
Central Laboratory
Statistician
Data Manager
NDA Clinical Data Regulatory Authority Clinician
21 Jan 2006
Core CDM Processes
DATA ACQUISITION
Data Collection Tool Design (paper) Data Collection Tool Design (electronic)
DATA STORAGE
Database Structure Specification Forms Management Data Archival (paper & electronic)
Core CDM Processes
DATA PROCESSING
Forms Processing Data Entry Coding Cleaning (manual clinical review & programmatic checks)
DATA VALIDATION
Design of Data Validation Strategy Specification of Design
Core CDM Processes
LAB, SAFETY REPORTING & OTHER EXTERNAL DATA
Data Transfers & Loads Database Reconciliation
DATA QUALITY
Auditing Quality Control Procedure Statistical Sampling Quantification of Database Quality
Core CDM Processes
DATABASE CLOSURE
Lock Criterion & Approval Breaking the Blind Handling of Post-lock Errata
VENDOR MANAGEMENT
Vendor Selection Vendor Monitoring
Why Technology in CDM • More automation reduces manual input • Allows processes to be linked • Allows re-use of established models • Increases processing speed • Stores large volumes of data • Enables to get answer that may
Why Technology in CDM • Web-based technologies allow site involvement earlier • Enables global studies • Can reduce time to move data downstream • Automates tracking of processes • Eliminates or simplifies steps in process
Why Technology in CDM • More updated information available in real time • Reduces chance of human error • Electronic data more accurate/eliminates guessing • Automated queries will have consistent terminology across sites
Head Clinical Data Management and Biometrics DATA MANAGEMENT
QUALITY SYSTEMS
Head Data Management
Project Team Leads
Applications Administrator
Senior Data Coordinators
Applications Developer
Data Coordinators Medical Coding
Safety Reporting
Head Quality
IT Services
Lead Data Coordinators
Data Entry Associates II
BIOSTATISTICS
CRF designer
Hardware Engineer
DM Lead
Head Biostatistics
QA Lead
Data reviewer
SOP’s Develo per
Coding & Safety Review
Validator
Report auditor
Project Team Leads
Sr. Statisticians Statisticians
Trainer Statistical Programmer
Data Entry Associates I
21 Jan 2006
OTHER PLAYERS ASSISTING CDM PERSONNEL IN CLINICAL RESEARCH
Code of Ethics for CDM Professionals Clinical Data Management is a key component of the development of new medications, medical procedures & devices Clinical Data Management professionals are:
Committed to following the laws & guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity & well being of patients & to maintain the confidentiality of medical records
Code of Ethics for CDM Professionals
Committed to creating, maintaining & presenting quality clinical data, thus supporting accurate & timely statistical analysis, & to adhering to applicable standards of quality & truthfulness in scientific research Committed to facilitating communication between clinical data management professionals & all other clinical research professionals, to maintaining competency in all areas of clinical data management, to keeping current with technological advances, & to ensuring the dissemination of information to members of the clinical research team
Code of Ethics for CDM Professionals
Committed to working as an integral member of a clinical research team with honesty, integrity & respect Commited to making & communicating accountability for clinical data management decisions & actions within the clinical trial process Committed to maintaining & respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, & to disclosing any conflict of interest
Code of Ethics for CDM Professionals
Committed to avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management Committed to advancing the profession of clinical data management through the development, distribution & improvement of good clinical data management practices Committed to aiding the professional development & advancement of colleagues within the clinical trial industry
Why CDM
Review & approval of new drugs by Regulatory Agencies is dependent upon a trust that clinical trials data presented are of sufficient integrity to ensure confidence in results & conclusions presented by pharma company Important to obtaining that trust is adherence to quality standards & practices Hence companies must assure that all staff involved in the clinical research are trained & qualified to perform data management tasks
The Scenario
Drug development is becoming more & more global Parallel multi-centric trials in US & Europe across continents is now common which leads to simultaneous regulatory submission With increase in globalization & consequent need for increased data management expertise needed for global submissions, data management organizations are being set up all over the globe
Global CDM Market All figures in USD Bn. 2.50
2.33 2.07
Global % DM Outsou rced Market 2 004 2 005
2.00
35%
1.00
1.61
40%
0.50
2003
2004
1.86
1.50
1.3
2002
1.29
1.34
1.39
0.00 US
Europe
Global Data Management spend
CDM is a significantly under leveraged outsourced opportunity for India Source: Own estimates based on Industry R&D numbers reported by PhRMA & European Commission. Clinical estimated as 35% of the total R&D exp. DM estimated to be 15% of clinical. Extent of outsourcing is assumed to be 35% in 2004, increasing to 40% 21 Jan 2006 in 2005.
Crux of the problem
Clinical Data Management positions are hard to fill, partly because many potentially good candidates do not have necessary training & experience Companies don’t have resources or time to train inexperienced people from scratch
India Advantage High
Ireland
•180,000 Engineering graduates per annum!
Australia
Singapore U.K.
Location Attractiveness Infrastructure Country-specific risks Time zone attractiveness
India
China
•70% of CMM level 5 companies are in India Philippines
Mexico
•185 of Fortune 500 outsource IT services to India
Low Low Note: Size of circle indicates resource availability
High People Strength Skills quality Resource costs Language abilities and other skills
Source: NASSCOM – McKinsey. 2002 21 Jan 2006
CDM Process STUDY CENTERS
DATA PAPER CRF FROM SITES/HOSPITALS SENT TO SCAN
DATA ENTERED INTO ORACLE DATABASE
ENTERED DATA CLEANED/VALIDATED
LOGICAL CHECKS IN ORACLE RUN
BOTH AUTOMATED VALIDATIONS AND MANUAL DISCREPANCY RESOLVED
INVESTIGATOR ANSWERS QUERY FAXED TO HIM
FREEZING OF DATABASE AFTER ALL DATA IS CLEAN
AFTER FREEZING BIOSTATICIANS DO ANALYSIS
FINAL ANALYSIS DONE FOR SAFETY AND EFFICACY
CDM Process Subject
CRF DCF Investigator
Monitor
Sample
CRF
DCF
Lab Results
Central Laboratory
Statistician
Data Manager
NDA Clinical Data Regulatory Authority Clinician
21 Jan 2006
Core CDM Processes
DATA ACQUISITION
Data Collection Tool Design (paper) Data Collection Tool Design (electronic)
DATA STORAGE
Database Structure Specification Forms Management Data Archival (paper & electronic)
Core CDM Processes
DATA PROCESSING
Forms Processing Data Entry Coding Cleaning (manual clinical review & programmatic checks)
DATA VALIDATION
Design of Data Validation Strategy Specification of Design
Core CDM Processes
LAB, SAFETY REPORTING & OTHER EXTERNAL DATA
Data Transfers & Loads Database Reconciliation
DATA QUALITY
Auditing Quality Control Procedure Statistical Sampling Quantification of Database Quality
Core CDM Processes
DATABASE CLOSURE
Lock Criterion & Approval Breaking the Blind Handling of Post-lock Errata
VENDOR MANAGEMENT
Vendor Selection Vendor Monitoring
Why Technology in CDM • More automation reduces manual input • Allows processes to be linked • Allows re-use of established models • Increases processing speed • Stores large volumes of data • Enables to get answer that may
Why Technology in CDM • Web-based technologies allow site involvement earlier • Enables global studies • Can reduce time to move data downstream • Automates tracking of processes • Eliminates or simplifies steps in process
Why Technology in CDM • More updated information available in real time • Reduces chance of human error • Electronic data more accurate/eliminates guessing • Automated queries will have consistent terminology across sites
Head Clinical Data Management and Biometrics DATA MANAGEMENT
QUALITY SYSTEMS
Head Data Management
Project Team Leads
Applications Administrator
Senior Data Coordinators
Applications Developer
Data Coordinators Medical Coding
Safety Reporting
Head Quality
IT Services
Lead Data Coordinators
Data Entry Associates II
BIOSTATISTICS
CRF designer
Hardware Engineer
DM Lead
Head Biostatistics
QA Lead
Data reviewer
SOP’s Develo per
Coding & Safety Review
Validator
Report auditor
Project Team Leads
Sr. Statisticians Statisticians
Trainer Statistical Programmer
Data Entry Associates I
21 Jan 2006
OTHER PLAYERS ASSISTING CDM PERSONNEL IN CLINICAL RESEARCH
Code of Ethics for CDM Professionals Clinical Data Management is a key component of the development of new medications, medical procedures & devices Clinical Data Management professionals are:
Committed to following the laws & guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity & well being of patients & to maintain the confidentiality of medical records
Code of Ethics for CDM Professionals
Committed to creating, maintaining & presenting quality clinical data, thus supporting accurate & timely statistical analysis, & to adhering to applicable standards of quality & truthfulness in scientific research Committed to facilitating communication between clinical data management professionals & all other clinical research professionals, to maintaining competency in all areas of clinical data management, to keeping current with technological advances, & to ensuring the dissemination of information to members of the clinical research team
Code of Ethics for CDM Professionals
Committed to working as an integral member of a clinical research team with honesty, integrity & respect Commited to making & communicating accountability for clinical data management decisions & actions within the clinical trial process Committed to maintaining & respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, & to disclosing any conflict of interest
Code of Ethics for CDM Professionals
Committed to avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management Committed to advancing the profession of clinical data management through the development, distribution & improvement of good clinical data management practices Committed to aiding the professional development & advancement of colleagues within the clinical trial industry
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