CLINICAL DATA MANAGEMENT COURSE

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What is Clinical Data Management?

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

Read More: https://xcelcareer.com/clinical-data-management-course/

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
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