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Basics of Clinical Data Management

NQR Code:NM-05-LS-01298-2023-V1-LSSSDC

  • Old Code: NM-05-LS-01298-2023-V1-LSSSDC

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About this Qualification

Job Description

The professional with Basics of Clinical Data Management have foundational knowledge and skills in the field of clinical data management (CDM). This includes understanding of the importance of CDM in clinical research, learn key terminology and concepts, explore data sources in clinical trials, delve into the design of case report forms (CRFs), and understand the critical processes of data entry, cleaning, and quality assurance in CDM. The professional with Basics of Clinical Data Management has good knowledge of regulatory guidelines and data privacy regulations that impact CDM practices.

Eligibility Criteria

Criteria 1 Criteria 2 Experience Training Qualification
Pursuing 2nd year of 3-year/ 4-years UG In relevant field No Experience None
Pursuing 2nd Year of 2 year diploma after 12th In relevant field No Experience None

Progression Pathway

  • N/A

Learning Module In Job Role/Qualifcation

National Occupation Standards (NOS)/Module NOS Code Mandatory/ Optional Estimated size (Hours) Nos Credit Level
Module 1- Introduction to Life sciences sector and Clinical Data Management N/A Mandatory 3 0.1 5
Module 2- Clinical Data Collection and Source Documentation N/A Mandatory 4 0.1333 5
Module 3- Clinical Data Entry and Cleaning N/A Mandatory 3 0.1 5
Module 4-Clinical Data Quality Assurance N/A Mandatory 3 0.1 5
Module 5- Regulatory Guidelines in CDM N/A Mandatory 2 0.0667 5