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A Summary of Clinical Safety (SCS) is a section of the Clinical Summary placed in Module 2.7.4 of the Common Technical Document. The purpose is to provide a summary of the data relevant to safety in the intended population, integrating the results of individual clinical trial reports as well as other relevant reports, eg, the integrated analyses of safety that are routinely submitted in some regions.
The SCS summarizes the data on exposure to the drug; adverse events; clinical laboratory evaluations; vital signs, physical findings, and other observations related to safety; and safety in special groups and situations. If the drug has already been marketed, all available and relevant post-marketing data are also summarized.
The display of safety-related data can be considered at 3 levels. (1) The extent of exposure (dose, duration, number of participants, type of participants) should be examined to determine the degree to which safety can be assessed from the database. (2) The more common adverse events and changes in laboratory tests should be identified and classified, and their occurrence should be summarized. (3) Serious adverse events and other significant adverse events should be identified and their occurrence should be summarized. These events should be examined for frequency over time, particularly for drugs that may be used chronically.
The safety profile of the drug, described based on analysis of all clinical safety data, should be outlined in a detailed, clear, and objective manner, with use of tables and figures. The SCS will be developed based on the key messages, agreements on document content (eg, what to present first), and feedback from document review.
The Integrated Summary of Safety (ISS) is a critical component of the submission file in the US (placed in Module 5.3.5.3). Note that, despite the name, this is not a summary but rather an integrated analysis of all relevant safety data from clinical trials. The ISS text can be developed first and used to derive the SCS.
The role of the Emtex Life Science medical writer is to ensure that the data are well structured, the key messages are brought forward clearly, it is a high-level summary (avoiding duplication), and to ensure consistency with other CTD documents that are developed in parallel.
FAQ: Summary of Clinical Safety (SCS)
What is a Summary of Clinical Safety (SCS)?
An SCS is a section of the Clinical Summary that provides a high-level overview of the safety data supporting the use of a drug in the intended population. It is based on safety findings from individual clinical trials, as well as other relevant sources.
What information is included in an SCS?
An SCS summarizes the safety data of a drug generated throughout clinical development, including data on adverse events, clinical assessments, and other safety-related observations. Relevant post-marketing safety data may be incorporated as well, if available.
Why is it challenging to prepare an SCS?
Preparing an SCS can be challenging because large amounts of safety data from multiple studies need to be summarized in a clear, detailed, and objective way.
How can Emtex Life Science support the preparation of the SCS?
Emtex Life Science can support the preparation of SCSs by ensuring that key safety messages are communicated clearly and concisely, and by ensuring consistency with other CTD documents that are developed in parallel.
Why is professional medical writing support valuable for the SCS?
Professional medical writers help transform detailed clinical trial results into a coherent summary that highlights the key safety findings.