Clinical Data Management Course 2024

Description

Below topics will cover in this Course:

- Introduction of CDM

- Glossary -1

- Glossary -2

- Guidelines for CDM

- Data Management Plan

- CDM Process

- Review and Finalization of study documents

- Database designing

- Data collection & CRF tracking

- Development /design of CRF

- CRF Processing & Inventory from site

- Data Entry

- Data Validation

- Discrepancy Management

- Medical Coding

- Database locking

- QA/QC checks & Data storage and Archival

- Tools for CDM

- Roles & Responsibility in CDM

- Additional Information related to CDM

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. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.

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