CLINICAL DATA MANAGEMENT COURSE

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.

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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