Clinical Data Management Course 2023

Glossary and Abbreviations, Guideline, DMP, CRF, Discrepancy Management, Tools for CDM

What you'll learn

Introduction of CDM

Glossary and Abbreviations

Guidelines for CDM

Data Management Plan(DMP)

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

Requirements

Basic Knowledge on Clinical Research & Clinical Trials

Basic level of English

Good quality of internet connection, Desktop /Laptop/Smartphone required(Since dealing with online mode)

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 CDMClinical 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.

Overview

Section 1: Clinical Data Management course 2023

Lecture 1 Importance and Purpose of Clinical Data Management

Lecture 2 Clinical Data Management Glossary 2

Lecture 3 Clinical Data Management Glosarry and Abbreviations

Lecture 4 Guidelines for Clinical Data Management

Lecture 5 Clinical Data Management Process

Lecture 6 Data Management Plan

Lecture 7 Review and Finalization of study documents

Lecture 8 Database designing

Lecture 9 Development /design of CRF

Lecture 10 CRF Processing & Inventory from Site

Lecture 11 Data collection & CRF tracking

Lecture 12 Data Entry

Lecture 13 Data Validation

Lecture 14 Discrepancy Management

Lecture 15 Medical Coding

Lecture 16 Database locking

Lecture 17 QA/QC checks & Data storage and Archival

Lecture 18 Tools for CDM

Lecture 19 Roles & Responsibility in CDM

Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences,Graduate or postgraduate degree in Medicine,Graduate or postgraduate degree in Life sciences