Below you will find a list of questions we are often asked in the NJRO.
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 firstname.lastname@example.org 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?
- Finance – set-up R&DFinancepreaward@nuth.nhs.uk
- Finance – study in progress – FinanceResearchandDevelopmentTeam
- Local Study Team – contact email@example.com who will refer you.
- Support Departments (if involved):
- Pharmacy Production Unit – PharmacyPPUClinicalTrials@nuth.nhs.uk
- Pharmacy RVI – PharmClinTrials@nuth.nhs.uk
- Pharmacy Freeman – PharmFRHClinTrials@nuth.nhs.uk
- Pharmacy North Centre for Cancer Care – NCCCPharmacy.ClinicalTrials@nuth.nhs.uk
- Radiology Support – Louise.Fox@nuth.nhs.uk
- Labs Support – tnu-tr.NewcastleLaboratories@nhs.net
- Ophthalmology Support – Aedheen.Regan@nuth.nhs.uk
- Medical Photography – Karen.Guy@nuth.nhs.uk
- For all other support departments that are required, please contact the local study team at NuTH.
My HRA Approval Letter states formal confirmation of capacity and capability is not required, what do I do?
- You will need to contact firstname.lastname@example.org 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 email@example.com for further information. For more information please see the Research Passports page.
I am a student and am looking to set up a research study at the Trust. How do I go about it?
We have prepared a guide for students looking to set up a research study in the Trust. Whilst this is primarily aimed at students, it may also be a useful resource for novice researchers.
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 firstname.lastname@example.org
How do I access the funds to my new award?
You need to advise the NJRO via email@example.com 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 firstname.lastname@example.org 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
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.
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/
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.
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)?
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: Tnuemail@example.com (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: Tnufirstname.lastname@example.org (e.g. this includes queries relating to Monitoring Plans, Monitoring Reports, confirmation of site actions completed etc.)
- Please direct all urgent safety queries to: Tnuemail@example.com (e.g. this includes SAEs, SUSARs, Deviations, Development Safety Update Reports, Reference Safety Information updates/reviews)
What is the Trust plan with respect to Research where the Trust is Sponsor?
Please see our updated ‘Restart, Reset and Recovery in clinical research’ guidance published on 11th May 2020 on https://newcastlejro.com/covid-19/covid-19-guidance/
I am interested in taking forward some research into COVID-19, what do I need to do?
The National Institute for Health Research (NIHR) is working with partners across the health and care system to ensure that the Government is making best use of the limited resource and capacity available to support research into COVID-19.
A single national process has been set up to allow the Chief Medical Officer (CMO)/Deputy Chief Medical Officer (DCMO) for England to draw on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges (Department of Health and Social Care’s expedited Urgent Public Health prioritisation).
This process will cover funded studies, irrespective of whether they are funded by the public sector, industry or charities; also, in partnership with UKRI, studies that require funding. It aims to prevent duplication of effort and to ensure that the capacity of the health and care system to support research is not exceeded.
Local CRNs, R&D Departments or healthcare sites should not be contacted directly with any new COVID-19 studies. Central, coordinated communications via the NIHR will enable the most effective delivery of the collective COVID-19 Urgent Public Health Research.
The Trust has established a COVID-19 Research Team with PIs, Clinical Team Leads, Clinical Trials Co-coordinators and Governance support to ensure studies during this time are resourced and activated as rapidly as possible.
What about HRA Approvals under this process?
With regard to HRA approvals, researchers should first make an application through the national prioritisation process. They will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.
Do we have to prioritise nationally prioritised studies?
Yes. All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. However, there are a large number of such studies and local prioritisation will also be necessary.
If we have the capacity to deliver COVID-19 studies that are not a national priority, can we do so?
Yes, only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.
What is happening with my study if it is a non COVID-19 study?
Until further notice, the NIHR Clinical Research Network is pausing the site set up of any new or ongoing studies at NHS and social care sites that are not nationally prioritised COVID-19 studies.
During this time, the MHRA and HRA will continue to provide an approvals service for all studies, prioritised in accordance with the national situation, ensuring site set-up can restart promptly in due course.
The NIHR Clinical Research Network will not be assessing any new commercial or non-commercial studies for CRN Support (with the exception of nationally sponsored COVID-19 studies received through the Department of Health and Social Care’s expedited Urgent Public Health processes).
The Trust, through the NJRO, will continue to support new commercial feasibility requests and non-commercial attribution support for non-commercial studies. Please be mindful that there may be delays during this period.
How will research delivery and support staff be impacted due to COVID-19?
In the event that COVID-19 places extreme pressure on NHS services, research delivery and support staff and facilities may be redeployed to support clinical services. Any redeployment will be agreed by the R&D Senior Management Team and take into account qualifications, skills and experience of research staff as well as the need to ensure there is sufficient capacity to deliver prioritised COVID-19 research.
At this time the Trust will not be allowing any external parties on the premises to conduct monitoring visits. Our research teams will continue to support central monitoring where this is deemed essential to the patient’s safety and/or treatment regime. Please note that this may change at short notice due to clinical demands.
We cannot send out source data via e-mail, PDF or other electronic means and it is also not possible to allow external parties access to our e-record systems.
How do we deal with any Urgent Safety Measures during this time?
Urgent Safety Measures (USMs) to trials that continue to follow-up must be reported in the usual way and CIs and PIs need to report any USM to sponsor immediately. Please refer to NJRO-GEN-SOP-002 ‘Protocol Deviations, Violations, Waivers and USMs in studies sponsored and hosted by NuTH FT’ available via https://newcastlejro.com/research/resources/documents/
To note: Regulation 3 amends the Medicines for Human Use (Clinical Trials) Regulations 2004 to allow for notice of USMs to be given as soon as possible to the licensing authority and an ethics committee. Prospective protocol waivers are unacceptable and should not be used to change a trial due to the pandemic (for example eligibility, patient safety and/or difficulties in assessments). CIs should discuss with R&D and consider use of USM, temporary halts or patient discontinuation.
Due to the current situation, we are not able to fully adhere to Trust SOPs. What do we do during this time?
Where possible, all applicable SOPs should be followed and are available for review at https://newcastlejro.com/research/resources/documents/. It is understood that, in some cases, deviations to current SOPs may be required to ensure patient safety during a pandemic. The NJRO have produced a COVID-19 deviation to SOPs document (also available on the website) that all Trial staff should familiarise themselves with.
What if a participant cannot complete key safety checks?
All options should be explored for safety follow-ups; in some cases it may be necessary for the participant to travel to site, for example for bloods. If the participant cannot travel and there is no other option to support the visit then formally withdrawing the patients should be considered. Please speak with your study Sponsor before making a decision to withdraw.
My study has been suspended and I may not be able to meet the contractual obligations
It is understood that the temporary suspension of research due to COVID-19 may make it difficult to meet contractual obligations. This is a particular concern for commercial research.
Most contracts follow model agreements for commercial and non-commercial research and therefore Force Majeure clauses in contracts could be enforced. If there are any concerns regarding commercial research contracts or studies, please contact the NJRO Team via nuth.TrustIndustry@nhs.net
My study is time and funding limited – what do I do if I need to extend?
Discussions are already underway with major funders including NIHR, UKRI, AMRC and others at a national level.
Early indications are that funders will be flexible in their approach and a comprehensive list of funder statements is currently in development and will be available shortly.
We are looking to co-ordinate these discussions with major funders on behalf of Newcastle University and the Trust. Please liaise with the Grants & Contracts Team if you have any concerns about your specific award via firstname.lastname@example.org
For internally funded research including RCF and DT accounts, where expenditure cannot be incurred in the intended Financial Year, the relevant budget holders, with support from the Research Senior Management Team, will need to review the availability of funds in the next Financial Year.
I am, or have staff on fixed-term contracts – what does this mean for them?
Depending on the nature of your research, the duration of the restrictions and the need to ensure front line clinical services are supported, we fully appreciate that productivity may be adversely affected and there may be a case to extend staff on fixed-term contracts.
Work is ongoing at national level asking for urgent consideration of steps to protect researchers in training. Any updates will be posted as soon as possible.
I am on a Fellowship and I have been asked to return to Clinical Duties – what does this mean for me and my Fellowship?
We recognise at this time of responsiveness to COVID-19 there are concerns regarding the practicalities of pausing research programs to return to clinical duties.
The Trust is acutely aware of the importance of research informing clinical practice at a time like this and there have inevitably been questions related to how we might support colleagues who are undertaking research fellowships at various stages.
This comes alongside full support from government, the health services in all the devolved nations and professional bodies. Major research funders have also come together to show that they also support this. These funders will do all they can to mitigate the impact of lost time on existing fellowships and grant awards and also the reduced capability to submit grants at this time
In light of the emerging advice, the Trust is recommending the following guidance:
- When current programmes are pausedto enable a return to frontline practice, individuals are asked to discuss and manage this within their own clinical departments, through line managers and academic supervisors where appropriate. The relevant university guidelines should be followed in requesting any pause to a specific academic programme.
- Those holding fellowships who are medics have all been contacted by their major funders to offer their support. NIHR, UKRI and the Wellcome Trust are all supportive and should meet excess incurred costs. Work is ongoing with other funders at the present time to determine how any excess incurred costs will be covered.
- Careful monitoring will be required to enable the accurate capture of time off-programme and clinical hours worked. For clinical staff employed on a substantive Newcastle University contract with Trust Honorary Status, please fill in the form https://secureforms.ncl.ac.uk/view.php?id=97877 which can be accessed through your Newcastle University e-mail account. For clinical staff employed on a substantive Trust contract, please fill in the proforma which can be found at https://newcastlejro.com/wp-content/uploads/2020/04/COVIDResearchProgrammePauseProforma.docx. This is to ensure that we can support, oversee and inform a timely and straightforward process of restarting in the future.
In the event of a programme extension incurring additional academic costs, this will need to be negotiated with the academic institution and your funder on a case by case basis at the time of restart. We will support this.
Can I still submit an application for external funding which is not COVID-19 related?
Yes – preparation of research grant applications is encouraged. The teams supporting the application process are, in the main, now working remotely but continue to have access to the systems needed to facilitate submission. The current process for submission should continue to be followed.
Please be mindful of the need to show consideration, patience and understanding as colleagues move to different ways of working and cover for those who may become unwell during this challenging time.
I have been successful in a research award and concerned about the start date
It is recommended that if you are concerned about the start date of your award, please liaise with the funder to agree a revised start date. Any agreed amendments to start dates should be sent to email@example.com so the necessary changes can be made.
- Newcastle University has paused all new staff recruitment until at least 31st July 2020. Exceptions will be granted on a case by case basis.
- For those staff on fixed-term contracts, Newcastle University has agreed to extend all contracts to 31st July 2020.
- If you have any queries regarding any of the above, please contact the Faculty of Medical Sciences People Services team on firstname.lastname@example.org
- The Trust continues to recruit staff at the present time, but please be mindful of the current circumstances when considering your recruitment and selection plan.
It is important to take all of the above into account when considering liaising with funders over any revised start date.
Will REF 2021 preparations be affected?
Yes. REF 2021 will be put on hold until further notice to allow institutions to divert staff resource to other critical areas, including those working in clinical and health-related fields.
The submission deadline on 27 November 2020 will no longer apply, and a new submission deadline will be announced no later than eight months prior to the deadline.
The funding bodies recognise the significant effort that has been invested so far by institutions in preparations for the current REF cycle. As a result, the REF staff census date (31 July 2020) remains unchanged at the present time.
When there is greater clarity about the period of serious disruption to universities, consultations will be held on the adapted details of the framework. This will be as light touch as possible, in view of these challenging times.
Whilst REF2021 has been put on hold until further notice, work is still ongoing at Newcastle University to prepare the documentation for submission. As the majority of this documentation can be completed electronically, it is still possible to be involved. If you receive any requests from the REF team at the University, for information or updates, please respond.