OpenSAFELY Project Application Form

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OpenSAFELY Project Application Form
This form should be completed by the Project Lead.

The Project Lead must be an OpenSAFELY Full User, is responsible for the co-ordination of the project team, and will be the primary point of contact with the OpenSAFELY team.

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GENERAL INFORMATION
What is your name?*

First NameLast Name
What is your email address?*
Please provide the email address provided to you by the organisation you work for or study at, not a personal email address.
YesNo, but I have submitted an applicationNo. I understand my Project Application cannot be progressed until I have completed a User Application
Please click here to access the Full User Application Form.
YesNo

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PHD STUDENT SUPERVISOR
Projects led by a Ph.D. student require explicit support from a supervisor. We will contact your supervisor to confirm their support for your project and to check that a Data Sharing Framework Contract (DSFC) with NHS England is in place with the employer of your supervisor. Your application will not be reviewed by NHS England until this has been confirmed.
What is your supervisor's name?*

First NameLast Name
What is your supervisor's email address? This must be the email provided to them by your organisation, not a personal email address.*
example@example.com

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YOUR PROJECT TEAM
Please tell us about the other members of your project team.

If you are unsure about the distinction between a Full User and a Collaborator, please see the glossary linked at the top of this page.

Please make sure you include:

- Their full name

- Their organisation

You will be able to amend/expand your project team in the future.
Please list all other OpenSAFELY Full Users working on this project.*
Please list any OpenSAFELY Collaborators working on this project.*
YesNo, but they have submitted applicationsNo. I understand my Project Application cannot be progressed until they have completed User Applications
Please click here to access the User Application Form.

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PROJECT TYPE AND ETHICS REVIEW
OpenSAFELY projects that meet the Health Research Authority's (HRA) definition of "research" require support from an institutional or organisational ethics board (for example, a university ethics committee). The HRA provide guidance and a self-assessment tool to help categorise projects correctly.
ResearchService EvaluationAuditOther

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RESEARCH PROJECTS
Research project applications cannot be approved by NHS England until evidence of review by an institutional or organisational ethics board (for example, a university ethics committee) has been provided.
Yes - please send a copy of this review to applications@opensafely.orgNo - please be aware that you will need to provide a copy of this review to NHS England before your application can be formally approved.

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NON-RESEARCH PROJECTS
Non-research project types do not ordinarily require an ethics review from an institutional or organisational ethics board.

If NHS England consider that your project meets the HRA definition of a research project, and this is different to the project type you have selected, we will contact you and request that you arrange an ethics review.
Using the HRA guidance and/or self-assessment toolThrough consultation with a REC

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YOUR PROJECT
This is a chance to explain your project in detail. Please provide as much information as you are able to.

Your project description should describe clearly the research you intend to conduct in OpenSAFELY. Please include the following details (max 500 words):
- The question(s) your project is intended to answer
- Data sources intended for use in this project
- Cohorts for analysis
- Time period of analysis
- Analytic or statistical methods intended to be used
- Expected outputs
Please read the NHS guidance if you need support writing about how you will reach your benefits.
What is your project title?*
Please describe your project. *
Your description should include the question(s) your project is intended to answer and your proposed methodology. Please see guidance above. Max 500 words.
Understanding risks to health, trends in diseases and such risks, and controlling and preventing the spread of diseases and such risksIdentifying and understanding information about patients or potential patients with, or at risk of diseaseUnderstanding information about patient access to health services as a direct or indirect result of illness, and the availability and capacity of those servicesHealth services research on changes in clinical activity and population health and impact, as well as consequences of thisInforming the development and tracking the implementation of new diagnostics and treatmentsOther, please specify
How will your project deliver these benefits?*
When constructing your text, you may wish to consult the NHS England guidance linked above. Max 250 words.
What Public and Patient Involvement and Engagement has been undertaken? If any, are there any key PPIE activities which directly informed the aims and scope of this project?*
Max 250 words
Lay summary. *
Please provide a lay summary of your project that is written in plain language, does not include any acronyms, and is easily understandable. Your lay summary will be made public on the OpenSAFELY website if you project is approved. Max 300 words.

NATIONAL DATA OPT OUT (NDOO)
By default, Type 1 Opt Outs for flow outside of GP practices are applied; by default, the National Data Opt Out (NDOO) for research and planning is not applied. If you think NDOO should be applied to your analysis, please indicate this in the question below.

See opt out of sharing your health records for details of Type 1 Opt Out and the National Data Opt Outs.
YesNo

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PROJECT SPONSOR
By default, the sponsor is the employer (organisation) of the Project Lead.

If you are unsure about the role of a Project Sponsor, please see the glossary linked at the top of this page.
The employer of the Project LeadOther

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PROJECT FUNDER
NHS England have introduced a cost-recovery charge for access to OpenSAFELY of £25,000 per project. You do not need to pay this at the point of application, but you must raise a Purchase Order with your organisation before running code against real patient data for your project.

Regular funders of research projects in OpenSAFELY are aware of this new charge. If you have a funding agreement which does not include this sum, NHS England advise that you should approach your funders for the additional amount, but can submit your application in advance of doing this.

If your project is currently not funded then, due to the short timescales in this round of applications, you are encouraged to apply for access, state that you do not yet have funding in place, and seek funding in parallel.
Yes - For project team and NHSE Access ChargeYes - For project team onlyNo - Project funding is not yet in place
The employer of the Project LeadNHS EnglandNIHRMRCOther

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CHECKS AND DECLARATION
Before you submit your application, you must check the box to confirm the statement below:

I confirm that the information within this application is true and complete. I understand that any omission or misrepresentation within the application may lead to its rejection, or cancellation of any resulting agreement.
Yes
Custom Submission ID
Should be Empty:

OpenSAFELY Project Application Form

GENERAL INFORMATION

PHD STUDENT SUPERVISOR

YOUR PROJECT TEAM

PROJECT TYPE AND ETHICS REVIEW

RESEARCH PROJECTS

NON-RESEARCH PROJECTS

YOUR PROJECT

NATIONAL DATA OPT OUT (NDOO)

PROJECT SPONSOR

PROJECT FUNDER

CHECKS AND DECLARATION