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.
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: Tnufirstname.lastname@example.org (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: Tnuemail@example.com (e.g. this includes queries relating to Monitoring Plans, Monitoring Reports, confirmation of site actions completed etc.)
- Please direct all urgent safety queries to: Tnufirstname.lastname@example.org (e.g. this includes SAEs, SUSARs, Deviations, Development Safety Update Reports, Reference Safety Information updates/reviews)
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/
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.
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 email@example.com
How do I access the funds to my new award?
You need to advise the NJRO via firstname.lastname@example.org 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 email@example.com 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
Does the Trust have an action plan in relation to the delivery of Research during this time?
Yes. A 7-stage action plan was activated on 12th March 2020 and is reviewed by the R&D Senior Management Team daily.
On 11th May 2020, clinical research moved to Restart, Reset and Recovery https://newcastlejro.com/wp-content/uploads/2020/05/RD_restart_final.pdf
Work is underway to re-open paused studies from Monday 1st June 2020. The research team has worked closely with all key stakeholders throughout and this will continue.
What is the Trust plan with respect to Research where the Trust is Sponsor?
Information below explains the requirements for Newcastle Sponsored trials and studies. Please note that Sponsor green light does not mean the trial/study can open at all participating sites. Investigators need to work with their Principal Investigators (PIs) across the UK to ensure all areas involved can restart. Chief Investigators (CIs) must have an awareness of other Trusts policies and opening of all sites will, in most cases, be staggered.
- CTIMPs, Devices and ATIMPs
Trials that require Competent Authority approval must complete a risk assessment. CIs are requested to work with your Senior Trial Manager from Newcastle Clinical Trials Unit to complete and return to Sponsor. For trials managed by other CTUs please contact firstname.lastname@example.org to gain a copy of the approved risk assessment.
- Randomised Control Trials (RCT)
For trials classified as RCT or ‘Trial’ on ReDA a risk assessment is available on the NJRO website. CIs should work with their Team Leads to complete and return to email@example.com
A Sponsor representative will review and respond with an e-mail confirming green light if appropriate at this time. For trials that require this risk assessment a NuTH capacity and capability form is not required as local governance will be completed at the same time.
- All Other Studies
Sponsor is not requiring the completion of a separate risk assessment for all other trials. The capacity and capability form should still be completed as per section 1 of this document. A Sponsor representative will review both site and Sponsor restart using this document.
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. A group, chaired by the Clinical Director for R&D, reviews all COVID-19 pipeline studies and decisions are taken as to whether to proceed or not. The final decision rests with the Clinical Director for R&D.
What is happening with my study if it is a non COVID-19 study?
On 21st May, 2020, NIHR published its Framework for Restart https://www.nihr.ac.uk/documents/restart-framework/24886
This guidance is to support not only local decision-making for non-COVID-19 studies which have been paused, but also COVID-19 research which does not meet the urgency criteria. The Framework will be updated in the coming weeks and months as we learn from early experiences of restart.
The guidance from NIHR is in line with Trust plans in relation to the Restart, Reset and Recovery of research https://newcastlejro.com/wp-content/uploads/2020/05/RD_restart_final.pdf
For hosted studies, Initial assessment is conducted by the PI and Team Lead. A reduced capacity form is to be completed and assessed by R&D which can be found on the NJRO website https://newcastlejro.com/wp-content/uploads/2020/06/Study-Restart-Capability-Form-V1.1-2020.06.09.docx
In cases where further medical expertise is required review will be supported by the R&D Clinical Director.
R&D will review NuTH sponsored restart risk assessments but consideration must be given that sites participating in the trial may need to have a staggered restart, depending on local policy and preparedness.
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 advice is frequently updated so it is advised to regularly check their websites for the most up to date information. 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 as we continue to implement new ways of working in the Team.
How will research delivery and support staff be impacted due to COVID-19?
In the event that COVID-19 once again 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 in line with the Restart, Reset and Recovery plan for clinical 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/
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/
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.
UKRI have indicated that they will be flexible with no-cost extensions but have yet to make any announcements regarding supplementary funding or costed extensions. NIHR and most of the medical charities intend to take a flexible approach and will evaluate costed extensions on a case-by-case basis. Wellcome have announced 6 month and 3 month extensions for grants which end in calendar year 2020 or 2021 respectively.
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. The response from government is awaited.
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.
Statements from NIHR and the Royal College of Physicians regarding the pausing of research programs can be found at:
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 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 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 until more is known about the duration of the COVID-19 restrictions and the response from UKRI and the Government. Updates will be provided as soon as possible.
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 funders change call deadlines?
There has been a range of responses from the many funding bodies, from call deadlines remaining the same, some extended and some put on hold. Please check funder web pages and Twitter accounts for information and continue to liaise with the University and Trust Funding Development Teams.
What are the Plans to Restart, Reset and Recover Research at Newcastle?
On 11th May, 2020, the Trust moved to Restart, Reset and Recovery of clinical research https://newcastlejro.com/wp-content/uploads/2020/05/RD_restart_final.pdf Work is underway to re-open paused studies from Monday 1st June 2020.
The team has worked closely with all key stakeholders throughout and this will continue.
The University’s COVID-19 Academic Group for Research & Innovation (COVID AGRI), chaired by Professor Brian Walker, is ensuring research and innovation funding and continuity are addressed during this unprecedented period. The group, which reports to University Executive Board, is also coordinating the University’s COVID-19 research and innovation response as part of the University COVID-19 Response Project. This page https://newcastle.sharepoint.com/hub/rsd/Pages/covidagri.aspx outlines some of the steps the University is taking to maintain its capabilities as a world-leading research-intensive institution.
As highlighted in the Prime Minister’s statement of 10th May 2020, there will be opportunities for researchers to return to campus during the 2019/20 session. However, recommissioning of buildings and research facilities needs to be managed carefully and a set of principles has been agreed which will act as a guide for staff and students https://newcastle.sharepoint.com/hub/rsd/Documents/NU%20Principles%20for%20Research%20during%20COVID19%2018.05.2020.pdf
The University’s COVID-19 Emergency Management Team will co-ordinate the re-opening of facilities, informed by the priorities set by Faculties and Academic Units.
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.
Research England has now launched a survey seeking views from the sector regarding the timing of revised submission deadline and a possible extension to the assessment period for impact beyond 31st July 2020. Following internal consultation, the preferred option is for a single submission deadline of 31st March 2021 and to retain 31st July 2020 as the end of the impact assessment period. There will also be a case-by-case mitigation route for Impact Case Studies that have been affected by COVID-19.
Research England and others rely on REF results to make the case to government circles for maintaining investment in university research. Assessment of research will not go away.
Whilst REF 2021 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.
An announcement from Research England regarding the revised submission deadline and approach to impact is expected soon. A review of the internal timetable will then be carried out and updates will be given regarding any important developments.