How to Write a Clinical Study Report
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What Is The Course About?
This course is inteded for people who are relatively new to writing clinical study reports (CSRs) or who feel that they need guidance in creating these documents. The course will put the CSR into context with the overall regulatory submission and will then review the structure and content of a ‘standard’ CSR, with guidance also provided on how to handle more complex reports.

The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.

Course Programme:
Introduction
Putting the CSR in context
- The regulatory pyramid
- The summary of the CSR
Presenting The Methods
- Following the protocol
- Following the statistical analysis plan
- Not following the protocol or statistical analysis plan
Efficacy Data
- Optimal data presentation
Safety Data
- Adverse events
- Laboratory data
- Other safety data
Discussion
- Writing a ‘proper’ discussion
End-of-Text Tables and Figures, and Appendices
- Compiling the CSR
Trouble-Shooting
- Dealing with problems that commonly arise
 
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My Location
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The course either has new dates in data loading, or is only run as a dedicated or In Company course.
Tools
 
Key Details
Duration1 day
 
£590
per delegate
 
 
Bookings Helpline: 01933 233884 (Monday to Thursday - 8:00am to 5:30pm and Friday 8:00am to 5:00pm).