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Clinical Data Management Training  

This course is designed to provide trainees with a working knowledge of the management of clinical data used in clinical trials and other projects, leading to an academic and professional qualification for Clinical Data Management (CDM). This course is suitable for health information managers, data managers and other health professionals working with, or planning to work with, clinical data and other health databases. This program provides those attending a stimulating and enjoyable opportunity to develop both as individuals and as professionals, increasing their efficiency, effectiveness, capacity and competence, and building on the skills and knowledge gained from valuable work experience. 

Clinical Data Management (CDM) is an important stage in Clinical Research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management helps collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research. 

About CDM

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. 

This program will help you to understand the technical part of Clinical Data Management process.

CDM Course Content

CASE REPORT FORM

• CRF DESING AND DEVELOPMENT
• ELECTONIC DATA CAPTURE
• STANDARD OPERATING PROCEDURE
• DATA PRIVACY
• PHYSICAL AND ELECTRONIC DATA SECURITY
• ELECTRONIC DATA CAPTURE PRINCIPLES
• PREPARATION AND PRESERVATION OF CRF Completion Guidelines
• CDM Presentation at investigator meetings

DATA STORAGE

• PHYSICAL STORGE

DATA ARCHIVAL

• DATABASE VALIDATION ,PROGRAMMING AND STANDARDS
• DATA ENTRY AND DATA PROCESSING

DATA CLEANING

DATA TRANSMISSION

DATA MANAGEMENT

• DICTONARY SELECTION
• AUTO-ENCODER

SAFETY DATA MANAGEMENT AND REPORTING

• SERIOUS ADVERSE EVENT DATA RECONCILIATION
• PROCEDURES
• ASSURING DATA QUALITY
• DATAbase Closure
• Recommende standard oerating procedures
• CLINICAL DATA ARCHIVING
• Vendor Evaluation
• Vendor MANAGEMENT

METRICS FOR CLINICAL TRIALS

• DATA MANAGEMENT METRICS
• COST
• TIME
• QUALITY
• AUDIT OF CLINICAL TRAILS

CHOOSING AN AUDITOR

• PLANNING THE AUDIT
• CONDUCTING THE AUDIT
• AUDIT CHECKLIST
• CHRONOLOGY LISTS
• AREAS TO REVIEW
• REGULATORY DOCUMENTATION
• CLINICAL DOCUMENTATION
• CRF AND SOURSE DOCUMENTATION CONSISTENCY
• CRF CORRELATIONS
• ADE DOCUMENTATIONAND REPORTING
• INVESTIGATIONAL DEVICE ACCOUNTABILITY RECORDS
• SPECIAL CHALLENGES FOR AUDITORS
• USING THE FINDINGS
• THE AUDIT REPORT

GLOBAL ISSUES

• Introduction
• Principles
• Operational benefits of data interchange standards
• Scientific benefits of data interchange standards
• CDISC Standards
• ODM –Operational Data Model

SDTM

• ADaM–Analysis Dataset Model
• Lab –Clinical Laboratory Data Model
• Case Report Tabulation Data Definition Specification
• Protocol Representation Standard
• CDISC standards integration

Clinical trials

• Responsibilities of Sponsor
• Post marketing surveillance
• 21 CFR PART 11
• Introduction
• Electronic Records
• Electronic Signatures