DAP-R Express Form

We can only provide data for research. Please select any options that apply:*

The participants in your study are randomised to different groups.Your study protocol demands changing treatment / care services from accepted standards for any of the patients services involved.Your study is designed to produce generalisable or transferable findings.
Note: In order to classify as research, you must answer 'yes' to at least one of the above points, as based on the HRA definition of research. For more information, please see the Defining Research Table.
The data extraction services we provide come at a cost. Do you have funds to do this extraction work?

I have or will have fundingI already have an agreement with SAFEHR in placeI do not have and will not require any funding
Note: The intent of this question is to provide upfront transparency that there are costs associated with the SAFEHR data extraction service. These costs are separate from the overall funding status for your research project.

Additional questions regarding project funding will come later in this for ot identify any potential conflicts of interest in the research.
Project Title
Project Title:
This should be a short title that gives an indication of what you're trying to achieve. We suggest using titles that can be shortened to acronyms to help with identification.
Study Details
Study Sponsor

UCLHUCL
Note: In order to qualify for our pathway, your study must be sponsored by UCL or UCLH.
Is the study--or any part of it--being undertaken as an educational project?

YesNo
Name of Student

First NameLast Name
Student's Educational Establishment
Primary Contact:

First NameLast Name
Primary Contact Email:
Note: a copy of the form will be sent to email entered here.
Primary Contact Job Title:
Primary Contact Contractual Status:

UCLH SubstantiveUCLH HonoraryUCL SubstantiveUCL HonoraryOther (please explain)
Chief Investigator:

First NameLast Name
Chief Investigator Job Title:
Chief Investigator Contractual Status:

UCLH SubstantiveUCLH HonoraryUCL SubstantiveUCL HonoraryOther (please explain)
Is the Chief Investigator the same as the Principal Investigator for your study?

YesNo
Principal Investigator:

First NameLast Name
Principal Investigator Job Title:
Principal Investigator Contractual Status:

UCLH SubstantiveUCLH HonoraryUCL SubstantiveUCL HonoraryOther (please explain)
Co-Investigator(s):
Note: Please list above all other investigators on this study that would be needed on the study delegation log.
Will there be any external collaborators involved in the study?

YesNo
External Collaborator(s)
Note: Please list all external collaborators and include the following details:
- Name of individual
- Role
- Name of organisation
- A description of what the collaboration entails
Are the contractual agreements for the collaboration in place?

YesNoNot required
Please upload the contractual agreement for the external collaboration in the field below.

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Lay Summary:
Note: Please provide a lay summary for the public. You can find guidance on how to write a plain English summary on the NIHR website here and on the NHS HRA website here. It is recommended that you format your summary with paragraphs and utilise headings where necessary to ensure readability.
Overall Aim of the Research:
What question(s) do you intend to answer by conducting this research study? The aim is a broad statement to describe the overall purpose of the study.
Study Objectives:
Describe the primary and secondary objectives of this research study. These should be specific, measurable, and achievable. Objectives break down the research aims into smaller, more manageable components and provide a clear picture of what you want to achieve and how you plan to achieve it.
Methodology: Analytical Plan
Please describe how you to intend to collect and analyse the data for the research study.
Study Start Date and Study End Date:
Note: The above dates can be an estimate if you are unsure.
Population:
Please give a high-level overview of the population you wish to include.
Patient / Public Benefit
Please write a summary detailing how patients or the public will benefit in at least one of these areas:
- Patient treatment/care (e.g. more accurate diagnosis, improved interpretation of test results, more proactive patient management, earlier/better assessment of clinical risk)
- Patient experience (e.g. reductions in appointments, fewer treatment delays)
- Patient outcomes/mortality
- Resource use (e.g. staffing, laboratory resources, medication use)
Patient / Public Benefit:
Patient and Public Involvement
Has there been Patient / Public Involvement in the research?

YesNo
Note: PPI may be in the design of the research or the conduct of the research. It may include PPI in your department.

Examples of how members of the public might get involved in research:
- as joint grant holders or co-applicants on a research project
- identifying research priorities
- as members of a project advisory or steering group
- commenting on and developing patient information leaflets or other research materials
- undertaking interviews with research participants
- carrying out research as user and/or carer researchers.
You can find resources for PPI here.
It is recommended to explain below why there has not been any patient / public involvement in the research. Ethics committees highly value PPI.
Please provide a description of the patient / public involvement:
Do you require additional help with Patient / Public Involvement and Engagement?

YesNo
Please follow this link for advice on PPIE and contact the helpdesk for support.
Plans for Dissemination
Plans for Dissemination:

Presenting at internal meetings (e.g. departmental meetings)Publishing in peer review journalsFeedback with PPIE groupsPresenting at conferencesOther (Please explain)
Funding
Has funding been secured for the research project?

YesNo
Who is providing funding for the research project?

Funding provided by a research councilFunding provided by a charityFunding from a commercial organisationEU fundingI have no fundingOther (Please explain)
Funder:
Please provide the name of the funder.
Intellectual Property Rights
The Chief Investigator confirms that the study sponsor will be the owner of the IP rights of the research.

YesNo
Note: This is required.
Anonymisation
Please review our current anonymisation policy here.
After reviewing our anonymisation policy, do you accept our approach to anonymisation?

YesNo
Peer Review

It is a requirement that the study goes through peer review.
Has the research proposal undergone peer review? Note: If your study has received funding from a research council or large charity for which the bidding process included a national open (competitive) process, you will have already undergone peer review.

YesNo
Please attach a letter or email confirming the details of Peer Review for this study.

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I agree to have my study undergo an independent, expert and proportionate peer review.

YesNo
Note: It is a requirement that the study goes through peer review. Our team will help direct you to the appropriate independent (i.e. individuals who have no involvement in the research) peer reviewers and provide you with a review template.
Information Governance Training
I confirm that my team and I have completed IG training. Note: this is mandatory training for UCL and UCLH. You can find the training in your leaner history.

YesNo
Please upload your IG training certificate in the field below.

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Data Specification
Will the data extraction be done or directly supervised by the SAFEHR team?

Yes, the extraction will be done by the SAFEHR teamYes, I (or a member of my team) will be directly supervised by the SAFEHR team to extract the dataOther (Please explain)
Note: If you are doing your own data extraction, you will be asked to fill out an additional anonymisation form to explain how you will ensure the data is adequately anonymised.
What is the date range of the required data?
Note: If unsure of the exact date range, please provide a reasonable estimate. Data from before April 2019 is pre-Epic and may be more challenging to extract, which will impact feasibility, time, and cost.
Please indicate the data sources that you think you will require.

Epic Data WarehousesEMAP - Star DatabaseArchive Data Store (data from retired systems)Your own curated dataset - e.g., a locally maintained spreadsheet or database.Staff DataOther (Please explain)
Which type(s) of data do you require?

Structured data itemsFree-text data (e.g. clinic notes, letters, scans)Imaging Data (e.g. DICOM data, NOT the free text reports)Other
Structured Data Items

You may upload a file to specify the data points required for this project. To explore what unstructured data is readily available, please use our data content tool, omopcat, from within the Trust environment.

Later on in this form, you will be able to add a description of any unstructured data and provide any other data points that are not available in omopcat.

It is highly recommended to use our template and use exemplars as a guide in your data request.
Structured Data Items

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Which type of free-text data do you require?

Clinic notesScanned documentsLettersImaging reportsOther (Please explain)
Which type of imaging data do you require?

MRIsX-RaysCT ScanOther (Please explain)
Are there any additional data points that would benefit this project?
To explore what structure data is readily available, please use our data content tool, omopcat from within the Trust intranet. (http://uclvlddpragae05:3838/). Please provide any other data points that are not available in omopcat.
How frequently does the data need to be refreshed for your project?

One-off extractAd-hoc extractsPeriodic update (e.g. monthly, quarterly)Other (Please explain)
Cohort Criteria: Please specify how you would like to define the inclusion or exclusion criteria from the following options:

A list of Medical Record Numbers (MRNs) or NHS numbersA list of Epic discharge codesA list of Epic procedure identifiersFiltering by the value of an Epic flowsheetOther (Please explain)
Do you require any non-standard data?*

Study-specific opt in that overrides NHS National Data Opt OutInclusion of prisonersInclusion of confidential patientsDo not use NHS National Data Opt OutNo, I do not require any non-standard data
Data Destination

The data will need to be held at a UCL DSH/internal UCLH data science environment.
Where will you store and/or analyse the data? Select all that apply.

UCL Data Safe Haven (Note: if you have a UCL-sponsored study with a UCL substantial contract, you should select this option)The UCL ARC TRE*UCLH SharePoint (Note: if this option is selected, the files should be marked as private and confidential within SharePoint)UCLH RStudio/Jupyter environmentAzure Workspace (Note: this will incur additional monthly costs)Other (Please explain)
Unsure of which data destination to use? See a comparison of the advantages and disadvantages of each option here.
*Read more about UCL's Advanced Research Computing (ARC) Trusted Research Environment (TRE) here.
Intended Use of Data
I can ensure that data is not used for anything other than the stated purpose.

YesNo
Note: It is required to only use the data for its intended purpose.
Data Retention and Storage
I agree that study documents will be archived for a minimum of 5 years from the study end, and no longer than 20 years from the study end.

YesNo
Note: This is required.
Code of Conduct & Acknowledgements
I agree that the Code of Conduct for handling UCLH data in research, service evaluations and audits will be read, agreed and signed by the Chief Investigator

YesNo
Note: Code of Conduct will be sent via email at a later date.
I agree to credit and acknowledge the support of the BRC within work in any subsequent publications

YesNo
Note: Acknowledgment is required.
Should be Empty:

Project Title

Study Details

Patient / Public Benefit

Patient and Public Involvement

Plans for Dissemination

Funding

Intellectual Property Rights

Anonymisation

Peer Review

Information Governance Training

Data Specification

Data Destination

Intended Use of Data

Data Retention and Storage

Code of Conduct & Acknowledgements