Introduzione
Clinical Study Reports (CSRs) are critical documents by which regulators can assess the outcome of clinical studies.
This virtual course in 2 sessions covers scheduling, managing, and authoring CSRs for clinical studies on drugs, biologics, and medical devices. CSRs for submission to the Health Authorities must also comply with the International Conference on Harmonization (ICH) standards and meet high-quality standards.
Participants will learn the elements of the CSRs and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidance to follow for reference. The course will provide the latest strategies for scheduling and preparing clear, well-organized, ICH-compliant CSRs more efficiently.
At the end of this course, participants should understand the resources and timelines and have gained the knowledge to schedule, manage, write, and deliver drafts through final version CSRs of the highest quality and fully ICH compliant. By completing the course, participants will also gain insight into the public disclosure requirements a CSR must fulfil.