Writing Clinical Study Reports
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 20/11/2025 | Writing Clinical Study Reports | Brussels | EUR 950 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
Craft clinical study reports that help the reader to appreciate the value of the clinical study. Elevate your writing from dense data dumps to clear, concise narratives that resonate with colleagues, regulators, and stakeholders alike. Our Writing Clinical Study Reports course equips you with the essential skills and insights to navigate the complexities of clinical research documentation with confidence. Learn from an industry veteran, master best practices, and stay ahead of evolving regulations. Network with a vibrant community of peers and share expertise. Invest in your future – enrol today and unlock the power of persuasive clinical study reports. 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 attendees to share their 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
Course schedule
- 1 day
Course Description
Are you ready to write clinical study reports (CSRs) that go beyond regulatory compliance and truly impact the lives of patients? Join our comprehensive Writing Clinical Study Reports course and transform your skills from good to exceptional. This in-depth, interactive program, led by renowned industry experts, provides you with the knowledge, tools, and confidence to craft clear, concise, and impactful CSRs. Through a blend of lectures, interactive workshops, and real-world case studies, you'll master the art of: • Structuring effective reports: Navigate the intricate ICH E3 guidelines and ensure your reports meet all regulatory requirements. • Translating data into stories: Learn how to present complex findings in an easily understandable and compelling manner. • Communicating with clarity and precision: Hone your writing skills to effectively convey scientific information to diverse audiences. • Navigating ethical considerations: Understand the ethical principles and regulatory frameworks crucial for responsible reporting. • Staying ahead of the curve: Gain insights into the latest best practices and evolving regulatory landscapes in clinical research reporting.Programme highlight
- Introduction to medical writing and data transparency
- Regulatory requirements – CSRs vs CIR
- Study Documents I Read Before Writing a Clinical Study Report
- The structure of the CSR/CIR
- Title page, abbreviations, definition of terms, ethics, investigators
- Introduction, study objectives, investigational plan, study patients, efficacy evaluation, safety evaluation
- Writing subject narratives
- The synopsis
- Quality control for CSRs/CIRs
- Sharing of experience in writing
Learning objectives
- Structure effective CSRs/CIRs: Adhere to regulatory guidelines and create reports that meet all regulatory requirements.
- Translate data into narratives: Present complex scientific data in a clear, concise, and understandable manner.
- Communicate with clarity and precision: Utilize language effectively to convey scientific information to diverse audiences.
- Navigate ethical considerations: Understand and apply ethical principles and reg-ulatory frameworks when writing CSRs/CIRs.
- Analyze and interpret clinical research data: Extract key findings and translate them into meaningful insights.
- Utilize appropriate scientific writing techniques: Demonstrate proficiency in for-matting, referencing, and language conventions.
- Build confidence in your writing skills: Effectively communicate research findings with clarity and precision.
- Work effectively with the study team.
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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