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1. UNDERSTANDING CLINICAL DATA
MANAGEMENT

2. INTRODUCTION
 Clinical Data Management is involved in all aspects of
processing the clinical data, working with a range of computer
applications, database systems to support collection, cleaning
and management of subject or trial data.
 Data management in clinical research relates to the processes
of gathering, capturing, monitoring, analysing and reporting on
data.
 Data management begins with the development of the data
management plan and design of the data capture instrument
(e.g. the case report form), continues with data collection and
regular quality control procedures, the database cleaning,
locking and ends with the analysis, archiving and write-up.

3. Protocol
Design
CRF
Design
Database
Design
Database
Validation
Database
Locked
Database
Cleaning
Database
Entry
Database
Collection
Medical
Coding
SAE
Reconciliation
Statistical
Analysis
Final Report

4. IMPORTANCE OF CDM
 The objectives of good clinical data management are to ensure that the
study database is: An accurate and true representation of what took
place in the study sufficiently clean to support the statistical analysis
and its interpretation
 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
pharmaceutical 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

5. DATA MANAGEMENT PLAN
DMP should give a complete picture of how the data will be handled
throughout the study by outlining all of the information relating to the
study’s data management procedures.
These should include:
 database structure specifications
 a description of the database building and testing procedures
 a list of SOPs for the data management processes (e.g. data entry and
data validation) which will be used to ensure consistency
 a description of how the data will be reviewed (e.g. data queries and
resolution processes) and information about how changes in data will
be managed
 details of how the data will be coded, analysed and archived

6. CASE REPORT FORM DESIGN
 A CRF (also known as a data collection form) turns the protocol
into the data capture system. The CRF is essential in obtaining
accurate and complete study data.
 CRF is a printed, optical, or electronic document that ‘is designed
to record all of the protocol required information to be reported
to the sponsor on each study subject.
 CRF can be
 Traditional Paper Based Case Report Forms
 e-CRF(Electronic Case Report Form)-Study
information directly entered into computer.

7. DATA MANAGEMENT SYSTEM
 The data management system is typically a computer system
used for data entry, editing, storage, and transmission into an
analysis package.
 There is a wide variety of software that can be used for
processing clinical study data.
 The choice of which software package to use is usually based
on the complexity of data handling required and the costs of
the different systems.

9. DATABASE VALIDATION
 Success of any clinical study depends on the quality and integrity of its
final database. Validation of the software system and database used for
a study are crucial risk-focused quality processes for assuring and
ensuring quality and integrity
 Generate a validation plan defining the testing methodology, scope,
problem reporting and resolution, test data, acceptance criterion and
members of the validation team.
 Ensure the CDMS meets user/functional and regulatory requirements
and continues to meet these requirements through the course of its
use.
 Implement the CDMS carefully, testing according to specifications,
documenting all testing and issues, and ensuring objective evidence of
testing is generated.

10. DATA ENTRY
 Data entry is a process of entering/transferring data from case
report form to the Clinical Data Management System (CDMS).
 Accurately transcribing the data from the CRF to the database is
essential. Errors in transcription are usually due to typographical
errors (“typos”) or illegibility of the values on the CRF.
 Data Entry:
① Single data Entry
② Double Data Entry

11. MEDICAL CODING
 The process of classifying the reported terms by using a large
list of possibilities is known as coding. The list of possibilities or
standard terms is known as a dictionary or thesaurus.
 The medical coding for a study is done as per the project
specific protocol requirement.

12. SAE RECONCILIATION
 The data on all Serious Adverse Events (SAE) that occur during a
clinical trial are recorded in two databases.
 a) Clinical database
 b) Master Drug Safety database
 Clinical database is created and maintained by the clinical data
management team. Master Drug safety database is the database
maintained by the sponsor.
 Reconciliation is performed to ensure that events recorded in SAE
Database and those residing in the clinical Database are
consistent.

14. DATABASE LOCK
 After the last patient’s data has been collected from the sites,
the race is on to close and “lock” the study. Once a study has
been locked, the final analysis can be made and conclusions
drawn.
 Types of database lock-
① Hard Lock
② Soft lock or Freeze

15. CAREER OPPORTUNITIES IN CDM
 Data Manager
 Database Programmer/Designer
 Medical Coder
 Clinical Data Coordinator
 Quality Control Associate
 Data Entry Associate

16. DATA MANAGER
 The data manager is responsible for supervising the entire
CDM process.
 The data manager prepares the DMP, approves the CDM
procedures and all internal documents related to CDM
activities.
 Controlling and allocating the database access to team
members is also the responsibility of the data manager.

17. DATABASE PROGRAMMER/DESIGNER
 The database programmer/designer performs the CRF
annotation, creates the study database, and programs the
edit checks for data validation.
 He/she is also responsible for designing of data entry
screens in the database and validating the edit checks with
dummy data

18. MEDICAL CODER
 The medical
coder will do the
coding for
adverse events,
medical history,
co-illnesses, and
concomitant
medication
administered
during the study

19. CLINICAL DATA COORDINATOR
 The clinical data coordinator
designs the CRF, prepares
the CRF filling instructions,
and is responsible for
developing the Data
validation plan and
discrepancy management.
 All other CDM-related
documents, checklists, and
guideline documents are
prepared by the clinical data
coordinator

20. DATA ENTRY ASSOCIATE
 The data entry personnel will be tracking the receipt of CRF
pages and performs the data entry into the database

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