Pitfalls of Clinical Study Report Writing

 

Pitfalls of Clinical Study Report Writing

Clinical Research Related Courses
Related Courses
dates
location
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16 May 2012 Brussels English
550,00 €
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

This one-day course is intended for medical doctors, pharmaceutical professionals and researchers in the biomedical field who are involved in clinical research and need to write clinical study reports.

Who should attend?

Investigators, representatives of academia running clinical trials, medical writers and clinical study managers

Trainers
  • Best practice in writing and reviewing a CSR
  • Approval and distribution of CSR
  • Changes to an approved CSR
  • Guidelines on structure and content of a full CSR
  • Ethics
  • Study objectives & endpoints
  • Investigational plan
  • Statistical methods and sample size estimation
  • Changes in the conduct of the study
  • Synopsis
  • CSR associated appendices
  • Other reports than the full CSR

The course provides practical guidelines on the content of clinical study reports & appendices. You will learn what the report is used for, who are the key players, and the best practices in writing and reviewing a CSR.

Extra's
  • This course is organised in collaboration with Pharma XL.
  • For this specific course students receive a discount of 75%
  • If combined with the course ‘Protocol Writing, the course fee is 950 EUR