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. It also supports the conduct, management and analysis of studies across the spectrum of clinical research.

 A key requirement of the globally implemented Good Clinical Practice (GCP) guideline, ICH E6(R3), is to ensure that clinical trial data are reliable.

This course covers the key GCP requirements relating to data collection and management. It also provides a wealth of valuable advice from a highly experienced data manager with years of pharma experience.

The course lasts about one hour. You can stop and restart at any time.

Content is provided in ten sections and includes:

• An ICH E6(R3) GCP overview.
• Risk assessment and monitoring, including identification of critical to quality factors and introducing quality by design.
• Personnel and SOPs
• Using computerised systems.
• Source data.
• Data collection.
• Database and its management.
• Outsourcing.
• Essential records and documentation requirements.
• Overall summary and final test.

 Narrated and read-only options.

Interactions to aid learning

For details of packages for training larger groups contact us at info@brookwood-global.com
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