When new drugs or devices are tested in humans, the data generated by and related to these trials is known as clinical data.

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Definition of 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. Clinical data management assures collection, integration and availability of data at appropriate quality and cost.

CLINICAL DATA MANAGEMENT is a process of ensuring that data collected during a clinical trial is…

• Accurate
• Complete
• Logical
• Consistent

Objectives of CLINICAL DATA MANAGEMENT:

To Ensure:

• That collected data is complete & accurate so that results are correct.
• That trial database is complete, accurate & a true representation of what took place in trial.
• That trial database is sufficiently clean to support statistical analysis & its subsequent presentation & interpretation.

Clinical Data Management Overview

• Clinical Trials and drug discovery introduction
• Principles of Clinical trials
• 21CFR part 11 introduction
• GCP (Good Clinical Practice Principles
• Clinical Data Management Introduction
• Clinical Data Management phases
• Start-up Phase introduction. Conduct Phase introduction
• Discrepancy Management
• Data set validation review
• Offline Listing review
• All third-party vendor reconciliation
• SAE reconciliation
• Study close-out phase introduction and activities