Writing Clinical Study Reports
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|---|---|---|---|---|
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About this course
Reasons to attend
The goal of this programme is a multistep journey allowing attendees not only to assimilate the knowledge provided but also to practice what has been learnt. We are aiming to bring competencies to the attendees and allow them to work more effectively.This course will start with providing the basic content requirements for a clinical study report (CSR). After that practical workshops and exercises will be organised using real-life cases and scenarios. The programme will finish with a live webinar allowing attending to share first experiences and get feedback from the expert trainers as well as from their peers.
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 schedule
Programme highlight
- The essential elements of a clinical study report
- Writing subject narratives
- The required appendices and their content
- Writing clinical study reports in view of their publication
- Quality control for CSRs
- Practical writing exercises
- Sharing of experience in writing
Learning objectives
Who should attend
- Anyone who would like to understand how a CSR is written
- Anyone who needs to contribute during CSR preparation
- All colleagues who are involved in the development of clinical protocols and who want to expand their work field to writing clinical study reports
- Anyone involved in the review of clinical study reports
Competencies
This course covers competencies that are part of the ECCRT Competency Framework:
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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