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Clinical Study Reports - Mastering the Essential Skills (Double Workshop)

Level:
Foundation
Area:
Drug Development
Code:
DDF33+34c
Duration:
08:15:00
Workshop profile:
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).
Objective:
The objective of this workshop is to equip you with the essential skills required for the management and preparation of high-quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences. This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Content:
The course will cover: • CSR project preparation and timelines • Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference • Writing the methods sections: brief overview and advice • Interpreting data, describing results: demography and baseline characteristics • Interpreting data, describing results: efficacy; using the statistical report • Interpreting data, describing results: safety and safety narratives • Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports • CSR review and quality control • Appendices: an overview