There will be variation in the questions asked by individual SDEs. These are just an example of the questions you may be asked.
Section A – Feasibility
Initial triage questions:
1. Is this application a new application or a change to an existing application?
2. Which SDE will you require data from (will offer a list of SDEs to select from)?
3. Is the project you are research according to the Heath Research Association (HRA) guidance?
Question relating to organisations and people:
4. Name of contracting organisation.
5. Full name of applicant.
6. Job title of applicant.
7. Work email address for applicant.
8. Are you the correct point of contact for further questions and discussions on the request process?
9. Provide details of the project team who will be accessing or analysing the data.
10. Name of sponsor organisation if different to the organisation named in question 3.
11. Indicate your funding arrangements including the stage of any grant applications.
12. Source of funding.
13. Provide the name and contact details of any other organisations who are collaborating on the project.
Questions relating to the project:
14. What is the title of the project. Include any reference or unique identification number.
15. Provide a summary of the project (300 -700-word limit).
16. What is the health condition, disease and/or therapeutic areas focussed on by the project? Use the Health Research Classification System (HRCS) Category (primary).
17. Provide up to 10 keywords which best summarise your research project.
18. Has this project been through external review? If Yes, provide details and documentation.
19. Indicate which priority use cases will be addressed by the proposed work.
20. Provide an outline of the public and patient involvement and engagement (PPIE*) strategy for the project.
21. Do you know which service you will require?
- Data (and SDE platform)
- Consultancy services
- Specialised tools and products to analyse data
- SDE platform only (bring your own data)
- Other (specify)
22. Provide the name of the data sets you require access to for the proposed work in the Secure Data Environment if you wish to use pre-existing data sets and know what it is called.
23. Note specific inclusion or exclusion criteria. This may include age, demographics, volume, data ranges.
24. Will you require periodic refreshes of the data?
25. Will you be providing your own data for integration?
26. Data compliance: ensure that your data complies with relevant regulations and standards.
27. Identify any software and applications (analysis) required if known.
28. Identify and provide details of any code or tool you intend to upload to the SDE platform for this project.
29. How long will you require access to the data?
30. How long will you require data to be available for analysis within the SDE? If different to the timeframes indicated in question 29.
Section B – Safe data
31. Indicate your proposed legal basis for requesting that the SDE process personal data for the proposed project, providing access to the dataset.
32. Further to information provided in section A also select the type of data access required, such as:
- aggregated data only
- record level data, pseudonymised
- record level data, contains individual identifiers
33. What risks do you foresee for individuals, and what measures have you incorporated into your project to mitigate them, if any?
34. Have you undertaken ethical consideration and assessment on the project?
35. Do you hold any data that might increase the risk of you being able to reidentify any individuals within the data set provided for this project.
36. In the feasibility section of the form, you have specified what data/data set you would like to access for the project. How have you identified this cohort/data and what logic, rationale have you used to ensure that it will support your research question whilst also being proportionate?
Safe projects
37. Outline the methodology you propose to employ, mentioning relevant statistical/analytical techniques and key variables.
38. How will you take account of any potential selection/causal bias arising from the nature of the data and/or the methodology employed?
Biases and Confounding | Health Knowledge
FOR-EQUITY – tools and resources to help reduce social and health inequalities
39. Indicate how the results and outcomes from the proposal will be published or disseminated to stakeholders and interested parties, including patients and the public.
40. How will the use of the data collected deliver potential benefit to public and the NHS and health purpose?
41. What are the further potential benefits to this research project in addition to the public benefits?
Safe people
42. Are there any specific known conflicts or risk in relation to this project or subject matter and the individuals named in this access request.
Safe settings/safe output
43. What outputs do you expect to take away from the SDE?