Requests for Clinical Attachments
Applications for Clinical Attachments/Observer can be made at NHS Scotland | Jobs | Search here for your perfect career
International recruitment enquires
Please direct your enquires to the Workforce Supply Unit at ggc.workforcesupply@ggc.scot.nhs.uk.
- Workforce Employability Officer – Mark Goldie
- Workforce Employability Officer – Donna Lennie
- Job Coach – Josh Thompson
- Job Coach – John McAulay
All Career insights enquiries and requests should be submitted via email below
ggc.earlycareers@ggc.scot.nhs.uk
All Modern Apprentice enquiries and requests should be submitted via email below
ggc.modern.apprentice@nhs.scot
Main workstreams
The NHS employees Graduates in a range of roles and disciplines and offers a number of Graduate Training Schemes.
If you are applying for employment as a Graduate, regardless of your degree you will need to complete the standard NHS Application form.
Newly Qualified Healthcare professionals are recruited thorough annual campaigns.
These programmes are advertised on the NHS Scotland Jobs Website.
NHS Scotland Graduate Training Schemes
NHS Scotland Management Training Scheme
Open to applicants with SCQF level 10 Qualifications in any discipline, this three year programme with placements in Health Boards across Scotland will give you real management responsibilities, and the chance to work with senior leaders and managers. You will be fully funded to compete a Masters (General Management) or a CIPFA professional qualification (Finance Management).
Find out more on the Management Training Scheme website.
Clinical Scientist Training Programme
The Clinical Scientist Training Programme is a three year training programme commissioned by NHS Education Scotland (NES). The programme recruits Life Sciences and Physics/Engineering graduates (minimum 2:1) who wish to train as Clinical Scientists.
The programme includes includes various work-based rotations in hospitals and you will also complete a part-time master’s degree at one of the universities which are part of the programme. During the training you will be paid a salary equivalent to Band 6 on the NHS pay scale (approx. £25000 pa).
Recruitment generally starts in January with a clearly defined deadline.
GCIL Professional Careers Programme
The Glasgow Centre for Inclusive Living (GCIL) is a user-led organisation, run by disabled people for disabled people. In partnership with organisations including NHS Scotland , the Professional Careers Programme is a 2-year salaried programme hosting placements for graduates on the programme. You will have a professional-level role and could work in any of the NHS Scotland Boards.
You can find out more on the NHS Scotland Careers website.
Graduate Career Advantage Service (GCAS)
Graduate Career Advantage Service (GCAS) is a new initiative which supports recent, eligible graduates living in Scotland to find rewarding employment. we are delighted to be supporting a new NHS Scotland programme of Graduate Internships in partnership with GCAS.
As part of the Scottish Government’s Young Person’s Guarantee, this programme aims to bridge the gap between employers and talented graduates; helping to ease the transition into valuable work experience.
To find out more visit Graduate Career Advantage Scotland
Course Dates
Monday 19th – Friday 23rd August 2024
The course will be held over Zoom, and directed at trainees who have passed the Part I exam, and are preparing to sit their Part II exam in September 2024. The virtual course will be based on exam topics and endeavour to reproduce the spirit of previous courses, while taking advantage of the strengths of virtual platforms.
The course fee is £750
When the course if fully subscribed, a waiting list will be held from which, trainees will be offered cancellations/withdrawal.
*Bank details provided on request.
Register Your Interest
To register interest, please fill out the application form.
If you require any further information or have any questions regarding the course please send email to: dorothy.stobie@ggc.scot.nhs.uk
For information or advice regarding the content of this toolkit, quality assurance process or amendments to resources please contact the SMT working group at:
substancemisuse.toolkit@ggc.scot.nhs.uk
Education Establishments
Advice and Support
If you are concerned that a young person requires support with alcohol or substance issues, please follow your organisation’s own policies and procedures and discuss with senior management.
There may be additional local support services available within your area. Please contact substance misuse working group for more information if you are unaware of these.
substancemisuse.toolkit@ggc.scot.nhs.uk
Youth Organisations
Advice and Support
If you are concerned that a young person requires support with alcohol or substance issues, you should direct them towards an appropriate service.
It is better to contact services now to clarify their referral criteria and procedures, rather than waiting until a young person urgently needs their help!
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
APPLICATION FOR FUNDING
NHSGG&C RESEARCH ENDOWMENT FUND ALLOCATION 2024/25
NHSGG&C-wide Research Endowment Fund will no longer be hospital specific but will otherwise be awarded in agreement with the terms of the original bequests.
The following categories are open for applications:
Cancer
Chest, Heart and Stroke
General
Renal
The usual amount of funding available for each project supported is in the region of £8-15k to support the costs of a specific research project lasting 1 or 2 years. Maximum funding available is £25K per project.
Endowment funds are specifically intended to support early stage researchers to establish their own research portfolio. Experienced researchers (e.g. 7 years post Consultant or Research team leads) should seek funding for their projects from an alternative source
Completed word document applications must be submitted to R&I for review and sign off by finance no later than Friday 27th September 2024. Please send these to Islay Morrison
Following agreement of costings with finance, fully completed and signed off application forms can be submitted. (1 ELECTRONIC COPY & CV).
Electronic signatures will be accepted. Please submit in word document format.
Submission Deadline Friday 11th October 2024
Applications received after this date will not be accepted
Email completed applications to islay.morrison2@ggc.scot.nhs.uk
Finance enquiries please email R&D finance
(R&D.Finance@ggc.scot.nhs.uk)
The Application Form, Finance Form and Guidance Notes can be downloaded below:
Application Form
Finance Form
Guidance Notes
———————————————————————————————————————————
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
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Form 52.003A – R&D Amendment Checklist
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Form 52.003B – Amendment Approval Email Category A or B
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Form 52.003C – Amendment Approval/Acknowledgement Emails – Substantial Amendment
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Form 52.003D – Amendment Approval/Acknowledgement Emails – Substantial Amendment & Protocol Amendment
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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
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Form 52.005A – Letter Template – Honorary Research Contract
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Form 52.005B – Letter Template – Letter of Access
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Form 52.005C – Letter Template – Letter of Access (Staff Studies Only)
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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
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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
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Form 53.010A – Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Medical Device Investigation
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Form 53.010B – NHSGGC Monitoring Risk Assessment
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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
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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
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Form 57.014A – ICU Notification of Early Phase Clinical Trial
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Form 57.014B – ICU Notification of Early Phase Clinical Trial Contact Sheet
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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
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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
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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