Overview
This tutorial will examine the myriad of issues around the authoring and publishing of clinical study reports and their related components for submission to the US and EU. This includes but is not limited to granularity, hyper linking and bookmarking best practices, content of appendices and the relationship between tables, figures and listings. Not all CSRs are created equal and the US requirements for additional components such as case report forms and datasets will also be addressed. An industry perspective will focus on the change management required to move from legacy clinical study reports to a granular report and it’s utilisation across Europe will also be presented. Demonstrations of published clinical study reports will be used as teaching aid.
Who Should Attend
- Regulatory Operations
- Medical Writing
- Biometrics/Clinical Programming
- Clinical Operations
Learning Objectives
At the conclusion of this tutorial, attendees will be able to:
- Evaluate legacy formats and need to employ granularity in creating CSRs
- Understand and utilise granular CSRs for submissions in both the US and EU
- Be aware of unique requirements that support US submissions and are associated with clinical study reports (Datasets and Case Report Forms)
- Establish best practices for publishing standards for clinical reports utilising ICH E3