A regulatory reviewer is assessing a clinical study report (…
A regulatory reviewer is assessing a clinical study report (CSR) submitted as part of Module 5 of a Common Technical Document (CTD) for a generic medicine application. During the review, the assessor notes the following issues:The report lacks a clear and standardised structure (e.g., missing synopsis, inconsistent section headings).Key sections such as patient disposition, efficacy evaluation, and safety results are incomplete or poorly organised Appendices (e.g., protocols, statistical analysis plans) are missing or not properly referenced.The sponsor argues that the report is acceptable because the study was conducted in compliance with Good Clinical Practice. Which guideline is most directly relevant for addressing the deficiencies identified of this clinical study report?