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​​​​​​​​Information for Researchers

These pages give information for researchers wishing to apply for access to the QResearch database. The online application system is available here. A blank version of the application form is available here, to help researchers develop their application offline, if necessary.

 

How does it work?

A group of researchers originate a research question or hypothesis and write an outline protocol.

The researchers contact QResearch to discuss the feasibility of undertaking the study. If the study is feasible, a broad estimate of the costs will be provided with a letter to accompany any application for funding (for more details see below).

The researchers secure the necessary funding.

The researchers work with QResearch to agree a detailed data specification.

The researchers work with PPI to produce a lay summary.

The researchers complete and submit the QResearch application form.

The researchers apply to data providers too, if necessary.

The application is considered by the QResearch Scientific Committee and feedback is given to the researchers.

The researchers make any necessary modifications to the protocol and approval is obtained.

The researcher is given a timescale for the data extraction.

Once the researcher has the data, they will approve it within one month of receipt.

 

What types of studies can QResearch be used to carry out?

The following studies and analyses are the most suitable:

  • case-control studies
  • cross sectional surveys
  • cohort studies
  • feasibility studies
  • sample size calculations

What types of studies can QResearch NOT be used to carry out?

QResearch cannot undertake studies which involve:

  • any intervention on practices or patients
  • any need to contact the practices or patients since this is impossible
  • any research that requires practices or the CCGs they are within to be identifiable
  • any changes to the fundamental principles underpinning QResearch

 

Eligibility

Who’s on the research team?

The chief investigator and researchers accessing the data need to be academics based at UK universities for the duration of the proposed project. These researchers can move between UK universities during the project although they would need to submit an amendment to their application – please see the amendments page. Co-applicants and researchers who are not accessing the data do not need to be based at UK universities.

At least one member of each team must be a medically qualified academic registered with the General Medical Council who signs a Data Access Agreement.

It is strongly recommended that at least one member of each team have experience in, or a good understanding of, UK primary care; this knowledge is essential when specifying the data the research project needs.

At least one member of each team must be a statistician who contributes to the design of the study and will advises on the analysis. This could be an econometrician for health economic research. It may be helpful to have both an econometrician and a statistician.

It is strongly recommended that least one member of each team have experience in Electronic Health Record (HER) research; this knowledge is essential throughout the project.

It is strongly recommended that least one member of each team have experience of data management. This person will need to undertake data management for the project which will be complex and time consuming.

All team members must be free to undertake this study and publish its findings.

Which UK universities are the team based at and which data can they access?

GP data

Academics at all UK Universities can access GP data subject to approval by the QResearch Scientific Committee and when a data sharing agreement is in place between their university and the University of Oxford.

Linked Hospital Episode Statistics (HES) and National Death Register data supplied by NHS Digital

Academics at all UK universities can access linked HES and death data subject to approval by the QResearch Scientific Committee, when a data sharing agreement is in place between their university and the University of Oxford, and appropriate permissions and data sharing agreements are in place with NHS Digital. The type of data sharing agreement and the application process will depend on which organisation is leading the research. For research led by other universities, researchers will need to apply to QResearch and NHS Digital. There may be a cost from NHS Digital. For research led by University of Oxford, researchers will need to apply to QResearch only. For further information please contact [email protected]

Linked Cancer Registry data and Public Health England (PHE) Second Generation Surveillance System (SGSS) COVID-19 data

Academics at all UK universities can access linked Cancer Registry data and PHE SGSS COVID-19 data subject to approval by the QResearch Scientific Committee, when a data sharing agreement is in place between their university and the University of Oxford, and written agreement from PHE is obtained. Researchers will need to apply to QResearch and PHE.

Linked Intensive Care National Audit & Research Centre (ICNARC) Case Mix Programme (CMP) data

Academics at the University of Oxford can access linked ICNARC data subject to approval by the QResearch Scientific Committee, which includes a member of the ICNARC team. At least one member of the research team must be a member of ICNARC who is involved throughout the research project. Research teams wishing to access ICNARC data should contact ICNARC to get a costing from them for their input. Researchers will need to apply to QResearch only.

 

What research practices do we need you to follow?

Your research must be original and capable of publication as original research in a peer-reviewed journal.

You must agree to have a lay summary published on the QResearch website.

You must check the data you are given within a month of receipt and report back any problems within that time.

You must agree not to attempt to identify patient(s) or practice(s).

You must agree not to provide access to raw data to any third party including the funder, sponsor or other such body.

You must agree not to use the data for any other work outside the scope of that within your approved application. If you wanted to alter the project you would need to submit an amendment to your application – please see the amendments page.

You must acknowledge the source of QResearch data and associated linked datasets in any publication, paper, report or software/tool. A template for the required text can be provided on request.

You must acknowledge the source of ICNARC data in any publication, paper, report or software/tool. A template for the required text can be provided on request.

You must provide a short report annually, when requested by QResearch.

You must provide a copy of the final report of the project and copies of any publications within one year of the project completion.

You must not transfer, distribute, share, sell or sublicense the data to any third party. Specifically, you may not transfer the data outside the UK.

 

Suggesting research

You may not meet the above requirements, or have the capacity to carry out the research you would like to do, to answer your questions. We have an “Ideas” page where researchers can post great ideas in the hope that other teams will pick them up.

Commissioning research

You may not meet the above requirements, or have the capacity to carry out the research you would like to do, to answer your questions. You may be able to commission the University of Oxford QResearch team to carry out the research for you. Please contact [email protected]

Access to the data for pharmaceutical companies

QResearch does not provide access to data for pharmaceutical companies except where there is a clearly defined concern regarding the safety of a drug. In these circumstances the pharmaceutical company will be referred to a third party approved by the QResearch Advisory Board to handle such requests. The normal governance procedures will be followed so that the analysis is independent and published.

 

Funding

All projects need to be funded to cover the costs of accessing the QResearch database.

 

QResearch support and indicative cost

With sufficient notice we can provide a letter of support and/or an indicative cost for grant applications.

Please supply the following information by email to [email protected], allowing a minimum of 10 working days prior to the deadline:

  • URL for funding call
  • deadline for submission
  • proposed project title
  • lead applicant
  • start and end dates
  • summary of research plan
  • which databases are required
  • if additional time from QResearch staff is required
  • draft copy of grant application form

If a researcher wishes to apply for funding for an application which has already been approved, and the grant application is based on, or contains reference to QResearch data, QResearch must be informed by email about the application before the application is submitted.

 

Costs

QResearch is not-for-profit and is self-funding so needs to cover the costs associated with providing a research service. We will estimate the cost of each data extraction plus VAT. The estimate will take account of the complexity of the data required and the time taken to extract it. If the specification becomes more complex, then the cost will be uplifted. QResearch will submit an invoice to the Chief Investigator for the work concerned. This will be paid in advance of the data being extracted.

 

Sources of funding

We ask you to declare the source of funding for the project, and for each individual working on it. You must be able to meet all the conditions of working with QResearch data. All applications are reviewed by the Scientific Board and reported to the Research Ethics Committee.  If there are concerns then we will discuss them with you.

 

Why we need funding in place first

We get many enquiries from academics who then don’t proceed to undertake the project. This can be for a variety of reasons, often, including a failure to identify the necessary funds. We only ask our Scientific Committee to review projects which are almost certainly going ahead.

 

Timeline

 

Study Protocol

All application forms must be submitted through the online application system. A blank version of the application form is available here, to help researchers develop their application offline, if necessary. A data specification and lay summary must be sent to [email protected].

 

Reporting guidelines

In order to help the Scientific Committee to easily understand and review your research protocol, we suggest you write the protocol section of the application form following RECORD reporting guidelines or TRIPOD reporting guidelines and other reporting guidelines appropriate to the study design.

 

Specification of the data

To be able to specify the data at either a broad or detailed level you will need to have a clear research plan. Researchers must have a specific research question/hypothesis that requires specific data. We do not license the whole database or give out entire medical records.

In order to safeguard the identity of the practices, we do not release any practice level data or any individual Townsend Score. We also make special consideration of data items relating to patients with very rare or unusual disease.

For the application form the data can be described in broad terms (variable types) such as by listing demographics, patient inclusion criteria, exposures, treatments, outcomes and time ranges. For example, you may be interested in demographics (age, sex, and ethnicity) of patients (age 18 and above with a diagnosis of type II diabetes) who have had a specific intervention (prescription of any anti-diabetic drug) and whether they had a specific outcome (amputation), while controlling for confounders (BMI, Townsend quintile) within a specific time (January 2015-January 2020). You can see the types of variables that datasets contain on our data page.

For the data specification we need more detail; you will need to exactly specify all the data you want from the QResearch database; we will extract for you the data you request that is needed to fulfil the protocol approved by the Scientific Committee.

You will be able to view the detail of variables that QResearch contains in QWeb and in variable lists that we share with you. There are many thousands of variables and you will need the member(s) of your research team with experience in, or a good understanding of, UK primary care to work on this detailed data specification. You will need to select specific variables to create code groups. Please contact [email protected] to request the most recent version of the data specification template and variable lists, and for guidance on how to create the data specification, and to submit your data specification.

You can work on your detailed data specification at any point in the application process, but it needs to be finalised by you and agreed with the QResearch team before your application can be considered by the Scientific Committee. We encourage you to start work on a detailed data specification as early as possible; exploring the variables available and considering which you need will inform both the data specification and protocol development.

The Scientific Committee will not peer review the data specification, it is for their information only, an indication of the data you will use.

 

Sample size calculations, feasibility calculations

Applications must include a feasibility calculation, and may also include a sample size calculation.

The Scientific Committee requires a feasibility calculation that consists of an evidence-based persuasive argument, including calculations and references, to show that there is a reasonable chance that QResearch contains enough of the right kind of data to answer your research questions.

They also welcome a sample size calculation. They need to know how much data you need us to share with you to answer your research questions - how many patients worth of data you would need data for to have sufficient power to detect the difference you expect between the groups you plan to compare, for your primary outcome. A sample size calculation is a calculation of how much data you need, not how much data you think exists within the QResearch database.

Your sample size calculation will be used by the QResearch core team to work out how much data to provide to you. If you provide a sample size calculation we will provide data for as many patients as you require as long as this number is equal to or fewer than the number of eligible (for inclusion in your research) patients in the database. In the absence of a sample size calculation we will provide data for up to 1 million patients, depending on the number of eligible patients in the database.

 

Lay summary

The lay summary needs to be written with patient and public involvement (PPI) and published on our website; this is one of the conditions of our HRA ethics approval. We require the lay summary to be submitted to the Scientific Committee before an application can be reviewed; please contact [email protected] to request the most recent version of the lay summary template and to submit your lay summary.

 

PPI

QResearch welcomes applications that have been developed with involvement of patients and the public. This includes applications for methodology research, COVID-19, or urgent research, which can be, are being, and ideally should be, developed with involvement of patients and the public. Our application form includes a PPI section which must be completed. Information about involving the public in research can be found on the NIHR INVOLVE website.

Methodology Research with PPI

The workshop “Actively Involving Patients/Public with Trials Methodology Research (TMR)” held on 13th November 2019 at University of Manchester identified top tips, developed into questions that researchers could ask of themselves, to aid patient & public involvement.

  • What is the aim and purpose of actively involving patients and the public with your Methodology Research?
  • What is distinct about this involvement with Methodology Research or methodologies and how will it ultimately benefit patients?
  • How do we best explain the complexity of this research?
  • What planning are you doing to define specific roles, expectations, perceptions and assumptions people might have in this context?
  • What examples and case studies of similar work can we draw upon?
  • What questions would we like to explore together with patient contributors?
  • Do we have the community capacity to carry this out?
  • How are we communicating the task (language and style)?
  • What planning and resources are required and how will the impact be measured?
  • How might we identify and overcome any challenges and leave preconceptions aside?
  • How might we tell others and disseminate the way we have involved patients & the public?

 

Scientific Committee Review

More information about the Scientific Committee can be found on the website.

Please do not contact reviewers directly; any correspondence with reviewers should be made via [email protected].

 

Criteria for review

The Scientific Committee judge applications against the following criteria:

  1. Do you have any conflicts of interest in reviewing this application? If so, please give brief details.
  2. Is the protocol clearly written? Is the reviewer able to easily understand what the researchers intend to do, why, and how? If not, the reviewer can ask the researchers to revise the application to improve clarity before further review.
  3. Is there a clear research question or hypothesis which is likely to lead to a generalizable finding, capable of publication in a peer reviewed medical journal?
  4. Are the researchers likely to be able conduct the study and analysis?
  5. Is QResearch the appropriate database to be used to conduct the research?
  6. Are the methods appropriate to answer the question including the possibility of biases and confounding, and dealing with each missing data?
  7. What patient and public involvement has there been, or will there be, in this research?
  8. Are there any potential direct or indirect benefits for patients, or the public, or the health service?
  9. Are there any potential risks to the ethical position of QResearch in undertaking this research (including the potential identification of patients or practices?)
  10. If any modifications are needed or might be considered, or you have any general comments, please include them here.
  11. Overall, do you think the University of Oxford should approve this research project? [Yes, OR Yes, but needs revision (if so, please say what), OR No, OR Refer to the QResearch Advisory Board]
  12. Would you be willing to review the response to your peer review if necessary?

 

Regular timeline for review by the Scientific Committee

Our Scientific Committee meets monthly to discuss applications. If you submit a complete application two weeks or more before the next Scientific Committee meeting, we aim to have an answer to you within two days of that meeting.

If the Scientific Committee makes a recommendation to revise and resubmit your application, we aim to have an answer to you within two weeks of your resubmission.

 

Fast track by the Scientific Committee

When research is of exceptional clinical importance and urgency, or where there is a public policy reason for urgent research, we may offer a review of your application and a decision from the Scientific Committee within 7 days of submission, and (if required) any further reviews and responses from the Scientific Committee each within 7 days.

Please be aware this does not mean the data will be made available to you within 7 days as the Scientific Committee may require more information from you before they can approve your application. In addition the data extract will need to be scheduled, run, and the extracted data checked. The scheduling will depend on the number of other projects already prioritised and the capacity of the team.

Please contact [email protected] to discuss the fast track process.

 

Applications to use ICNARC data

The Scientific Committee will be expanded to include one member of staff from ICNARC as a reviewer when applications to use ICNARC data are under consideration.

 

Rejected applications

The QResearch Scientific Committee aims to approve with or without modifications following review. If an application is rejected the reasons for the rejection will be provided. Should an application be rejected, the applicant is welcome to appeal to the chair of the Scientific Committee via the QResearch inbox, make the appropriate changes, and submit a new application which would be expected to be substantially different to the original one. A covering letter documenting the reason for the appeal, what reasons had been given by QResearch for the rejection, and what actions and amendments have been undertaken should be included.

 

Conflicts of Interest and Confidentiality

Applicants will be asked in the application form to make a declaration about any conflict of interest which may, or may be perceived to, affect the integrity or validity of the research. Information on types of conflict of interest is contained in the ICMJE declaration form.

All reviews will be kept confidential.

Scientific Committee members who are co-applicants or researchers named on an application will not take part in reviewing or discussing that application, and will not be present when other members discuss it.

Scientific Committee members who have some other conflict of interest, such as an ongoing application for a similar project, will not take part in reviewing or discussing that application.

Applicants will be able to see who has reviewed their proposal and the individual reviews. All correspondence regarding reviews will be conducted via the [email protected] email account and via the QWeb interface.

 

Amendments

You must notify the Scientific Committee of all changes to your application after its initial approval, for them to consider. To do this please contact [email protected] and complete the online application amendment form. A blank version of the application amendment form is available here [link to media], to help researchers develop their application for amendment offline, if necessary. Changes that are considered to be amendments include, but are not limited to,:

  • Changes to any hypotheses being tested
  • Change to the design of the study
  • Changes to the definition of the study population
  • Changes to the exposures, comparators, or outcomes
  • Changes to the analysis strategy
  • Not performing a planned analysis
  • Changes to other methods, such as to control for missing data, confounding or sensitivity analyses
  • Use of additional linkages to other databases
  • Not using linked data which are part of the approved protocol
  • Change of Chief Investigator or co-applicant
  • Change of UK university by Chief Investigator or co-applicant

We will contact you each year to request a progress report at which point any extensions to the original duration can be discussed.

Large amendments may require a new application to be submitted. An amendment to the data sharing agreement may be required. An additional charge is likely since data are licensed on a per study basis.

 

Extraction and preparation of the data

We will extract the data you have requested from the QResearch database and place in in a folder on a QResearch virtual server that you will be given access to. This sounds like a short process but the database contains billions of rows of data and it can take days of server time to extract the data for your research. The data extract will need to be scheduled; scheduling will depend on the number of other projects already prioritised and the capacity of the team. After the data has been extracted it needs to be prepared which can take another few days.  Our team check the dataset for completeness and for errors. They may need to carry out some modifications to that dataset that could not be made before the extraction.

We aim to provide requested datasets within 28 days of the final data specification being submitted but this can vary according to the number of other projects already prioritised and the capacity of the team (which may be reduced over the school holidays or Christmas).

 

Access to the data

Approved researchers are given access to the data on Oxford Servers via a very secure mechanism. In addition to the other requirements previously discussed, in order to access the individual participant data, individual researchers must meet criteria laid out by our information governance and security policies, data supplier permissions, and ethics approvals, including:

  • physically being in the UK
  • undertaking regular data protection and information governance training
  • using workstations compliant with QResearch’s security requirements
  • signing a Data Access Agreement

We will contact you in advance of sharing the data to ensure these are in place.

 

Mistakes in the data

Check within 28 days

QResearch will take every precaution to ensure that the data requested match the specification made and signed off by the Chief Investigator. The data extraction and preparation process will be subject to routine quality assurance procedures. It is the Chief Investigator’s responsibility to confirm receipt of the data, check the data, and notify QResearch of any errors or omissions within 28 days. In the absence of any such notification we shall consider that the data are correct. If there is a mistake in the data, then the principal investigator should contact QResearch who will investigate the problem.

Mistake by QResearch

If there is a mistake in the data extraction caused by QResearch error, then the Chief Investigator will be provided with a corrected dataset within 28 days or as soon as is reasonably possible. QResearch will not be liable for the cost of any staff time spent working on the data.

Mistake by Researchers

If the mistake is due to an error in the data specification drawn up by the researchers (e.g.: the researchers have selected the wrong Read codes), then QResearch will endeavour to help by re-running the data extraction routine with the new codes within the following 3 months. There will be an additional cost for this.

 

Your applications and research, and confidentiality

All approved projects will be published in the form of a lay summary on the QResearch website.

All publications resulting from approved projects will be listed on the QResearch website.

We publish an annual summary of applications and of applications that have been approved.

No details of individual applications, including of unsuccessful applications, will be shared.

 

Publication

All research using QResearch data must be published in peer-reviewed journals and the results made publically available. All algorithms should be published e.g. as open source software.

Every form of publication arising from the work utilising the QResearch database shall acknowledge it as the source of the raw data in keeping with the conditions of access to the database. Publications should also refer to the version of the database and the date of last data download for the data used in the study. A template for the required text is here [link].

The underlying individual level data for the paper must not be shared under any circumstances. Queries about publications should be directed to the corresponding author in the first instance. Requests to access the individual level data must be directed to QResearch at [email protected] who will consider the request as a new application.

Researchers must consider the risk of identifying individuals in their analysis prior to publication and must not publish small numbers (which are counts 1-4). A higher level of aggregation should be considered when analyses produce less than 5 cases.

Researchers must notify QResearch when manuscripts written involving research carried out using QResearch data are accepted for publication.

Researchers will be expected to follow best practice guidance on authorship as published by the International Committee of Medical Journal Editors (ICJME) here.

 

What happens if a researcher contravenes the conditions of using the database?

Attempts to break the confidentiality of the practices or patients or evidence of research misconduct will be treated extremely seriously by QResearch and, if proven, will result in a bar on further access to data for the research team and their university.  It will also lead to referral to the General Medical Council which is why at least one member of the team needs to be registered with the GMC.

 

Other research and researchers

Applications and research using other databases

Approved QResearch projects are listed here. Applicants are encouraged to check the QResearch website for details of published and ongoing studies to avoid unnecessary duplication of research. Other approved research using UK primary care EHRs may be found or sought from.

Non Exclusivity

QResearch undertakes research and analysis for a variety of organisations covering a wide scope of questions including both research and audit. Nothing in any agreement with a third party will prevent QResearch from supplying data and services to any other party at any time. At all times copyright in core material from the QResearch database licensed by any client remains the absolute property of QResearch.