CLINICAL DATA MANAGEMENT COURSE
Posted 2022-11-05 14:39:07
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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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