The Greater Glasgow and Clyde Substance Misuse Education Working Group consists of NHS and Education staff who have worked together to create the ‘Substance Misuse Toolkit’. This online resource contains quality assured substance misuse education resources to support staff working with young people in both education and community settings. Resources include lesson plans, resource packs and relevant websites.
The Substance Misuse Toolkit aims to reduce harm caused by substance misuse by:
- Equipping staff with the knowledge and confidence they require to teach pupils about the effects, risks and consequences of substance use by providing them with a range of materials and methodologies.
- Encouraging learners to make informed choices about alcohol, drugs and tobacco.
- Supporting an age appropriate and inclusive approach to education in relation to substances within the context of a Curriculum for Excellence.
- Identifying evidence based resources and approaches and share good practice with staff across the Greater Glasgow and Clyde area.
- Ensuring that resources are up to date and fit for purpose.
- Ensuring ongoing quality assurance processes are in place to monitor and further develop the site.
Quality Assurance
The Greater Glasgow and Clyde Substance Misuse Education Working Group meets regularly to ensure that resources included within the Substance Misuse Toolkit are evidence based, up to date and of a high standard. The group consults with key stakeholders regarding the accessibility, content, usefulness and areas for improvement.
The Greater Glasgow and Clyde Substance Misuse Education Working Group has developed a quality assurance tool to assess the content of resources against agreed indicators. The tool is consistent with the principles and values of local and national policy including Curriculum for Excellence, GIRFEC and the Greater Glasgow and Clyde Alcohol and Drug Prevention and Education Model. Resources which meet the standards set by this review process are then incorporated into the Substance Misuse Toolkit.
The Quality Assurance Tool Template can be accessed here.
Policy Context
The need to support children and young people to make positive choices about alcohol, drugs and tobacco has been highlighted by a number of national and local policy documents. Substance Misuse Education is a priority within the Greater Glasgow and Clyde Alcohol and Drug Prevention & Education Model and is a Health & Wellbeing organiser within Curriculum for Excellence. Getting it Right for Every Child (GIRFEC) ensures that wellbeing is central to all of our work in meeting children and young people’s needs.
Further information on the policy context can be found here.
NHS Research Scotland definition
Research Governance concerns setting standards to improve research quality and safeguard the public. It involves enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring lessons are learned and preventing poor performance and misconduct.
A broad range of regulations, principles and standards of good practice exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.
Research governance applies to everyone connected to healthcare research including Chief investigators, health care professionals, researchers, and support staff.
Introduction
Research Governance is essential for the conduct of research on humans and encompasses regulations, good practices, and world- wide collaboration to create an environment ensuring safety of the participants while conducting the studies and trials and the collection and analysis of data to quality standards.
The Research Governance team at NHS Greater Glasgow and Clyde is a support department to researchers and teams and is made up a range of highly qualified individuals such as PhD level scientists with research and Industrial experience, an engineer, auditors and monitors with key skills in QA, clinical trials, Industry, medical devices, drug development, Intellectual property and safety.
The team provide Sponsor support starting from the grant stage of a study, to protocol development, to assessing vendors, to identifying and managing risk and overseeing the conduct of the study, to managing non-compliances, protocol deviations and serious breaches of GCP. This activity covers hundreds of sites across the UK and internationally as NHS GG&C and Glasgow University researchers lead on worldwide research.
The QA team carry out GCP audits, a requirement of the Clinical Trial Regulations, engage with third parties to audit our own activities and provide a Quality system for the production and maintenance of SOPS incorporating all of the departments involved in research e.g. Imaging, safehaven, Bio repository.
The team activity is inspected by the MHRA during Regulatory Sponsor inspections. The Governance manager is a lead for these inspections involving all departments and other organisations. Together with the QA manager they manage the outcomes of inspections and ensure that the findings are addressed.
The Team are also responsible for the oversight of other studies such as surgical, medical devices and hosted studies including commercial and other academic led studies. Due to limited resources this is managed by assessing risk and focusing on areas which may potentially pose safety or quality issues.
During the 2020 COVID-19 pandemic the team led the development and implementation of a process to oversee safety of research participants still taking part in sponsored clinical research led by NHSGGC and its partners.
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.
Who are we?
Registering a project
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
Please visit our website for more info
www.woshealthinnovation.scot
Diabetes SBRI
Deliver safe and better care for people in Scotland with diabetes, Phase 1 SBRI Competition
The following link provides a recording of the launch event held on 17th August 2020 which was attended by some 79 participants: Click here
The presentations from the event can be viewed here:
01 Brian Kennon Diabetes SBRIs B Kennon 17th Aug 2020
02 Andrew Fowlie – sbri slides Andrew Fowlie 17-Aug
03 Jon Hazell_SBRI APPLICANT BRIEFING DIABETES
04 Sandra AI diabetic Ulcer infograph – S.MacRury
04 Sandra SBRI Diabetes Foot Disease pptx V3
05 Stuart Ritchie Innovation meeting – August 2020
06 Maria Talla Osteoporosis
07 Paul McGinness (Storm) SBRI August 2020
SBRI Diabetes & Endocrine Briefing Event, 17 Aug – Agenda
SBRI Launch event Q&As
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.
You need to submit a separate application for each challenge you wish to apply for. Further details can be found at: https://apply-for-innovation-funding.service.gov.uk/competition/664/overview
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.
For more information about the response mode grant scheme please see our website: Response Mode Research Grants – Open for Applications – Chief Scientist Office or contact Louise Campbell or Alan McNair.
—————————————————————————————————————————————————————————–
Applications are Invited for the Endowment Research Facility Investment fund
Purpose of fund:
Investment in Equipment, Information and Communication Technology CT and physical infrastructure for research facilities and activity”.
Please complete Endowment Funds Block Grant Application Form and submit to michelle.mcdermott@ggc.scot.nhs.uk
Deadline for submission of applications: Wednesday 20 November 2024 for 26 November 2024 meeting
Automatic registration of clinical trials
On the 20th of October the HRA have announced a partnership with ISRCTN, which will enable automatic registration of clinical trials.
Registering studies before the first participant is recruited is one of the pillars of research transparency, it reduces research waste and prevents duplication. A key commitment they make in the Make it Public strategy is to register trials on behalf of sponsors. The aim is to ease the burden on sponsors and help to make transparency easy and the norm.
Chapter 17 – NHS GG&C Clinical Research Facility – Clinical
SOP 17.001 – Adult Emergency Resuscitation Procedures in GCRF
- Author Name: Naomi Hickey
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.003 – Research Participant’s Clinical Measurements
- Author Name: Karen Duffy
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.005 – Urinalysis
- Author Name: Linda Wilson
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.006 – Refrigerator and Freezer Unit Use and Monitoring
- Author Name: Barbara McLaren
- Version: 4
- Active Date: 31/12/2018
- Review Date: 31/12/2023
SOP 17.007 – Use of laboratory centrifuge
- Author Name: Dominic Rimmer
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.008 – Recording an Electrocardiograph (ECG)
- Author Name: Barbara McLaren
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.009 – Obtaining Spirometry Measurements
- Author Name: Hilary Peddie
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.012 – Obtaining Informed Consent (Adults)
- Author Name: Helen Hart
- Version: 6
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 17.013 – Study Site Coordination and Delivery of an ATIMP Study
- Author Name: Karen Duffy
- Version: 1
- Active Date: 31/12/2019
- Review Date: 31/12/2023
Associated Documents
-
Form 17.013A – Clinical Alert Template for Genetically Modified Advanced Therapy IMP
-
Form 17.013B – Inter-site Communication Form for Genetically Modified Advanced Therapy IMP Delivery
SOP 17.015 – Measurement of Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV)
- Author Name: Barbara McLaren
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.016 – Ambulatory Electrocardiograph Monitoring
- Author Name: Karen Duffy
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.020 – Monitoring Expiration of Clinical Consumables
- Author Name: Barbara McLaren
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 17.020A – Glasgow Clinical Research Facility Consumable Checklist
SOP 17.025 – Initialising the 24 hour BP monitor
- Author Name: Barbara McLaren
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.026 – Use of Ambulatory Blood Pressure Monitoring Machines
- Author Name: Barbara McLaren
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.027 – Role of GCRF Nurse Coordinator
- Author Name: Naomi Hickey
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.028 – Management of Hypoglycaemia in adults
- Author Name: Hilary Peddie
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.029 – Management of Anaphylaxis in Adults and Paediatrics
- Author Name: Naomi Hickey
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.030 – Measuring and Recording Blood Pressure using digital or electronic equipment
- Author Name: Karen Duffy
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.032 – Return of stock drugs and IMPs
- Author Name: Barbara McLaren
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 17.032A – Glasgow Clinical Research Facility Spot Check Rota
SOP 17.034 – Storage and management of Medication
- Author Name: Dominic Rimmer
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.035 – Administration of a Vaccine
- Author Name: AnneMarie Munro
- Version: 2
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 17.041 – GCRF Management of Samples
- Author Name: Barbara McLaren
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.042 – Paediatric Emergency Resuscitation Procedures in GCRF
- Author Name: Susanne Cathcart
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 17.042A – GCRF QEUH Paediatric Emergency Trolley Checklist
SOP 17.044 – NHS Research Scotland Children s Network SOPs in GCRF
- Author Name: Susanne Cathcart
- Version: 3
- Active Date: 31/12/2019
- Review Date: 31/12/2023
SOP 17.045 – Case Report Form (CRF) Completion
- Author Name: Dominic Rimmer
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.047 – Transfer of the Unwell Research Participant to Acute Care
- Author Name: Steven Henderson
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.048 – GCRF Risk Assessment and Mitigation
- Author Name: Karen Duffy
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.052 – Grantbio Shaker-Incubator
- Author Name: Shona Perry
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.053 – Blood Sampling from a Peripheral Venous Catheter
- Author Name: Naomi Hickey
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 17.055 – Obtaining Informed Consent and Assent (Children)
- Author Name: Naomi Hickey
- Version: 1
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Chapter 21 – NHS GG&C Pharmacy – Sponsor IMP Management
SOP 21.001 – Review of grant applications with respect to IMP manufacture, distribution and management
- Author Name: Elizabeth Douglas
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.001A – Summary of Pharmacy and IMP Related Costs (Grants/Support)
-
Form 21.001B – Template Specification for IMP Manufacturing Activity
SOP 21.003 – Sponsor IMP Management and Accountability
- Author Name: Pamela Surtees
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.003A – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist: Site IMP Management & Accountability Manuals
-
Form 21.003B – NHS GG&C Sponsored/Co-Sponsored Clinical Trials Checklist: Sponsor IMP Management & Accountability Manuals
-
Form 21.003C – IMP Management File Note
-
Form 21.003D – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist:
-
Form 21.003E – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist:
SOP 21.004 – Sponsor management of IMPs permanently stored external to pharmacy
- Author Name: Elizabeth Douglas
- Version: 1
- Active Date: 31/12/2020
- Review Date: 31/12/2023
Associated Documents
-
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
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
- Author Name: Elizabeth Douglas
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.005A – Defective Medicines Alert Tracker for Sponsored/Co-sponsored by NHS GG&C
SOP 21.007 – Site-to-site transfer of Investigational Medicinal Products
- Author Name: Elizabeth Douglas
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 21.008 – Development and approval of labelling text for IMPs and NIMPs
- Author Name: Pamela Surtees
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.008A – NHS GG&C IMP Label Specification Sponsor Approval Form
SOP 21.009 – Expiry Date Monitoring for Study Products Supplied as Part of a Clinical Trial
- Author Name: Pamela Surtees
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 21.010 – Disposal of Investigational Medicinal Products and other study products
- Author Name: Pamela Surtees
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
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
- Author Name: Paula Morrison
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 21.012 – R&I Pharmacy Review Of Sponsored Clinical Trials
- Author Name: Elizabeth Douglas
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.012A – Technical Agreement, Contract and Work Order Checklist for delegation of IMP responsibilities
-
Form 21.012B – R&I Pharmacy Task Tracker
-
Form 21.012C – Sponsor Risk Assessment for IMP Delivery from Participating Study Site to Participant s Home
SOP 21.013 – Testing of Emergency Unblinding System for Blinded research
- Author Name: Elizabeth Douglas
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.013A – Emergency Unblinding Test Plan (Non-Automated Process)
-
Form 21.013B – Record of IVRS/IWRS systems review for emergency unblinding
SOP 21.014 – Sponsor Investigational Medicinal Product Management Document Control Process
- Author Name: Paula Morrison
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.014A – Sponsor Pharmacy Investigational Medicinal Product (IMP) Management Document Control Log
SOP 21.016 – R&I Pharmacy Site Initiation Training
- Author Name: Pamela Surtees
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.016A – NHS GG&C Sponsored/Co-sponsored Study product Checklist: Site Pharmacy Initiation Training Form
SOP 21.017 – Regulatory approval of IBs not submitted for approval by commercial partner
- Author Name: Paula Morrison
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 21.018 – Sponsor Pharmacy Review of Study Amendments
- Author Name: Angela Carruth
- Version: 2
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 21.019 – Reconciliation of Study Product at site or study close out
- Author Name: Pamela Surtees
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 21.020 – Periodic review/end of Trial Management File check for studies Sponsored, Co-Sponsored or facilitated by NHSGGC
- Author Name: Pamela Surtees
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 21.020A – Checklist for periodic review/end of trial TMF(Section 10) check for studies Sponsored, Co-Sponsored or facilitated by NHSGGC
SOP 21.023 – IVRS/IWRS IMP management specification development, testing & training
- Author Name: Elizabeth Douglas
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
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
- Author Name: Elizabeth Douglas
- Version: 1
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Chapter 22 – NHS GG&C Pharmacy – Hosted CTIMP
Chapter 23 – NHS GG&C Pharmacy – Hosted Non-CTIMPs
SOP 23.001 – Role of Pharmacy Services in Support of Other Clinical Research within NHSGGC: an Overview
- Author Name: Kirsty McLeish
- Version: 3
- Active Date: 31/12/2024
- Review Date: 31/12/2027
Chapter 50 – NHS GG&C General
SOP 50.009 – Project Numbering
- Author Name: Kirsty Theron
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 50.010 – Project Data Entry on SReDA
- Author Name: Radek Penar
- Version: 6
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 50.011 – Setting up and Maintaining Research and Innovation project files (for R&I office approvals)
- Author Name: Kirsty Theron
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 50.013 – Setup and maintenance of training files: NHS
- Author Name: Nicola Thomson
- Version: 4
- Active Date: 31/12/2019
- Review Date: 31/12/2023
SOP 50.016 – Development of new processes within NHS GG&C R&I
- Author Name: Paul Gribbon
- Version: 4
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 50.017 – Clinical Research & Innovation Document Management
- Author Name: Paul Gribbon
- Version: 4
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 50.019 – Independent Stakeholder Assessment
- Author Name: Paul Gribbon
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 50.020 – eCRF User Acceptance Testing (Glasgow Clinical Trials Unit)
- Author Name: Paul Gribbon
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 50.021 – Participant recruitment sourcing and recording
- Author Name: Radek Penar
- Version: 2
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 50.022 – Preparation and Maintenance of Terms of Reference
- Author Name: Paul Gribbon
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 50.023 – Management of SOPs within NHS GG&C R&I
- Author Name: Paul Gribbon
- Version: 1
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 50.024 – Management of the Central Portfolio Management System
- Author Name: Radek Penar
- Version: 1
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 50.025 – Quality Check of Project Entries on SReDA
- Author Name: Radek Penar
- Version: 1
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 50.026 – Internal QC checks of Scottish Research Database Application (SReDA)
- Author Name: Radek Penar
- Version: 4
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 50.027 – Service Level and Operational Level Agreements
- Author Name: Paul Gribbon
- Version: 1
- Active Date: 31/12/2024
- Review Date: 31/12/2027
Chapter 51 – NHS GG&C Sponsor R&I
Chapter 52 – NHS GG&C Hosted R&I
SOP 52.001 – Obtaining NHS Management Approval Non-commercial
- Author Name: Karen Chase
- Version: 3
- Active Date: 31/12/2020
- Review Date: 31/12/2023
SOP 52.002 – Obtaining NHS Management Approval for Commercial Studies
- Author Name: Ross Nicol
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 52.003 – R&I Review of Amendments
- Author Name: Ruth Pink
- Version: 5
- Active Date: 31/12/2022
- Review Date: 31/12/2025
Associated Documents
-
Form 52.003A – R&D Amendment Checklist
-
Form 52.003B – Amendment Approval Email Category A or B
-
Form 52.003C – Amendment Approval/Acknowledgement Emails – Substantial Amendment
-
Form 52.003D – Amendment Approval/Acknowledgement Emails – Substantial Amendment & Protocol Amendment
-
Form 52.003E – Amendment Acknowledgement
SOP 52.004 – R&I Contract Development and Review
- Author Name: Ross Nicol
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 52.005 – Review of Research Passport and issuing of Honorary Research Contracts/Letters of Access
- Author Name: Rozanne Suarez
- Version: 5
- Active Date: 31/12/2024
- Review Date: 31/12/2027
Associated Documents
-
Form 52.005A – Letter Template – Honorary Research Contract
-
Form 52.005B – Letter Template – Letter of Access
-
Form 52.005C – Letter Template – Letter of Access (Staff Studies Only)
-
Form 52.005D – Letter Template – Letter of Access (NHS to NHS)
SOP 52.007 – Authorisations for NHS resource use in R&D submissions
- Author Name: Karen Chase
- Version: 3
- Active Date: 31/12/2020
- Review Date: 31/12/2023
Associated Documents
-
Form 52.007A – Imaging Research – Research Trial Imaging Details
-
Form 52.007B – Sample email of notification to Head of Clinical Department or Clinical Service Manager
SOP 52.009 – Validation of Project Submissions for R&I Management Approval: NHS
- Author Name: Shanice White
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 52.013 – Process for approving studies and trials involving a Genetically Modified Organism (GMO)
- Author Name: Caroline Watson
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 52.014 – Archiving Essential Documents from Clinical Research Process for Hosted Research
- Author Name: Radek Penar
- Version: 1
- Active Date: 31/12/2017
- Review Date: 31/12/2023
SOP 52.015 – Phase I First in Human Committee Review Process
- Author Name: Emma Whitelaw
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Chapter 53 – NHS GG&C Sponsor Governance
SOP 53.001 – Handling Urgent Safety Measures for Clinical Trials for Investigational Medicinal Products and non-CA marked Medical Devices
- Author Name: Caroline Watson
- Version: 4
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 53.002 – The Handling of Poor Quality and Fraud in Clinical Research
- Author Name: Caroline Watson
- Version: 4
- Active Date: 31/12/2022
- Review Date: 31/12/2025
Associated Documents
-
Form 53.002A – Reporting of fraud in clinical trials of an investigational medicinal product not identified as a serious breach of GCP
SOP 53.003 – Temporary halt or early termination of clinical trials of investigational medicinal products
- Author Name: Caroline Watson
- Version: 4
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 53.004 – Monitoring Clinical Research – Site Monitoring Visit
- Author Name: Sheila Mcgowan
- Version: 7
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 53.005 – GCP Audit of Research studies and systems supporting research
- Author Name: Paul Gribbon
- Version: 7
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 53.006 – Monitoring Handover Checklist Process
- Author Name: Sheila Mcgowan
- Version: 2
- Active Date: 31/12/2022
- Review Date: 31/12/2025
Associated Documents
-
Form 53.006A – Research & Innovation Monitoring Handover Checklist
SOP 53.007 – Unblinded Monitoring Process
- Author Name: Sheila Mcgowan
- Version: 2
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 53.008 – Accompanied and Training Visit Process
- Author Name: Sheila Mcgowan
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 53.009 – Preparation and Maintenance of a Clinical Trial Monitoring File
- Author Name: Sheila Mcgowan
- Version: 2
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 53.010 – Monitoring Clinical Research Preparation and Management of a Monitoring Plan
- Author Name: Emma Moody
- Version: 2
- Active Date: 31/12/2024
- Review Date: 31/12/2027
Associated Documents
-
Form 53.010A – Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Medical Device Investigation
-
Form 53.010B – NHSGGC Monitoring Risk Assessment
-
Form 53.010C – Research & Innovation Monitoring Plan Tracking Log
SOP 53.011 – Sponsor Source Data Requirements and Guidance
- Author Name: Sheila Mcgowan
- Version: 1
- Active Date: 31/12/2021
- Review Date: 31/12/2024
SOP 53.012 – Monitoring Clinical Research Site Close Out Monitoring visit
- Author Name: Emma Moody
- Version: 1
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 53.013 – Monitoring Clinical Research For Cause Monitoring Visit
- Author Name: Emma Moody
- Version: 1
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 53.014 – External Sponsor Monitoring Arrangement
- Author Name: Sheila Mcgowan
- Version: 1
- Active Date: 31/12/2024
- Review Date: 31/12/2027
Associated Documents
-
Form 53.014A – External Sponsor Monitoring Process Arrangement
SOP 53.015 – Monitoring Clinical Research – Site Compliance Visit
- Author Name: Sheila Mcgowan
- Version: 1
- Active Date: 31/12/2024
- Review Date: 31/12/2027
Chapter 54 – NHS GG&C Hosted Governance
Accordion title 1
This is a placeholder tab content. It is important to have the necessary information in the block, but at this stage, it is just a placeholder to help you visualise how the content is displayed. Feel free to edit this with your actual content.
Accordion title 2
This is a placeholder tab content. It is important to have the necessary information in the block, but at this stage, it is just a placeholder to help you visualise how the content is displayed. Feel free to edit this with your actual content.
Chapter 55 – NHS GG&C Pharmacovigilance
SOP 55.001 – Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit)
- Author Name: Marc Jones
- Version: 8
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 55.002 – Preparation and Submission of the Development Safety Update Report
- Author Name: Marc Jones
- Version: 5
- Active Date: 31/12/2019
- Review Date: 31/12/2026
SOP 55.004 – Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices
- Author Name: Marc Jones
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 55.005 – Initial Review and Management of Updates to Reference Safety Information
- Author Name: Marc Jones
- Version: 5
- Active Date: 31/12/2021
- Review Date: 31/12/2027
SOP 55.006 – Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
- Author Name: Marc Jones
- Version: 5
- Active Date: 31/12/2021
- Review Date: 31/12/2027
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)
- Author Name: Marc Jones
- Version: 2
- Active Date: 31/12/2018
- Review Date: 31/12/2025
SOP 55.015 – Sponsor Pharmacovigilance Data
- Author Name: Marc Jones
- Version: 4
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 55.016 – Sponsor IB Assessment
- Author Name: Paula Morrison
- Version: 1
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 55.017 – Sponsor Quality Control of SAEs Processed by the Pharmacovigilance Office
- Author Name: Marc Jones
- Version: 1
- Active Date: 31/12/2021
- Review Date: 31/12/2024
Chapter 56 – NHS GG&C Sponsor Project Management Unit
SOP 56.001 – Site Set up – Green for Go Process
- Author Name: Lynsey Gillespie
- Version: 8
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 56.002 – Project Management Trial Set-up
- Author Name: Lynsey Gillespie
- Version: 5
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 56.003 – Project Management: Managing an Active Trial
- Author Name: Lynsey Gillespie
- Version: 5
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 56.004 – Project Management Trial Site Close-Out
- Author Name: Lynsey Gillespie
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 56.007 – Project Management Site Capability Assessment
- Author Name: Lynsey Gillespie
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Chapter 57 – NHS GG&C Clinical Research Facility – Administration
SOP 57.001 – Managing a Monitoring Visit
- Author Name: Helen Hart
- Version: 9
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 57.002 – Management of paper health records
- Author Name: Kate Smith
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.003 – GCRF Internal Audit
- Author Name: Helen Hart
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.004 – GCRF Booking, Admission and Discharge of Research Participants
- Author Name: Kate Smith
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.005 – GCRF Hosted Study Documentation and Data Management
- Author Name: Helen Hart
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.006 – GCRF Principal Investigator Responsibilities
- Author Name: Helen Hart
- Version: 3
- Active Date: 31/12/2022
- Review Date: 31/12/2025
SOP 57.007 – GCRF Communications
- Author Name: Karen Duffy
- Version: 4
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.008 – External Audit and Inspection
- Author Name: Helen Hart
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.010 – Study Planning, Set-up and Start-up
- Author Name: Helen Hart
- Version: 4
- Active Date: 31/12/2024
- Review Date: 31/12/2027
SOP 57.011 – GCRF Study Management
- Author Name: Helen Hart
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.012 – GCRF Security and Access
- Author Name: Kate Smith
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 57.014 – GCRF Support of Early Phase Clinical Trials
- Author Name: Patricia Clark
- Version: 1
- Active Date: 31/12/2018
- Review Date: 31/12/2023
Associated Documents
-
Form 57.014A – ICU Notification of Early Phase Clinical Trial
-
Form 57.014B – ICU Notification of Early Phase Clinical Trial Contact Sheet
-
Form 57.014C – Early Phase Clinical Trial Verification
SOP 57.016 – EDGE Clinical Research Management System
- Author Name: Kirsty McAinsh
- Version: 2
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Chapter 58 – NHS GG&C Clinical Research Imaging Facility
SOP 58.001 – CRIF QEUH Adult Emergency Resuscitation Procedures
- Author Name: Tracey Hopkins
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 58.002 – CRIF QEUH Paediatric Emergency Resuscitation Procedures
- Author Name: Tracey Hopkins
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 58.004 – Clinical Research Involving Imaging
- Author Name: Tracey Hopkins
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 58.005 – CRIF Risk Assessment and Risk Mitigation
- Author Name: Tracey Hopkins
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 58.005A – Clinical Research Imaging Facility Study Risk Assessment Form
SOP 58.006 – Reporting of Research Images
- Author Name: Tracey Hopkins
- Version: 3
- Active Date: 31/12/2023
- Review Date: 31/12/2026
SOP 58.008 – CRIF QEUH Controlled Access
- Author Name: Tracey Hopkins
- Version: 1
- Active Date: 31/12/2023
- Review Date: 31/12/2026
Associated Documents
-
Form 58.008A – CRIF MRI Researcher Entitlement & Authorisation Application Form
SOP 58.009 – CRIF Study Data and Document Management
- Author Name: Tracey Hopkins
- Version: 1
- Active Date: 31/12/2023
- Review Date: 31/12/2026
What is the Pharmacy Clinical Trials Service?
The Research Pharmacy Clinical Trials Team work to ensure all patients participating in clinical trials derive maximum benefit and minimum harm from their medicines. We strive to achieve a high quality, effective and efficient service at all times. The team is spread across NHSGGC with bases in the Research and Innovation office (for clinical research sponsored by NHSGGC or co-sponsored by NHSGGC & University of Glasgow) and across NHSGGC acute hospital sites (for hosted clinical research.
What can the Pharmacy Clinical Trials Service do for you?
The service has a dual role providing support to investigators and members of the research study team on medicines related aspects of research and clinical trials in addition to dispensing medicines for study subject and patient use. The Pharmacy Clinical Trials Service works in tandem with the R&I Department and Clinical Research Facilities.
Pharmacy Q&A
What does Pharmacy do?
Pharmacy services in NHSGGC work in tandem with the Research and Innovation (R&I) department, reviewing all clinical trials to ensure the appropriate standards for conducting research involving medicines are met and also that the study is clinically appropriate and operationally viable. As part of the review process, the Portfolio Pharmacy Clinical Trials Team will liaise with fellow staff e.g. Quality Assurance, Aseptic Services, Clinical Pharmacists and Lead Directorate Pharmacists, whereupon satisfactory completion of the review, Pharmacy approval is given and forms part of the R&I management approval process. Where NHSGGC are sponsor or co-sponsor for a clinical trial, Pharmacy will assist you from the very early stages of preparing your protocol, assisting you with your medicines related aspects of regulatory applications and setting up your study. Pharmacy can also help prepare the necessary documentation and assist you with IMP management processes at all stages from receipt into Pharmacy to administration to the patient. For all other clinical trials, Pharmacy work to facilitate multi-site clinical trials as a single working stream and provide information and training to you and your study Team to ensure the trial meets the appropriate standards. We also have close links with Pharmacy clinical trial colleagues throughout Scotland via the Clinical Trial Special Interest Group (CTSIG), sharing best practices in developing our service. A very visible part of the Pharmacy contribution to clinical trials and research is in the dispensing of medicines to patients or study subjects. Pharmacy work to Standard Operating Procedures (SOPs) and have processes in place to deal with problems such as temperature deviations or medicine defects. Medicines are generally dispensed from the local hospital pharmacy where the patient is attending for their study visits. All Pharmacy sites in NHSGGC currently provide or have the potential to provide local services to support research.
What happens if my clinical trial does not come under the clinical trial regulations but still involves medicines?
R&I work closely with Pharmacy to ensure you are given the best advice.
What can I do to help obtain Pharmacy approval for my study?
To help ensure your trial receives Pharmacy approval as quickly as possible, you should approach R&I and Pharmacy in the early planning stages. Often there is a site selection process by the Sponsor and the Pharmacy Team should be included in that process. Pharmacy staff will often need to ask some follow-up questions and it is very helpful if researchers keep in contact with Pharmacy staff and update them on their progress and proposed start dates.
What is the procedure if my study involves multiple sites within NHSGGC?
A system of single pharmacy review and approval is in development for multi-site clinical trials within NHSGGC. If you are aware your study is going to run over two or more sites, you should contact the R&I-Pharmacy Pharmacy Project Officer/Facilitator in the first instance.
Who should I contact if I have a query with my hosted clinical trial?
The first point of call should be your local site Portfolio Pharmacy Clinical Trials Team contact, alternatively you can contact the R&I Pharmacy Team if you have a general query.
What will it cost for Pharmacy Clinical Trial Services?
Pharmacy work with R&I Finance to cost of the Pharmacy service undertaking a research project, using nationally agreed costs and processes. Pharmacy Clinical Trials Services are required to charge for their involvement in all commercial clinical trials. Similarly there are costs for participating in non-commercial research – also cited as per nationally agreed process using AcORD. Depending on the design of non-commercial research, some Pharmacy support services may be free-of-charge to researchers undertaking non-commercial research.
Do I need to notify Pharmacy if I have received a protocol amendment?
Pharmacy should receive notification of protocol amendments for hosted trials by R&I and the Sponsor, however, investigators are responsible for ensuring all relevant staff have access to the correct study protocol. It would be helpful if you verified this with the local Pharmacy site. If you need advice relating to the potential impact of your amendment on Pharmacy, you should contact your site Portfolio Pharmacy Clinical Trials Team or the R&I Pharmacy Project Officer/Facilitator if your clinical trial involves multiple sites.
What qualifications, skills and experience do Pharmacy have in research and clinical trials?
The Pharmacy Clinical Trial Teams throughout NHSGGC are composed from a mix of Pharmacists, Pharmacy Technicians, Pharmacy Support Workers and a Pharmacy Project Officer/Facilitator. In addition to each staff group’s professional and vocational qualifications, all Pharmacy clinical trial staff undergo regular Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) training. Many of our staff have significant experience of working within research and clinical trials over several years.
How do Pharmacy Services link in with research and innovation?
The R&I Sponsor Pharmacy Team are based in the R&I Management Office in the grounds of Dykebar Hospital. This team forms the central hub of communication between R&I and the wider Portfolio Pharmacy Clinical Trials service. Communication is also conducted directly between R&I and the Pharmacy sites in acute hospitals as necessary.
What should I do when my research study or clinical trial is nearing an end?
IIt is helpful if you let Pharmacy know when you are planning to stop recruiting new patients and/or when patients have completed active treatment involving medicines. This can help Pharmacy ensure they have sufficient supplies to the end of the study in the most cost-effective way. It is standard practice for the Pharmacy file to be archived with the investigators file and arrangements will need to be made with your local Portfolio Pharmacy Clinical Trials Team.
I am planning a study involving medicines that will be sponsored or co-sponsored by NHSGGC, what do I do?
If you are planning a new clinical trial or research where medicines are used then you should contact the relevant R&I Co-ordinator in the first instance. The co-ordinator will then alert the R&I Sponsor Pharmacy Team who will work with you to develop the IMP management processes for your clinical trial and liaise with the relevant site Portfolio Pharmacy Teams that may host the research within NHSGGC.
What is an IMP?
IMP stands for Investigational Medicinal Product and is the special term used for medicines when they are studied as part of a clinical trial or used as part of a study protocol. Any medicines used within a clinical trial or research study must be of an appropriate quality and this is governed by UK/EU legislation. A key role of Pharmacy is to ensure the medicines used within research are always of a suitable standard for administration to study subjects.
I’m Planning to participate in hosted clinical research involving medicines on behalf of a commercial/non-commercial Sponsor: Does Pharmacy need to be involved in my research?
Pharmacy reviews all hosted clinical trials and research studies where medicines are used. This will ensure the proposed study meets standards around the management of medicines in research e.g. they are the appropriate quality, and the study meets the requirements of NHS GG&C Safe and Secure Handling of Medicines Policy.
Can R&I Sponsor Pharmacy help me with my research proposal?
Yes, R&I Sponsor Pharmacy will work closely with R&I to assist you with the design and IMP related aspects of your protocol. We will be involved from grant application to close out of your research project. We will provide costs in relation to the medicines and pharmacy aspects of the trial for inclusion in the grant. This will include the pharmacy costs for participating sites, as per ACoRD. Real costs incurred such as manufacturing costs and the cost of additional medicines over standard care need to be met out of the study funding and these will be provided for inclusion in the grant application. In addition, we will provide IMP Management documents, prescription forms, accountability logs and any other documents required to ensure the safe handling and administration of medicines in projects sponsored or co-sponsored by NHSGGC. We will provide support in relation to the medicine to participating sites and to the trial management group for the life of the research project.
How do I source my IMP for a project sponsored or co-sponsored by NHSGGC?
The R&I Sponsor Pharmacy Team will be able to assist you with sourcing IMPs and any other medicines that may be required for your research. There may be option to use NHS licensed manufacturing units, but R&I Sponsor Pharmacy will advise you on potential contractors to deliver the medicines required for your project.
I am planning a study involving medicines that will be hosted within NHSGGC, what should I do?
If the clinical trial is to be run at only one site within NHSGGC, you should contact the site Pharmacy as soon as possible. However, Pharmacy will not undertake a formal review for approval or begin setting up your study until notified by R&I. If the clinical trial is to be run over two or more sites within NHSGGC, contact the R&I-Pharmacy Team as soon as possible.
Pharmacy Contact Details
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):
——————————————————————————————————————————————————————–
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
———————————————————————————————————————————————————————-
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
The Research and Innovation Finance team actively contributes to the delivery of clinical research and innovation projects, working closely with research teams, coordinators and project managers to:
- Secure funding for research and innovation projects in line with ACORD national research costing guidelines
- Provide robust financial management of research and innovation contracts – typically milestone or recruitment driven
- Provide timely financial advice and business support to research active professionals across NHSGGC.
Who does what?
Sandra Quinn – Head of R&I Finance
Brenda Colvin – Senior R&I Accountant
Lee Irvine – Senior R&I Accountant
Paul Kerins – Senior R&I Accountant
Paula Rainey – R&I Projects Accountant
BCRF Portfolio (ON; HM; MG)*
Generic email: BCRF, R&I Finance
Vacancy – BCRF Lead R&I Accountant
Polina Ferguson – BCRF R&I Accountant
Mason Simpson – BCRF R&I Accountant
Jodie Richmond – BCRF R&I Accountant
GCRF Portfolio (A-Z excluding ON; HM; MG)*
Generic email: GCRF, R&I Finance
Sehrish Ali-Siddiqi– GCRF Lead R&I Accountant
Alison McKenzie – GCRF R&I Accountant
Karen Hyslop – GCRF R&I Accountant
Tracie Coote – GCRF R&I Accountant
*NOTE: Portfolios are based on Activity Areas from the R&I project reference
The R&I Finance Team can be found at the following address:
R&I Finance Department
Ward 16
Dykebar Hospital
Grahamston Road
Paisley, PA2 7DE
Scotland, UK
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:
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