The public benefit of the use of NHSS data for this application must be clearly made. If there is no public benefit, then the application is likely to be referred to Tier 2 or not approved. The use of personal data from NHSS must provide a benefit to the public and / or patients. 3.1.09 Please provide a concise details of the proposal. It is essential that you use this section to paint a clear picture of the processing of data which you propose to undertake. Please use language that is understandable by colleagues and public partners without a clinical background or extensive knowledge and expertise in epidemiology or health research. This should include background and the reasons for requesting the data and data sources, as well as details of sample size, cohort inclusion or exclusion criteria, ranges of data to be used, and incidences of proposed data access / extract / transfer and linkage / matching / anonymisation, etc. You should use clear, concise language which can be easily understood by colleagues and public partners without a clinical background or extensive knowledge and expertise in epidemiology or health research. Please justify the use of the datasets requested and how these will answer your aims and objectives. A number of prompt questions are provided to help you understand and provide the information required by the review panel. If you are using extracts from study protocols or other relevant existing documentation, please ensure that it is relevant to the section. Please do not include academic literature references in the application form. A separate protocol can be provided as a supporting document. 3.1.10 Please provide a clear and concise outline of any statistical methods that will be used in the project. This should be a brief, non-technical description of the statistical analysis, for people who may not have a background in statistics. 3.1.11 Please include a data flow diagram showing what data sources are being accessed and processed by which parties and at what point in the proposal methodology, from patient to outcomes, so that the roles and responsibilities for data controllers and/or processors are clear (e.g. including data controllers, processors and transfers). This illustration can also include key processes undertaken with respect to data, such as anonymisation or linkage. The flow diagram should also show from where the data will be accessed and stored at any point in the process and by whom. Please ensure the flow diagram is large enough for the text to be read. If the flow diagram is included in another supporting document, e.g. eDRIS PSD, please state where it can be found, but do not leave this question blank. 3.1.12 Please indicate whether the proposal has focuses on or includes people who might be considered vulnerable. A non-exhaustive list of vulnerable people is included in Table 5 of Appendix A of these guidance notes, but you should include any group or cohort which might reasonably be considered vulnerable in nature. This is part of the assessment of how safe is a proposal. Most applications are likely to include vulnerable people, unless they have been specifically excluded. 3.1.12a If the application is focused on or includes vulnerable people, please give further details of these people and why they may be thought to be vulnerable. It is good to acknowledge that vulnerable people might be present in the population for the data requested, even if they are not the focus of the proposal. If vulnerable people are the focus of the proposal, this should be taken into account in Q 4.2.01 about how patients are informed and aware of the use of their data. 3.1.13 Please indicate whether the proposal seeks to access sensitive data. Under GDPR, all health data is classed as special category personal data, some could be considered highly sensitive health data. In addition, some commonly requested variables are also classed as special category data but are not health data (e.g. ethnicity). A non-exhaustive list of special category data and potentially highly sensitive health data categories is included at Table 6 of Appendix A of these guidance notes, but you should include any data that, e.g. in combination, might reasonably be