Contact
CRIF Approval Group:
Email: CRIFDevelopmentApplications@ggc.scot.nhs.uk (Abbey Rea)
Tracey Hopkins
Lead Research Radiographer
Queen Elizabeth University Hospital
Call: 0141 201 2455
Email: tracey.hopkins@ggc.scot.nhs.uk
CRIF Approval Group for MR Optimisation
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.
Useful documents (hyperlinks):
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VOLUNTEER LAY REP POSITION AVAILABLE
Urgent Call for members
Clinical Research Imaging Facility Approval Group
COMMITTEE DETAILS:
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.
FOR FURTHER DETAILS PLEASE EMAIL – CRIFDevelopmentApplications@ggc.scot.nhs.uk
2024 – Lay Rep Application Form
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Volunteers Needed for MRI Scans
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.
Please click here for more information
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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
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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:
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 courses, including GCP can be booked here: – https://www.nhsresearchscotland.org.uk/research-in-scotland/facilities/clinical-research-facilities/glasgow-research-facility/training-and-courses/
Quality
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
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.
For further details please contact: griteam.gcrf@ggc.scot.nhs.uk
southteam.gcrf@ggc.scot.nhs.uk
National information – Anaesthesia, Perioperative Medicine, and Critical Care | NHS Research Scotland | NHS Research Scotland
Mental Health Research
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.
For further details please contact: mentalhealthteam.gcrf@ggc.scot.nhs.uk
National information – Mental Health | NHS Research Scotland | NHS Research Scotland
Renal Research
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.
For further details please contact: renalteam.gcrf@ggc.scot.nhs.uk National information – Renal | NHS Research Scotland | NHS Research Scotland
Surgical Research
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:
- Pancreatic cancer
- Head and neck cancer
- Oesophageal cancer
- Barret’s oesophagus
- Short bowel syndrome
- Sinusitis
- Sudden sensorineural hearing loss
For further details please contact: griteam.gcrf@ggc.scot.nhs.uk or southteam.gcrf@ggc.scot.nhs.uk
National information – Ear, Nose and Throat | NHS Research Scotland | NHS Research ScotlandCancer | NHS Research Scotland | NHS Research Scotland
Cardiovascular Research
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.
For further details please contact: cardiovascularteam.gcrf@ggc.scot.nhs.uk
Cardiovascular Patient & Public Involvement: Cardiovascular | NHS Research Scotland | NHS Research Scotland
Stroke Research
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.
For further details please contact: Karen.McBurnie@ggc.scot.nhs.uk or southteam.gcrf@ggc.scot.nhs.uk
National information – Stroke | NHS Research Scotland | NHS Research Scotland
Reproductive Health Research
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
For further details please contact: gcrf.obstetric@ggc.scot.nhs.uk
National information – Reproductive Health and Childbirth | NHS Research Scotland | NHS Research Scotland
Emergency Medicine Research
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.
- Acute unexplained Syncope
- Assay finding for New Diagnostic Devices
- Intracerebral Haemorrhage
- Sepsis
- Concussion
- Toxicology
- Acute coronary syndrome
For further details please contact: emergencymedicineteam.gcrf@ggc.scot.nhs.uk National information – Trauma and Emergencies | NHS Research Scotland | NHS Research Scotland
Diabetic Research
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.
For further details please contact: diabetesteam.gcrf@ggc.scot.nhs.uk
National information – Diabetes | NHS Research Scotland | NHS Research Scotland
Ophthalmology Research
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.
For further details please contact: southteam.gcrf@ggc.scot.nhs.uk
National information – Ophthalmology | NHS Research Scotland | NHS Research Scotland
Respiratory Research
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
For further details please contact: respiratoryteam.gcrf@ggc.scot.nhs.uk National information – Respiratory | NHS Research Scotland | NHS Research Scotland
Musculoskeletal Research
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
- fibromyalgia
For further details please contact: griteam.gcrf@ggc.scot.nhs.uk National information – Musculoskeletal Health | NHS Research Scotland | NHS Research Scotland
Dermatology Research
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.
For further details please contact: southteam.gcrf@ggc.scot.nhs.uk
National information – Dermatology | NHS Research Scotland | NHS Research Scotland
Gastrointestinal / Hepatology Research
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:
- ulcerative colitis
- Crohn’s disease
- Crohn’s perianal fistula
- primary biliary cholangitis
- primary schlerosing cholangitis
- hepatitis B
- alcoholic hepatitis
- oesophageal varices
- liver cirrhosis
For further details please contact: griteam.gcrf@ggc.scot.nhs.uk
southteam.gcrf@ggc.scot.nhs.uk National information – Gastroenterology | NHS Research Scotland | NHS Research Scotland
Neurological Research
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)
- Neurological Critical Care
- Critical Care
- Head & Neck Cancers
For further details please contact: southteam.gcrf@ggc.scot.nhs.uk National Information: Neuroprogressive and Dementia | NHS Research Scotland | NHS Research Scotland
Dental Research
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.
For further details please contact: shauna.culshaw@glasgow.ac.uk or southteam.gcrf@ggc.scot.nhs.uk
Paediatric Research
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
- Cardiology
- Emergency medicine
For further details please contact: paediatricteam.gcrf@ggc.scot.nhs.uk
National Information: Paediatrics | NHS Research Scotland | NHS Research Scotland
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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:
Engage Support Departments
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:
Governance check – Key points
GCP Training:
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.
Lab accreditation certificates
Good clinical practice
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.
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Congratulations, your research study has Management Approval! What happens next? R&I will ensure that all research studies are carried out in line with national guidelines as described in the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and other relevant government legislation.
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)
- Ensuring research teams are working to GCP standards as required by the EU Directive and Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended) (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.
Monitoring R&I has a responsibility to monitor research studies conducted on its premises under ICH-GCP, the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and the Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended).
Investigator responsibilities
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:
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
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************************ 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 table should help you decide if your project is research. Should you be unsure, please do not hesitate to contact the R&I office who will be happy to advise. For projects classed as clinical audit or service evaluation, the clinical 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.
Pharmacovigilance Office
Glasgow Clinical Trials Unit Robertson
Centre for Biostatistics
Boyd Orr Building
University of Glasgow
Glasgow G12 8QQ
Tel: +44(0)141 330 4744
Fax: +44(0)141 357 5588
Web: Can be accessed here
Pharmacovigilance Enquiries: pharmacovig@glasgowctu.org
Research facing primary care
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:
Published information data transparency
Document is available here
Research activity confirmation
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).
Managed recovery process
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.
(https://www.nihr.ac.uk/documents/guidance-on-the-managed-recovery-of-the-uk-clinical-research-portfolio/27749 _
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)
Handbook for Researchers involved in Non-CTIMPs (NHSGGC)
The Handbook for Researchers involved in Non-CTIMPs (NHSGGC) can be accessed here
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************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact *************************
Research affects us all; many of the technologies and therapies that we associate with the delivery of a modern health service have their origin in research. Therefore, research is essential to developing the evidence base for the successful promotion and protection of health and well-being and to modern and effective health and social services.
By its very nature, research can involve an element of risk, both in terms of return on investment and sometimes for the safety and well-being of research participants. Therefore proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and community care. Glasgow has a long history of groundbreaking research that has resulted in real benefits to patients around the globe.
The team at R&I are keen to foster this spirit and offer extensive support to new and experienced researchers
Research and Innovation Department
NHS Greater Glasgow & Clyde
Admin Building – Level 2
Gartnavel Royal Hospital
1053 Great Western Road
Glasgow
G12 0YN
About Us
R&I Approval Process
What is R&I approval?
R&I approval provides permission for a study to commence within NHS Greater Glasgow & Clyde (NHSGGC) and is required for all research studies involving NHS patients, their tissues or information, or studies involving NHS staff participating by virtue of their profession.
R&I approval ensures that the legal obligations of the board, outlined in the Research Governance Framework (2nd edition, 2006), are met and is issued following a formal review of the project by designated staff. In addition, R&I approval provides insurance/indemnity for research projects under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS) and is a condition of ethical favourable opinion. The Research Governance Framework can be found here
The R&I approval process ensures:
- An appropriate study sponsor is identified
- The scientific quality of the proposal (as required)
- That there is a favourable ethical opinion from an appropriate REC
- Appropriate regulatory authorisations are in place
- Appropriate risk/benefit analysis
- Provisions for appropriate insurance/indemnity
- The financial and resource implications of the study are assessed
- Appropriate trial registration
- All researchers have substantive or honorary NHS GG&C contracts
- All researchers are adequately qualified
- Support department approval
- Formal agreements or contracts with external bodies meet the requirements of the Board.
All research conducted within the NHS must have R&I Management Approval
Who provides R&I approval?
Commercial
Commercial research is defined as research that is funded and sponsored by a commercial organisation. A study is defined as industry sponsored and funded if a commercial company has developed the study protocol and is fully funding the additional costs of hosting the trial within the NHS. These trials must be supported by a Clinical Trials Agreement and appropriate indemnification.
The Co-ordinators for Commercial research in NHSGGC are:
Click here for further information on Commercial Research, including details on the specific therapy areas covered by each Portfolio Team
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Non Commercial NHSGGC Sponsored
A ‘sponsor’ is defined as – an individual or organisation that takes on responsibility for confirming there are proper arrangements in place to initiate, manage, monitor and finance a study. Sponsors must also ensure that appropriate indemnity is in place before research begins.
The Co-ordinators for Non Commercial research Sponsored by NHSGGC are:
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Low Risk Non Commercial NHSGGC Sponsored
We have deemed “low risk” studies to be all Study Types from the IRAS Form that are:
- Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
- Study involving qualitative methods only
- Study limited to working with human tissue samples (or other biological samples) and data (specific project only)
- Study limited to working with data (specific project only)
- Research tissue bank or Research database
- Patient Information Centres (PIC)
Click here for further information on NHS GG&C Sponsored Research, including details on the specific therapy areas covered by each Portfolio Team
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Non Commercial NHSGGC Hosted
For all Non Commercial studies that aren’t Sponsored by NHSGGC, the Research Facilitators will be:
Click here for further information on NHS GG&C Hosted Research, including details on the specific therapy areas covered by each Portfolio Team
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Low Risk Non Commercial NHSGGC Hosted
We have deemed “low risk” studies to be all Study Types from the IRAS Form that are:
- Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
- Study involving qualitative methods only
- Study limited to working with human tissue samples (or other biological samples) and data (specific project only)
- Study limited to working with data (specific project only)
- Research tissue bank or Research database
- Patient Information Centres (PIC)
- Basic Science Study involving procedures with human participants
Ms Rozanne Suarez Senior Research Administrator (Line manager – Mrs Ruth Pink)
Mr Euan Rennie Senior Research Administrator (Line Manager – Mr Ross Nicol)
Commercial therapy areas
Portfolio 1
Co-ordinator: Dr George Bakirtzis (Line Manager – Dr Melissa Robert)
- Haematology (Oncology only)
- Medical Genetics
- Oncology
- Pathology
Network: Cancer
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Portfolio 2
Co-ordinator: Mr Ross Nicol (Line Manager – Dr Melissa Robert)
- Cardiology
- Cardiovascular & Exercise Medicine
- Diabetes
- Gastroenterology
- Haematology (Non Oncology)
- Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy)
- Haepatology
- Infectious Diseases (Includes Infectious Diseases, Microbiology, Virology and Bacteriology)
- Metabolic and Endocrine (Includes Dietetics, Metabolic Disease and Human Nutrition)
- Orthopaedics
- Public Health (Includes Occupational Health, Sexual Health and Family Planning)
- Physiotherapy
- Renal and Urology
- Rheumatology
- Respiratory Medicine
- Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
Networks: Cardiovascular; Diabetes; Infectious Diseases; Stroke; Musculoskeletal Health;
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Portfolio 3
Co-ordinator: Mrs Ruth Pink (Line Manager – Dr Melissa Robert)
- A&E, Injuries and Emergencies
- Anaesthetics
- Critical Care
- Dermatology
- Ear, Nose and Throat (ENT)
- Mental Health (Includes Adolescent Psychiatry, Alcohol/Drugs Misuse, Adult Mental Health, Psychological Medicine/ Clinical Psychology, Family Psychiatry, Forensic Psychiatry and Learning Disability)
- Neurology (Non Stroke) (Includes Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache)
- Paediatrics
- Obstetrics, Gynaecology and Midwifery
- Ophthalmology
- Oral and Dental Health (Includes Oral Medicine, Dentistry/Community Dentistry and Dentistry – Restorative)
- Stroke
Networks: DEnDRON; Mental Health; Children’s Research Network
Non commercial NHSGGC sponsored therapy areas
Sponsor Co-ordinator: Ms Liz-Anne Lewsley (Line Manager – Dr Melissa Robert) (for ALL Oncology and CRUK co-ordinated Oncology studies)
Networks: Cancer; NRS Non- Malignant Haematology
- Haematology
- Ophthalmology
- Oncology
- Pathology
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Sponsor Co-ordinator: Ms Heather Flanagan (Line Manager – Dr Melissa Robert)
Networks / Speciality Group: Stroke; NRS Renal Speciality Group; Cardiovascular;
- Renal and Urology
- Cardiology (Colin Berry and John McMurray team led)
- Cardiovascular & Exercise Medicine
- Metabolic and Endocrine (Includes Dietetics, Metabolic Disease and Human Nutrition)
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Sponsor Co-ordinator: Ms Laura Alexander (Line Manager – Dr Melissa Robert)
Networks: Dental; NRS Oral & Dental Specialty Group; ENT; Cardiovascular Diabetes; Musculoskeletal Health;
- Anaesthetics
- Dermatology
- Diabetes
- Ear, Nose and Throat (ENT)
- Gastroenterology
- Medical Genetics
- Oral and Dental Health* (Includes Oral Medicine, Dentistry/Community Dentistry, Restorative Dentistry and Paediatric Dentistry)
- Orthopaedics
- Public Health (Includes Occupational Health, Sexual Health, Reproductive Health and Family Planning)
- Rheumatology
- Respiratory Medicine
- Stroke
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Sponsor Co-ordinator: Mrs Louise Ner (Line Manager – Dr Melissa Robert)
Networks:NRS Trauma and Emergencies; Infectious Diseases;Mental Health;Children’s Research Network;
- A & E, Trauma and Emergencies
- Critical Care
- Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy)
- Haepatology
- Infectious Diseases (Includes Infectious Diseases, Microbiology, Virology and Bacteriology)
- Mental Health (Includes Adolescent Psychiatry, Alcohol/Drugs Misuse, Adult Mental Health, Psychological Medicine/ Clinical Psychology, Family Psychiatry, Forensic Psychiatry and Learning Disability)
- Neurology (Non Stroke) (Includes Dementia, Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache)
- Obstetrics, Gynaecology and Midwifery
- Paediatrics and Neonatal
- Physiotherapy
- Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
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Based on disease area for:
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Low Risk Non Commercial NHSGGC Sponsored
Research Facilitator: Mr Adam Wade (Line Manager – Mrs Louise Ner)
We have deemed “low risk” studies to be all Study Types from the IRAS Form that are:
- Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
- Study involving qualitative methods only
- Study limited to working with human tissue samples (or other biological samples) and data (specific project only)
- Study limited to working with data (specific project only)
- Research tissue bank or Research database
- Patient Information Centres (PIC)
Non commercial NHSGGC hosted therapy areas
Portfolio 1
Research Facilitator: Ms Sandi Conway (Line Manager – Dr George Bakirtzis)
- A & E, Injuries and Emergencies
- Critical Care
- Ear, Nose and Throat (ENT)
- Haematology (Oncology only)
- Medical Genetics
- Mental Health (Includes Adolescent Psychiatry, Alcohol/Drugs Misuse, Adult Mental Health, Psychological Medicine/ Clinical Psychology, Family Psychiatry, Forensic Psychiatry and Learning Disability)
- Neurology (Non Stroke) (Includes Dementia, Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache)
- Obstetrics, Gynaecology and Midwifery
- Oncology
- Ophthalmology
- Oral and Dental Health (Includes Oral Medicine, Dentistry/Community Dentistry and Dentistry – Restorative)
- Pathology
Network: Cancer; DEnDRON; Mental Health; Children’s Research Network
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Portfolio 2
Research Facilitator: Mrs Karen Puglisevich Chase (Line Manager – Mr Ross Nicol)
- Anaesthetics
- Cardiology
- Cardiovascular & Exercise Medicine
- Dermatology
- Diabetes
- Gastroenterology
- Haematology (Non Oncology)
- Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy)
- Haepatology
- Infectious Diseases Includes Infectious Diseases, Microbiology, Virology and Bacteriology)
- Metabolic and Endocrine) (Includes Dietetics, Metabolic Disease and Human Nutrition)
- Orthopaedics
- Public Health (Includes Occupational Health, Sexual Health, Reproductive Health and Family Planning)
- Physiotherapy
- Renal and Urology
- Rheumatology
- Respiratory Medicine
- Stroke
- Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
Networks: Cardiovascular; Diabetes; Infectious Diseases; Stroke; Children’s Research Network; Musculoskeletal Health
Thanks for your feedback!
Harm reduction refers to policies, programmes, interventions and practices that aim to minimise the negative health, social and legal impacts associated with drug and/or alcohol use.
Harm reduction focuses on positive change and working with people without judgement, coercion, discrimination, or requiring that people stop using drugs or alcohol as a precondition of support.
Alcohol
- Alcohol Change UK Charity – Alcohol Change UK is a leading UK alcohol charity, formed from the merger of Alcohol Concern and Alcohol Research UK. Alcohol Change UK works for a society that is free from the harm caused by alcohol. Alcohol Change UK creates evidence-driven change by working towards five key changes: improved knowledge, better policies and regulation, shifted cultural norms, improved drinking behaviours, and more and better support and treatment.
- Alcohol Focus Scotland | Working to Reduce Alcohol Harm – Alcohol Focus Scotland (AFS) are the national alcohol charity working to reduce harm caused by alcohol, this is done by promoting evidence-based, cost-effective policy measures
- Alcohol | NHS inform Information on drinking sensibly, knowing your limits and getting support for alcohol abuse
- SAFER Initiative – The World Health Organisation (WHO), in collaboration with international partners, launched the SAFER Initiative in 2018 alongside the United Nations third high-level meeting on prevention and control of noncommunicable diseases (NCDs). SAFER was developed to deliver health and development gains in order to meet global, regional and country health and development goals and targets and to reduce human suffering and pain caused by the harmful use of alcohol.
- World Health Organisation (WHO) – European Region – The European framework for action on alcohol 2022 – 2025 draws on the latest evidence on alcohol attributable harm and the best evidence to reduce such harm. It reflects the context that Member States find themselves in, including dealing with the impacts of the COVID-19 pandemic, and highlights priority areas for action.
Drugs
- Cocaine Toolkit – This toolkit provides guidance primarily for staff working with individuals currently in treatment with Opiate Substitution Therapy (OST) for opiate dependence and using cocaine but may also be relevant to individuals presenting with primary cocaine use.
- European Union Drug Agency (EUDA) – The EUDA mission focuses on contributing to EU preparedness on drugs through four main actions: anticipate, alert, respond and EUDA. The EUDA is a source of drug-related expertise in Europe sharing independent, scientifically validated knowledge, alerts and recommendations.
- GGC ADRS OST Prescribing Guideline – This guidance is aimed at all independent prescribers, doctors and staff involved in the community care of individuals who use opioid drugs and in particular new and inexperienced prescribers.
- Harm Reduction International (HRI) – The HRI use data and advocacy to promote harm reduction and drug policy reform. Rights-based, evidence-informed responses to drugs contribute to healthier, safer societies.
- Naloxone – Naloxone is a drug that can reverse the effects of opioid drugs like heroin, methadone, opium, codeine, morphine and buprenorphine. Naloxone is only effective for opioid overdoses and won’t work with on other drugs, however as most drug related deaths in Scotland involve more than one drug the use of naloxone is advised and may help keep the person someone alive until medical help arrives. Naloxone is available in two different forms, Prenoxad, which is a pre-filled syringe or Nyxoid, which is a nasal spray. Naloxone kits are available to anyone who may be supporting someone at risk or likely to witness an overdose. Scottish Families provide a ‘Click & Deliver’ take-home naloxone service to anyone living in Scotland who is over the age of 16 (for injection kit) and 14 (for nasal kit). Scottish Drugs Forum have also developed a short e-learning course that will show you how to respond to an overdose and administer Naloxone. Every pharmacy in Scotland also has Naloxone available for use in an emergency either within the premises or for anyone overdosing near the premises. The pharmacy can administer the Naloxone or provide the kit to a member of the public who has had training in Naloxone and allow them to administer.
- NHS Inform – Drug information and guidance.
- Nitazenes – The Scottish Drugs Forum (SDF) has published an updated resource on nitazenes, a group of synthetic opioids that have been increasingly detected in Scotland’s drug supply and are linked to rising numbers of overdoses, hospitalisations and deaths.
- WEDINOS – Welsh Emerging Drugs & Identification of Novel Substances Project – The Welsh Drug Checking Service WEDINOS provides a robust mechanism for the collection and testing of unknown / unidentified or new psychoactive substances and combinations of substances, and the production and dissemination of pragmatic harm reduction advice.
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Alcohol
- Responding to Substance Use (Including Vapes and Other Nicotine Products) in Schools – Scottish Government’s 2026 response to substance use in schools.
- Preventing Harm, Promoting Recovery: Scotland’s Alcohol & Drugs Strategic Plan 2026-2035 – sets out the Scottish Governments direction for addressing alcohol and drug related harms in Scotland through a public health, evidence-based approach. The Plan is grounded in a commitment to a human rights-based approach, ensuring that everyone affected by alcohol and drugs is treated with dignity, respect and compassion, in line with the Charter of Rights for People Affected by Substance Use.
- Rights, Respect and Recovery – 2018. The Scottish Government 2018 Alcohol and Drugs Strategy.
- Scottish Government Alcohol Framework 2018: Preventing Harm – 2018. A framework which sets out the Scottish Government’s national prevention aims on alcohol.
- European Union Drugs Agency European School Survey Project on Alcohol and Other Drugs – 2024. Key findings from the survey.
- Alcohol and Drug Partnerships: Delivery Framework – 2019. Framework for local partnerships between health boards, local authorities, police and voluntary agencies working to reduce the use of and harms from alcohol and drugs.
- Count 14 – 2019. In 2019 Count 14 campaign was launched to raise awareness of the UK Chief Medical Officers’ Low Risk Drinking Guidelines, and what 14 units mean in terms of specific alcoholic drinks.
- Alcohol Brief Interventions National Guidance 2019-2020 – 2019. The guidance outlines what should be considered to ensure appropriate planning and delivery of ABIs and the related reporting requirements for NHS Boards and their Alcohol and Drug Partnership (ADP) partners.
- WHO: Global Status Report On Alcohol and Health – 2018. World Health Organisation report which presents a comprehensive picture of alcohol consumption and the disease burden attributable to alcohol worldwide.
- Getting Our Priorities Right: Good Practice Guidance – 2013. Good practice guidance for all agencies and practitioners working with children, young people and families affected by problem alcohol and/or drug use. This includes sections on information sharing, multi-agency working and strategic leadership.
- Monitoring and Evaluating Scotland’s Alcohol Strategy programme – 2011 to present. NHS Scotland set up the Monitoring and Evaluating Scotland’s Alcohol Strategy (MESAS) programme to evaluate Scotland’s alcohol strategy. Annual monitoring reports present data on alcohol sales, alcohol price, self-reported consumption, alcohol-specific deaths, alcohol-related hospitalisations and social harms.
- Alcohol (Scotland) Act – 2010. The act made provision to regulate the sale of alcohol and licensing of premises on which alcohol is sold.
- Supporting the Development of Scotland’s Alcohol and Drug Workforce – 2010. A Scottish Government and COSLA statement which outlines the important roles and contributions of those directly involved in workforce development. It outlines learning priorities for all levels of the alcohol and drug workforce.
- Charter of Rights for People Affected by Substance Use in Scotland. The Charter of Rights aims to help people to know what their rights are, and know what support they can expect to receive from services.
Drugs
- Responding to Substance Use (Including Vapes and Other Nicotine Products) in Schools – Scottish Government’s 2026 response to substance use in schools.
- Preventing Harm, Promoting Recovery: Scotland’s Alcohol & Drugs Strategic Plan 2026-2035 – sets out the Scottish Governments direction for addressing alcohol and drug related harms in Scotland through a public health, evidence-based approach. The Plan is grounded in a commitment to a human rights-based approach, ensuring that everyone affected by alcohol and drugs is treated with dignity, respect and compassion, in line with the Charter of Rights for People Affected by Substance Use.
- Rights, Respect and Recovery – 2018. The Scottish Government 2018 Alcohol and Drugs Strategy.
- A Whole-system Response to Drug Prevention in the UK – 2025. An independent report published 28 May 2025 by the UK Advisory Council on the Misuse of Drugs on the long-term prevention of drug use and related harms among young people.
- Scottish Drug Related Deaths Reports for 2023
- National Mission – Drug Deaths Plan 2022-2026 – 2022. The aim of the National Mission is to reduce drug deaths and improve the lives of those impacted by drugs. This document shows how this will be done.
- The Lancet Public Health – Premature Mortality in People Affected by Co-Occurring Homelessness, Justice Involvement, Opioid Dependency and Psychosis – September 2022. A retrospective cohort study using linked administrative data.
- Changing Lives: Our Final Report – July 2022. From the Scottish Drug Deaths Taskforce.
- “Taking Away the Chaos” – the health needs of people who inject drugs in public places in Glasgow City Centre.
- Alcohol and Drug Partnerships: Delivery Framework – 2019. Framework for local partnerships between health boards, local authorities, police and voluntary agencies working to reduce the use of and harms from alcohol and drugs.
- Why Are Drug-Related Deaths Among Women Increasing in Scotland? – 2018.
- Rights, Respect and Recovery – 2018. Scotland’s strategy to improve health by preventing and reducing alcohol and drug use, harm and related deaths.
- Psychoactive Substances Act – 2016. The act makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess on custodial premises, import or export psychoactive substances.
- ‘What Works’ in Drug Education and Prevention – 2016. The Scottish Government published a literature review on ‘what works’ in substance use education and prevention, including schools-based approaches and prevention beyond schools.
- Getting Our Priorities Right: Good Practice Guidance – 2013. Good practice guidance for all agencies and practitioners working with children, young people and families affected by problem alcohol and/or drug use. This includes sections on information sharing, multi-agency working and strategic leadership.
- Home – Harm Reduction International – Harm Reduction International(HRI) use data and advocacy to promote harm reduction and drug policy reform. Rights-based, evidence-informed responses to drugs contribute to healthier, safer societies.
- EUDA home page | www.euda.europa.eu. – The European Union Drug Agency (EUDA) mission focuses on contributing to EU preparedness on drugs through four main actions: anticipate, alert, respond and EUDA. The EUDA is a source of drug-related expertise in Europe sharing independent, scientifically validated knowledge, alerts and recommendations.
- Medication Assisted Treatment (MAT) standards: access, choice, support – gov.scot – Evidence based standards to enable the consistent delivery of safe, accessible, high-quality drug treatment across Scotland. These are relevant to people and families accessing or in need of services, and health and social care staff responsible for delivery of recovery oriented systems of care.
- Needle Exchange Surveillance Initiative (NESI) August 2024
- Medicated Assisted Treatment (MAT) standards. Evidence based standards to enable the consistent delivery of safe, accessible, high-quality drug treatment across Scotland.
- Charter of Rights for People Affected by Substance Use in Scotland. The Charter of Rights aims to help people to know what their rights are, and know what support they can expect to receive from services.
- Misuse of Drugs Act – 1971. The Misuse of Drugs Act 1971 is a UK law that regulates the production, supply, possession and use of controlled drugs.
Public Health Scotland
- Defining Prevention – 2026. This paper sets out how the Scottish Government Prevention Unit defines prevention and provides guidance on how this is applied in practice.
- Interventions to Reduce Harms from Cocaine – 2025. A scoping review of interventions aimed at reducing harms associated with cocaine use in Scotland: The conclusions from the report are intended to inform policy and practice developments, support service managers and third sector organisations prioritise interventions in reducing cocaine harm.
- Scotland’s Public Health Priorities – gov.scot (www.gov.scot) – 2018. The Scottish Government and COSLA agreed six Public Health Priorities in June 2018.
Other
- Prisoners in Scotland face mental health and substance use crisis after release, research reveals | About | University of Stirling – People released from prison in Scotland are facing a mental health and substance use crisis, according to a first-of-its-kind study. The University of Stirling-led research, tracking more than 8,000 prisoners over four years, shines a spotlight for the first time on their unmet needs on release from prison.
- SRC Policy Scoping Review McFall and Nugent Final Version 061025. This scoping review has been undertaken to explore the policy landscape in Scotland as it relates to women in recovery.
- The Illicit Project was developed by researchers at the University of Sydney, with funding from the Centre of Research Excellence in Prevention and Early Intervention in Mental Illness & Substance Use. Clinically validated education that teaches neuroscience and harm reduction to young people.
- Co-Occurring Substance Use and Mental Heath Concerns in Scotland: A Review of the Literature and Evidence – November 2022.
- Hard Edges Report – 2019. Report highlighting the complexity of the lives of people facing multiple disadvantage in Scotland.
- National Standards for Community Engagement – 2019. Scottish Community Development Centre: The National Standards for Community Engagement are good-practice principles designed to improve and guide the process of community engagement
- Scottish Schools Adolescent Lifestyle and Substance User Survey (SALSUS) – 2018. SALSUS is our main source of information on alcohol, drug and tobacco use among Scotland’s young people. It is vital because the survey data acts as the official measures of progress towards targets for reducing smoking and drug use, and to monitor their priority of addressing harmful drinking.
- A Connected Scotland – 2018. The Scottish Government’s first national strategy to tackle social isolation and loneliness and to build stronger social connections.
- Turning the Tide through Prevention – 2018. NHS Greater Glasgow and Clyde’s Public Health Strategy 2018-2028 which emphasises the importance of the prevention of ill health and improvement of wellbeing in order to increase the healthy life expectancy of the whole population and reduce health inequalities.
- Recovery Oriented Systems of Care (ROSC) – 2018. A co-ordinated network of community based services and supports that is person centered and builds on strengths and resilience of individuals, families and communities
- Transforming Psychological Trauma: Knowledge and Skills Framework – 2017. A framework designed to support the development of the Scottish workforce in both recognising existing skills and knowledge and also helping them and their organisations to make informed decisions about the most suitable evidence-based training to meet gaps.
- Restoring the Public Health Response to Homelessness in Scotland – 2015. A report which brings together academic evidence and service experience within Scotland to provide a route map for Public Health to engage fully in the prevention and mitigation of homelessness and its health consequences.
- Community Empowerment (Scotland) Act – 2015. The act sets out national outcomes and seeks to empower community bodies through the ownership or control of land and buildings, and by strengthening their voices in decisions about public services.
- Children and Young People (Scotland) Act – 2014. An act to make provision about the rights of children and young people; and services and support for children and young people.
- Equally Well Review – 2013. A review of the Scottish Government’s national policy on health inequalities, including what works to address health inequalities and where to focus activity.
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Training Opportunities
Please find below a range of organisations offering alcohol and drug related training throughout Greater Glasgow and Clyde. Please note there may be a cost attached to some of the training below.
National Alcohol and Drug Competency Framework and Learning Directory
The Alcohol and Drugs Competency Framework describes the practice-specific knowledge and skills required by those whose primary role is to support people affected by substance use. These are focused on embedding care, compassion and empathy in service delivery.
The Drug and Alcohol Learning Directory complements this Framework by providing access to a range of resources that support development of the knowledge and skills underpinning each of the five key themes. These two resources are designed to be used together to support comprehensive learning and development.
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