One to one practical, emotional and confidential staff support to listen and address your specific concerns and/or questions
Group Support – at times, various staff from one ward/department may be cited
Q & A sessions covering expectations of witness
Working in collaboration with external agencies such as Witness Service, Victim Information and Advice (VIA), NMC enabling a dedicated staff centred approach for NHS witnesses
Court Familiarisation visit in advance of trial (subject to COVID restrictions)
Support in court on day of giving your evidence (subject to COVID restrictions)
A dedicated point of support and guidance to you throughout the legal process aiding in your preparation and familiarisation of court and legal process.
Practical information around court processes and expectation of witnesses
Please read over the appropriate pages linked to the side relating to the type of case you are cited to attend. If further support is required, please get in touch with Rachel McGowan or your appropriate Legal Claims Manager for your area if matters relate to a legal claim against the Board.
The Witness Support and Corporate Legal Manager is based at West Glasgow ACH.
Please note: Witness Support is not coaching, influencing or tactical support and advice for attending Court. Witness Support offers reassurance for NHS staff who have been cited to attend Court.
The following videos highlight the support available to NHSGGC staff around Fatal Accident Inquiries (FAI) and Sudden and Unexpected Death Investigations (SUD)
Privacy Notice
As part of our requirements under Data Protection legislation, we have published a Staff Privacy Notice. By issuing this privacy notice, we demonstrate our commitment to openness and accountability.
We recognise the need to treat staff’s personal and sensitive data in a fair and lawful manner. No personal information held by us will be processed unless the requirements for fair and lawful processing can be met.
Contact Information
Rachel McGowan, Witness Support and Corporate Legal Manager based at West Glasgow ACH. Working as a Witness Support and Corporate Legal Manager involves me working closely with a wide variety of clinical and non-clinical staff across the organisation in relation to various legal cases on behalf of the Board.
If you have been asked to attend a Scottish Hospitals Inquiry oral hearing, this short video will provide you with an overview of the hearing room before you arrive.
NHSGGC has already earned a reputation with companies for being open to innovative ideas and partnership working. We aim to build on this. In response to the scale of funding and innovation opportunities that are becoming available, NHSGGC has set up an Innovation Governance Group (IGG). The role of the IGG is to primarily assess consortia and bids that aim to use NHSGGC as an innovation test bed with an aim to;
Prioritise those that align with NHSGGC objectives and strategic delivery plans
Position NHSGGC to attract Innovation funding to support strategic developments.
As part of the processes for IGG we are now using a new system for the registration of innovation projects. To register your innovation project please complete the registration form (here) and send to innovation@ggc.scot.nhs.uk
The competition is live, with registration closing on the 23rd September 1100am and the competition closing on the 30th September 1100am
This is a Small Business Research Initiative (SBRI) competition funded by NHS Scotland. Successful applicants receive 100% funding and access to advice from NHS Highland, NHS Lothian and NHS Greater Glasgow and Clyde.
The overall programme will be delivered in up to 2 phases. This is phase 1. A decision to proceed with phase 2 will depend on the outcomes from phase 1. Only successful applicants from phase 1 will be able to apply to take part in phase 2.
NHS Scotland is investing up to £300,000 including VAT, in innovative solutions in 3 challenge areas as follows:
Challenge A
Using artificial intelligence and machine learning to help develop prediction algorithms and risk stratification for diabetes foot ulceration, amputations and mortality.
Challenge B
Improving the clinical care of patients with a pre-existing diagnosis of diabetes when admitted to hospital by developing a real-time decision support tool and alert mechanism. The tool must improve triage, prevent medication errors, identify emergencies and streamline the diabetes care pathway.
Challenge C
Improving the identification (case finding) of people at risk of osteoporosis and fracture, including those with diabetes.
NHSGG&C RESEARCH ENDOWMENT FUND ALLOCATION 2025/26
NHSGG&C-wide Research Endowment Fund will no longer be hospital specific but will otherwise be awarded in agreement with the terms of the original bequests.
The following categories are open for applications:
Cancer (Funds available – £63,000) Chest, Heart and Stroke (Funds available – £74,000)
General (Funds available – £88,000) Renal (Funds available – £27,000)
The usual amount of funding awarded for each project is in the region of £20k to support specific projects running for a duration of 1 or 2 years. However, exceptional projects are eligible to apply for the full funding available in each funding pot. Priority will be given to projects that demonstrate a clear benefit to the NHS and their Patients.
Endowment funds are specifically intended to support early stage researchers to establish their own research portfolio and attract eligible grants for future studies. Experienced researchers (e.g. 7 years post Consultant or Research team leads) should seek funding for their projects from an alternative source
Completed word document applications must be submitted to R&I for review and sign off by finance no later than the 24th of October 2025. Please send these to Islay Morrison (islay.morrison2@nhs.scot)
Following agreement of costings with finance, fully completed and signed off application forms can be submitted. (1 ELECTRONIC COPY & CV).
Electronic signatures will be accepted. Please submit in word document format.
Submission Deadlines
Submission deadline for project to be costed by finance Friday 24th October
Deadline for project costs to be finalised with R&I finance team – Friday 7th November
Endowment Award Meeting anticipated to take place week commencing Monday 12th January
Applications received after this date will not be accepted
Email completed applications to islay.morrison2@nhs.scot>
CSO are delighted to announce that applications are now open for the next round of CSO Response Mode Research Grants. The deadline for submitting the outline application is Friday 27th June 2025.
We would like to highlight that CSO have implemented a new grants management system.Applicants will be able to submit and manage their applications through all the pre-stage and post award stages through this portal.
Deadline for submission of applications: Friday 15 August 2025 for 19 August 2025 meeting.
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Form 21.004A – Sponsor IMP Management Risk Assessment Process: Permanent Storage of IMP External to Pharmacy
Form 21.004B – IMP Storage Assessment – Permanent Storage of IMP External to Pharmacy
Guideline 21.004A – Permanent Storage of IMPs External to Pharmacy: Guidance on Risk Mitigation Strategies
SOP 21.005 – Managing Drug Alerts and Other Urgent Defective Medicine Reports for IMPs and NIMPs in Clinical Trials Sponsored or Co-Sponsored by NHS GG&C
SOP 21.011 – Management of temperature deviations and defects in IMPs and NIMPs supplied by Sponsor for clinical trials sponsored or co-sponsored by NHSGGC
Form 21.023A – IVRS/IWRS Specification for Drug Supply Management System(s)
Form 21.023B – IXRS Drug Supply Management Acceptance Testing Approval & Training
Form 21.023C – IXRS User Acceptance Testing Tracker
SOP 21.024 – Management of shelf-life extension for IMPs for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
Guideline 21.024A – Detailed guidance on IMP date extension process for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
SOP 21.025 – Management of Dose Escalation in Early Phase IMP/ATIMP Clinical Trials
Guideline 22.008E – Process for configuring data loggers for mapping and commissioning of refrigerators and freezers and monitoring temperatures external to pharmacy
SOP 22.009 – Dispensing and accuracy checking for clinical trial supplies
Form 51.007D – Responsibilities delegated to the Chief Investigator for CTIMP Trials Co-Sponsored by the University of Glasgow and NHS GG&C
Form 51.007E – Responsibilities delegated to the Chief Investigator for CTIMP Trials Sponsored by NHS GG&C
SOP 51.008 – Handling Non-Compliance with Good Clinical Practice (GCP) and/or the trial protocol in clinical research Sponsored, Co-Sponsored or Hosted by NHS Greater Glasgow and Clyde
Guideline 51.008C – Guidance on Types of Non-Compliance and Associated Documentation
SOP 51.009 – Notification of Serious Breaches of Good Clinical Practice or the Trial Protocol for Clinical Trials of Investigational Medicinal Products and non-CA marked Medical Devices
Form 51.028A – Categorising Laboratory Tests undertaken within Research Projects Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
SOP 51.029 – Writing Study Specific Laboratory Manuals for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
SOP 51.030 – Writing Sample Handling Manuals for Sites Participating in Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
SOP 51.033 – Research Imaging for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow (UoG)
SOP 51.034 – Writing a Trial Specific Research Imaging Manual for Sites Participating in CTIMP Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and University of Glasgow (UoG)
SOP 51.036 – Trial Steering Committee for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow
Form 51.036A – Letter of Invitation to TSC member GG&C sole Sponsor
Form 51.036B – Letter of Invitation to TSC member GG&C/UoG co-sponsor
SOP 51.037 – Storage and Transfer of Laboratory Data for Clinical Trials and Investigations Sponsored by NHS Greater Glasgow & Clyde (NHS GG&C) or Co-Sponsored by NHS GG&C & University of Glasgow
Guideline 55.002A – PV Office Creation and submission of Development Safety Update Reports
SOP 55.004 – Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices
Guideline 55.006A – Summary of Product Characteristics (SmPC) & Investigator s Brochure Checks
SOP 55.007 – Safety Reporting in Clinical Trials of Medical Devices of Non CE Marked Medical Devices or CE Marked Devices Used Outside of their Intended Purpose (Sponsored and Hosted Clinical Investigations)
Research often involves new MR imaging techniques, and optimisation of these techniques is essential before they can be successfully applied in clinical studies. The CRIF Approval Group is responsible for reviewing and approving requests for access to the research scanners for technical development and proof of principle MR research projects. Researchers requesting optimisation of imaging study protocols will complete a CRIF Development Application Form and submit to CRIF Approval Group. The CRIF ApprovalGroup will assess both the scientific aspects of the protocol as well as conduct an ethical review under delegated authority from the main REC. The CRIF Approval Group meet monthly.
Clinical Research Imaging Facility (CRIF) Approval Group
Delegated by West of Scotland Research Ethics Committee
Expected meeting date: Monthly – Usually the last Tuesday every month
Meeting Duration: 1-2 hours
Volume of activity: maximum of 3 imaging development applications considered per meeting
Location: Online
We have an opportunity for those interested in health research and ethics. Research Ethics Committee members are volunteers who review new research projects taking place in the UK from an ethical viewpoint, protecting patients and the public while promoting good ethical research. The West of Scotland Research Ethics Service is currently seeking to recruit a new member, either Expert or Lay to support the Clinical Research Imaging Facility (CRIF) Approval Group, which specifically reviews studies that are developing new scanning techniques with MRI. Since March 2020 meetings have been conducted virtually (currently via Microsoft Teams), which allows us to expand our membership outside of the Glasgow area and avoid travel.
The committee reviews research applications and gives an opinion as to whether the research is ethical. The position can be highly rewarding and covers a diverse range of research topics. Projects are focused on developing scanning techniques and may involve healthy volunteers as well as patients. You should expect to spend approximately 2 hours per month at meetings and some additional time in preparatory work. Meetings provide an opportunity to interact with researchers and discuss proposals. REC members receive training in ethical review and have opportunities to debate challenging ethical issues.
The work is voluntary and involves reading submissions prior to the meeting and attending a monthly meeting of the CRIF Approval Group (there are usually about 11 meetings in the year). Training is provided.
Meetings are generally scheduled for the last Tuesday afternoon each month, approximately 2-4pm, but may vary depending on availability of members.
Members may also be involved in follow-on work, which is generally conducted via email.
The MRI Research Team at Queen Elizabeth University Hospital is looking for volunteers to undergo an MRI scan so that we can test and optimise new techniques before they are used in clinical research studies.
The Safe Haven is the result of a unique collaboration between NHS Greater Glasgow & Clyde Research & Innovation and the Robertson Centre for Biostatistics, offering an excellent resource for health-related data research in Scotland. All Safe Haven staff are trained in ICH Good Clinical Practice and regularly undertake training in a variety of research related subjects.
The goal of the Safe Haven is ambitious to achieve but simple in concept; to establish a large research resource which is able to link health information datasets at patient level, to provide answers to clinical research questions and inform health service improvement.
For more information, click here for the Safe Haven Website
Glasgow Clinical Research Facility supports a wide ranging portfolio of studies ranging from complex early phase or novel technique experimental medicine to large population based public health initiatives across NHS Greater Glasgow and Clyde. We boast state-of-the-art facilities at sites across the city, including in-patient beds, clinical trial pharmacy, laboratory and bio-repository storage facilities with a specialised multidisciplinary team who support cutting-edge patient centred research. Each area provides high-quality clinical spaces and outreach services where patients and healthy volunteers can take part in international clinical research studies, providing the opportunity to participate in high quality research and access to the latest treatment modalities and medicines.
GCRF staff include project management, projects assistants, education, quality assurance, administrators and clinical research nurses (adult, paediatric and mental health) and midwives. Clinical research nurses and midwives in the GCRF have a range of clinical specialty-specific skills, these are also complimented by experience in obtaining informed consent, interview skills, protocol specific assessments, sample management and safety reporting.
We employ multi-professional clinical teams to support a wide ranging portfolio of research studies both commercial and non-commercial. The GCRF works hand-in-hand with NRS Networks and Specialty groups to deliver research across the spectrum of diseases. The main clinical themes, are not exclusive, and include:
For further information
Education and Quality Team and contact details
Education
The Glasgow Clinical Research Facility (GCRF) Education and Quality Team support all specialties in GCRF and provide training and advice for researchers across the research community.
The Education Programme provides a range of courses and workshops tailored to meet the needs of the clinical research community. The aim of the education programme is to increase and promote research capacity and capability through a multi-professional programme.
By working closely with our partners in the NHS, academic institutions, other CRF’s, and the NIHR, the Education Team ensures a cohesive standardised programme that meets the requirements of local and national research communities.
NHS Research Scotland Good Clinical Practice (NRS GCP) Training
The GCRF Education Team lead on the national NRS GCP Training programme to develop and support a Good Clinical Practice (GCP) course approved by Transcelerate® inc., meeting pharmaceutical and biotech industry requirements.
All clinical research activities performed within Glasgow Clinical Research Facility (GCRF) are conducted to the highest quality, ensuring rights, safety and dignity of our research participants. The GCRF Quality Assurance (QA) Team work with the clinical and administrative teams to ensure all research studies work to the regulatory requirements of Good Clinical Practice (GCP), approved research protocols and local our procedures.
The QA Team promote a positive quality culture within the facility, frequently performing internal audits, supporting the research teams, supporting development of training programmes and continuously improving the efficiency of GCRF processes.
For further details please contact: glasgowcrfeducation@nhs.scot
Clinical specialities supported by GCRF and contact details
Critical Care Research
We support high-quality research studies relating to the care of critically ill patients. The research relates primarily to intensive care, high dependency care and acute medical care.
Key topics of Critical Care research include:
Interventions to improve outcomes from Acute Respiratory Distress Syndrome (ARDS) and sepsis
Understanding the long-term implications of critical illness and how to improve recovery
The mechanisms and management of brain injury
Developing risk models to guide intensive care treatments for common conditions or complications
Minimising risk and morbidity associated with major surgery.
Glasgow Clinical Research Facility supports a wide range of studies across many areas. These include psychological and biological studies and involve people representing a number of conditions, including schizophrenia, psychosis, depression and eating disorders.
Glasgow Clinical Research Facility aims to provide people with kidney disease the opportunity participate in relevant clinical research studies. We currently support both commercial and non-commercial research studies:
Involving medicines to treat kidney disease
In acute kidney injury, chronic kidney disease, dialysis and kidney transplantation
In disorders of the bladder and urinary problems
In vasculitis, diabetic kidney disease and glomerulonephritis
In inherited kidney disease such as polycystic kidney disease and other rarer kidney disorders
To reduce the complications of kidney disease such as high blood pressure and cardiovascular disease
To improve the symptom control and quality of life of patients with kidney failure
Developing imaging technology such as MRI, ultrasound and CT scanning
To improve outcomes for patients needing dialysis or kidney transplants.
Glasgow Clinical Research Facility currently support both commercial and non-commercial surgical research studies. We have a diverse portfolio of surgical studies covering specialities including ENT, upper GI, general surgery and oncology. Conditions covered in our portfolio include:
Glasgow Clinical Research Facility currently hosts both commercial and non-commercial cardiovascular research, the team supports phase I to III drug, device and observational trials in collaboration with specialised clinical staff. The cardiovascular portfolio encompasses multiple theme areas including, Hypertension, Hyperlipidaemia, Ischaemic Heart Disease, Arrhythmias, Cardiomyopathy and Heart Failure.
Our team has a range of specific specialty research skills including vascular studies involving Pulse Wave Analysis and Velocity, plethysmography and gluteal biopsy. In collaboration with our clinical partners we also support Cardiac Echo, Exercise tolerance testing, cardio-pulmonary exercise testing and cardiac imaging; CT Coronary Angiography and Cardiac MRI through our dedicated research imaging department at the Queen Elizabeth University Hospital.
Stroke studies are offered at several sites across NHS GGC, at the QEUH we focus on clinical trials of treatments for acute stroke, prevention of recurrent stroke and device trials in rehabilitation. Currently we are researching comparative efficacy of different thrombolytic agents for ischaemic stroke, factor XII antagonists for prevention of recurrent ischaemic stroke, use of a hand orthosis for early post stroke rehabilitation and different methods of monitoring for atrial fibrillation after stroke.
The Reproductive Health and Childbirth Team consist of research midwives, research nurses, a project assistant and our health care support workers.
Our highly skilled research midwives and nurses have a range of clinical specialty-specific skills including, psychological and developmental assessments, ECG’S, Pulse wave velocity and bladder ultrasound. In addition we have clinical research skills such as obtaining informed consent, interview skills, protocol specific assessments, safety reporting, sample handling and processing.
Our role includes supporting investigators and training clinical staff to facilitate the clinical research trials.
The Reproductive Health and Childbirth team support research in the following areas but other research areas could be supported.
Obstetric – pregnancy, birth and the postpartum period, including miscarriage and fertility
Neonatal – preterm birth, nutrition and respiratory support.
Gynaecology – menopause, pelvic pain and menstrual disorders
Uro-Gynaecology − incontinence, recurrent UTI and over active bladder syndrome
Child Health – childhood obesity and infant mental health
We strive to deliver an efficient and quality service but ultimately provide our patients with a positive research experience and safeguard their wellbeing
The Glasgow Clinical Research Facility Emergency Medicine research team support investigators to deliver their research in a modern and busy major trauma centre. Our current portfolio ranges from clinical validation studies for novel devices, to controlled trials of interventions and medicines. We also support clinical research which focusses on disease surveillance, providing up-to-date information which facilitate rapid strategic and policy changes by decision-makers.
The Emergency Medicine team support research in the following areas but other research areas could be supported.
The Diabetes Team support a large and diverse range of studies from Phase 1 to Phase 4 including a balance of commercial and academic studies. We support an increasing number of PI s and their studies including long term cardiovascular outcomes; obesity including nutritional counselling; Diabetes Education programmes; pregnancy; prevention of diabetes; new combination therapies; observational and medical devices. We work closely with Clinical Fellows and Diabetes Nurse Specialists.
We work mainly across the two GCRF sites at QEUH and GRI, but also support studies at other sites including Gartnavel; Inverclyde; New Stobhill; New Victoria and Vale of Leven.
The Diabetes Research Network Nurse for GG&C is embedded in GCRF, enabling strong links with the DRN and the other main network sites including Aberdeen; Edinburgh and Dundee. Some of our work is allocated directly from the network and there are networking opportunities to get involved in studies and to share experiences of study management.
The Ophthalmology Research Team support a wide range of studies from phase I to phase IV with a mix of both commercial and academic sponsors. These studies cover a vast range of conditions including retinal detachment, glaucoma, endophthalmitis and genetic diseases. The types of studies vary from observational standard of care studies to more complex medical devices and procedures.
Based at GGH we work in a large multidisciplinary team made up of multiple PI’s, clinical scientists, optometrists, photographers and more. As many of the studies involve surgical procedures we also work closely with the ophthalmology ward allowing us to follow up patients easily after interventions. We are skilled in managing a patient’s journey through the ophthalmology departments many specialties ensuring they have a positive experience.
The Respiratory Team consist of principle investigators, research nurses, clinical research fellows, a project assistant and is also supported by our health care support workers.
Our highly skilled research nurses have a range of clinical specialty-specific skills including, spirometry, ECG’S. In addition to clinical skills the team also have clinical research skills such as obtaining informed consent, interview skills, protocol specific assessments, safety reporting, sample handling and processing.
The team support a wide and diverse portfolio of studies, phase I to IV in both commercial and non-commercial settings including:
Asthma and COPD
Cystic fibrosis and bronchiectasis
Lung infections
Interstitial lung diseases
Lung cancer
Pleural disease
Disorders affecting the chest wall and respiratory muscles.
Whilst we do have a dedicated respiratory unit within the Gartnavel site, respiratory research is supported by the team across all of NHS GGC
Musculoskeletal Studies are currently mainly supported by the team within Glasgow Royal Infirmary. The team support a wide and diverse portfolio of studies, phase I to IV in both commercial and non-commercial settings. As well as their core skill set the nursing team are trained in performing specialist assessments including joint counts, the leeds enthesitis index, dactylitiyis assessments, psoriasis skin assessments and the schermer’s test.
osteoarthritis and joint replacement surgery
osteoporosis and fracture prevention
orthopaedic surgery
rheumatoid arthritis
psoriatic arthritis and spondyloarthropathies
paget’s disease of bone
lupus, vasculitis and connective tissue disease
diseases of skeletal muscle
rare and inherited diseases that affect the musculoskeletal system
The Dermatology research team is multidisciplinary including research nurses, medics, pharmacists and a project Assistant. Our portfolio at present is small, but expanding.
We are skilled in all aspects of clinical research eg. the informed consent process, carrying out assessments, safety reporting, processing samples in our laboratory and safe drug administration through a variety of routes..
Our portfolio includes both adult and paediatric/young adult studies, and covers a wide range of disease areas including atopic dermatitis, alopecia, and genetic disorders such as Netherton syndrome.
The Gastrointestinal and Hepatology Research Team consists of research nurses and a project assistant. The GI Team supports investigators to facilitate academic and commercial clinical research within NHS Greater Glasgow & Clyde. Below is an overview of current research topics within the GI Team to demonstrate the areas of research that can be supported:
The Neurology Team consists of research nurses, research doctors, research psychiatrists, project assistants, research physiotherapists, research pharmacists & healthcare support workers, all with a wide range of skills.
In addition to our core skills our research nurses & doctors have a range of specific clinical skills including: completing neurological assessments, physical health assessments & mental health assessments.
Many different types of research are completed within our team, including:
Clinical drug trials – to assess how new drugs can improve symptoms of a disease area or improve quality of life, administering both oral, injectable and intravenous drug therapies
Observational trials – to understand patient views and experiences of care
Surgical procedures – to help professionals gain knowledge of the best surgical treatments
The Neurology Research team support studies in specific disease areas including:
Motor Neuron Disease
Multiple Sclerosis
Epilepsy
Parkinson’s Disease
Neuropathy (Multifocal Motor Neuropathy & Chronic Inflammatory Demyelinating Polyneuropathy)
At Glasgow Dental Hospital Clinical Research Facility (GDH CRF) our aim is to improve oral and general health by advancing new and better ways of preventing and treating disease. The facility includes a small multi-disciplinary team working together to support investigators from start up to close. We work with a full range of dental and oral health research – recent examples include in periodontal disease, head and neck cancer, and oral HPV infection. We operate from a dedicated two chair dental research facility embedded within the Glasgow Dental Hospital and adjacent to University Research Laboratories. We work closely with the University of Glasgow Dental School, NHS GG&C Oral Health Directorate, the CRF at Queen Elizabeth University Hospital, and with general dental practices involved in research across the West of Scotland.
The Paediatric Team works closely with the Royal Hospital for Children to support access to cutting-edge research for children and families receiving care at the hospital. Our diverse team is made up of medical staff, experienced children’s nurses, a healthcare support worker, a project manager and a project assistant.
We support approximately 50 studies taking place across the children’s hospital, including Phase I-IV drug trials and large scale observational studies. Our skilled research nurses work closely with clinical teams to ensure high quality, safe care for children and young people who choose to participate in research.
The Paediatric Team support research in many clinical areas such as:
Dermatology – eczema and dermatitis
Gastroenterology – including Inflammatory Bowel Disease and liver disease
Renal medicine
Neurology – including epilepsy, migraine and Duchenne Muscular Dystrophy
Respiratory – conditions such as asthma and CF
Rheumatology
Infectious diseases and allergy
Mental health
Surgery
Critical care and anaesthetics
Metabolic and endocrine medicine – including diabetes and a range of congenital conditions
Clinical trials are essential to the development of beneficial treatments for NHS patients as the consumers of medicine and healthcare. Clinical trials supported by the pharmaceutical industry play an important part in keeping the NHS at the forefront of modern treatments and research. In addition, commercial research activity offers clinicians early access to the latest technologies for diagnosing and treating disease and is essential for the development of new medicines and healthcare technologies. NHS GG&C supports the conduct of high-quality commercially funded research, carried out to recognised international quality standards, by NHS staff on NHS premises. However, NHS R&I support funding can not be used to support or subsidise industry sponsored R&I and studies should be fully financed to ensure it does not incur a cost to the NHS.
Governance of commercial research
Application Flow
NHS GG&C has responsibility to ensure that there are appropriate governance arrangements in place for any commercially funded research, thus ensuring that:
The interests and safety of patients enrolled in trials are protected in all eventualities
All trials are fully costed and that the costs are properly recovered
Maximum benefit is provided to the investigator and to the board
The interests of both the investigator and the board are protected in the event of Intellectual Property arising out of research
Any external regulatory, ethical and financial approvals are obtained
Any risks (liabilities) are properly considered and minimised
The board presents a thoroughly professional approach in its dealings with industry.
In order to ensure Governance of commercial projects, all studies must receive Management approval. Only protocols and trials approved by the R&I Management Office will be covered by the appropriate insurance or NHS indemnity arrangements and the Board will not accept liability for any activity that has not been approved. This website contains a practical guide to help you navigate the R&I process and highlights key steps required to get your research project up and running. Please refer to this flow diagram for additional information on specific aspects of your R&I application
Initial R&I contact and document request
Investigators
If you have been approached to participate in a commercial research study your first port of call should be your Research Co-ordinator. The Co-ordinator will be able to advise on the steps required to get up and running, and will take over negotiations over fees and contracts with the company concerned. With your help the Co-ordinator should be able to manage the approval process from start to finish.
Companies
If you would like to run a study within NHS GG&C please contact the relevant Research Co-ordinator who will be able to advise on the best way to submit an R&I application.
Documents
In order to gain R&I approval as quickly as possible, we advise that you submit to R&I as early as possible. We are happy to receive documents as they become available, this will allow us to look at your application and progress quickly. The very minimum we require to start our process is a copy of the protocol and proposed budget. A checklist of documents required for R&I approval, and a documentation guide, can be downloaded here:
Once we have identified what support departments will be involved in the study we can contact the relevant personnel for confirmation of costs and approval for research to be conducted within the department
Cost project
Once a copy of the protocol has been submitted to R&I the Research Co-ordinator can begin costing the project. Costs associated with a research project are calculated on the staff time required and on the allocated price for procedures. The Research Co-ordinator will usually work closely with the research team to ensure that time required to complete the study is accurately captured. The project costing is then sent to R&I finance and the investigator for approval. If required, the Research Co-ordinator can negotiate fees with the commercial company. Details of some of the fixed fees, payment details and wording for the remittance section of the contract can be downloaded here: CTA Finance Template
Commercial contract agreements
Before any commercial study can proceed within NHS GG&C a written agreement between the Board and the commercial company should be signed by both parties. Contracts should only be negotiated by Research Co-ordinators and are signed by an R&I director. The agreement should define the following:
Scope of work
Acceptable payment arrangements
Important issues such as the right to publish results
Protection of confidential information
Indemnification of third parties.
To help facilitate timely completion of the appropriate contractual documentation, the Association of British Pharmaceutical Industry (ABPI) and the Department of Health have developed, and published, a model Clinical Trials Agreement (mCTA) as a standard contractual framework for commercial trials involving NHS patients. To incorporate slight differences in Scottish Law and policy, a revised mCTA for use in Scotland has been developed. All legal agreements between the Board and commercial companies should be governed by the laws of Scotland. Legal advice on any aspect of the mCTA can be obtained from the CLO. Examples of CTA’s can be found here:
All members of the research team participating in a clinical trial of any type are required to complete a recognised GCP training course. These courses are run at the Glasgow CRF regularly and are free for NHS GG&C staff members.
In addition, there is a recognised online GCP course that is free to NHS GG&C employees.
A copy of the Board’s GCP training policy can be downloaded here.
All members of the research team participating in a clinical trial of any type are required to complete a recognised GCP training course. These courses are run at the Glasgow CRF regularly and are free for NHSGGC staff members.
In addition, there is a recognised online GCP course that is free to NHSGGC employees.
Once R&I has issued Management Approval the Investigator is authorised to proceed with the research study. R&I is then responsible for research management and governance of the research study and will require updates on recruitment, study progress and will approve all study amendments throughout the lifetime of the study
NHSGGC responsibilities
Once R&I approval has been issued NHS GG&C has responsibility for:
Ensuring investigators perform pharmacovigilance to required regulatory timelines as dictated by government legislation (CTIMPS only)
Following the trial to completion and ensuring regulatory requirements are met for the termination and final reports are submitted to ethics and/or the regulatory authority
Capturing publication and dissemination, service benefits and other key research outputs
Multi-site Studies Where a research study is being extended to sites outwith GG&C to other NHS organisations, R&I will generate multi-site agreements which set out the responsibility of each party. R&I regularly organise international trials which have global sites round the world, e.g. U.S.A, Australia, France and Japan.
The Investigator is responsible for the conduct of the research study. As a condition of Management Approval the following information is required to be submitted to R&I during the lifespan of the project:
Notification of the commencement of recruitment at site
Change of Principal Investigator
Change of staff or site from the original SSI form
Notification of any regulatory site inspections (CTIMPS only)
Notification of trial end including final recruitment figures and archiving arrangements.
Investigator Site File All research studies must have a site file to aid in document storage and management of the research study. The site file should contain all essential documents required to be stored at site and retained for five years following the study end (CTIMPS only). Please download an Investigator Site File template here.
Progress Reports The Chief Investigator (CI) must submit an annual progress report each year to Ethics. More information can be found at National Research Ethics Committee (NRES). R&I must also be supplied with a copy of the report made to ethics and the Principal Investigator (PI) must inform R&I when the study ends.
Safety SAE Reporting (CTIMPS only)CTIMPS sponsored by NHS GG&C or co-sponsored with The University of Glasgow The PI should ensure that all members of the research team are familiar with GCTU SOPs for Pharmacovigilance available here. Further information on the SAE/SUSAR reporting procedure and services provided by the PV office including assistance with the preparation and submission of Annual Safety Reports are available here.
CTIMPs hosted by NHS GG&C Adverse events must be recorded, assessed and reported as specified in the study protocol. SUSAR Reports and Annual Safety Reports must be provided to R&I as per the conditions of Management Approval. Further information available here
Safety Reporting (Research other than CTIMPs) The NRES has specific reporting requirements for safety reporting in research other than CTIMPs. Details are available here
Amendments
Amendments made to any study specific documentation must be reported to ethics, the MHRA (if the research study is a CTIMP or medical device) and R&I. The NRES require changes to studies to be reported with those deemed substantial to be approved. Guidance on whether an amendment is substantial or non-substantial can be found here. Please submit the following documentation to R&I to ensure management Approval of your study is still valid:
Copy of the Notification of Amendment form sent to ethics
Copy of the favourable opinion of the amendment from ethics
Copies of all documentation listed in the amendment favourable opinion letter received from ethics
Copy of amendment approval letter from the MHRA (only required for CTIMP or medical device).
Once the above documents have been satisfactorily reviewed by R&I you will receive an email confirming R&I Approval is still valid
************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact*************************
The R&I team aim to provide a comprehensive support service throughout the duration of the project from inception to submission of final report. With this in mind, it is important that you contact the appropriate R&I portfolio team as early as possible.
New academic studies (including student projects): please provide a brief summary of the background to the study along with a draft protocol.
Ongoing academic studies at other sites: if you would like to participate in a study sponsored by another Board or Trust, please provide a copy of the current study protocol and contact details of the study Co-ordinator.
Researchers should be aware there is a separate research review process for projects requiring access to social work service users, social work staff or social work data in relation to social care and community health services falling under Glasgow City Health and Social Care Partnership, further information available here.
This website contains a practical guide to help you navigate the R&I process and highlights key steps required to get your research project up and running. Please refer to this flow diagram for additional information on specific aspects of your R&I application.
Is your project research?
Research is defined as: ‘..an attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’ As R&I approval is required for all research studies it is important to know if your project can be classed as research or not.
Research must be systematic and follow a series of predefined steps defined in a protocol
Research must be well organised and undergo rigorous planning, including performing an in-depth literature review and evaluation of questions to be answered
The scientific definition of research generally states that a variable must be manipulated, although case studies and purely observational science do not always comply with this.
This tableshould help you decide if your project is research. Should you be unsure, please do not hesitate to contact the R&I officewho will be happy to advise. For projects classed as clinical audit or service evaluation, theclinical effectiveness team can provide specialist support and advice.
Data Handling Measures
Interim data handling procedures can be found here
Developing your protocol
Study protocols, patient information leaflets and patient consent forms should be prepared in standard templates (below) and should be date and version controlled.
When developing your protocol click here for a few key elements that you should consider
Once you have developed a full draft of your Protocol, Patient Information Sheets, Consent Forms and IRAS forms you should ask your Research Co-ordinator to review and provide some comments. Co-ordinators can advise on the level of detail required in each of the documents and can check for consistency between them.
Identify a sponsor
The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage, monitor and finance a study. For any health research study covered by the Research Governance Framework, it is for the sponsor to be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing. For any research that takes place in the context of the NHS in Scotland, there must be a sponsor. Normally, the sponsor will be one of the organisations taking the lead for particular aspects of the arrangements for the study. The sponsor may be the Chief Investigator’s employing organisation, the lead organisation providing healthcare, or the main funder. NHS GG&C can act as sponsor in the following situations:
A study where the CI is an NHS GG&C employee
A study involving NHS GG&C patients, staff or resources.
For more information on study sponsorship, please contact your Research Co‑ordinator.
Clinical Trials
For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution, company or organisation) who takes responsibility for the initiation management and financing (or arranging the financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials) Regulations 2004. Following appropriate risk assessment, NHS GG&G may act as sponsor on a trial where the Chief Investigator is an employee of NHS GG&C. Where the Chief Investigator is an employee of the University of Glasgow, NHS GG&C and the University may act as co-sponsor. Clinical trials sponsored by NHS GG&C should be formally adopted by and run by standards outlined by the Glasgow Clinical Trials Unit (CTU) standard operating procedures (SOPs).
Will your study generate intellectual property?
The Greater Glasgow Health Board Policy on the Management of Intellectual Property can be found here
Pharmacovigilance
Pharmacovigilance ensures the safety, quality and efficacy of medicines and healthcare products. The Scottish Executive Health Department Research Governance Framework for Health and Community Care (Second Edition, 2006) further defines the responsibilities in clinical trials and in other research carried out in Scotland. In CTIMPs sponsored by NHS Greater Glasgow and Clyde or co-sponsored with the University of Glasgow, the delivery of pharmacovigilance activity within the CTIMP is delegated to the Chief Investigator (CI). However, the ultimate responsibility and accountability for pharmacovigilance remains with the sponsor. The Pharmacovigilance Office facilitates and ensures compliance with this responsibility and provides central coordination of pharmacovigilance activity within the Glasgow Clinical Trials Unit.
A useful guide to research in a Primary Care setting is available here.
Good clinical practice
All researchers are required to adhere to the relevant legislation, frameworks and principles and take responsibility for ensuring any staff and students involved in research are familiar with the appropriate requirements. To achieve working to this level, the Good Clinical Practice Training for Staff Involved in Clinical Research policy outlines the expectation for staff and students to attend Good Clinical Practice (GCP) training, which is integral to the research experience and culture within NHS GG&C. Each person involved in a clinical trial must receive training in GCP appropriate to their roles and responsibilities.
The NHS GG&C Good Clinical Practice Training for Staff Involved in Clinical Research policy document is available here.
To book a GCP course (1/2 day or full day) please follow the links below:
We wanted to inform you that all Scottish recruitment data relating to your study/studies from the 1st April 2019 onwards is now visible on the UK Central Portfolio Management System (CPMS).
A National process is currently underway to identify interventional, multi-site clinical research studies that are both urgent and should benefit from the support of NIHR CRN, NHS research Scotland, and R&I to fully recruit and/or close in the next year. Chief Investigators will be contacted directly if their projects have been selected by the funder for the managed recovery process. There is no intention that this process will result in any pause or withdrawal of support for studies active within NHS GG&C.
Since July 2020, NHS GG&C have initiated a local process for restarting all studies paused due to COVID-19. Locally, work continues to ensure that all studies are able to return to normal recruitment activities. In addition to local efforts and participating in the UK Managed Recovery Process we will continue to prioritise (please note the order does not indicate priority levels):
NHS GGC locally sponsored/co-sponsored studies and in particular those involving early career researchers who have limited time to complete their funded clinical research.
Studies that include routine standard of care as an option
On going “urgent public health COVID-19” studies (e.g., Oxford-Astra/Zeneca, Novavax, Valneva and COV-BOOST vaccine trials; OCTAVE and SIREN etc)
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