Overview:

This advanced course equips learners with the technical and practical skills required for writing clear, concise, and comprehensive ICSR narratives. It focuses on the structure and components of narratives, best practices to ensure consistency and completeness, and adapting writing styles based on the sources of information. Through hands-on exercises, learners will gain confidence in crafting narratives that meet regulatory and quality standards.

Objectives:

1. To understand the essential components that make up an ICSR narrative.
2. To learn and implement best practices for effective narrative writing.
3. To tailor narrative writing to the source of information, ensuring clarity and accuracy.
4. To develop hands-on expertise in handling diverse case scenarios.

Outcomes:

By the end of this course, learners will:

• Master the structure and elements of ICSR narratives.
• Be able to write narratives that are clear, concise, and aligned with regulatory expectations.
• Gain proficiency in tailoring narratives to specific sources of information.
• Demonstrate the ability to document case details comprehensively while maintaining clarity and readability.

Hands-On Training Components:

1. Real-World Case Exercises:
• Write narratives based on real-world ICSRs using sample safety data.
• Address challenges such as incomplete or conflicting data.
2. Peer Review Assignment:
• Collaborate with peers to review and refine narratives, focusing on structure, clarity, and compliance.
3. Self-Assessment Tools:
• Utilize checklists to evaluate the completeness and quality of written narratives.
4. Feedbacks:
• Receive feedback from mentors on written exercises to identify strengths and areas for improvement.

Assessment Criteria:

• Knowledge Evaluation:
• Quizzes to assess understanding of narrative components, formats, and best practices.
• Practical Application:
• Evaluation of hands-on exercises for narrative quality, completeness, and compliance.
• Submission of at least three fully developed narratives for grading and feedback.