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Research and Innovation

Chloe Cowan 

  • Interim Acting R&I Director

Email: Chloe.Cowan@ggc.scot.nhs.

Chloe Cowan 

  • Senior R&I Manager

Email: Chloe.Cowan@ggc.scot.nhs.uk  

Dr Katriona Brooksbank

  • Innovation Lead

Email: katriona.brooksbank2@ggc.scot.nhs.uk

Dr Melissa Robert 

  • Research & Innovation Systems & Operations Manager 

Email: melissa.robert@ggc.scot.nhs.uk  

Dr Caroline Watson 

  • Research Governance Manager 

Email: Caroline.Watson@ggc.scot.nhs.uk  


Dr Samantha Carmichael 

  • Lead Pharmacist 

Email: Samantha.Carmichael@ggc.scot.nhs.uk  


Dr Judith Godden 

  • Ethics Manager 

Email: Judith.Godden@ggc.scot.nhs.uk  


Charlie Mayor 

  • Safe Haven Manager 

Email: Charlie.Mayor@ggc.scot.nhs.uk  


Clare Orange 

  • Biorepository Manager 

Email: clare.orange@ggc.scot.nhs.uk  


Tracey Hopkins 

  • Lead Research Radiographer  

Email: Tracey.Hopkins@ggc.scot.nhs.uk  


Sandra Quinn 

  • Head of R&I Finance 

Email: Sandra.Quinn2@ggc.scot.nhs.uk  

The West of Scotland Research Ethics Service forms part of the UK wide NHS research ethics service (https://www.hra.nhs.uk/) and applications can be reviewed from across the UK.  Applicants are free to apply to any suitably flagged REC in the UK although a local REC is advised.  The applicant should book a slot that they are able to attend.  The meetings are generally held remotely and instructions for joining the meeting are sent out ahead of time.

The central West of Scotland office is manned by four Research Ethics Committee Managers and Assistants who cover the four West of Scotland Research Ethics Committees.

A list of all contact details and the meeting and submission dates can be found here:   https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/

In Scotland the REC Service is managed regionally across four Health Boards.  The Health Board is the appointing authority for each REC.  All NHS RECs in the UK work within the guidelines detailed in Governance Arrangements for Research Ethics Committees (20th July 2021)   https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/

The role of RECs

The Role of NHS Research Ethics Committees (RECs)

NHS RECs safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. NHS RECs are entirely independent of research sponsors (that is, the organisations funding and hosting the research) and investigators. This enables them to put participants at the centre of their research. Each year, NHS RECs review around 6,000 research applications. On average, they give an opinion in less than 30 days: well within the maximum allowance of 60 days. Proportionate Review studies are reviewed within a maximum of 21 days.

REC Membership

Each Research Ethics Committee (REC) consists of between seven and 18 volunteer members. At least one-third of the members must be ‘lay’. Lay members are people whose main personal or professional interest is not in a medical research area. The remainder of the committee are expert members, who are specialists including doctors, other healthcare professionals and academics.  Membership also includes a category known as ‘lay plus’. This category excludes anyone who has been involved in clinical research other than as a participant. REC members often have the sort of experience which will be useful in scrutinising the ethical aspects of a research proposal. For example, they might be patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background.

Interested in becoming a member of an NHS REC?

Please get in touch with us and we can send you further details and let you know of any local vacancies available. All NHS RECs are established by the UK Health Departments for the purpose of reviewing research applications that fall within our remit as set out in GAfREC.

Different types of REC

There are two main types of RECs:

Recognised RECs

These are recognised by the United Kingdom Ethics Committee Authority (UKECA) for the review of clinical trials of investigational medicinal products (CTIMPs), in accordance with The Medicines for Human Use (Clinical Trials) Regulations.  

Authorised RECs

Established under GAfREC but not recognised by UKECA.  Authorised RECs can review most research that is not a CTIMP.   

Many RECs are fagged to look at particular types of research and these flags can be seen here;  https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/

During the online booking process you will be directed to an appropriately flagged REC if this is required; https://www.hra.nhs.uk/about-us/committees-and-services/online-booking-service/

In the West of Scotland we have one Recognised REC and three Authorised RECs 

 Information for applicants

Information to help you define if your research project requires review by a Research Ethics Committee can be found here

Research Application Submission

All researchers wishing to undertake a piece of research within the NHS are required to complete an IRAS form. All guidance and information is contained within the site to allow completion of the IRAS form.

Once the application is ready for submission i.e. complete with electronic authorisations etc.  Please follow the current guidance on online submission; https://www.hra.nhs.uk/about-us/committees-and-services/online-booking-service/

Once you have uploaded all of the study documentation the REC Manager will check and validate the submission.  The REC Manager will then issue a validation letter indicating the date and time of the Ethics Meeting and inviting the investigator to attend.  The dates and times of all ethics meetings can be found here: https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/

After the meeting the investigator will receive a letter within 10 working days stating the outcome which will be one of four possible decisions:

  • Final opinion – favourable or unfavourable
  • Provisional opinion – with request for further information, clarification or revision
  • No opinion – gone to referee for consultation before opinion given

The national ethics service allows 60 days from the submission of the application to final opinion. Clear guidance is given within the IRAS website for researchers who wish to make an amendment to their application after approval or add extra sites.

Contacts and committee details

Contacts and committee details  (dates can vary due to public holidays always check on HRA website)

Committee DetailsMeetsContacts
West of Scotland Research Ethics Committee 1 WoSREC 1 Recognised Type III Flags: CTIMPs Paediatrics Phase I Patients1st Tuesday of the month 9am-12pm
WestofScotland.ResearchEthicsCommittee1@ggc.scot.nhs.uk
West of Scotland Research Ethics Committee 3 WoSREC3 Authorised Flags: QualitativeResearch 4th Thursday of the month, 2-5pm WestofScotland.ResearchEthicsCommittee3@ggc.scot.nhs.uk
West of Scotland Research Ethics Committee 4 WoSREC4 Authorised Flags: Device Trials, Tissue Banks, Research Databases & Paediatrics1st Friday of each month 12-3pm WestofScotland.ResearchEthicsCommittee4@ggc.scot.nhs.uk
West of Scotland Research Ethics Committee 5 WoSREC5 Authorised Flags: Paediatrics 3rd Wednesday of each month 2-5pm WestofScotland.ResearchEthicsCommittee5@ggc.scot.nhs.uk

Any queries regarding the service or whether an application requires ethical review should be directed to the Scientific Officer / Ethics Manager – Dr Judith Godden 

We wanted to inform you that all Scottish recruitment data relating to your study/studies from the 1st April 2019 onwards is now visible on the UK Central Portfolio Management System (CPMS).

The benefit of reviewing your Scottish recruitment data within CPMS is for you to be able to confirm your local site data as accurate or not accurate and provide you with the benefits of tracking your recruitment data at all sites across the UK. This will also help provide NHS Research Scotland and the Chief Scientist Office with accurate recruitment data for Scotland.

What is CPMS?

CPMS is a UK platform which collates local study site recruitment information from local portfolio management systems (LPMS). Since the 1st April 2019 our Scottish R&D offices have been collating recruitment information from your local study teams across Scotland and uploading this to our LPMS. We have now established links between our LPMS and CPMS which means you will be able to login, track and view all Scottish recruitment data to your study at each site since the 1st April 2019.  You are kindly requested to confirm if this data is accurate or not accurate using the below attached guides.  England, Northern Ireland and Wales have already been live with their recruitment data in CPMS since 1st April 2019. 

My study has sites only in Scotland

To reduce the burden of confirming a backlog of recruitment since the 1st April 2019, the Chief Scientist Office has agreed for the NIHR to automatically confirm recruitment data on CPMS for your study during the FY 19/20. Any studies which recruited from the 1st April 2020 we would like to request that you access CPMS and confirm recruitment from this date onward on a monthly basis. You can do this using the attached guides.

Recruitment data for your study will continue to upload into CPMS (including zeros for months where a site did not recruit) and we would request that you access, review and confirm or reject the data on a monthly basis as long as your study is open to recruitment. Once your study halts recruitment please inform your lead R&D office so that they can update the study records.

My study has sites in other UK Nations as well as Scotland

If your study has sites in other nations you will be requested to also confirm recruitment from sites in other nations as well as recruitment from Scotland, if you are not already doing so.

To reduce the burden of confirming a backlog of recruitment since the 1st April 2019, the Chief Scientist Office and Health and Care Research Wales have allowed portions of recruitment data to be automatically confirmed.  Scottish and Welsh recruitment data for FY 19/20 will be automatically confirmed on your behalf. If you have sites in England you will be asked to complete the backlog of recruitment from 1st April 2019 or when your study opened if this is later.

Recruitment data for your study will continue to upload into CPMS (including zeros for months where a site did not recruit) and we would request that you access, review and confirm or reject the data on a monthly basis as long as your study is open to recruitment. Once your study halts recruitment please inform your lead R&D office so that they can update the study records.

Training and Help

Individuals who can confirm recruitment must be associated with your CPMS study record. Those individuals who are copied in on this email all have associations with the CPMS record to confirm recruitment. If you wish to add another member of your team to perform this function you must contact your local R&D office and inform them that you require a name added to the CPMS record. You can access your study record here https://cpms.nihr.ac.uk/ and use the email which has been used to contact you in this email to login. Attached is also guidance to help you login.

Attached are a quick start guide which provides an overview of how to confirm recruitment and the full Research Activity Confirmation Guidance which provides more detailed information to help you navigate the confirmation process including help on viewing your recruitment and explanations of the differences between nations where they exist.

There are short videos and guidance which can be found by logging into NIHR learn using your CPMS login details.

************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact *************************

In order to gain R&I approval as quickly as possible, we advise that you submit to R&I in parallel with your ethics submission. This will allow us to look at your application and progress while under review by the REC.

In order to define the appropriate contact in the R&I Office for your study, please find contact details for your portfolio team here.

The Research and Innovation Service in NHS Greater Glasgow and Clyde operates to support researchers in the NHS and academia. It has multiple roles including offering consultancy and advice, providing Management Approval and aiding in the achievement of a successful conclusion to research projects.

Our goal is to release the potential to world class clinical studies across the region, and to play our part in enabling Scotland to grow as an internationally competitive location for medical research.

The Research and Innovation management office acts as a catalyst for discovery and innovation within NHSGGC. We have a ‘can-do’ attitude, striving to support both experienced and new researchers in the design and execution of high quality research studies and ensure compliance to all regulatory requirements.

As the busiest Research and Innovation office in Scotland, we received in excess of 640 new research applications in 2024 and have approximately 1000 studies ongoing at any one time.

To ensure consistency of contact, and to help develop an in-depth understanding of therapy area-specific research projects, the NHSGGC Research and Innovation Management office has adopted a ‘portfolio-team’ structure. The portfolio teams form the functional core of Research and Innovation and are comprised of Research Co-ordinators, Research Facilitators, Co-ordinator’s Assistants and clerical support staff.

Research and Innovation Strategy

Research and Innovation Teams

Further Information and Resources

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 2025/26

NHSGG&C-wide Research Endowment Fund will no longer be hospital specific but will otherwise be awarded in agreement with the terms of the original bequests.

The following categories are open for applications:

Cancer (Funds available – £63,000)
Chest, Heart and Stroke (Funds available – £74,000)

General (Funds available – £88,000)
Renal (Funds available – £27,000)

The usual amount of funding awarded for each project is in the region of £20k to support specific projects running for a duration of 1 or 2 years. However, exceptional projects are eligible to apply for the full funding available in each funding pot.  Priority will be given to projects that demonstrate a clear benefit to the NHS and their Patients.    

Endowment funds are specifically intended to support early stage researchers to establish their own research portfolio and attract eligible grants for future studies.  Experienced researchers (e.g. 7 years post Consultant or Research team leads) should seek funding for their projects from an alternative source

Completed word document applications must be submitted to R&I for review and sign off by finance no later than the 24th of October 2025. Please send these to Islay Morrison (islay.morrison2@nhs.scot)

Following agreement of costings with finance, fully completed and signed off application forms can be submitted. (1 ELECTRONIC COPY & CV).

Electronic signatures will be accepted. Please submit in word document format.

Submission Deadlines

  • Submission deadline for project to be costed by finance Friday 24th October
  • Deadline for project costs to be finalised with R&I finance team – Friday 7th November
  • Endowment Award Meeting anticipated to take place week commencing Monday 12th January

Applications received after this date will not be accepted

Email completed applications to islay.morrison2@nhs.scot>

Finance enquiries please email R&I finance

(ggc.randifinancegrants@nhs.scot)

The Application Form, Finance Form and Guidance Notes can be downloaded below, and all Contact Details can be found on the R&I website:

————————————————————————————————————————————————————————–

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@nhs.scot

Deadline for submission of applications: Friday 15 August 2025 for 19 August 2025 meeting.

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Quality Manuals
QM-RI-1 – Research and Innovation Quality Manual
  • Author Name: Paul Gribbon
  • Version: 1.0
  • Active Date: 09/11/2023
  • Review Date: 31/12/2024
QM-IN-1 – Innovation Quality Manual
  • Author Name: Elaine O’Neill
  • Version: 1.0
  • Active Date: 18/03/2024
  • Review Date: 31/12/2025
QM-BIO-1 – Biorepository Quality Manual
  • Author Name: Clare Orange
  • Version: 1.1
  • Active Date: 24/04/2024
  • Review Date: 31/12/2025
QM-SH-1 – Safe Haven Quality Manual
  • Author Name: Alison Hamilton
  • Version: 1.0
  • Active Date: 10/10/2023
  • Review Date: 31/12/2024
Chapter 17 – NHS GG&C Clinical Research Facility – Clinical
SOP 17.001 – Adult Emergency Resuscitation Procedures in GCRF
  • Author Name: Naomi Hickey
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.003 – Research Participant’s Clinical Measurements
  • Author Name: Karen Duffy
  • Version: 5.0
  • Active Date: 18/10/2023
  • Review Date: 31/12/2026
  • None
SOP 17.005 – Urinalysis
  • Author Name: Linda Wilson
  • Version: 4.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.006 – Refrigerator and Freezer Unit Use and Monitoring
  • Author Name: Barbara McLaren
  • Version: 5.0
  • Active Date: 04/01/2025
  • Review Date: 31/12/2028
SOP 17.007 – Use of laboratory centrifuge
  • Author Name: Dominic Rimmer
  • Version: 5.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.008 – Recording an Electrocardiograph (ECG)
  • Author Name: Barbara McLaren
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.009 – Obtaining Spirometry Measurements
  • Author Name: Hilary Peddie
  • Version: 5.0
  • Active Date: 27/09/2023
  • Review Date: 31/12/2026
  • None
SOP 17.012 – Obtaining Informed Consent (Adults)
  • Author Name: Helen Hart
  • Version: 6.0
  • Active Date: 28/09/2022
  • Review Date: 31/12/2025
SOP 17.013 – Study Site Coordination and Delivery of an ATIMP Study
  • Author Name: Karen Duffy
  • Version: 1.0
  • Active Date: 20/12/2019
  • Review Date: 31/12/2023
  • 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: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.016 – Ambulatory Electrocardiograph Monitoring
  • Author Name: Karen Duffy
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.020 – Monitoring Expiration of Clinical Consumables
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • Form 17.020A – Glasgow Clinical Research Facility Consumable Checklist
SOP 17.025 – Initialising the 24 hour BP monitor
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.026 – Use of Ambulatory Blood Pressure Monitoring Machines
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.027 – Role of GCRF Nurse Coordinator
  • Author Name: Naomi Hickey
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.028 – Management of Hypoglycaemia in adults
  • Author Name: Hilary Peddie
  • Version: 4.0
  • Active Date: 21/07/2023
  • Review Date: 31/12/2026
SOP 17.029 – Management of Anaphylaxis in Adults and Paediatrics
  • Author Name: Naomi Hickey
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.030 – Measuring and Recording Blood Pressure using digital or electronic equipment
  • Author Name: Karen Duffy
  • Version: 4.0
  • Active Date: 24/11/2023
  • Review Date: 31/12/2026
  • None
SOP 17.032 – Return of stock drugs and IMPs
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • Form 17.032A – Glasgow Clinical Research Facility Spot Check Rota
SOP 17.034 – Storage and management of Medication
  • Author Name: Dominic Rimmer
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.035 – Administration of a Vaccine
  • Author Name: AnneMarie Munro
  • Version: 2.0
  • Active Date: 25/10/2024
  • Review Date: 31/12/2027
  • None
SOP 17.041 – GCRF Management of Samples
  • Author Name: Barbara McLaren
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.042 – Paediatric Emergency Resuscitation Procedures in GCRF
  • Author Name: Susanne Cathcart
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • 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: 3.0
  • Active Date: 29/08/2019
  • Review Date: 31/12/2026
SOP 17.045 – Case Report Form (CRF) Completion
  • Author Name: Dominic Rimmer
  • Version: 4.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.047 – Transfer of the Unwell Research Participant to Acute Care
  • Author Name: Steven Henderson
  • Version: 2.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.048 – GCRF Risk Assessment and Mitigation
  • Author Name: Karen Duffy
  • Version: 3.0
  • Active Date: 09/04/2023
  • Review Date: 31/12/2026
SOP 17.052 – Grantbio Shaker-Incubator
  • Author Name: Shona Perry
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.053 – Blood Sampling from a Peripheral Venous Catheter
  • Author Name: Naomi Hickey
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.055 – Obtaining Informed Consent and Assent (Children)
  • Author Name: Naomi Hickey
  • Version: 1.0
  • Active Date: 02/03/2023
  • Review Date: 31/12/2026
  • None
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: 3.0
  • Active Date: 26/09/2023
  • Review Date: 31/12/2026
  • Form 21.001A – Summary of Pharmacy and IMP Related Costs (Grants/Support)
  • Form 21.001B – Template Specification for IMP Manufacturing Activity
  • Guideline 21.001A – Generating anticipated pharmacy and IMP related study costs
SOP 21.003 – Sponsor IMP Management and Accountability
  • Author Name: Pamela Surtees
  • Version: 5.0
  • Active Date: 26/09/2023
  • Review Date: 31/12/2026
  • 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:
  • Guideline 21.003A – IMP Management and Accountability Processes and Documentation
  • Guideline 21.003B – IMP /Study Product management and accountability processes and documentation for Investigator site file
SOP 21.004 – Sponsor Management of IMPs Permanently Stored External to Pharmacy
  • Author Name: Paula Morrison
  • Version: 2.0
  • Active Date: 31/03/2025
  • Review Date: 31/12/2028
  • Form 21.004A – Sponsor IMP Management Risk Assessment Process: Permanent Storage of IMP External to Pharmacy
  • Form 21.004B – IMP Storage Assessment – Permanent Storage of IMP External to Pharmacy
  • Guideline 21.004A – Permanent Storage of IMPs External to Pharmacy: Guidance on Risk Mitigation Strategies
SOP 21.005 – Managing Drug Alerts and Other Urgent Defective Medicine Reports for IMPs and NIMPs in Clinical Trials Sponsored or Co-Sponsored by NHS GG&C
  • Author Name: Elizabeth Douglas
  • Version: 4.0
  • Active Date: 28/09/2023
  • Review Date: 31/12/2026
  • 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: 3.0
  • Active Date: 28/09/2023
  • Review Date: 31/12/2026
SOP 21.008 – Development and approval of labelling text for IMPs and NIMPs
  • Author Name: Pamela Surtees
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • 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: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • None
SOP 21.010 – Disposal of Investigational Medicinal Products and other study products
  • Author Name: Pamela Surtees
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • None
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: 4.0
  • Active Date: 26/09/2023
  • Review Date: 31/12/2026
SOP 21.012 – R&I Pharmacy Review Of Sponsored Clinical Trials
  • Author Name: Elizabeth Douglas
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • 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
  • Guideline 21.012A – R&I pharmacy review of sponsored clinical trials
SOP 21.013 – Testing of Emergency Unblinding System for Blinded research
  • Author Name: Elizabeth Douglas
  • Version: 3.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • 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: 4.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • 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: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.016A – NHS GG&C Sponsored/Co-sponsored Study product Checklist: Site Pharmacy Initiation Training Form
  • Guideline 21.016A – R&I Pharmacy Study Product Management Training for sites
SOP 21.017 – Regulatory approval of IBs not submitted for approval by commercial partner
  • Author Name: Paula Morrison
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • None
SOP 21.018 – Sponsor Pharmacy Review of Study Amendments
  • Author Name: Angela Carruth
  • Version: 2.0
  • Active Date: 25/01/2024
  • Review Date: 31/12/2027
SOP 21.019 – Reconciliation of Study Product at site or study close out
  • Author Name: Pamela Surtees
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.019A – Pharmacy Study Product Reconciliation Check
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: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • 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: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • 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: 1.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.024A – Site IMP Labelling Form
  • Guideline 21.024A – Detailed guidance on IMP date extension process for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
SOP 21.025 – Management of Dose Escalation in Early Phase IMP/ATIMP Clinical Trials
  • Author Name: Elizabeth Douglas
  • Version: 2.0
  • Active Date: 26/05/2025
  • Review Date: 31/12/2028
SOP 21.026 – Investigational Medicinal Product Dossier requirements for Sponsored and Co-Sponsored CTIMPs
  • Author Name: Elizabeth Douglas
  • Version: 1.0
  • Active Date: 31/07/2025
  • Review Date: 31/12/2028
  • Form 21.026A – Template Simplified Investigational Medicinal Product Dossier
  • Form 21.026B – Template UK IMP Supply Chain
SOP 21.027 – Development and Maintenance of an Investigator s Brochure for IMP/ATIMPs owned by Co-Sponsor
  • Author Name: Elizabeth Douglas
  • Version: 1.0
  • Active Date: 29/07/2025
  • Review Date: 31/12/2028
  • None
Chapter 22 – NHS GG&C Pharmacy – Hosted CTIMP
SOP 22.001 – Defects in Clinical Trial Supplies
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • None
SOP 22.002 – Recall of Clinical Trial Supplies
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • None
SOP 22.003 – Clinical Trial Training for Pharmacy Staff
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • None
SOP 22.006 – Development and maintenance of the Pharmacy Dispensing and Study Management Procedure for studies hosted by NHSGGC
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • Form 22.006A – Pharmacy Dispensing & Study Management Procedure
  • Form 22.006B – Pharmacy Dispensing and Study Management Procedure Change Control Log
SOP 22.007 – Receipt and release of IMPs and NIMPs on delivery to pharmacy sites
  • Author Name: Maria Nygren
  • Version: 7.0
  • Active Date: 25/11/2024
  • Review Date: 31/12/2027
  • Form 22.007A – IMP Quarantine and Tracking Release record (Pharmacy – Excluding New Deliveries)
  • Form 22.007B – Storage Location Log (Pharmacy)
  • Form 22.007C – IMP Quarantine Release Record (Pharmacy New deliveries only)
SOP 22.008 – Temperature monitoring for IMPs and other medicines involved in research
  • Author Name: Eliza Valentine
  • Version: 6.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.008A – Clinical Trials Temperature Monitoring Record (Ambient Temperature)
  • Form 22.008B – Temperature Deviation Alert Summary
  • Form 22.008C – Annual Temperature Mapping Exercise
  • Form 22.008D – Commissioning Temperature Mapping Exercise
  • Guideline 22.008A – Environmental monitoring for IMPs and other medicines involved in research: temperature monitoring
  • Guideline 22.008B – Standards for Refrigerators and Freezers and Temperature Monitoring Equipment for Clinical Trials
  • Guideline 22.008C – Temperature Mapping for Refrigerators and Freezers used to Store IMPs and Other Medicines Involved in Research
  • Guideline 22.008D – Kelsius Temperature Monitoring System
  • Guideline 22.008E – Process for configuring data loggers for mapping and commissioning of refrigerators and freezers and monitoring temperatures external to pharmacy
SOP 22.009 – Dispensing and accuracy checking for clinical trial supplies
  • Author Name: Jennifer McAughtrie
  • Version: 4.0
  • Active Date: 26/05/2022
  • Review Date: 31/12/2027
SOP 22.010 – Managing participant returns for clinical trials
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • Form 22.010A – Pharmacy Clinical Trial Returned Medication Log
SOP 22.011 – Disposal and destruction of clinical trial related pharmaceutical waste
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.011A – Destruction of clinical trial supplies log (Pharmacy)
  • Form 22.011B – NHSGGC Statement of clinical trial supplies destruction policy
  • Form 22.011C – Clinical Trials Supplies Returns to Sponsor Log (Pharmacy)
  • Guideline 22.011A – Disposal of clinical trial drugs back to Sponsor
  • Guideline 22.011B – Destruction of clinical trial related pharmaceutical waste
SOP 22.012 – Emergency unblinding of treatment allocation in clinical trials
  • Author Name: Ramis Qureshi
  • Version: 4.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.012A – Emergency Unblinding of Assigned Treatment
SOP 22.013 – Managing storage of IMPs and NIMPs external to pharmacy
  • Author Name: Sharon Grant
  • Version: 7.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.013A – Assessment to Support IMP Management External to Pharmacy
  • Form 22.013B – Local procedures for the management of IMPS and other medicines as part of a clinical trial
  • Guideline 22.013A – Short term and long term management of IMPs and NIMPs external to pharmacy
SOP 22.014 – Transfer of IMPs/NIMPs in clinical trials
  • Author Name: Sharon Grant
  • Version: 5.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
SOP 22.015 – Continuous pharmaceutical input to research involving medicines
  • Author Name: Jennifer McAughtrie
  • Version: 4.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
SOP 22.016 – NHSGGC Pharmacy Clinical Trials Site File
  • Author Name: Kirsty McLeish
  • Version: 3.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.020 – Collation of workload information for pharmacy clinical trials services in NHSGGC
  • Author Name: Kirsty McLeish
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.021 – Pharmacy authorisation process for clinical trials hosted by NHSGGC
  • Author Name: Kirsty McLeish
  • Version: 5.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.022 – Pharmacy review of clinical trials hosted by NHSGGC
  • Author Name: Kirsty McLeish
  • Version: 5.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • Form 22.022A – Pharmacy Clinical trials set-up tracking form
  • Form 22.022B – Checklist for Pharmacy Review of Study Protocol for Clinical Trials hosted by NHSGGC
  • Form 22.022C – Key Sponsor and Local Study Contacts for Pharmacy
  • Form 22.022D – NHSGGC Clinical Trials Pharmacy Pro-forma
  • Form 22.022G – Prescription Form
  • Form 22.022H – Master Site Level Accountability Log
  • Guideline 22.022A – Process for Pharmacy Review of Studies hosted by NHSGGC
  • Guideline 22.022B – Documentation Review and Requirements for Clinical Trials that are Hosted within NHSGGC
SOP 22.023 – Re-labelling of clinical trial medicines for expiry date extension
  • Author Name: Linda Taylor
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.024 – Use of hospital stock for clinical trials
  • Author Name: Sharon Grant
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.025 – Expiry date monitoring of clinical trial medicines
  • Author Name: Ramis Qureshi
  • Version: 6.0
  • Active Date: 26/02/2025
  • Review Date: 31/12/2028
SOP 22.026 – Closure of a clinical trial pharmacy process
  • Author Name: Karen Montgomery
  • Version: 5.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.027 – Managing monitoring visits and subsequent reports
  • Author Name: Karen Montgomery
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.028 – Labelling of IMPs and NIMPs in Clinical Trials that are hosted by NHSGGC
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • Guideline 22.028A – Labelling of IMPs and NIMPs in Clinical Trials Hosted by NHSGGC
SOP 22.030 – Role of NHSGGC Pharmacy Clinical Trial Services: an overview
  • Author Name: Kirsty McLeish
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.031 – Role of pharmacy services in support of trials that are hosted by NHSGGC: an overview
  • Author Name: Kirsty McLeish
  • Version: 4.0
  • Active Date: 28/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.033 – Incident reporting for pharmacy clinical trials
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.034 – Management of controlled drug IMPs within pharmacy sites
  • Author Name: Kirsty McLeish
  • Version: 3.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.035 – Clinical trial information provided to site on-call pharmacists
  • Author Name: Ramis Qureshi
  • Version: 3.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • Form 22.035A – Clinical Trial Information Provided to Site On-Call Pharmacists
SOP 22.037 – Tracking and Release of IMPs placed into quarantine post delivery at pharmacy sites
  • Author Name: Linda Taylor
  • Version: 3.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.038 – Introduction To Genetically Modified Organism (GMO) Products Within Clinical Trials
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • Guideline 22.038A – Introduction to Genetically Modified Product (GMO) in Clinical Trials
SOP 22.039 – Cleaning The Aseptic Room And Isolator Used To Prepare Genetically Modified Organism Products (GMO)
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.040 – Safe Handling Of Spillage, Personal Contamination or Injury Involving Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.041 – Aseptic Preparation of Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.042 – Personal Protective Equipment (PPE) To Be Worn When Handling Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.043 – Environmental Monitoring Of The Isolator And Room Used To Prepare Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.044 – Transportation Of Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.045 – Safe Handling Of Genetically Modified Organism (GMO) Products Waste
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.046 – Remote Provision of Professional Check of Clinical Trial Prescriptions
  • Author Name: Jennifer McAughtrie
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.047 – Processing of clinical trial prescriptions scanned to pharmacy
  • Author Name: Ramis Qureshi
  • Version: 2.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.048 – Pharmacy authorisation process for studies involving Advanced Therapy Investigational Medicinal Products (ATIMPs)
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.049 – Pharmacy process for receipt and transfer of Advanced Therapy Investigational Medicinal Products (ATIMPs)
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.050 – Recording Pharmacy Clinical Trial Activity for Income Generation
  • Author Name: Angela Carruth
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
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: 3.0
  • Active Date: 28/06/2024
  • Review Date: 31/12/2027
  • None
Chapter 50 – NHS GG&C General
SOP 50.009 – Project Numbering
  • Author Name: Kirsty Theron
  • Version: 5.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
SOP 50.010 – Project Data Entry on SReDA
  • Author Name: Radek Penar
  • Version: 7.0
  • Active Date: 22/04/2025
  • Review Date: 31/12/2028
SOP 50.011 – Setting up and Maintaining Research and Innovation project files (for R&I office approvals)
  • Author Name: Kirsty Theron
  • Version: 5.0
  • Active Date: 09/06/2023
  • Review Date: 31/12/2026
SOP 50.013 – Setup and maintenance of training files: NHS
  • Author Name: Nicola Thomson
  • Version: 5.0
  • Active Date: 04/03/2025
  • Review Date: 31/12/2028
SOP 50.016 – Trial of New Processes Within NHSGGC R&I
  • Author Name: Paul Gribbon
  • Version: 5.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
SOP 50.017 – Research & Innovation Document Management
  • Author Name: Paul Gribbon
  • Version: 5.0
  • Active Date: 14/05/2025
  • Review Date: 31/12/2028
  • None
SOP 50.019 – Independent Stakeholder Assessment
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
SOP 50.020 – eCRF User Acceptance Testing (Glasgow Clinical Trials Unit)
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • None
SOP 50.021 – Participant recruitment sourcing and recording
  • Author Name: Radek Penar
  • Version: 2.0
  • Active Date: 08/05/2024
  • Review Date: 31/12/2027
  • None
SOP 50.022 – Preparation and Maintenance of Terms of Reference
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
SOP 50.023 – Management of SOPs within NHS GG&C R&I
  • Author Name: Paul Gribbon
  • Version: 1.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
SOP 50.024 – Management of the Central Portfolio Management System
  • Author Name: Radek Penar
  • Version: 1.0
  • Active Date: 29/08/2023
  • Review Date: 31/12/2026
SOP 50.025 – Quality Check of Project Entries on SReDA
  • Author Name: Radek Penar
  • Version: 1.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
  • None
SOP 50.026 – Internal QC checks of Scottish Research Database Application (SReDA)
  • Author Name: Radek Penar
  • Version: 4.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
  • None
SOP 50.027 – Service Level and Operational Level Agreements
  • Author Name: Paul Gribbon
  • Version: 1.0
  • Active Date: 25/10/2024
  • Review Date: 31/12/2027
  • None
Chapter 51 – NHS GG&C Sponsor R&I
SOP 51.001 – Protocol Development for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 7.0
  • Active Date: 21/08/2025
  • Review Date: 31/12/2028
  • None
SOP 51.002 – Participant Information Sheet and Consent Forms: Design and Approval
  • Author Name: Louise Ner
  • Version: 6.0
  • Active Date: 30/06/2025
  • Review Date: 31/12/2028
  • Guideline 51.002A – Participant Information Sheet and Informed Consent Form Guidelines
SOP 51.003 – Peer review
  • Author Name: Maureen Travers
  • Version: 4.0
  • Active Date: 02/11/2022
  • Review Date: 31/12/2025
SOP 51.004 – Risk Assessment
  • Author Name: Maureen Travers
  • Version: 5.0
  • Active Date: 18/01/2022
  • Review Date: 31/12/2025
SOP 51.005 – R&I – End of study procedures
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
  • None
SOP 51.007 – Identifying a Sponsor organisation
  • Author Name: Louise Ner
  • Version: 6.0
  • Active Date: 01/09/2025
  • Review Date: 31/12/2028
  • Form 51.007A – International Site Questionnaire
  • Form 51.007B – NHSGGC and University of Glasgow Co-Sponsor Letter
  • Form 51.007C – NHSGGC Sponsor Letter
  • Form 51.007D – Responsibilities delegated to the Chief Investigator for CTIMP Trials Co-Sponsored by the University of Glasgow and NHS GG&C
  • Form 51.007E – Responsibilities delegated to the Chief Investigator for CTIMP Trials Sponsored by NHS GG&C
SOP 51.008 – Handling non-compliance with Good Clinical Practice (GCP) and/or the trial protocol in clinical research sponsored, co-sponsored or hosted by NHS Greater Glasgow and Clyde
  • Author Name: Caroline Watson
  • Version: 4.0
  • Active Date: 19/04/2022
  • Review Date: 31/12/2025
SOP 51.009 – Notification of Serious Breaches of Good Clinical Practice or the Trial Protocol for Clinical Trials of Investigational Medicinal Products and non-CA marked Medical Devices
  • Author Name: Caroline Watson
  • Version: 5.0
  • Active Date: 25/11/2024
  • Review Date: 31/12/2027
SOP 51.010 – Preparation and Review of Grant Applications and Costs
  • Author Name: Heather Flanagan
  • Version: 5.0
  • Active Date: 24/07/2023
  • Review Date: 31/12/2026
  • Form 51.010A – NHS Project Costs for Non-commercial Research
  • Form 51.010D – Grant with potential non CA/CE marked medical device – Checklist
  • Form 51.010E – R&I Study Strategic Plan
  • Guideline 51.010A – Guidelines for identifying category of research funding organisation
SOP 51.011 – University of Glasgow and NHS Greater Glasgow and Clyde Co-Sponsorship Agreement
  • Author Name: Maureen Travers
  • Version: 4.0
  • Active Date: 10/04/2021
  • Review Date: 31/12/2024
  • Form 51.011A – Short Letter CTA CI Employer
  • Form 51.011C – Proforma for signing of Non-Commercial Funded Clinical trial Agreement
SOP 51.014 – Preparation and submission of IRAS forms
  • Author Name: Maureen Travers
  • Version: 4.0
  • Active Date: 02/11/2022
  • Review Date: 31/12/2025
  • None
SOP 51.015 – Assessment of Vendors
  • Author Name: Paul Gribbon
  • Version: 5.0
  • Active Date: 10/04/2024
  • Review Date: 31/12/2027
SOP 51.016 – Preparation and Maintenance of a Trial Master File
  • Author Name: Liz Anne Lewsley
  • Version: 6.0
  • Active Date: 05/08/2025
  • Review Date: 31/12/2028
SOP 51.017 – Registration of research projects on public databases
  • Author Name: Heather Flanagan
  • Version: 4.0
  • Active Date: 26/07/2023
  • Review Date: 31/12/2026
  • None
SOP 51.019 – Sponsor End of study procedures
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 22/04/2025
  • Review Date: 31/12/2028
SOP 51.020 – Sponsor Regulatory Green Light
  • Author Name: Liz Anne Lewsley
  • Version: 4.0
  • Active Date: 29/04/2024
  • Review Date: 31/12/2027
  • Form 51.020A – Sponsor CTIMP Regulatory Green Light Letter
  • Form 51.020B – Sponsor Oversight Checklist For Issuing RGL
SOP 51.021 – Review and Approval of Amendments for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 5.0
  • Active Date: 10/04/2024
  • Review Date: 31/12/2027
SOP 51.022 – Research & Innovation Data & Administration tasks
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 29/08/2023
  • Review Date: 31/12/2026
SOP 51.023 – Sponsor process for an IDMC
  • Author Name: Liz Anne Lewsley
  • Version: 5.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
SOP 51.024 – Archiving Essential Documents from Clinical Research Process for a GGC Sponsored/Co Sponsored CTIMP and/or CIMD
  • Author Name: Heather Flanagan
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 51.024A – Essential Documents for Archiving Archiving Checklist (for CTIMPs)
  • Form 51.024E – Trial Archiving Oversight
SOP 51.025 – Archiving Essential Documents from Clinical Research Process for a Sponsored Non CTIMP
  • Author Name: Maureen Travers
  • Version: 1.0
  • Active Date: 04/12/2018
  • Review Date: 31/12/2023
  • Form 51.025A – Essential Documents for Archiving – Archiving Checklist (for Non-CTIMPs)
SOP 51.028 – NHS Laboratory samples for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow or hosted by NHSGGC.
  • Author Name: Lynsey Gillespie
  • Version: 5.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
  • Form 51.028A – Categorising Laboratory Tests undertaken within Research Projects Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
SOP 51.029 – Writing Study Specific Laboratory Manuals for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Lynsey Gillespie
  • Version: 4.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
SOP 51.030 – Writing Sample Handling Manuals for Sites Participating in Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Lynsey Gillespie
  • Version: 3.0
  • Active Date: 25/01/2024
  • Review Date: 31/12/2027
SOP 51.031 – Corrective and Preventative Action Plan Management
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
  • None
SOP 51.033 – Research Imaging for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow (UoG)
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 03/09/2020
  • Review Date: 31/12/2023
  • Form 51.033A – Categorising Imaging Tests undertaken within CTIMPS Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
  • Form 51.033B – MRI Site Survey Template
  • Form 51.033C – CT Site Survey Template
SOP 51.034 – Writing a Trial Specific Research Imaging Manual for Sites Participating in CTIMP Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and University of Glasgow (UoG)
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 03/09/2020
  • Review Date: 31/12/2023
SOP 51.035 – Design and Development of CRFs/eCRFs in CTIMPs and Clinical Investigations
  • Author Name: Marc Jones
  • Version: 1.0
  • Active Date: 02/11/2022
  • Review Date: 31/12/2025
  • None
SOP 51.036 – Trial Steering Committee for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow
  • Author Name: Heather Flanagan
  • Version: 2.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
  • Form 51.036A – Letter of Invitation to TSC member GG&C sole Sponsor
  • Form 51.036B – Letter of Invitation to TSC member GG&C/UoG co-sponsor
SOP 51.037 – Storage and Transfer of Laboratory Data for Clinical Trials and Investigations Sponsored by NHS Greater Glasgow & Clyde (NHS GG&C) or Co-Sponsored by NHS GG&C & University of Glasgow
  • Author Name: Marc Jones
  • Version: 1.0
  • Active Date: 03/03/2022
  • Review Date: 31/12/2028
  • None
SOP 51.040 – Study Handover for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 1.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
  • None
Chapter 52 – NHS GG&C Hosted R&I
SOP 52.001 – Obtaining NHS Management Approval Non-commercial
  • Author Name: Karen Chase
  • Version: 4.0
  • Active Date: 27/06/2025
  • Review Date: 31/12/2028
SOP 52.002 – Obtaining NHS Management Approval for Commercial Studies
  • Author Name: Ross Nicol
  • Version: 4.0
  • Active Date: 09/06/2023
  • Review Date: 31/12/2026
SOP 52.003 – R&I Review of Amendments
  • Author Name: Ruth Pink
  • Version: 5.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
SOP 52.004 – R&I Contract Development and Review
  • Author Name: Ross Nicol
  • Version: 5.0
  • Active Date: 03/09/2023
  • 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: 5.0
  • Active Date: 08/05/2024
  • Review Date: 31/12/2027
  • 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: 3.0
  • Active Date: 18/03/2020
  • Review Date: 31/12/2023
  • 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: 4.0
  • Active Date: 09/06/2023
  • 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: 2.0
  • Active Date: 28/09/2023
  • Review Date: 31/12/2026
SOP 52.014 – Archiving Essential Documents from Clinical Research Process for Hosted Research
  • Author Name: Radek Penar
  • Version: 2.0
  • Active Date: 06/10/2025
  • Review Date: 31/12/2028
SOP 52.015 – Phase I First in Human Committee Review Process
  • Author Name: Emma Whitelaw
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
SOP 52.017 – Process for Local Review of Non-Commercial, Hosted, Multi-Centre and Single-Centre PR Studies with NHS Staff as Participants
  • Author Name: Euan Rennie
  • Version: 1.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
  • None
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: 4.0
  • Active Date: 10/04/2024
  • Review Date: 31/12/2027
  • None
SOP 53.002 – The Handling of Poor Quality and Fraud in Clinical Research
  • Author Name: Caroline Watson
  • Version: 4.0
  • Active Date: 07/05/2022
  • Review Date: 31/12/2028
  • 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: 4.0
  • Active Date: 25/01/2024
  • Review Date: 31/12/2027
  • None
SOP 53.004 – Monitoring Clinical Research – Site Monitoring Visit
  • Author Name: Sheila Mcgowan
  • Version: 7.0
  • Active Date: 29/10/2024
  • Review Date: 31/12/2027
SOP 53.005 – GCP Audit of Research studies and systems supporting research
  • Author Name: Paul Gribbon
  • Version: 7.0
  • Active Date: 18/02/2022
  • Review Date: 31/12/2025
SOP 53.006 – Monitoring Handover Checklist Process
  • Author Name: Sheila Mcgowan
  • Version: 3.0
  • Active Date: 09/08/2025
  • Review Date: 31/12/2028
  • Form 53.006A – Research & Innovation Monitoring Handover Checklist
SOP 53.007 – Unblinded Monitoring Process
  • Author Name: Sheila Mcgowan
  • Version: 2.0
  • Active Date: 12/06/2022
  • Review Date: 31/12/2025
  • None
SOP 53.008 – Accompanied and Training Visit Process
  • Author Name: Sheila Mcgowan
  • Version: 2.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
SOP 53.009 – Preparation and Maintenance of a Clinical Trial Monitoring File
  • Author Name: Sheila Mcgowan
  • Version: 3.0
  • Active Date: 09/08/2025
  • Review Date: 31/12/2028
  • None
SOP 53.010 – Monitoring Clinical Research Preparation and Management of a Monitoring Plan
  • Author Name: Emma Moody
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • 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: 2.0
  • Active Date: 01/08/2025
  • Review Date: 31/12/2028
  • None
SOP 53.012 – Monitoring Clinical Research Site Close Out Monitoring visit
  • Author Name: Emma Moody
  • Version: 2.0
  • Active Date: 09/08/2025
  • Review Date: 31/12/2028
SOP 53.013 – Monitoring Clinical Research For Cause Monitoring Visit
  • Author Name: Emma Moody
  • Version: 1.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
  • None
SOP 53.014 – External Sponsor Monitoring Arrangement
  • Author Name: Sheila Mcgowan
  • Version: 1.0
  • Active Date: 29/04/2024
  • Review Date: 31/12/2027
  • Form 53.014A – External Sponsor Monitoring Process Arrangement
SOP 53.015 – Monitoring Clinical Research – Site Compliance Visit
  • Author Name: Sheila Mcgowan
  • Version: 1.0
  • Active Date: 29/10/2024
  • Review Date: 31/12/2027
  • None
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: 8.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
SOP 55.002 – Preparation and Submission of the Development Safety Update Report
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 10/09/2019
  • Review Date: 31/12/2026
  • Form 55.002A – Development Safety Update Report (DSUR) Template
  • Form 55.002B – DSUR Investigator Checklist
  • Guideline 55.002A – PV Office Creation and submission of Development Safety Update Reports
SOP 55.004 – Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
SOP 55.005 – Initial Review and Management of Updates to Reference Safety Information
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 18/11/2021
  • 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: 5.0
  • Active Date: 18/11/2021
  • Review Date: 31/12/2027
  • Form 55.006A – SmPC Tracker for Sponsored/Co-Sponsored Clinical Trials
  • Form 55.006B – IB Tracker for Sponsored/Co-Sponsored Clinical Trials
  • Form 55.006C – SmPC Update Monitor Form
  • Guideline 55.006A – Summary of Product Characteristics (SmPC) & Investigator s Brochure Checks
SOP 55.007 – Safety Reporting in Clinical Trials of Medical Devices of Non CE Marked Medical Devices or CE Marked Devices Used Outside of their Intended Purpose (Sponsored and Hosted Clinical Investigations)
  • Author Name: Marc Jones
  • Version: 2.0
  • Active Date: 19/07/2018
  • Review Date: 31/12/2025
  • Guideline 55.007A – PV Office Processing for Clinical Investigations of Non CE Marked medical Devices
SOP 55.015 – Sponsor Pharmacovigilance Data
  • Author Name: Marc Jones
  • Version: 4.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
SOP 55.016 – Sponsor IB Assessment
  • Author Name: Paula Morrison
  • Version: 1.0
  • Active Date: 05/09/2022
  • Review Date: 31/12/2025
  • None
SOP 55.017 – Sponsor Quality Control of SAEs Processed by the Pharmacovigilance Office
  • Author Name: Marc Jones
  • Version: 2.0
  • Active Date: 26/02/2025
  • Review Date: 31/12/2028
Chapter 56 – NHS GG&C Sponsor Project Management Unit
SOP 56.001 – Site Set up – Green for Go Process
  • Author Name: Lynsey Gillespie
  • Version: 8.0
  • Active Date: 22/05/2024
  • Review Date: 31/12/2027
SOP 56.002 – Project Management Trial Set-up
  • Author Name: Lynsey Gillespie
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 56.003 – Project Management: Managing an Active Trial
  • Author Name: Lynsey Gillespie
  • Version: 5.0
  • Active Date: 28/06/2024
  • Review Date: 31/12/2027
SOP 56.004 – Project Management Trial Site Close-Out
  • Author Name: Lynsey Gillespie
  • Version: 3.0
  • Active Date: 21/08/2023
  • Review Date: 31/12/2026
SOP 56.007 – Project Management Site Capability Assessment
  • Author Name: Lynsey Gillespie
  • Version: 2.0
  • Active Date: 18/08/2023
  • 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: 9.0
  • Active Date: 28/09/2022
  • Review Date: 31/12/2025
SOP 57.002 – Management of paper health records
  • Author Name: Kate Smith
  • Version: 4.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 57.003 – GCRF Internal Audit
  • Author Name: Helen Hart
  • Version: 4.0
  • Active Date: 10/10/2023
  • Review Date: 31/12/2026
SOP 57.004 – GCRF Booking, Admission and Discharge of Research Participants
  • Author Name: Kate Smith
  • Version: 3.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
SOP 57.005 – GCRF Hosted Study Documentation and Data Management
  • Author Name: Helen Hart
  • Version: 4.0
  • Active Date: 08/03/2023
  • Review Date: 31/12/2026
SOP 57.006 – GCRF Principal Investigator Responsibilities
  • Author Name: Helen Hart
  • Version: 3.0
  • Active Date: 28/09/2022
  • Review Date: 31/12/2025
SOP 57.007 – GCRF Communications
  • Author Name: Helen Hart
  • Version: 5.0
  • Active Date: 25/03/2025
  • Review Date: 31/12/2028
SOP 57.008 – External Audit and Inspection
  • Author Name: Helen Hart
  • Version: 3.0
  • Active Date: 17/11/2023
  • Review Date: 31/12/2026
  • Form 57.008A – External Audit/Inspection Notification Checklist
  • Form 57.008B – External Audit/Inspection Document Request
  • Form 57.008C – External Audit/Inspection Scribe Template
  • Form 57.008D – External Audit/Inspection Document Tracker
  • Form 57.008E – External Audit/Inspection CAPA Tracker
SOP 57.010 – Study Planning, Set-up and Start-up
  • Author Name: Helen Hart
  • Version: 4.0
  • Active Date: 13/05/2024
  • Review Date: 31/12/2027
SOP 57.011 – GCRF Study Management
  • Author Name: Helen Hart
  • Version: 3.0
  • Active Date: 24/11/2023
  • Review Date: 31/12/2026
SOP 57.012 – GCRF Security and Access
  • Author Name: Kate Smith
  • Version: 3.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 57.014 – GCRF Support of Early Phase Clinical Trials
  • Author Name: Patricia Clark
  • Version: 1.0
  • Active Date: 20/12/2018
  • Review Date: 31/12/2023
SOP 57.016 – EDGE Clinical Research Management System
  • Author Name: Kirsty McAinsh
  • Version: 2.0
  • Active Date: 19/10/2023
  • 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: 3.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
SOP 58.002 – CRIF QEUH Paediatric Emergency Resuscitation Procedures
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • None
SOP 58.004 – Clinical Research Involving Imaging
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 21/08/2023
  • Review Date: 31/12/2026
SOP 58.005 – CRIF Risk Assessment and Risk Mitigation
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • Form 58.005A – Clinical Research Imaging Facility Study Risk Assessment Form
SOP 58.006 – Reporting of Research Images
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 21/08/2023
  • Review Date: 31/12/2026
SOP 58.008 – CRIF QEUH Controlled Access
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • Form 58.008A – CRIF MRI Researcher Entitlement & Authorisation Application Form
  • Guideline 58.008A – CRIF Researcher MRI Entitlement and Authorisation Guidelines
SOP 58.009 – CRIF Study Data and Document Management
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • None
Investigator SOPs

There is a set reading list for Chief Investigators for Sponsored CTIMPs and CIMDs within NHSGGC which can be downloaded as a zip file below.

In addition, Principal Investigators within the Glasgow CRF must follow the relevant SOPs which can also be downloaded as a zip file below.

If you are both the Chief Investigator and the Principal Investigator for a GCRF site you will need to read both sets which may contain some overlap.

Contact

CRIF Approval Group:

Email: CRIFDevelopmentApplications@ggc.scot.nhs.uk (Abbey Rea)

Tracey Hopkins
Lead Research Radiographer
Queen Elizabeth University Hospital

Call: 0141 201 2455
Email: tracey.hopkins@ggc.scot.nhs.uk

CRIF Approval Group for MR Optimisation

Research often involves new MR imaging techniques, and optimisation of these techniques is essential before they can be successfully applied in clinical studies. The CRIF Approval Group is responsible for reviewing and approving requests for access to the research scanners for technical development and proof of principle MR research projects. Researchers requesting optimisation of imaging study protocols will complete a CRIF Development Application Form and submit to CRIF Approval Group.  The CRIF ApprovalGroup will assess both the scientific aspects of the protocol as well as conduct an ethical review under delegated authority from the main REC. The CRIF Approval Group meet monthly.

Useful documents (hyperlinks):

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VOLUNTEER LAY REP POSITION AVAILABLE

Urgent Call for members

Clinical Research Imaging Facility Approval Group

COMMITTEE DETAILS:

Clinical Research Imaging Facility (CRIF) Approval Group

Delegated by West of Scotland Research Ethics Committee

Expected meeting date: Monthly – Usually the last Tuesday every month

Meeting Duration: 1-2 hours

Volume of activity: maximum of 3 imaging development applications considered per meeting

Location: Online

We have an opportunity for those interested in health research and ethics. Research Ethics Committee members are volunteers who review new research projects taking place in the UK from an ethical viewpoint, protecting patients and the public while promoting good ethical research.  The West of Scotland Research Ethics Service is currently seeking to recruit a new member, either Expert or Lay to support the Clinical Research Imaging Facility (CRIF) Approval Group, which specifically reviews studies that are developing new scanning techniques with MRI.  Since March 2020 meetings have been conducted virtually (currently via Microsoft Teams), which allows us to expand our membership outside of the Glasgow area and avoid travel.

The committee reviews research applications and gives an opinion as to whether the research is ethical. The position can be highly rewarding and covers a diverse range of research topics.  Projects are focused on developing scanning techniques and may involve healthy volunteers as well as patients.  You should expect to spend approximately 2 hours per month at meetings and some additional time in preparatory work. Meetings provide an opportunity to interact with researchers and discuss proposals. REC members receive training in ethical review and have opportunities to debate challenging ethical issues.

The work is voluntary and involves reading submissions prior to the meeting and attending a monthly meeting of the CRIF Approval Group (there are usually about 11 meetings in the year). Training is provided.

Meetings are generally scheduled for the last Tuesday afternoon each month, approximately 2-4pm, but may vary depending on availability of members.

Members may also be involved in follow-on work, which is generally conducted via email.

FOR FURTHER DETAILS PLEASE EMAIL – CRIFDevelopmentApplications@ggc.scot.nhs.uk

2024 – Lay Rep Application Form

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Volunteers Needed for MRI Scans

The MRI Research Team at Queen Elizabeth University Hospital is looking for volunteers to undergo an MRI scan so that we can test and optimise new techniques before they are used in clinical research studies.

Please click here for more information

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