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
Click here for brochure
A Guide to GCP for Clinical Data Management
- Product Code: A Guide to GCP for Clinical Data Management
- Availability: In Stock
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£100.00
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