Importance of the Involvement of Clinical Operations in Clinical Study Protocol Review
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About this course
Reasons to attend
During this half day training you will learn about the importance of the involvement of Clinical Operations in the review process for clinical study protocols with emphasis on how to do the review and how it can be optimised.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course Description
During this half day training you will learn about the importance of the involvement of Clinical Operations in the review process for clinical study protocols with emphasis on how to do the review and how it can be optimised.Programme highlight
- Protocol review process
- Common problems in the review process of clinical study protocols.
- What makes a good review process?
- Exercise on clinical study protocol review.
Learning objectives
- Making the clinical study protocol review process work.
- Optimizing the review process for clinical study protocols.
Who should attend
Clinical Operations Staff that is required to review critically study protocols before their finalisation.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (5)
- Ethical & Participants Safety Considerations (4)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (5)
- Communication (0)
- Teamwork (3)
- Business acumen (0)
Trainers
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