Below you will find a list of questions we are often asked in the NJRO.

Funding Development Team

I need a research Sponsor but how do I go about arranging this?

Clinical research taking place at Newcastle Hospitals will require a research Sponsor that takes on the overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. Upon your submission of a Project Initiation Form (PIF), your proposed study will be discussed by teams within the NJRO at a weekly meeting who will be able to advise on which organisation would be best placed to act as Sponsor for your specific project. This advice will be relayed to you by the FDT following the NJRO meeting.

What does it mean for the costings if my study is eligible for NIHR Research Delivery Network portfolio adoption?

If research studies have been funded through open and nationally competitive grant calls administered by the NIHR, NIHR Non-commercial Partners, or other areas of central Government (e.g. UK Research and Innovation Research Councils), they are automatically eligible for NIHR Portfolio adoption. The NIHR has provided further information on Portfolio eligibility.

If you are applying for funding from a portfolio eligible funder, your study would be eligible for NHS support as defined by the ‘Attributing the costs of health & social care Research & Development’ (AcoRD) guidance. This means that the study costs attributed as service support costs would be covered separately and not requested from the funder. If your funder is an AMRC charity, the NIHR may also cover study activities attributed as Research Part B costs according to AcoRD. The cost attribution of study activities forms part of the costing process carried out by the FDT so please contact the team so that your study can be costed accurately according to the specific costing model of the funder. 

The funding application requires a SoECAT to be submitted. What is this and who can help with this?

The Schedule of Events Cost Attribution Template (SoECAT) is a tool used to ensure that cost attributions for study activities are correctly allocated in line with the AcoRD guidance. Further information about the SoECAT can be found on the NIHR website.

Where appropriate the FDT can support with the completion of the SoECAT so it is helpful to highlight to the team if your application requires a SoECAT at the earliest opportunity. To contact the FDT about a new funding application, please submit a Project Initiation Form (PIF).

The SoECAT is completed online and requires an IRAS number so if you are applying for funding for a new study, please register the study in IRAS and provide the IRAS reference number and short study title to the FDT. Once the SoECAT is completed, it will be reviewed and validated by a member of the Research Delivery Network team, which can take 5 working days. Therefore,  it is important to provide as much time as possible for this process to take place to ensure a validated SoECAT can be submitted with your funding application.

Please note that as the SoECAT is a cost attribution template rather than a costing tool, research costs calculated by the SoECAT are likely to differ from the research costs that should be included in your funding application which will be collated by the FDT.

Can I use the SoECAT to calculate the NHS costs of a study?

The Schedule of Events Cost Attribution Template (SoECAT) functions as a cost attribution tool and should not be used as a study costing tool. Whilst there are costs associated with certain study activities in the SoECAT, this document does not include all site-level costs that are required within an application for research funding. For further information about this, please see the NIHR website. To have your proposed clinical study costed accurately, please submit a Project Initiation Form (PIF) or contact the Funding Development Team who will support you with the costs for your project and submission of a SoECAT where required.

I am a nurse, midwife, or allied health professional (NMAHP), where can I go for support with my research applications?

As an organisation, Newcastle Hospitals is committed to supporting staff in developing their critical thinking skills, new ideas and research to inform and influence best practice. To realise these aspirations, the Trust has invested in dedicated support, policies and strategies for Nurses, Midwives and Allied Health Professionals (NMAHPs) to be able to pursue research ideas and access opportunities to apply for training and research related funding. As a result, there are a team of individuals who are happy to support you with your next steps. For further information about NMAHP research and the funding opportunities available, please visit the NMAHP website.

Linda Tinkler is the Trust Lead for NMAHP Research, Education and Practice Development and can be contacted if you have an idea or research question related to your role that you would like to pursue. The generic inbox for NMAHP research can also be contacted and you will be signposted for further support and guidance.

I have received my application outcome, where do I send this information?

When you receive the outcome of your funding application, please inform the member of the Funding Development Team (FDT) at NuTH and the Newcastle University Research Officer that supported you with the costings for your application.

If the application has been successful, please provide the Award letter. The FDT or NU team (depending on the lead organisation for the grant application) will then notify the Awards team and will send the relevant documents required for their assessment and acceptance of the award. The Awards team will contact you to guide you through the awards process. Once the award has been assessed, an R&D number will be requested for your study if NuTH sponsorship has been requested and you will be guided through the sponsorship review process.

I would like to apply for funding for a research project, how do I do this?

The Funding Development Team (FDT) in the Newcastle Joint Research Office (NJRO) are the first point of contact for researchers at Newcastle looking to submit a funding application for clinical research projects involving the NHS. To initiate support from the team, please complete a Project Initiation Form (PIF) to provide details of your proposed project. The PIF will be discussed at a weekly meeting within the NJRO and a member of the FDT will contact you to support with your project logistics and NHS costings.

How much notice is required for the FDT to assist with funding applications?

PIFs should be submitted a minimum of 4 weeks before a funder deadline for low-risk studies and a minimum of 8 weeks for complex studies such as CTIMPs (however please note that to prepare robust and fully considered applications for complex studies can require months). 

Governance

How long does it take for my study to be confirmed for capacity and capability?

  • For a high risk study it would be a minimum of 6 weeks however, this can be quicker depending on the study queries.
  • For low risk studies it would be a minimum of 3 weeks however, this can be quicker depending on the study queries.

Is my study research and how do I find this out?

We would advise using the HRA Decision Tool to identify if your study is research. If your study is research please contact nuth.genericqueries@nhs.net and someone can advise appropriately. If your study is a Service Evaluation or not considered to be research we would advise contacting the Clinical Effectiveness Manager at NuTH.

What is a Principal Investigator (PI) and Chief Investigator (CI) and do I need one for my study?

  • A PI is an individual responsible for the conduct of the research at a research site. There should be one PI for each research site.
  • A CI is an individual who is responsible for the conduct of the whole project in the UK.
  • All Research Studies running at NuTH will need a local PI, this is someone clinical who is employed by NuTH who is a specialist in that area. It can also be someone who is not employed by NuTH but holds a Clinical Contract with the Trust.

What is the HRA?

Our core purpose is to protect and promote the interests of patients and the public in health and social care research. In order to achieve this we:

  • Make sure research is ethically reviewed and approved
  • Promote transparency in research
  • Oversee a range of committees and services
  • Provide independent recommendations on the processing of identifiable patient information where it is not always practical to obtain consent, for research and non-research projects (HRA, 2017)

What is IRAS?

  • Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
  • Enables you to enter the information about your project once instead of duplicating information in separate application forms
  • Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
  • Helps you to meet regulatory and governance requirements (IRAS, 2019)

Do I need a sponsor for my study?

All Research Studies running through NuTH will always require a study Sponsor. There are instances when conducting smaller projects for instance, prospective tissue collection studies will not require a sponsor.

How do I cost my study?

  • Commercial – Sponsor should provide you with an NIHR Validated Industry Costing Template.
  • Non-Commercial – the latest version of the NuTH Costing Tool should be used, please contacting R&D Funding Development Team for NuTH Sponsored Studies. Please work with local Study Team (Team Lead & Coordinator) for Hosted Studies.

Who do I need to get involved in my study?

My HRA Approval Letter states formal confirmation of capacity and capability is not required, what do I do?

  • You will need to contact nuth.genericqueries@nhs.net and provide them with the HRA Approval Letter, R&D will be able to put you in contact with a local study team here at NuTH who will be able to advise if they have a suitable PI/Point of Contact and the capacity to conduct the study.
  • Local R&D Documents will need to be submitted by the study team so we can process this.
  • If you require access to the trust and need to come onto NuTH premises you will need to apply for a research passport to obtain a Letter of Access.

What is the portfolio?

The NIHR Clinical Research Network (CRN) is the research delivery arm of the National Health Service (NHS), supporting a portfolio of over 5,000 clinical research studies. identifying and recruiting patients onto Portfolio studies, so that researchers can be confident of completing the study on time, and on target. The Central Portfolio Management System (CPMS) is a cloud-based portfolio management system, which has replaced the UKCRN Portfolio and Industry Application Gateway databases.

Is my study portfolio eligible?

  • Please visit the NIHR Website to identify whether your study is portfolio eligible.
  • For NuTH Sponsored Studies you can contact the Funding Development Team.

Do I need a Letter of Access or Honorary Research Contract?

If you are planning to undertake research at NuTH but do not have an employment contract with the Trust, you will need to obtain a LoA or HRC (depending on the type of research activity). More information on how to apply for this can be found on IRAS Help pages or contact nuth.researchpassports@nhs.net for further information. For more information please see the Research Passports page.

Regulatory Compliance

What is an Investigational Medicinal Product?

A pharmaceutical form of an active substance or placebo being tested, or used, as a reference in a clinical trial, including products already with a marketing authorisation but, for the purposes of the trial, used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form (SI 2004/1031).

Is my study a trial of an Investigational Medicinal Product (IMP)?

Click here for an algorithm that can help determine whether your study involves an IMP.

However you can also contact the Regulatory Compliance Team for confirmation via tnu-tr.sponsormanagement@nhs.net

What is a Medical Device?

According to the Medical Devices Directive (MDD), a ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

Which Sponsor team do I contact for NuTH sponsored high risk studies?

  • Please direct all urgent sponsor management queries to: Tnu-tr.sponsormanagement@nhs.net (e.g. this includes queries relating to Annual Progress Reports, End of Study Reports, Trial Management Group meetings, Risk Assessments, amendments, sponsorship requests etc.)
  • Please direct all urgent monitoring queries to: Tnu-tr.trialmonitoring@nhs.net (e.g. this includes queries relating to Monitoring Plans, Monitoring Reports, confirmation of site actions completed etc.)
  • Please direct all urgent safety queries to: Tnu-tr.safetyreporting@nhs.net (e.g. this includes SAEs, SUSARs, Deviations, Development Safety Update Reports, Reference Safety Information updates/reviews)

Quality Assurance

What should we be doing to ensure we are audit ready?

Please read our dedicated audit page for further information on preparing for an audit.

How often do I need to complete GCP training?

When you are just starting out in research it is beneficial to complete the full introduction to GCP course within 6 months of your start date. Courses are available via CRN NENC online and face-to-face. Once you have completed the introduction, a GCP refresher course should be attended every three years.

GCP can be booked via https://learn.nihr.ac.uk/

Informatics

Why do researchers collect information?

They collect information to help provide patients with the best possible care. The information they collect could include a patient’s name, date of birth, NHS number, contact details and notes and correspondence about their health and care.

This information helps researchers to plan and improve local services and contributes to medical research. For research purposes, they remove any information that identifies patients personally.

What are the legal duties of The Newcastle upon Tyne Hospitals NHS Foundation Trust?

The law allows researcher to use patient information for patient care, for service improvement and for research. They are bound by the General Data Protection Regulation to use information fairly and lawfully.

In certain circumstances, there may be other reasons why researchers would use patient’s information – for example, to share information with the police in order to prevent a serious crime – but it will always be in line with The Newcastle upon Tyne Hospitals NHS Foundation Trusts legal duty.

How is research information kept secure?

The Newcastle upon Tyne Hospitals NHS Foundation Trust has a legal duty to keep patient information secure. Their staff undertake annual training about information security and have regular audits and independent reviews to make sure that they do keep information safe. If researchers use other organisations to help process information. They make sure these organisations also comply with the trusts legal obligations to keep patient information secure, including when they are based outside of the UK.

REDCap

What is REDCap?

REDCap is a browser-based Electronic Case Report Form (eCRF) system, designed to capture research data from both research staff in medical settings and directly from patients via online tools. The Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) REDCap is hosted on secure cloud servers held by ARO, an NHS certified cloud systems provider based in Liverpool, UK. The system is managed by the Newcastle Research Informatics Team, who ensure that patient data is only accessible by authorised individuals and is appropriately anonymised for analysis.

REDCap is typically used to facilitate secure data capture and analysis for research projects including single and multi-site studies, but more advanced implementations include services such as randomisation, pre-screening and electronic consent. The Research Informatics Team can provide access to REDCap or build an entire research project within REDCap, with a costing model based on each individual project.

Is REDCap suitable for my project?

Newcastle REDCap is often the simplest and most practical way to securely collect and store research data for your project, from single and multi-site research studies through to pre-screening, electronic consent and online registries.

To arrange a demonstration, or to discuss using REDCap for your project, please get in touch with the Research Informatics Team. If you find that our system appears suitable after this discussion, we can then set up an account for you to test out the key functionality that you will need for your project.

Is REDCap suitable for high risk studies (e.g. CTIMPs)?

The Newcastle REDCap has been validated in-house by the Newcastle Research Informatics team to ensure it is suitable for high risk clinical trials. For more information about our Validation process, see our NCL REDCap Validation Process SOP.

Do I have to use REDCap for Newcastle projects?

Use of Newcastle REDCap is not mandatory, however we offer a practical, cost-effective and compliant way to store research data. If you decide not to use our REDCap but are wanting to store patient data, please ensure you are complying with the relevant local and NHS governance policies to do so.

What functionality does REDCap offer?

REDCap has a vast range of functionality, much of which has been tested and utilised by the Newcastle Research Informatics Team. Some of these functions include:

Data capture. This includes the design and use of forms/CRFs with appropriate validation, ensuring high data quality. Projects can be set up longitudinally if necessary, to collect standardised data at specific time points throughout the study.

Multi-site projects. This allows logged-in users to automatically tag data to their own site, and ensures they are only able to see data belonging to their own site.

Reporting. Table-based and graphical reporting, including dashboards, allows an instant snapshot of the data held within your project. A dedicated data quality area lets you monitor the study for specific criteria, and raise queries within the system.

Randomisation. REDCap can be used to implement a randomisation model, allowing participants to be randomised into a study based on defined parameters at the simple click of a button.

Online questionnaires (surveys). Questionnaires can be sent to participants to complete remotely, with a customisable interface geared towards user-friendliness. Data will automatically feed back into REDCap, keeping your entire dataset in one place. Advanced logic can be implemented to automatically send these questionnaires at specific time points or based on specific criteria.

Twilio SMS messaging. SMS messages can be used to send questionnaire links and reminders to a participant’s phone. REDCap adapts to the device it is opened on, so becomes touch-screen friendly for participants accessing via a touch-enabled device.

Electronic Consent. REDCap can be used to consent participants into a study electronically either during a visit or remotely. The eConsent workflow can be customised to suit the needs of each study, including the display of the PIF, counter-signatures, self-consent and automatic PDF generation. Newcastle Hospitals teams working on a Newcastle REDCap project can purchase standard tablets to use for face-to-face electronic consent (if their project design includes eConsent).

Multi-lingual module. Alternate languages can be inserted into a REDCap project, giving staff or participants the choice of a different language when accessing and entering data into the system.

REDCap app. A REDCap app is available for devices in remote locations where an internet connection is unavailable. Data can be held locally on-device and synced back to the REDCap server at a later time.

What are the costs associated with using REDCap?

We have worked with the NuTH finance department to create a costing model which is based on each individual project. The most important factors affecting cost are administration time (e.g. number of users and sites), build time (if you are not building the project yourself) and length of data storage.

Please get in touch with the Research Informatics Team to discuss your project and receive an accurate quote.

Where are your REDCap servers located?

Our REDCap system is hosted by ARO, an NHS certified cloud systems provider based in Liverpool, UK.

REDCap is connected to the internet, meaning it can be accessed from any computer with an internet connection by using increased security measures. This also means that the ‘survey’ functionality of REDCap can be used to send online questionnaires and consent forms to study participants.

Please read our REDCap Data Security SOP for further information on the security measures implemented in our REDCap system.

For more information about data security in research, please visit our dedicated data security page.

Can you provide REDCap support and training?

REDCap offers a suite of robust training videos, accessible by logging into REDCap and clicking on ‘Training’ at the top of your screen.

We are happy to answer any queries you have regarding the functionality of REDCap while you set up and run your project on the system. However we can also offer an additional level of support for an additional cost. We will quote these support costs to you based on your specific project requirements and agree these with you before proceeding.

When can I start collecting real data on my REDCap project?

When you are satisfied with your project design in REDCap and are ready to start recruiting, click the ‘Move project to production’ button on the bottom of the Project Setup page. This will submit the project to the Research Informatics Team to look over. At this stage we will need verification that all of the necessary approvals are in place to allow data collection to begin. Once we have confirmation of this, you will receive an e-mail to inform you that the project is officially in production mode.

If you make any changes to your project design after it has been moved to production mode, they will need to be submitted to the Research Informatics Team for inspection to ensure there will be no accidental data loss. When you make changes to the forms in production mode, you will be asked to submit them rather than save them and will receive an e-mail once they have been approved.

How do I provide others with access to my REDCap project?

Please e-mail the Research Informatics Team with the name of the project and the full name, email address and organisation/site of the person(s) who require access, as well as the level of access required. This e-mail must originate from someone who has previously authorised access to the project, or has clearly been given permission to do so.

Grants and Contracts

Who do I inform if I have been successful, or unsuccessful, in obtaining funding for my research project?

You need to advise the NJRO via Research.Awards@newcastle.ac.uk

How do I access the funds to my new award?

You need to advise the NJRO via Research.Awards@newcastle.ac.uk who will then liaise with the relevant Finance Department

Will someone at the Joint Research Office sign my grant application on behalf of the organisation?

NJRO will arrange for the appropriate authorised legal signatory to to sign applications, awards and agreements

Who can I approach if I require a contract to be put in place?

You need to advise the NJRO via Research.Awards@newcastle.ac.uk who will then assess your study and draft any relevant contracts

What do I do if I receive an MTA?

Please complete the relevant questionnaire in the first instance via our link http://forms.ncl.ac.uk/view.php?id=1682

What do I do if I need an outgoing MTA?

Please complete the relevant questionnaire in the first instance via our link http://forms.ncl.ac.uk/view.php?id=1698

What do I do if I receive an CDA?

Please complete the relevant questionnaire in the first instance via our link http://forms.ncl.ac.uk/view.php?id=9041

What do I do if I need an outgoing CDA?

Please complete the relevant questionnaire in the first instance via our link http://forms.ncl.ac.uk/view.php?id=9041

What do I do if I receive a Data Agreement?

Please complete the relevant questionnaire in the first instance via our link http://forms.ncl.ac.uk/view.php?id=1612223

What do I do if I need an outgoing Data Agreement?

Please complete the relevant questionnaire in the first instance via our link http://forms.ncl.ac.uk/view.php?id=1570010