UNDERSTANDING CLINICAL DATA MANAGEMENT

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UNDERSTANDING CLINICAL DATA MANAGEMENT
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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.

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

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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
  studys 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

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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.

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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. 

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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. ?

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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
• Single data Entry
• Double Data Entry

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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.

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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.

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DATABASE LOCK

• After the last patients 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-
• Hard Lock
• Soft lock or Freeze

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CAREER OPPORTUNITIES IN CDM

• Data Manager
• Database Programmer/Designer
• Medical Coder
• Clinical Data Coordinator
• Quality Control Associate
• Data Entry Associate

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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.

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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

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MEDICAL CODER

• The medical coder will do the coding for adverse
  events, medical history, co-illnesses, and
  concomitant medication administered during the
  study

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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

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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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