CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of is to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis.
COURSE CONTENT
BASIC TERMINOLOGIES
INTRODUCTION TO CLINICAL RESEARCH
INTRODUCTION TO CLINICAL DATA MANAGMEMENT
GUIDING PRINCIPLES AND REGULATIONS ASSOCIATED WITH CDM
STANDARD OPERATING PROCEDURE
DATA MANAGEMENT PLAN
CRF DESIGN
DATABASE VALIDATION,PROGRAMMING AND STANDARDS
ELECTRONIC DATA CAPTURE
DATA PRIVACY AND ENTRY
MANAGING LAB DATA AND COLLECTING ADVERSE EVENT DATA
MEDICAL CODING
SAE RECONCILIATION
CREATING REPORT AND TRANSFERING DATA
QUALITY MANAGEMENT OF CLINICAL DATA
LOCKING STUDIES
MIGRATING AND ARCHVING OF DATA
ROLE AND RESPONSIBILITIES IN CLINICAL DATA MANAGEMENT