Course Description
This course will train you in the basic areas within
clinical monitoring. All typical tasks of a Clinical Research Associate (CRA)
will become clear to you, from selecting the investigators till study site
close-out, with a great focus on the “monitoring practice”.
Who is the target audience?
No previous knowledge
of clinical research is required. A must for all inexperienced CRAs,
experienced Clinical Trial Assistants or Clinical Trial Coordinators. This course
will also be beneficial to people working in related areas such as clinical
data processing, (bio-) statistics, regulatory affairs, etc.
What am I going to get from this course?
- Describe the elements of functional Quality Systems for Sponsors, Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs), and Clinical Investigators in addition to the identification of the universal and local components of GCP
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Recognize key differences in pharmaceutical, device, and biologics GCP
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Examine recent trends in non-compliance in order to develop and implement site-specific approaches for corrective action of non-compliance
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Describe a CRA management philosophy based on competencies, performance objectives and metrics based on effective communication skills
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Analyze performance problems and understand the goals and limitations
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Describe methods for managing clinical research projects more effectively
