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OVERVIEW OF CDM
PROCESS
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022
Contents
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Evolution
What is Data Management
CDM Overview
Objectives of CDM
Multidisciplinary Team
Role of DM
Divisions of CDM Process
GCP Guidelines
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Importance of CDM
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CDM has evolved from a mere data entry process to a much diverse
process today
It provides data in a usable format in a timely manner
It provides a database fit for use
It ensures clean data & a ‘ready to lock’ database
CDM manages
entry of CRF data into the database
merging of non-CRF data
systems & processes designed to identify bad data
generate & track CRFs & queries
determine protocol violators
interact with site personnel to resolve
data issues
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Processes in Clinical Trials
Trial Planning
FSFV LSLV
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Protocol
Regulatory
approvals
Site
selection
Ethics approval
Monitoring Plan Monitoring Visits Close-out Visits
CRF DB Set-up
Data - capture, review and reconciliation, Query Management
Protocol Violation,
Lock, Blind break
Statistical Analysis Plan, Programming and Validation
Statistical Analysis
Medical Writing CSR
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What is Data Management?
• Ways in which data are managed:
Monitoring and Source Document Verification
Validation checks within a database
Electronic data capture, at the clinical site,
generates discrepancies automatically*
Manual data checks
Double data entry of all CRF data
Blinded data review (BDR)
Issue and resolve site queries
Code Adverse Event & Medication terms
Review of data listings
Database QC audit
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CDM Process Overview
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Who can do clinical data Management?
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Pharmacists.
Graduates/Post graduates in Life Sciences, IT, Statistics.
Graduates with post graduation diploma in Clinical Research.
Licensed Medical Practitioners
ICH.E6.5.5.1: Utilize qualified individuals to;
Supervise overall conduct of trial (Project Manager)
To handle and verify the data (Data Management)
To conduct the statistical analysis (Biostatistician)
To prepare study reports (Medical Writer)
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Objectives of CDM
CDM is a vital vehicle in Clinical Trials to ensure:
Integrity & quality of data being transferred from trial subjects
to a database system.
That collected data is complete & accurate so that results are
correct.
That clinical trial database is complete & accurate & a true
representation of what took place in trial
That clinical trial database is sufficiently clean to support
statistical analysis & its subsequent presentation &
interpretation
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Multidisciplinary Teams in Clinical Trials
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1. Clinical Investigator 11. Regulatory affairs
2. Site coordinator 12. Clinical Data
3. Pharmacologist Management
4. Trialist/Methodologist 13. Clinical Safety
Surveillance Associate
5. Biostatistician
(SSA)
6. Lab Coordinator 14. IT
7. Reference lab 15. IT/IS personnel
8. Project manager 16. Trial pharmacist
9. Clinical Research 17. Clinical supply
Manager/Associate
18. Auditor/Compliance
10. Monitor
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How Does DM Fit into Clinical Research?
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• The data management function provides for all data
collection and data validation for a clinical trial program.
• Data management is essential to the overall clinical
research function, as its key deliverable is the data to
support the submission.
• Assuring the overall accuracy and integrity of the clinical
trial data is the core business of the data management
function.
• Data management starts with the creation of the study
protocol.
• At the study level, data management ends when the
database is locked and the Clinical Study Report is final.
• At the compound level (of the drug), data management
ends when the submission package November
is assembled
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When does Clinical Data Management begin?
It begins with design of data capture instrument & data collection,
continues with data QC procedures to assure quality of all aspects of
process & ends with database finalization along with analysis,
reporting and Clinical Study Report Submissions.
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What is the general CDM process?
Protocol Design CRF Design Database
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Design
Quality check
Quality check
START UP Edit checks
Quality check
Overview of CDM process
Data Entry
Activated
Discrepancy
Management
Database QC
Database updates Query to Investigator
Database lock
Coding of Medical terms
CLOSE OUT CONDUCT
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Different Divisions of CDM process
CDM is divided into the following:
Study Start-up
Study Conduct
Study Close-out
Analytics and Reporting
Medical Communications
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Final Protocol, Creation of Study in DB
Final CRF,
Site and Investigator Creation of Sites and
assignments Patient (Dummy and
Production)
Standard Library Study Specific
components (S&E) components (E)
Creation of DCMs &
SSU PROCESS DCIs
OVERVIEW
Provisional DB for
review & testing
Activated DB
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Study Start-up Process
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Role – CRF designers, DB designers, Procedure writers, Data Managers
Responsibilities –
To design CRF:
Task – Design CRF as per protocol, QC of CRF.
To design DB:
Task – Design DB as per protocol, QC of DB and activate the DB.
To write procedures:
Task – Write Validation and Derivation procedures, QC of procedures and
activate them.
To test database and procedures:
Task of Data manager – To test the database and procedures thus ensuring
they are designed as per the requirement and create DMP.
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Data Discrepancy
Activated Entry/Data Management
DB Loading
Coding Safety Data
terms Reconciliation
Query Generation
Study Conduct
PROCESS
OVERVIEW Resolution and update
of database
Lab
Review
Manual checks/QC
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Study Conduct
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Role – Data Loaders, Data Entry Operators, Data Managers, Safety Data
Managers, Coders.
Responsibilities –
Data Entry/Data Loading:
Task – To enter the data (in case of paper studies),load data (in case
of electronic studies)
Data Management:
Task – Identify and resolve discrepancies, Issue queries to site &
resolve them, Manual checks, Lab review and CRF tracking.
Safety Data Management:
Task –Safety reconciliation by comparing the clinical database with
the safety database.
Coding of Medical terms:
Task – To code medical terms.
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Discrepancy 18
Management
Coding Safety Data
terms Reconciliation
Query Generation
Study Close-out
PROCESS Resolution and update of
OVERVIEW database
Lab
Review
Manual checks/QC/CRF
Tracking
Database
Lock & Freeze
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Study Closeout
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Role – Safety Data Managers, Data Manager, Coder.
Responsibilities –
Data Management:
Task – Ensure Data cleaning, CRF tracking and DB QC, Lock
& Freeze the DB.
Safety Data Management:
Task –Safety reconciliation by comparing the clinical database
with the safety database.
Coding of Medical terms:
Task – To code medical terms.
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Data Value Added Dataset
Database
Extraction/ creation
Release Mapping
QC/ Paeer
Analytics & Statistical Report Reaview
Reporting Generation
PROCESS
OVERVIEW
E-Publishing
Creation of
Submission
Clinical Study Published Tables,
of CSR Reports (CSR)
Figures and Listings
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Analytics and Reporting
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Role – Statisticians & e-Publishers
Responsibilities –
Extracting Data:
Task –To extract data and create Value Added Datasets
(VADs) by applying specifications as defined in the
Derived Dataset Requirements / Specifications document
(DDR/DDS).
Generating and Publishing Reports:
Task –To generate and publish the reports.
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Medical Communications
Role – Medical Writers
Responsibilities –
Generating Clinical Study Reports (CSRs):
Task – To generate CSR, thus summarizing the overall
findings and conclusions of a clinical trial and Quality
Check before submission of the final CSR.
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ICRI
THANK YOU
