Skip to content
Home > Staff & Recruitment > Staff Resources & Support > Page 3

Staff Resources & Support

These preceptorship resources will support nurses, midwives and Specialist Community Public Health Nurses (SCPHN) in their transition to new roles and in practice settings. Not only from the point of registration, but also as they progress through their career. Furthermore, they aim to promote consistency in the provision and support offered by preceptorship programmes across Scotland.

Scotland’s Preceptorship Framework

This preceptorship resource has been developed to support nurses, midwives and Specialist Community Public Health Nurses (SCPHN) in their transition to new roles and practice settings from the point of registration and as they progress through their career. Not only does this national resource aim to promote consistency in the provision and support offered by preceptorship programmes across Scotland. It also builds on the NMC Principles for Preceptorship and offers guidance to preceptees, preceptors, managers and the wider organisation.

Preceptorship | Turas | Learn (nhs.scot)

The Midwifery Preceptorship Framework for Scotland 2023

This framework provides guidance on how midwifery preceptorship should be planned, delivered and evaluated within an enabling environment.

The Midwifery Preceptorship Framework for Scotland 2023 | Turas | Learn (nhs.scot)

Scotland’s Preceptorship Framework (NES Presentation)

This NHS Education for Scotland PowerPoint presentation is a preceptorship resource that not only defines preceptorship and outlines why it is needed, but also describes the roles and responsibilities of the preceptee, preceptor and line manager.

NES Preceptorship Presentation

Principles for Preceptorship (NES Webinar)

NES Principles for Preceptorship Webinar

Recorded in 2021 to support the launch of the NES Preceptorship resource.

NMC Principles of Preceptorship 

The NMC developed the Principles of Preceptorship in recognition of the benefits that a supported, structured period of preceptorship brings to employers, preceptees, and people who use services.

Principles of preceptorship – The Nursing and Midwifery Council

NHSGGC Resources/NES Templates

Click here to return to Practice Education’s main page

Was this helpful?

Yes
No
Thanks for your feedback!

Welcome to NHSGGC Practice Supervisor and Practice Assessor Portal. This portal has been designed to provide information and support for those who supervise and assess learners in our practice learning environments.

NHSGGC Practice Supervisor and Practice Assessor Portal – Feedback and Suggestions

If you would like to make a suggestion or provide the Practice Education Team with feedback as to how we could improve the PS/PA Portal, please email: ggc.practiceeducation@nhs.scot

Return to Practice Education’s main page

Was this helpful?

Yes
No
Thanks for your feedback!

This section provides practice supervision / assessment related documents and resources for all those involved in the supervision and assessment of student nurses and midwives within NHSGGC. If you can’t find what you are looking for here, our FAQs might help.

Audio Podcast

Enjoy our audio podcasts at a time that suits you. We offer a series of 5 podcasts giving information on the new NMC standards and a variety of topics to support your CPD in the practice supervisor or practice assessor role.

Blood Glucose Monitoring for Student Nurses and Midwives

NHSGGC Pre-Reg Student Nurse and Midwife Blood Glucose Monitoring Process outlines the process to allow student nurses (all fields) and midwives to obtain their own unique barcode to operate the Abbot FreeStyle Precision Pro System, blood glucose monitor.

Blood transfusion

Please refer to page 9 of the GGC Clinical Transfusion Policy for information on the involvement of students in the transfusion process.

Communication and relationship management skills – Examples from practice

This resource has been developed to assist you in your role as practice supervisors and practice assessors to support students to achieve Annexe A: Communication and relationship management skills.

Datix guidance for healthcare student involvement

Datix guidance for healthcare student involvement outlines the process for reporting Datix incidents involving student nurses, midwives, paramedics and HNC students. It explains how to record student involvement or witness details and ensure incidents are appropriately linked to Practice education for follow-up.

FAQs

Can’t find an answer to your question. Our FAQs might be able to help.

Roles in student assessment
Does a student need both PS/PA?

Yes, The roles of mentor, sign-off mentor, practice teacher and teacher have been withdrawn, and three new roles introduced to undertake the supervision and assessment of students; the practice supervisor, practice assessor and academic assessor.

Can I be a PS and/or PA to two students at once?

You cannot be the PS and PA for the same student – each student must have two different people assigned – one as PS and another as PA – this cannot be the same person. However, you may carry out both roles at the same time for different students, for example, you may be the PS for one student whilst also being the PA for another student. You may also be the PS or PA for two different students at the same time.

Can I be both roles for the same student?

No, you cannot be both PS and PA for the same student. However, you can be PS for two different students, PA for two different students or PS for one and PA for another as guidance contained in A National Framework for Practice Supervisors, Practice Assessors and Academic Assessors in Scotland

How much time do I need to spend with my student before signing them off?

There is no set time a student needs to spend with their PS/PA. However, we would recommend that students work alongside their assigned PS/PA as much as possible for continuity.

The Practice Supervisor and Practice Assessor are responsible for gathering feedback from other staff in their area that have worked alongside their assigned student to deliver a fair and objective assessment.

How do I access student feedback?

Student feedback for Practice Learning Environments is submitted via “QMPLE”. Each area has an assigned member of staff (e.g. charge nurse, SCN or Educator) who will have access to view feedback submitted by students. All feedback via QMPLE is anonymous and is released after review from both Practice Education Facilitator and the link lecturer for the area. Practice Education would encourage PS/PAs to obtain individual feedback in their role from students (if they are willing to do so) which can then be used for their revalidation and to help improve upon their practice.

Student documentation and assessment

This is a placeholder tab content. It is important to have the necessary information in the block, but at this stage, it is just a placeholder to help you visualise how the content is displayed. Feel free to edit this with your actual content.

What does a student Practice Assessment Document (PAD) look like?

Examples of PADs from different universities.

Also, this interactive PAD resource will provide you with information and guidance on how to complete the different sections of the Practice Assessment Document. From recommended timelines for each stage of the student journey, who completes the different sections, to clear and simple examples of evidence needed for each platform.

Who can sign what in the PAD?
  • Orientation and intial meeting – PA or PS (to be completed within first 48 hours)
  • Learning Development Plan – PA or PA
  • Record of signatories – PA and PS (individual records for each role)
  • Interim review – PA or PS
  • Service user/carer feedback – PA or PS (one required per PART)
  • Proficiencies – PA or PS
  • Skills and procedures – PA or PS
  • Final assessment – PA only
  • Attendance record – PA or PS (complete after each week)
  • End of part confirmation – PA only (discussion between PA and AA to agree on student progression)
How do I complete an interim assessment?

The interim assessment is usually completed mid-way through the placement. It is recommended that a date is set for the interim assessment during the first 48 hours of placement.

The interim assessment can be completed by either the Practice Supervisor (PS) or Practice Assessor (PA). It may be that the PS completes the interim assessment to allow the PA to complete an objective final assessment at the end of the placement, but this is not essential.

If there are concerns surrounding a student’s performance the interim assessment can be completed early or alternatively, you may wish to complete several interim assessments throughout the placement to reflect and document the student’s progress.

The NMC agreed the new standards for student supervision and assessment in 2018. They have structured the standards into 7 platforms – the interim and final assessments are structured around these 7 platforms and, additionally, any progress made within Annexes A and B. Further information on the standards can be found here: NMC Standards for Supervision and Assessment

It can be helpful to look at the language used within the proficiencies (blue pages of the PAD) relating to each platform as an aid to structure your feedback.

The interim assessment is also a good opportunity to ask the student if they have any feedback that they would like to provide regarding their placement.

If any issues are raised during the interim assessment (or at any point throughout the placement) please contact your PEF/CHEF. You can find their details here: Who is my PEF/CHEF?

How do I grade my student?

Glasgow Caledonian University (GCU), University of Glasgow (UoG), Open University (OU), and University of West of Scotland (UWS) all utilise different grading for their students.

UWS: Pass or Fail

OU: Pass or Fail

UoG: Graded A-H using a specific grading rubric per PART

GCU: Graded A-F using a specific grading rubric per PART. Each platform is graded individually and then an overall grade is calculated using a percentage,

Please see example using link:

Grading Rubric Calculator – NHSGGC

My Colleague and I disagree on a student’s performance, what should we do?

If there is a disagreement between a Practice Supervisor and Practice Assessor, Practice Education would advise having a discussion around the differences between each other’s observations. It would also be useful to look back at previous assessments (if appropriate) to look for common themes.

We would also advise reviewing the grading rubric for the specific learning stage of the student using the participation in care framework.

Another tip would be to ask other staff who have worked alongside the student. What are their observations? Are there any differences? For further information or advice, reach out to the PEF/CHEF for your area. Who is my PEF/CHEF?

Our Student’s PA is on annual leave for the student’s last week, who signs them off?

The student should be assigned another Practice Assessor as soon as possible.

The new Practice Assessor should gather feedback from the original Practice Assessor if appropriate and from Practice Supervisors/ other staff in the area in order to complete a fair and objective assessment.

My student has forgotten their PAD on multiple occasions, what can I do?

Students are expected to bring their PAD with them on their first day of placement

and if they do not bring it on the first day then must bring it on their second day. If they then do not bring it you can send them home to retrieve it as it is there responsibility to make it available to their PS/PA throughout the placement.

The student should bring the full document with no pages/sections missing. If the student is continually forgetting to bring their PAD despite being prompted to do so then contact your PEF/CHEF for further advice and support.

I have some concerns regarding my student’s performance, what should I do?

Both the student and Practice Supervisor/ Assessor have access to a Practice Learning Support Protocol which details the steps to follow should there be any concerns. It is important to highlight these concerns as soon as possible. A copy of this can also be found in the student PAD.

How do I complete a Learning Development Support Plan?

You may have a student who requires some additional support to achieve a specific learning outcome/proficiency for example, time keeping, assessment skills, improving communication. In this situation it may be helpful to create a Learning Development Support Plan (LDSP) to support and guide the student to meet the outcomes required.

These sample Learning Development Support Plans will to help you to write an effective plan to support students to progress in their practice learning environment. There is also an example LDSP within the PAD.

You will also find an example Learning Development Support Plan within the PAD and further examples are available through this link:

If you are implementing a LDSP you may wish to contact your PEF/CHEF for support and guidance.

Attendance and Rostering
My student has said they have a part-time job and cannot work certain shifts, how should this be approached?

All students are made aware of the Working Time Directive prior to undertaking their placement. By law, the Maximum weekly working hours state they can only work a maximum of 48 hours per week (on average) which includes placement hours.

How many hours does a student get credited with per shift? Are breaks included?

Students should be credited with full shift hours, including breaks. For example, 7am-7.30pm shifts would be credited as 12.5 hours.

9am-5pm shifts would be credited as 8 hours.

**Reduced working week does not apply to student nurses

My student is requesting specific/ adjusted hours. How can we accommodate this?

Students are made aware that they have a requirement to be flexible to accommodate their placement hours. However, this is not always possible.

Practice Education would advise that any adjustments (within reason) are made at the area’s discretion. Students should NOT be credited with any hours they have not worked.

My student has an organised study day at university, are they credited hours for this?

Credited study days are usually highlighted within the original placement allocation email which is sent out to the student link for your area. This may be your SCN/ CN or Educator. However, sometimes study days can be arranged following these emails and the university may advise students to make their placement aware. Some of these are credited and some are not. If you are unsure, reach out to your local PEF/CHEF who will be able to find out for you.

My student has an appointment during shift time, what is the policy for this?

There is not a specific policy in relation to allowing time for appointments. However, it is encouraged by both Practice Education and Educational Institutions that students inform their PLE manager of any scheduled appointments at their earliest convenience so accommodations such as shift changes can be made.

My student hasn’t turned up for their shift or called in sick, what do I do?

All students must adhere to the NHS GGC/ local absence reporting policy. This is explained to them prior to placement and detailed within their student documentation. They also have a duty to report any absences to the university. The way of doing this differs between universities but this information is readily available within the guidance pages of the students Practice Assessment Document.

The PEF/ CHEF for your area will be able to contact the student’s PT if there are any concerns regarding absence.

Reasonable Adjustments
My student has disclosed a disability/learning need, how do I approach this?

Firstly, it is at the student’s discretion whether they disclose any additional learning needs or disabilities. This can sometimes make our roles as Practice Supervisors and Assessors a bit more challenging but there are resources available to support you. Students can often have a Reasonable Adjustment Plan or a “RAP” in place from the university. Should the student wish to share this with their PS/PA it should remain confidential and should be accommodated where possible.

Your local PEF/ CHEF will be on hand to support you with this.

Additional information and support can be accessed via our Practice Supervisor/Practice Assessor Portal

Practical Skills
Can my student take part in venepuncture and cannulation/ IV medication?

Yes, they can, however, this depends on the stage of training the student is at and whether they have had the relevant theory within University. It is important to note that when this theory is delivery may differ between different fields of nursing which is detailed in the skills statement linked below. When undertaking these skills student nurses and midwives must do so under the direct supervision of a registered healthcare professional who is competent in the skill.

Please see the staff guide for new NMC Skills and Procedures for student nurses.

Can students countersign and administer controlled medication?

Yes, Students can be involved in controlled medication administration as per NHSGGC Administration of intravenous (IV medicines and flush policy.

Responsibility ultimately lies with the administrator of the drug unless a student nurse is involved. Therefore, it is the responsibility of the registered practitioner.

Other common questions
How does my student get an ID badge?

All students should have photographic ID in the form of their student card from their university.

Swipe cards for student nurses are only available for students on placement at QEUH/ RHC at this time. This does not apply to other sites within NHSGGC.

Students about to commence their first placement within QEUH/ RHC will receive an email from university advising how to obtain a swipe card. However, they can also contact their PLE’s local PEF who can pass on a form to obtain a swipe card. They need to complete and print this form and take it to the sites facilities open sessions which are held between 9am-10am

Learning Development Support Planning

Learning Development Support Plans are used to support students to meet specific objectives, particularly if they face challenges in achieving the level of knowledge and/or skills required by their educational programme or if there are concerns regarding their professional practice. These sample plans can be used to help you to write an effective Learning Development Support Plan to support students to progress in their practice learning environment.

**Coming Soon** Learning and Development Support planning resource and Assessment and Grading Terminology document.

NES Pharmacology Learning Resources Toolkit

This resource will supplement practice supervision / assessment in the workplace for student nurses and midwives. Additionally, it is practice supervisor and practice assessor facing and provides information and guidance on Pharmacology.

New skills and procedures for student nurses

WoS guide for staff regarding the supervision and assessment of new skills and procedures for student nurses undertaking pre-registration 2020 programmes (updated 2025).

Practice Assessment Documents

(NHS Scotland sign in may be required)

If additional PAD pages are required, please refer to the relevant PAD and print the individual page(s).

PAD Learning Resources

PAD Terminology for Practice Supervisors and Assessors

If you’re unsure about the terms used in the PAD when it comes to student assessment, we’ve created a helpful guide just for you. the PAD Terminology for Practice Supervisors and Practice Assessors explains key terms (called level outcomes) and gives examples to help you understand what’s expected of your student by the end of their placement.

Practice Learning Support Protocol

These flowcharts illustrate guidance for student nurses and midwives, as well as PS / PAs, on dealing with concerns, although not care concerns, we come across in Practice Learning Environments.

Practice Supervisor Practice Assessor Checklist

Use our Practice Supervisor Practice Assessor Checklist to identify key areas will ensure your student has a smooth journey throughout their practice learning experience.

Raising concerns in practice

Raising concerns in practice – a national approach for nursing and midwifery students, non-NHS practice learning experience providers and higher education institutions in Scotland.

‘Speaking up’ – National Whistleblowing Guidance for Nursing and Midwifery Students in Scotland

This guidance details the process for raising a concern and intends for nursing and midwifery students in Scotland to use it while undertaking PLEs during their pre-registration nursing and midwifery programmes.

Strengthening Student Nurse and Midwife Practice

This 10 minute narrated presentation on Strengthening Student Nurse and Midwife Practice will help practice supervisors and practice assessors to develop increased insight and awareness around supporting student nurses and midwives with additional competency requirements (NHS Scotland log in required).

eHealth and Student IT Information

Student Access to NHSGGC eHealth Systems

Students on placement are issued NHSGGC eHealth accounts to enable access to essential digital systems.

First-Time Login

Guidance for logging in for the first time is available from NHSGGC Student IT Access

Reporting IT Issues and Accessing Learning Resources

Students must register for the West of Scotland eHealth portal to:

  • Raise IT support tickets
  • Access additional eHealth learning materials

Important:

Students do not have access to staff eHelp services and must not contact the IT Service Desk directly.

  • a step-by-step guide to registering and using the student eHealth portal is available from NHSGGC Student eHealth Portal
  • The portal is accessible from any web browser and does not require access to an NHSGGC computer.

Quick Overview

A downloadable poster summarising the student access process is available from NHSGGC Student eHealth Awareness Poster.

Newly Qualified Nurses and Midwives (NQN/Ms)

A step-by-step flowchart outlining the NHSGGC process for requesting eHealth accounts for band 4 NQN/Ms is available to support NQN/Ms and their line managers in updating or requesting eHealth account access and creating an NHSGGC email address.

Need eHealth help?

If you’re unsure where to start or need further support, please contact your Practice Education Facilitator or refer to the guides above.

Supplementary factsheets about specific eHealth programmes

Hospital Electronic Prescribing and Medicine Administration (HEPMA)

Student nurse Digital Clinical Notes module on TURAS Learn

University Programme Information

Return to our Practice Supervisor / Practice Assessor Portal

Was this helpful?

Yes
No
Thanks for your feedback!

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 the REC Policy Document   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. The REC will give an initial outcome withing 30 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. 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 the REC policy document.

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
  • Request for further information – with request for further information, clarification or revision
  • No opinion – gone to referee for consultation before opinion given

The national ethics service allows 30 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 ggc.wosres@nhs.scot 

Was this helpful?

Yes
No
Thanks for your feedback!

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.

Was this helpful?

Yes
No
Thanks for your feedback!

************************ 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.

Was this helpful?

Yes
No
Thanks for your feedback!

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 630 new research applications in 2025 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

Was this helpful?

Yes
No
Thanks for your feedback!

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

Was this helpful?

Yes
No
Thanks for your feedback!

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: Thursday 28 May 2026 for 2 June 2026 meeting.

Accordion title 1

This is a placeholder tab content. It is important to have the necessary information in the block, but at this stage, it is just a placeholder to help you visualise how the content is displayed. Feel free to edit this with your actual content.

Accordion title 2

This is a placeholder tab content. It is important to have the necessary information in the block, but at this stage, it is just a placeholder to help you visualise how the content is displayed. Feel free to edit this with your actual content.

Was this helpful?

Yes
No
Thanks for your feedback!
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: 1.2
  • Active Date: 14/01/2026
  • Review Date: 31/12/2027
QM-SH-1 – Safe Haven Quality Manual
  • Author Name: Alison Hamilton
  • Version: 2.0
  • Active Date: 27/07/2026
  • Review Date: 31/12/2027
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: Naomi Hickey
  • Version: 7.0
  • Active Date: 01/05/2026
  • Review Date: 31/12/2029
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 17.020 – 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 17.027 – 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
SOP 21.028 – Additional Sponsor Pharmacy Requirements for Clinical Trials with Advanced Therapy Investigational Medicinal Products (ATIMPs)
  • Author Name: Elizabeth Douglas
  • Version: 1.0
  • Active Date: 22/09/2025
  • Review Date: 31/12/2028
  • Form 21.028A – Additional ATIMP Requirements for Sponsor IMP Management & Accountability Manuals (Form21.003B)
  • Form 21.028B – Template Temperature Deviation & Defect Reporting Form
  • Form 21.028C – Additional ATIMP Requirements for Site Pharmacy Initiation Training (Form 21.016A)
  • Form 21.028D – Additional ATIMP Requirements for Pharmacy Site Initiation Report (Template)
  • Guideline 21.028A – Guidance on Additional Sponsor Pharmacy Requirements for Clinical Trials with Advanced Therapy Investigational Medicinal Products (ATIMPs)
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: 6.0
  • Active Date: 25/05/2026
  • Review Date: 31/12/2029
SOP 50.010 – Project Data Entry on SReDA
  • Author Name: Radek Penar
  • Version: 8.0
  • Active Date: 19/08/2026
  • Review Date: 31/12/2029
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 NHSGGC R&I
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 22/09/2025
  • Review Date: 31/12/2028
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: Heather Flanagan
  • Version: 7.0
  • Active Date: 21/08/2025
  • Review Date: 31/12/2028
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 of NHSGGC Sponsored and Co-Sponsored Research Studies
  • Author Name: Heather Flanagan
  • Version: 5.0
  • Active Date: 26/05/2026
  • Review Date: 31/12/2029
  • Form 51.003A – PEER REVIEW FORM
  • Form 51.003B – Email Templates for Identification and Invitation of Independent Peer Reviewers
SOP 51.004 – Risk Assessment
  • Author Name: Liz Anne Lewsley
  • 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: Laura Alexander
  • 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: 6.0
  • Active Date: 07/07/2026
  • Review Date: 31/12/2029
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: Louise Ner
  • 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: Heather Flanagan
  • Version: 5.0
  • Active Date: 20/10/2025
  • Review Date: 31/12/2028
  • 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: Liz Anne Lewsley
  • Version: 5.0
  • Active Date: 12/04/2025
  • Review Date: 31/12/2028
SOP 51.015 – Assessment of Vendors
  • Author Name: Paul Gribbon
  • Version: 5.2
  • Active Date: 14/07/2026
  • Review Date: 31/12/2029
SOP 51.016 – Preparation and Maintenance of a Trial Master File
  • Author Name: Liz Anne Lewsley
  • Version: 7.0
  • Active Date: 16/07/2026
  • Review Date: 31/12/2029
SOP 51.017 – Registration of research projects on public databases
  • Author Name: Louise Ner
  • Version: 5.0
  • Active Date: 14/05/2026
  • Review Date: 31/12/2029
  • 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 Modifications for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 6.0
  • Active Date: 26/05/2026
  • Review Date: 31/12/2029
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: Heather Flanagan
  • Version: 6.0
  • Active Date: 21/10/2025
  • Review Date: 31/12/2028
  • Form 51.023C – Letter of Invitation to IDMC member NHSGGC Sole Sponsor
  • Form 51.023D – Letter of Invitation to IDMC member NHSGGC/UoG Co-Sponsor
SOP 51.024 – Archiving Essential Documents from Clinical Research Process for a GGC Sponsored/Co Sponsored CTIMP and/or CIMD
  • Author Name: Liz Anne Lewsley
  • 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: Laura Alexander
  • Version: 2.0
  • Active Date: 28/11/2025
  • Review Date: 31/12/2028
  • Form 51.025A – Essential Documents for Archiving – Archiving Checklist (for Non-CTIMPs)
  • Form 51.025B – Non-CTIMP Archiving checklist for sites
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 Locations Participating in Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Lynsey Gillespie
  • Version: 4.0
  • Active Date: 14/07/2026
  • Review Date: 31/12/2029
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: 31/12/2028
  • None
SOP 51.036 – Trial Steering Committee for Trials involving an Investigative Medicinal Product (CTIMP) Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Heather Flanagan
  • Version: 3.0
  • Active Date: 22/12/2025
  • Review Date: 31/12/2028
  • Form 51.036A – Letter of Invitation to TSC member NHSGGC sole Sponsor
  • Form 51.036B – Letter of Invitation to TSC member NHSGGC/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 51.039 – Contracts Management for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 1.0
  • Active Date: 28/10/2025
  • 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: Laura Alexander
  • Version: 1.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
  • None
SOP 51.042 – Preparation and Maintenance of a Non-CTIMP Sponsor e-File
  • Author Name: Louise Ner
  • Version: 1.0
  • Active Date: 04/08/2026
  • Review Date: 31/12/2029
  • 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: 5.0
  • Active Date: 11/06/2025
  • Review Date: 31/12/2028
SOP 52.003 – R&I Local Review of Modifications
  • Author Name: Ruth Pink
  • Version: 7.0
  • Active Date: 27/07/2026
  • Review Date: 31/12/2029
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: 6.0
  • Active Date: 15/05/2026
  • Review Date: 31/12/2029
  • 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)
  • Form 52.005E – SHARE NHSGGC Letter of Access Template
SOP 52.007 – Authorisations for NHS Resource use in R&I Systems Submissions
  • Author Name: Karen Chase
  • Version: 4.0
  • Active Date: 16/07/2026
  • Review Date: 31/12/2029
  • 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: 3.0
  • Active Date: 14/07/2026
  • Review Date: 31/12/2029
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
SOP 52.018 – NHSGGC R&I Process for Research Database
  • Author Name: Adam Wade
  • Version: 1.0
  • Active Date: 11/06/2025
  • Review Date: 31/12/2028
  • None
SOP 52.019 – R&I Review Of Hosted, Non-Commercial Research Projects Involving GP Practices
  • Author Name: Rozanne Suarez
  • Version: 1.0
  • Active Date: 23/12/2025
  • Review Date: 31/12/2028
  • Form 52.019A – NHSGGC Governance Check Letter for GP studies
  • Form 52.019B – Covering Email To Accompany The Governance Check Letter
  • Form 52.019C – Covering Email To Accompany Management Approval Letter For Studies With NHSGGC Employees Based In GP Practices
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: 5.0
  • Active Date: 23/06/2026
  • Review Date: 31/12/2029
  • 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 – Audit of Research Studies and Systems Supporting Research
  • Author Name: Paul Gribbon
  • Version: 8.0
  • Active Date: 22/12/2025
  • Review Date: 31/12/2028
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: 3.0
  • Active Date: 19/02/2026
  • Review Date: 31/12/2029
  • 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 – Preparation and Management of a Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Advanced Medicinal Investigation Product/ Medical Device Investigation/High Risk Non-CTIMP
  • Author Name: Emma Moody
  • Version: 3.1
  • Active Date: 21/08/2026
  • Review Date: 31/12/2029
  • Form 53.010A – Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Medical Device Investigation/High Risk Non-CTIMP
  • Form 53.010B – NHSGGC Monitoring Risk Assessment
  • Form 53.010C – Research & Innovation Monitoring Plan Tracking Log
  • Form 53.010D – Safety Review Committee Table
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: 2.0
  • Active Date: 21/10/2025
  • Review Date: 31/12/2028
  • 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
  • Guideline 55.002A – PV Office Creation and submission of Development Safety Update Reports
SOP 55.004 – Safety 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 – Management of Reference Safety Information for Clinical Trials of IMPs (including ATMPS)
  • Author Name: Marc Jones
  • Version: 6.0
  • Active Date: 03/03/2026
  • Review Date: 31/12/2029
SOP 55.006 – Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
  • Author Name: Marc Jones
  • Version: 6.0
  • Active Date: 03/03/2026
  • Review Date: 31/12/2029
  • 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 Non CE/UKCA Marked Medical Devices Or CE/UKCA Marked Devices Used Outside Of Their Intended Purpose (Sponsored And Hosted Clinical Investigations)
  • Author Name: Marc Jones
  • Version: 3.0
  • Active Date: 02/11/2026
  • Review Date: 31/12/2029
  • Guideline 55.007A – PV Office Processing for Clinical Investigations of Non CE/UKCA 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
SOP 55.019 – Sponsor Review of Expectedness for Serious Adverse Reactions: CTIMPs (Including ATMPs)
  • Author Name: Marc Jones
  • Version: 1.0
  • Active Date: 19/08/2026
  • Review Date: 31/12/2029
  • None
Chapter 56 – NHS GG&C Sponsor Project Management Unit
SOP 56.001 – Location Set up Green for Go Process
  • Author Name: Lynsey Gillespie
  • Version: 9.0
  • Active Date: 12/03/2025
  • Review Date: 31/12/2028
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: 6.0
  • Active Date: 14/05/2026
  • Review Date: 31/12/2029
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: 10.0
  • Active Date: 04/10/2026
  • Review Date: 31/12/2029
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: 4.0
  • Active Date: 04/10/2026
  • Review Date: 31/12/2029
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: 2.0
  • Active Date: 25/09/2025
  • Review Date: 31/12/2028
SOP 57.015 – GCRF Clinical Research Training
  • Author Name: Naomi Hickey
  • Version: 1.0
  • Active Date: 27/11/2025
  • Review Date: 31/12/2028
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.

Was this helpful?

Yes
No
Thanks for your feedback!