Trial Investigator responsible for DSUR submission: Name: Signature: The cautionary statement below should be amended as appropriate Note: This Development Safety Update Report contains confidential information. This report includes unblinded adverse trial data. Executive Summary This section should provide a concise summary of the important information contained in the report. Together with the title page, it can serve as a document suitable for the ‘stand-alone’ submission to ethics committees and other stakeholders. The following information should be included in the Executive Summary: Introduction report number and reporting period; – Investigational drug(s) mode(s) of action, therapeutic class (es), indication(s), dose(s), – route(s) of administration, formulation(s); Estimated cumulative exposure of clinical subjects; Marketing approval(s)? (yes/no) If yes, number of countries; – Summary of overall safety assessment (based on section 18 of the DSUR); Summary of important (based on Section 19 of the DUSR); Actions taken for safety reasons including significant changes to the IB; Conclusions. of Contents Introduction This section should include: Date of Clinical Authorisation approval, Development International Birth Date of drug or International Birth Date of Drug as appropriate;
Investigator responsible for DSUR submission: Name: Signature: The cautionary statement below should be amended as appropriate Note: This Development Safety Update Report contains confidential information. This report includes unblinded adverse data. Executive Summary This section should provide a concise summary of the important information contained in the report. Together with the title page, it can serve as a ‘stand-alone’ document suitable for the submission to ethics committees and other stakeholders. The following information should be included in the Executive Summary: Introduction – report number and reporting period; Investigational drug(s) – mode(s) of action, therapeutic class (es), indication(s), dose(s), route(s) of administration, formulation(s); Estimated cumulative exposure of clinical trial subjects; Marketing approval(s)? (yes/no) – If yes, number of countries; Summary of overall safety assessment (based on section 18 of the DSUR); Summary of important (based on Section 19 of the DUSR); Actions taken for safety reasons including significant changes to the IB; Conclusions. of Contents Introduction This section should include: Date of Clinical Trial Authorisation approval, Development International Birth Date of drug or International Birth Date of Drug as appropriate;
UoA-NHSG-TMP-038-V1.00_DSUR_Template.docx