CDM

CDM

Clinical Data Management

What is Clinical Data Management?

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. 

COURSE CONTENT

  • Introduction to CDM
  • CDM process flow
  • Data Management Plan (DMP)
  • CRF Design
  • Database Design & Build
  • Edit Checks
  • Data Entry
  • 21 CFR Part 11
  • Data Validation
  • Data Coding
  • Safety Data Management & Reporting
  • SAE Reconciliation
  • Quality Control
  • Data Storage
  • Database Lock & Data Transfer
  • Clinical Data Archiving
  • CDISC Basics
  • CDMS Systems

For More information on this course,

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