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The National Neonatal Research Database (NNRD) has been created through the collaborative efforts of neonatal services across the country to be a national resource. The NNRD was developed and is maintained and managed at the Neonatal Data Analysis Unit (NDAU) at the Chelsea and Westminster NHS Foundation Trust campus of Imperial College London, led by Professor Neena Modi.

Researchers, clinicians, managers, commissioners, and others are welcome to utilise the NNRD and NNRD-AI. The NDAU receives no core funding to support the NNRD or NNRD-AI. For this reason a charge is necessary to cover the costs of maintaining and developing the NNRD/NNRD-AI, data transfer, extraction, cleaning, and storage, and any analyses requested.

A Steering Board provides oversight of the NNRD/NNRD-AI. The Steering Board does not provide peer review but ensures the request is legitimate, feasible and in the interests of patients or the public. If the request is approved, the applicant is notified and asked to obtain necessary regulatory approvals. Applicants are asked to confirm that research findings will be published. On confirmation of regulatory approval, all eligible neonatal units are sent a copy of the research protocol, inviting them to participate. In the case of nationally commissioned service evaluations, all neonatal units are notified of the request by the lead organisation. These processes ensure that neonatal units are able to decline participation in research if they wish and are fully informed about national initiatives. 

Accessing the National Neonatal Research Database

If you are thinking of using the NNRD or NNRD-AI for research or health services audit or evaluations, please first read the following information carefully, follow the process shown and complete the Health Data Research UK data access request

Please note that if you only need access to your own neonatal unit data you should contact your Electronic Patient Record supplier directly.

 

Research studies

Step 1. Starting the Process

To start the process contact the NNRD manager at the Neonatal Data Analysis Unit at Imperial College London by clicking the ‘How to requet access’ function in the NNRD or NNRD-AI pages at the HDR-UK Gateway and provide a brief description of the project and data you require. Please ensure you have checked that the NNRD/NNRD-AI contains the data you require by reviewing the data specification. You will receive a message explaining next steps; if you do not receive a message within 5 days please contact ndau@imperial.ac.uk, directly.

In your enquiry, please be sure to answer the following questions:

  • Please specify the data items required (using the NNRD/NNRD-AI Data Dictionary)
  • Do you require any derived items? If so, can you provide the definition/s you would like to use?
  • How many (complete or part) years of NNRD/NNRD-AI data are required?
  • Please specify the start date and end date for the period of data required.
  • From which countries do you require data (England; Wales; Scotland)?
  • Does your study involve de-identified data, or consented data?
  • Will you require a single or a multiple data extraction?

 Step 2. Submitting an application

If you receive a message asking you to complete the data access request form, click the ‘Request Access’ button. Please read through the pre-application checklist in the ‘About this application’ page and confirm that you have read the guidance. The application form is structured following the Five Safe model (https://blog.ons.gov.uk/2017/01/27/the-five-safes-data-privacy-at-ons/). Once you start your application you will be presented with five pages (Safe people, Safe projects, Safe data, Safe settings, Safe outputs) and you will be able to scroll through the pages to view the entire form. You will find application guidance embedded in the form.

We require you to complete all sections which are marked mandatory and to upload supporting information and signatures where applicable. Important elements of an application that often require further discussion include:

  • The legal basis under which you are accessing the data
  • Feasibility: does the NNRD/NNRD-AI contain what you need
  • The purpose for wanting the data, including what public benefit will be yielded

Please note that even after an application is submitted, the data custodian may still request additional information. Please contact the NNRD manager at the Neonatal Data Analysis Unit if you are uncertain about any aspect of the form.

 Step 3. NNRD Steering Board Evaluation

The NNRD Office will evaluate the proposal. The Steering Board is notified of all requests and is formally asked to approve all commercially sponsor studies. The NNRD Office considers proposals at an early stage to be certain that the research question can be answered using the NNRD or NNRD-AI, and has public benefit.

 Step 4. Regulatory Approvals

If the proposal is approved, the applicant is required to obtain all regulatory approvals. Please be advised that:

  • All research projects involving the NNRD/NNRD-AI require UK National Research Ethics Committee approval
  • The use of Scottish neonatal data requires additional approval from the Public Benefit and Privacy Panel for Health and Social Care
  • HRA approval (“R&D approval”) is only required from Chelsea and Westminster NHS Foundation Trust as the host organisation of the NNRD/NNRD-AI and is not required from each NHS Trust contributing data to the study through the NNRD/NNRD-AI
  • If patient identifiers without patient consent are necessary, the applicant must obtain specific additional approval from the Health Research Authority Confidentiality Advisory Group

 Step 5. Agreement of Neonatal Units

Agreement is sought from all neonatal units contributing data to the NNRD/NNRD-AI for all research studies. Neonatal units are notified by the NNRD manager on behalf of the applicant to invite participation and request agreement. In the case of service evaluations, all neonatal units are notified of the request by the lead organisation. These processes ensure that neonatal units are able to i) decline inclusion of data from their neonatal unit if they wish, and ii) are fully informed about national initiatives.

 Step 6. Data Sharing Agreement

Once all approvals are received, applicants are asked to sign a Data Sharing Agreement that specifies the purpose for which the data are to be used, confirmation that the costs will be met, and the acknowledgements to be made, including that all contributing Trusts, Networks, Lead Clinicians, and other contributing members of the UK Neonatal Collaborative, as appropriate, are acknowledged in all outputs.

 Step 7. Data Extraction and Analysis

Upon receipt of the Data Sharing Agreement, the NNRD team will proceed with data extraction (and analyses if requested) and provide an estimation of the time to completion.

Additional information We recommend data users undertake an Information Governance accreditation course; e.g.:

  • Safe Researcher Training course and online assessment; run by ONS, the UK Data Service or the Administrative Data Research UK partners.
  • MRC Research, GDPR and confidentiality: what you really need to know

 

We recognise that this process can seem daunting. If you would like to discuss your project or are unsure about any of the above points we will be happy to help. Please email ndau@imperial.ac.uk who will put you in touch with an appropriate member of the team.

Health services evaluations and audits

If you have a health services evaluation or audit to undertake, the NDAU team can also help. The first step is to clarify your needs. We recommend you then to contact us for an informal discussion via the HDR-UK gateway links above.