This virtual course in 2 sessions covers scheduling, managing and authoring of clinical study reports (CSRs) for modern design clinical studies. It discusses the stages of preparation of CSRs in the context of precursor documents including the clinical study protocol (CSP), the statistical analysis plan (SAP), and the incorporation of study data. Components of the integrated CSR include narratives and appendices, and the preparation of these sections of the CSR will also be covered. Scheduling an achievable reporting timeline for this complex and multi-component document will be explained.
The practical use of CORE Reference for writing integrated CSRs is demonstrated. Open access CORE Reference (www.core-reference.org/) launched in 2016, provides interpretational guidance on CSR authoring that incorporates ICH, regional (EU and US) guidances and real-world insights. CORE Reference helps writers to author CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements.
At the end of this course participants should understand the resources and have gained the knowledge to schedule, manage, write and deliver draft through final version CSRs that are of the highest quality, and are fully ICH compliant. By completing the course, participants will also gain insight into the public disclosure requirements that a CSR must fulfil.