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An FAI is a legal process that seeks to explain the circumstances and facts leading up to a person’s death.  Once an FAI has been decided and intimated on the Board by the Crown Office and Procurator Fiscal Service (COPFS), the Legal Claims Manager will instruct NHS Central Legal Office  (CLO) to protect the interest of the Board and staff at the inquiry. Inquiries are normally held before Sheriffs and generally take place in Sheriff Court buildings.   

Staff involved in the case will be called as witnesses to give their evidence on knowledge of fact or as an expert witness. If you have previously given a statement to the police/PF during the initial Investigation, it is most likely you will be called to give evidence at the FAI.   

Leading up to the FAI, staff may be contacted to provide a further statement (precognition) along with any other information that may be relevant in the preparation of the FAI.  This contact could be from either the CLO Solicitor who is acting on behalf of the Board or the Procurator Fiscal during the preparation of the FAI.   

The FAI needs to determine five main points:- 

  • Where and when the death took place
  • The cause or causes of death
  • The reasonable precautions, if any, that might have avoided the death
  • The defects, if any, in any system of work that contributed to the death
  • Any other facts relevant to the circumstances of the death

Preparation for FAI

Preparation for Court is essential. The gap between the initial PF investigation and the decision being made to hold an FAI can be months or even years.  Take this time to prepare and familiarise yourself about FAIs ensuring you have all the support you need professionally and emotionally to assist and guide you through what can be a stressful and worrying time for staff.  Staff should try and keep in mind that FAIs are not held to find fault or apportion blame with an individual, but to identify and rectify any systematic defects.

You should familiarise yourself with records and reports in relation to the matter and consider what decisions were taken, when and why.  It may also be helpful to think about any factors which may have had a bearing on the death and how you will respond to questions about these.  You will be expected to give evidence on the five main points listed above.   

Questioning

Generally, you will be questioned on who you are, your qualifications, age and experience and place of work before going in to the circumstances surrounding the death.  Try to:- 

  • Be calm, courteous and honest – remain objective
  • Speak clearly and concisely
  • Focus on the question at hand
  • Take time to consider your response
  • Be ready to confirm/back up your evidence from medical notes, reports, etc
  • Refer to your notes if required
  • If you can’t remember or don’t know the answer to a question – say so – and do not guess
  • If unsure of the question, ask for it to be repeated or clarified
  • Do not give an opinion on a matter which you are not qualified to do so
  • Do not discuss your evidence with other witnesses
  • Do not attribute fault to others unless you are an expert witness
  • Try not to use any abbreviations or slang

Questioning is led by the Procurator Fiscal who is representing the public’s interest which then follows on to:-

  • Solicitor representing the deceased’s family (if they have chosen to appoint legal representation)
  • Solicitor representing the NHS (CLO)
  • Legal representation of any individuals who have chosen to be represented in their own right

All relevant medical records, reports are lodged in Court in advance of the trial and can be placed in front of you when in the witness stand to allow you to refer to when giving your evidence, these are known as productions.    

The following support and guidance is available to staff during the PF/FAI:-

  • Practical support and guidance in relation to FAI process
  • Information on court procedures and what to expect as a witness
  • Court familiarisation visit in advance of FAI
  • Support in court on day(s) of giving your evidence
  • One to one support to address any specific concerns or questions
  • Signposting on to other support agencies
  • FAI resource booklet

Support for NHSGGC staff

The following video outlines the support available to NHSGGC staff around Fatal Accident Inquiries.

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NHSGGC has a process in place for the handling and management of Sudden and Unexpected Deaths Investigations under investigation by the Crown Office and Procurator Fiscal Service (COPFS) led by Rachel McGowan, Legal Claims Manager who works closely with NHS staff and the Procurator Fiscals Service (The Scottish Fatalities Unit) during all PF Investigations underway within NHSGGC. 

The Procurator Fiscals Office investigates sudden, unexpected, suspicious, accidental and unexplained deaths occurring in Scotland.  When a death occurs, and the circumstances appear to give cause for concern, the PF will undertake an investigation looking at the facts surrounding the death.  The initial investigation is not an FAI, but it may lead to one as this is the purpose of the investigation to determine whether an FAI should be considered. 

Mandatory FAI’s are held in to deaths that result from an accident in the course of employment and deaths in legal custody, for example, prison deaths, police custody. 

The sole purpose of the PF investigation is to determine if there should be an FAI. The undernoted five main points will be considered, investigated allowing PF/Crown Office to come to a decision:- 

  • Where and when the death took place
  • Cause or causes of the death
  • The reasonable precautions, if any, that might have avoided the death
  • The defects, if any, in any system of work that contributed to the death
  • Any other facts relevant to the circumstances of the death

During the investigation stage, PF can request various pieces of information to assist them, for example, Significant Critical Incident Report (SCI), Action Plan, training details, complaints paperwork, information on any recommendations and actions taken as a result of internal review.  PF may also seek statements (precognition statement) from relevant clinical and nursing staff involved in the treatment and care of the deceased leading up to their death.  Precognition statements taken by the PF or a Precognition Officer are normally done face to face and on a one to one basis with no other parties present.  The purpose of taking a precognition statement is to allow PF to evaluate your evidence in respect of the circumstances surrounding the death. 

The PF investigation can last months or even years and once concluded, recommendations will be made by PF to the Crown Office on whether an FAI should take place in relation to the facts surrounding the death. 

If you are currently involved in a procurator fiscal investigation, it may be helpful to have a read over the NHS Staff Resource Guide on FAI’s along with the Fatal Accident Inquiry (FAI) link on this site providing you with some helpful information and guidance in respect of that process, if and when, an FAI is determined by the Crown Office and Procurator Fiscal Service (COPFS).

Support for NHSGGC staff

The following video outlines the support available to NHSGGC staff around Sudden and Unexpected Death Investigations.

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Staff could be cited in respect of litigation cases raised against NHS Greater Glasgow and Clyde which could relate to a Personal Injury and/or Medical Negligence claim. 

Personal injury law in Scotland is designed to support people who have suffered injury or illness through no fault of their own. This area of law makes it possible for injured parties to make a claim for any pain or loss suffered. Personal injury can include, for example, an injury at work or an injury caused by an error in hospital treatment. 

Staff can be called by either the Pursuer’s Solicitor (Solicitors acting on behalf of the person who raises the claim) or the NHS Central Legal Office (CLO, NHS Solicitors) who will defend the claim. 

Support and guidance is available to NHS staff called in respect of Legal Claims as follows:-

  • Practical support and guidance
  • Information on court and legal process
  • Guidance regarding further support
  • One to one support to address specific concerns or questions
  • Signposting

Please note, in respect of legal claims, each service/sector will have a designated Legal Claims Manager dealing with the case who will be able to respond to your questions in the first instance.

Attending court can be a daunting and anxious experience for staff, therefore, it may be helpful for you to think about having a court visit in advance of your trial/hearing.  A court visit is one way, if not the best way, to prepare and familiarise yourself with the court and court process.  This will help you know where the court is located, allowing you to plan your route, parking and travelling on the day of giving your evidence, the less stress the better on the day!  This may seem like simple measures but will ease a great deal of stress for you on the day of giving your evidence.

Having a court familiarisation visit will also help prepare you in advance of the court surroundings, allowing you to become familiar with the court, courtroom, witness room giving you plenty of information and guidance on who is who along with court process. This will take away the unknown formality of the court and allow you to approach the witness stand feeling more confident and assured of the process, keeping in mind, you are assisting the court as a professional witness.  If you are feeling anxious about an upcoming trial or an upcoming Fatal Accident Inquiry, I would encourage you to consider a court visit which I will be happy to assist and support you with this. 

Court visits have been of great assistance to many NHS staff over the years (specifically in FAI’s cases) helping staff prepare well in advance.   

Court visits are normally arranged between 1.00pm until 2.00pm when the court stop for lunch. This allows you to visit the court and witness room when everything is a little quieter to allow you to take it all at your own pace and allows for any specific concerns and questions you may have.

When the day arrives of giving your evidence, dress comfortably and smart, arrive in plenty of time. 

When you arrive at the court you will have to go through court security first (a bit like airport security – you will be searched, bag, jacket) which can take time if court is busy, specifically, first thing in the morning when everyone is arriving at court.

Make sure to take your citation with you to court and report to the main reception desk where court staff will direct you to the appropriate area/witness room where you will wait until you hear your name being called by court staff.  Be prepared for a wait!   

When the court is ready for you to give your evidence, you will hear your name being called by a court official who will take you to the court room, once inside the court room they will direct you to the witness box where you will remain standing to give your evidence (unless you are unable to do so due to medical reasons).  You will then be asked to take the oath or affirm by the Sheriff or Judge and questioning will then begin with the Procurator Fiscal/Advocate Depute who will address you first.  

Version 1.4 (updated: April 2024)

1. Introduction

The aim of this document is to inform and advise NHS Greater Glasgow and Clyde staff on the Scottish Hospitals Inquiry. It outlines the Public Inquiry process, gives advice on how staff can prepare and where staff can find support.

Taking part in a Public Inquiry can be stressful. Staff can find their actions questioned and challenged in an environment that can feel alien. Making sure that all staff understand what is involved will help our staff and help the Inquiry establish what happened.

NHS Greater Glasgow and Clyde (NHSGGC) is fully committed to supporting staff through the Scottish Hospitals Inquiry. Appendix 1 has details on the type of support available and how to access this support.

2. The Scottish Hospitals Inquiry

Background

In November 2019, the Cabinet Secretary for Health and Sport, Jeanne Freeman, announced in the Scottish Parliament that a Public Inquiry would be held to examine issues at the Queen Elizabeth University Hospital Campus (QEUH) (which includes the Royal Hospital for Children) and the Royal Hospital for Children and Young People (RHCYP) and Department of Clinical Neurosciences (DCN), following concerns about patient safety and wellbeing, in order to determine how issues relating to ventilation, water and other key building systems gave rise to those concerns, how they occurred and what steps could be taken to prevent such issues arising in future projects.

The Scottish Hospitals Inquiry (‘the Inquiry’) is a Public Inquiry, set up under the Inquiries Act 2005. Lord Brodie was appointed as the Chair of the Inquiry with effect from 28 November 2019 and the Inquiry work commenced on 3 August 2020. The Terms of Reference of the Inquiry, which specify its remit and the issues it is examining in more detail, were published on 15 June 2020 (Appendix 2). There have been five diets of evidential hearings, commencing in September 2021.

What is a Public Inquiry?

A Public Inquiry is a formal, independent review relating to particular events which have caused or have potential to cause public concern, or where there is public concern that particular events may have occurred. It is inquisitorial in nature, not adversarial. The aim of a Public Inquiry is to help to restore public confidence in systems or services by investigating the facts through consideration of documentary and witness evidence, to determine what happened and help prevent recurrence. The outcome of a Public Inquiry is the production by the Chair, with input from the Inquiry Team, of a report which details key findings of fact and makes recommendations. It is not the purpose of a Public Inquiry to determine issues of civil or criminal liability.

NHSGGC is a Core Participant at the Inquiry. This designation affords the Board the opportunity to have more active involvement in the Inquiry process, including enabling its legal representatives to: make opening and closing statements (where permitted by the Chair); ask questions of witnesses giving oral evidence (where permitted by the Chair); and receive
early sight of, and in some circumstances comment on, certain Inquiry documentation.

Format of the Public Inquiry

The Inquiry Team gathers evidence in the form of statements and documents, considers that evidence and prepares for hearings at which the evidence is tested.

The first formal hearing of the Scottish Hospitals Inquiry was held on 22 June 2021 remotely, in line with COVID-19 restrictions. This was a short hearing where Lord Brodie set out arrangements for the hearings commencing in September.

The first diet of oral hearings was conducted over the course of five weeks, between 20 September and 5 November 2021. Evidence from patients and their families was heard about their perceptions of the impact on patient safety and care from issues arising in relation to ventilation, water and drainage and other matters, and the communication with patients and their families in relation to those issues.

A further diet of hearings took place in May 2022, where the Inquiry focused primarily on ventilation and other matters relating to the project governance and funding model at the RHCYP and DCN.

Hearings in respect of the RHCYP and DCN were conducted over a two-week period, commencing on 24 April 2023, which considered the procurement exercise for the Edinburgh project.

Thereafter, a further diet of hearings relating to the QEUH commenced on 12 June 2023 for a period of two weeks. The purpose of that hearing was to allow the Chair to hear evidence on the perspective from clinicians and nurses working at the QEUH, following on from the evidence of patients and families heard in September 2021.

The third and final hearing in relation to the RHCYP and DN commenced on 26 February 2024 for a period of three weeks, which focused on the reasoning behind the decision not to open the hospital in 2019 and to open in 2021 instead.

A third hearing in relation to the QEUH has been set down for 19 August 2024 for a period of 12 weeks, which will focus on water and ventilation systems and infection at the QEUH.

3. Statements

Appendix 1 has information on the support available to staff who have been asked to provide a statement.

Investigations continue to be carried out by the Inquiry Team. This involves reviewing all relevant paperwork, notes and records; and interviewing individuals with knowledge of the circumstances surrounding the issues in relation to adequacy of ventilation, water contamination and other matters which arose in the construction and delivery of the hospital(s). There are also investigations relating to the response to emerging issues related to infections of patients at the QEUH after it was opened.

You may be asked by the Inquiry team to provide a witness statement, in which case you will be contacted by a named team member from the Inquiry Team’s Witness Engagement and Support Team either to arrange a suitable time for an interview appointment or to let you know that they intend to issue a questionnaire to you in the first instance, prior to arranging a meeting. When asked to attend for an interview, your named team member will confirm the interview details in writing,

to arrange a suitable time for an interview appointment. Your named team member will confirm the interview details in writing, provide the name of the person who will conduct the interview, and will also ensure that you understand what is involved in providing evidence, giving statements and attending hearings.

You may have somebody present with you at this meeting, such as a work colleague, friend, official from your Trade Union or Professional Organisation, or a solicitor from the NHS Central Legal Office’s (“CLO”) dedicated Scottish Hospitals Inquiry team (which is acting for NHSGGC in the Inquiry). It is recommended that whoever accompanies you is not themselves likely to be asked to provide a statement.  The recommendation is that a solicitor from CLO attends with you to provide as full legal support as possible.

However, if you would prefer to be accompanied by an independent solicitor, the Inquiries Act 2005 allows for the possibility of an award of funding for legal representation for witnesses; applications for funding for legal representation must be approved in advance. There is further information on this on the Inquiry website and you would have to speak with the Inquiry’s witness support team about this.

You can arrange a meeting with the Inquiry team during your work time but, if you wish to do so, you must inform your Line Manager to organise your work pattern and arrange cover if required.

Preparation

It is important that, if you are asked to provide a witness statement, you review and are familiar with relevant records, case notes and documentation. The Inquiry team will inform you in advance of the issues about which you will be asked, as well as providing you with copies of the documentation you may be asked about.

Interviews

If you have been asked to provide a witness statement, you will also be informed of the location of the interview, or whether it will be appropriate to take the statement remotely.

There are likely to be two members of the Inquiry team in attendance, who will take your statement. Giving a witness statement may take some time.  The statement takers will allow regular breaks, but you should feel free to ask for breaks whenever you want. If a meeting is likely to last a long time, the interview will be spread over more than one day. Consider making your own notes of the interview; this will help in remembering what was said when you receive the draft statement of your interview.

You will have the opportunity to get support from the NHSGGC Witness Service and/or CLO before you give a statement to the Inquiry Team.  See Appendix 1.

Signing the Statement

After your interview, you will receive a draft copy of your witness statement. This must be read thoroughly, and any changes, additions or deletions can be made at this stage. You should sign the statement once you are satisfied that it accurately reflects your evidence. You may be asked to provide electronic verification in place of a signature, if the process is taking place remotely. Once the statement is signed, it then becomes your evidence to the Inquiry. If you subsequently wish to say something more, you can make a further statement.

4. Appearing as a Witness

Any individual who has been interviewed and provided a statement to the Inquiry Team may then be called as a witness at the Public Inquiry. However, in many cases, a witness’ statement will be sufficient and they will not also be required to give evidence at a hearing. Appendix 1 has information on the support available to staff who have been called to appear as a witness.

Statements

Shortly before a witness gives evidence at the hearings his/her statement will be published on the Inquiry website.  A witness’ personal details (i.e. address and date of birth) and signature will not be published.

Called as a witness

If you are called to give evidence, it is important that you prepare for this by:

  • Reviewing all personal notes and files.
  • Familiarising yourself with the hearing surroundings by viewing the film of the venue provided by the Inquiry Team in advance.
  • Being prepared for media interest in the lead up to the hearing and at the hearing venue. See Section 6 for media advice.
  • Being aware that you may have to wait at the hearing venue before you are called as a witness.

Giving Evidence

When called to give evidence, a witness must take an oath, or affirm, declaring that they will tell the truth at all times. Listen carefully to the questions you are asked and take time to consider your response. Do not feel pressured to give a “yes” or “no” response and be ready to explain your view. If you can’t remember the date of an event or don’t know the answer to a question, say so – don’t try to guess. If a question has multiple parts, break down your answer. If you are unsure of the question, ask for it to be repeated.

Generally, you will be questioned on who you are, your qualifications and experience, and your place of work before going on to the circumstances surrounding the issues in relation to adequacy of ventilation, water contamination and other matters which arose in the construction and delivery of the QEUH as well as issues which emerged after its opening. Be calm, courteous and honest. Remain objective, and do not get personal. Speak clearly and concisely, and be ready to confirm your evidence from notes taken at the time, or by reference to your witness statement. If your role is a central one, be prepared for a possible lengthy session in the witness box which may last several hours.

What are key things to remember in giving evidence?

Do:

  • prepare in advance
  • be fully familiar with the issues in the case
  • give detailed and relevant answers
  • say if you cannot remember
  • be alert and astute to the atmosphere in the venue
  • direct your answers to the Chair, even though counsel to the Inquiry is asking the questions: the Chair is the decision maker
  • be clear in what you say and speak loudly enough for the Chair and Counsel to the Inquiry to hear you
  • be ready and willing to expand and explain your answers if requested
  • be ready and willing to see the argument in opposing views but be firm and clear about your own evidence
  • be prepared for delays
  • be aware this is a formal proceeding and dress appropriately
  • try to remain calm and not react emotionally
  • try to avoid appearing defensive, impatient or argumentative
  • stick to the facts – don’t make assumptions about what other people did or did not do
  • try to avoid jargon, medical or hospital language that others may not understand.
5. Conclusion

Once all of the evidence has been taken, Lord Brodie will close the Inquiry to consider his determination. The Inquiry is required to report to the Scottish Ministers, making recommendations identifying any lessons learned as soon as reasonably practicable. The Inquiry will end when Lord Brodie has submitted his report to the Scottish Ministers.

6. Media

Public inquiries are open to the public and the media. Witness statements will be posted on the Inquiry website when witnesses are called to give evidence, so the media will have access to materials during each stage of the Inquiry hearings. This could lead to witnesses being quoted in media reports when appearing at the Inquiry.

While newspaper and broadcast media would normally attend a public inquiry, numbers of attendees are restricted at the Inquiry premises. Therefore, reporting on the hearings will largely be done remotely and proceedings are being live-streamed on the Inquiry’s YouTube channel. The hearings will be available to watch again following the hearing. Transcripts of the hearings will also be published following the hearing, unless any contrary order or restriction notice is in place.

6.3       The Inquiry has measures in place to ensure that witnesses to the Inquiry are not approached by the media within the Inquiry premises. Should you be approached by a journalist outside the Inquiry premises, there is no obligation for you to make comment. The media may also take photographs of witnesses arriving at or departing from the Inquiry.

The NHSGGC Communications team is on hand to advise and support you if you are in any doubt about what to do if contacted by the press. They can be contacted by telephone, 0141 201 4429, or email, press.office@ggc.scot.nhs.uk 24 hours a day.

7. Expenses

Staff called to give evidence at the hearing may be entitled to travelling expenses and subsistence allowances. Further information can be found in Appendix 3.

8. Compellability

All staff asked to provide evidence, a statement or appear as a witness will receive a formal request to do so and your cooperation is appreciated. If a member of staff refuses this request, Lord Brodie has the power to apply for an Order from the Court of Session requiring a witness to provide evidence, a statement or appear as a witness, failing which they may be found to have committed a criminal offence.

9. Further Information

Further information on the Scottish Hospitals Inquiry can be found on the Inquiry website: www.hospitalsinquiry.scot

NHS GG&C Communications web portal: NHSGGC : Corporate Communications at NHSGGC

If you would like further advice or someone to support you during an interview, the following contacts may be helpful:

Appendix 1 – Staff Support

NHS Greater Glasgow & Clyde is fully committed to providing support to all staff who may be involved in the Scottish Hospitals Inquiry.

Witness Support

NHS Greater Glasgow & Clyde Legal Office operates a “Witness Service” that offers support and guidance to all witnesses asked to give evidence at a hearing. The service they can provide which would be helpful to any NHS staff member if required is:

  • Practical help
  • Information on Inquiry procedures
  • Guidance regarding further support
  • A listening ear for your anxieties/concerns

Staff who have used this service in the past have found it to be very helpful. If you are invited to give a statement/evidence and would like some support from this service, please contact Rachel McGowan, 07583 121674 or rachel.mcgowan@ggc.scot.nhs.uk  

Alternatively, you can ask your trade union or professional organisation for support. 

Occupational Health Service 

The Occupational Health service is available to offer additional advice and support if required.   You can contact them in the following ways: 

To arrange an appointment with the OH Counselling service please call: 0141 201 0600 – Lines are open Monday to Friday 8.00am until 5.00pm. 

To speak to an Occupational Health Nurse please call our telephone advice line on 0141 201 0594 Lines are open Monday to Friday 8.00am until 5.00pm. 

To speak to a member of the OH Psychology Staff Support Service please call 0141 277 7623 Lines are open Monday to Friday 8.00am until 5.00pm. 

Alternatively, you can email your enquiry to the Occupational Health Department via our generic email address and a member of the team will get back to you as soon as possible:  Occupational.Health@ggc.scot.nhs.uk

Debriefing

Once the Scottish Hospitals Inquiry hearings are over, all staff involved will have the opportunity for debriefing.

Appendix 2 – Remit and Terms of Reference

Remit

The overarching aim of this Inquiry is to consider the planning, design, construction, commissioning and, where appropriate, maintenance of both the Queen Elizabeth University Hospital Campus (QEUH), Glasgow and the Royal Hospital for Children and Young People and Department of Clinical Neurosciences (RHCYP/DCN), Edinburgh. The Inquiry will determine how issues relating to adequacy of ventilation, water contamination and other matters adversely impacting on patient safety and care occurred; if these issues could have been prevented; the impacts of these issues on patients and their families; and whether the buildings provide a suitable environment for the delivery of safe, effective person-centred care. The Inquiry will make recommendations to ensure that any past mistakes are not repeated in future NHS infrastructure projects. The Inquiry will do this by fulfilling its Terms of Reference.

Terms of Reference

To examine the issues in relation to adequacy of ventilation, water contamination and other matters adversely impacting on patient safety and care which arose in the construction and delivery of the QEUH and RHCYP/DCN; and to identify whether and to what extent these issues were contributed to by key building systems which were defective in the sense of:

a) Not achieving the outcomes or being capable of the function or purpose for which they were intended;

b) Not conforming to relevant statutory regulation and other applicable recommendations, guidance and good practice.

To examine the arrangements for strategic definition, preparation and brief and concept and design, including the procurement, supply chain and contractual structure adopted for the financing and construction of the buildings, to determine whether any aspect of these arrangements has contributed to such issues and defects.

To examine during delivery of QEUH and RHCYP/DCN projects:

 a) Whether the Boards of NHS Greater Glasgow & Clyde and NHS Lothian put in place governance processes to oversee the projects and whether they were adequate and effectively implemented, particularly at significant project milestones;

b) Whether operational management provided by the Boards of NHS Greater Glasgow and Clyde and NHS Lothian was adequate and effective for the scale of such infrastructure projects;

c) The extent to which decision makers involved with the projects sought and facilitated the input and took account of the advice and information provided by, or available from, the clinical leadership team; infection control teams; estate teams; technical experts and other relevant parties to ensure that the built environment made prior provision for the delivery of clinical care;

d) Whether, the organisational culture within the Boards of NHS Greater Glasgow and Clyde and NHS Lothian encouraged staff to raise concerns and highlight issues in relation to the projects at appropriate times throughout the life cycles of the projects;

e) Whether failures in the operation of systems were a result of failures on the part of the individuals or organisations tasked with specific functions.

To consider whether any individual or body deliberately concealed or failed to disclose evidence of wrongdoing or failures in performance on inadequacies of systems whether during the life of projects or following handover, including evidence relating to the impact of such matters on patient care and patient outcomes; and whether disclosures of such evidence was encouraged, including through implementation of whistleblowing policies, within the organisations involved.

To examine whether, based on the governance arrangements in place, national oversight and support of such a large-scale infrastructure projects was adequate and effective and whether there was effective communication between the organisations involved.

To examine, during the life cycle of the QEUH and RHCYP/DCN projects, how the Boards of NHS Greater Glasgow and Clyde and NHS Lothian secured assurance and supporting evidence that:

a) All necessary inspection and testing had taken place;

b) All key building systems had been completed and functioned in accordance with contractual specifications and other applicable regulations, recommendations, guidance and good practice and;

c) Adequate information and training were provided to allow end-users effectively to operate and maintain key building systems.

To examine what actions have been taken to remedy defects and the extent to which they have been adequate and effective.

To examine the physical, emotional and other effects of the issues identified on patients and their families (in particular in respect of the environmental organisms linked to infections at the QEUH) and to determine whether communication with patients and their families supported and respected their rights to be informed and to participate in respect of matters bearing on treatment.

To examine the processes and practices of reporting healthcare associated infections with QEUH and determine what lessons have been or should be learned.

To examine whether the choice of sites was appropriate or gave rise to an increased risk to patients of environmental organisms causing infections.

To examine whether there are systematic knowledge transfer arrangements in place to learn lessons from healthcare construction projects and whether they are adequate and effective.

To examine whether NHS Lothian had an opportunity to learn lessons from the experience of issues relating to ventilation, water and drainage systems at the QEUH and what extent they took advantage of that opportunity.

To report to the Scottish Ministers on the above matters, and to make recommendations identifying any lessons learnt to ensure that any past mistakes are not repeated in any future NHS infrastructure projects, as soon as reasonably practicable.

Appendix 3 – Expenses

Expenses forms and guidance can be found on HR Connect at the following links:

Car Users

Members of staff who are registered car users should complete a paper expenses form with details of travel to the hearing venue and this would be reimbursed at the public transport rate of 24p per mile.    

Members of staff who use their own car to travel (and are not registered as a car user) are also entitled to claim public transport rate of 24p per mile and should also complete a paper expenses form.

Public Transport

Members of staff who use public transport to get to the hearing venue should retain their receipts and attach to a completed an expenses form in relation to daily expenses. 

Lunch

Members of staff who are away from their usual workplace and are not close to NHS dining facilities over lunchtime are entitled to claim a subsistence allowance up to £5.00.

Expenses Forms

Refer to the guidance for instructions on how to complete the expenses form. Once authorised by local management, completed forms and receipts should be forwarded to:

Expenses Team
Caledonia House
140 Fifty Pitches Road
Cardonald Business Park
Glasgow
G51 4EB

Queries

If you have any questions about claiming expenses or completing an expenses form, please contact eexpenses@ggc.scot.nhs.uk

Appendix 4 – Venue

The Inquiry premises are at: 20 West Register Street, Edinburgh, EH2 2AA.

Just off St Andrew Square, the venue is close to Waverley train station, Edinburgh bus station and has good tram links. No car parking is available at the venue.

Being a Witness

Going to Court as part of your NHS profession is more common for some staff than others. This site offers some key things to consider when you are cited as a witness, providing some details around the various legal cases some NHS staff could be called to attend.

It is important to keep in mind that witnesses play a key role by giving information in court. The courts need witnesses to give evidence so that they can build up a picture of the facts surrounding the case allowing the court to come to a decision/verdict.  Understandably, witnesses can feel intimidated and anxious about the prospect of attending court and hopefully this site will help answer some questions you may have at this time. 

What is Witness Support?

Preparation is essential when you are being called as a professional witness.  Witnesses have to prepare themselves professionally for Court by reviewing all relevant documents, notes relative to their involvement. The more they prepare the more beneficial and less daunting it should be when the time comes to take the witness stand in court. 

Witness support is practical, emotional and confidential support and guidance on court and legal process.  Witness Support is not coaching or influencing witnesses on how to give your evidence but helping you become more prepared, confident and familiarised in the legal process you are about to embark.  Sometimes, the gap between giving a witness statement/precognition statement and a trial/hearing date being set can take many months or years, depending on the type of case.  Therefore, use that time to prepare and familiarise yourself with relevant medical notes/investigation reports ensuring you have all the support you need professionally and emotionally to assist and guide you through what can be a stressful and sometimes worrying time for NHS staff.  

As a starting point, have a read over the site content and familiarise yourself with the appropriate sections, for example, if you are being cited in respect of a Criminal Trial, have a read over Cited to a Criminal Trial section first and then section around court attendance/court visit – Attendance at Court & Court Familiarisation Visit.  This will give you some practical information and guidance and a good starting point in aiding your preparation for Court.

NHS Staff may be cited at some point in their professional career in relation to cases such as:-

  • Public Inquiry (for the Scottish Hospitals Inquiry – please see guidance and FAQs)
  • Litigation cases – Personal Injury/Medical Negligence Claims
  • Procurator Fiscal Office Investigation (SUD)/ Fatal Accident Inquiry (FAI)
  • Criminal Trial
  • Nursing and Midwifery Hearing (NMC)
  • Children’s Hearing

What witness support can offer staff:-

  • One to one practical, emotional and confidential staff support to listen and address your specific concerns and/or questions 
  • Group Support – at times, various staff from one ward/department may be cited
  • Q & A sessions covering expectations of witness
  • Working in collaboration with external agencies such as Witness Service, Victim Information and Advice (VIA), NMC enabling a dedicated staff centred approach for NHS witnesses
  • Court Familiarisation visit in advance of trial  (subject to COVID restrictions)
  • Support in court on day of giving your evidence (subject to COVID restrictions)
  • A dedicated point of support and guidance to you throughout the legal process aiding in your preparation and familiarisation of court and legal process. 
  • Practical information around court processes and expectation of witnesses

Please read over the appropriate pages linked to the side relating to the type of case you are cited to attend. If further support is required, please get in touch with Rachel McGowan or your appropriate Legal Claims Manager for your area if matters relate to a legal claim against the Board.

The Witness Support and Corporate Legal Manager is based at West Glasgow ACH. 

Please note: Witness Support is not coaching, influencing or tactical support and advice for attending Court. Witness Support offers reassurance for NHS staff who have been cited to attend Court. 

The following videos highlight the support available to NHSGGC staff around Fatal Accident Inquiries (FAI) and Sudden and Unexpected Death Investigations (SUD)

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Privacy Notice

As part of our requirements under Data Protection legislation, we have published a Staff Privacy Notice. By issuing this privacy notice, we demonstrate our commitment to openness and accountability.

We recognise the need to treat staff’s personal and sensitive data in a fair and lawful manner. No personal information held by us will be processed unless the requirements for fair and lawful processing can be met.

Contact Information

Rachel McGowan, Witness Support and Corporate Legal Manager based at West Glasgow ACH. Working as a Witness Support and Corporate Legal Manager involves me working closely with a wide variety of clinical and non-clinical staff across the organisation in relation to various legal cases on behalf of the Board. 

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If you have been asked to attend a Scottish Hospitals Inquiry oral hearing, this short video will provide you with an overview of the hearing room before you arrive. 

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More Information

NHSGGC has already earned a reputation with companies for being open to innovative ideas and partnership working. We aim to build on this. In response to the scale of funding and innovation opportunities that are becoming available, NHSGGC has set up an Innovation Governance Group (IGG). The role of the IGG is to primarily assess consortia and bids that aim to use NHSGGC as an innovation test bed with an aim to;

  • Prioritise those that align with NHSGGC objectives and strategic delivery plans
  • Position NHSGGC to attract Innovation funding to support strategic developments.

Who are we?

Registering a project

As part of the processes for IGG we are now using a new system for the registration of innovation projects. To register your innovation project please complete the registration form (here) and send to innovation@ggc.scot.nhs.uk

Please visit our website for more info 

www.woshealthinnovation.scot

Diabetes SBRI

Deliver safe and better care for people in Scotland with diabetes, Phase 1 SBRI Competition 

The following link provides a recording of the launch event held on 17th August 2020 which was attended by some 79 participants: Click here

The presentations from the event can be viewed here:

01 Brian Kennon Diabetes SBRIs B Kennon 17th Aug 2020

02 Andrew Fowlie – sbri slides Andrew Fowlie 17-Aug

03 Jon Hazell_SBRI APPLICANT BRIEFING DIABETES

04 Sandra AI diabetic Ulcer infograph – S.MacRury

04 Sandra SBRI Diabetes Foot Disease pptx V3

05 Stuart Ritchie Innovation meeting – August 2020

06 Maria Talla Osteoporosis

07 Paul McGinness (Storm) SBRI August 2020

SBRI Diabetes & Endocrine Briefing Event, 17 Aug – Agenda

SBRI Launch event Q&As

The competition is live, with registration closing on the 23rd September 1100am and the competition closing on the 30th September 1100am

This is a Small Business Research Initiative (SBRI) competition funded by NHS Scotland. Successful applicants receive 100% funding and access to advice from NHS Highland, NHS Lothian and NHS Greater Glasgow and Clyde.

The overall programme will be delivered in up to 2 phases. This is phase 1. A decision to proceed with phase 2 will depend on the outcomes from phase 1. Only successful applicants from phase 1 will be able to apply to take part in phase 2.

NHS Scotland is investing up to £300,000 including VAT, in innovative solutions in 3 challenge areas as follows:

Challenge A

Using artificial intelligence and machine learning to help develop prediction algorithms and risk stratification for diabetes foot ulceration, amputations and mortality.

Challenge B

Improving the clinical care of patients with a pre-existing diagnosis of diabetes when admitted to hospital by developing a real-time decision support tool and alert mechanism. The tool must improve triage, prevent medication errors, identify emergencies and streamline the diabetes care pathway.

Challenge C

Improving the identification (case finding) of people at risk of osteoporosis and fracture, including those with diabetes.

You need to submit a separate application for each challenge you wish to apply for. Further details can be found at: https://apply-for-innovation-funding.service.gov.uk/competition/664/overview

APPLICATION FOR FUNDING

NHSGG&C RESEARCH ENDOWMENT FUND ALLOCATION 2025/26

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

The following categories are open for applications:

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

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

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

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

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

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

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

Submission Deadlines

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

Applications received after this date will not be accepted

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

Finance enquiries please email R&I finance

(ggc.randifinancegrants@nhs.scot)

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

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

CSO are delighted to announce that applications are now open for the next round of CSO Response Mode Research Grants. The deadline for submitting the outline application is Friday 27th June 2025.

We would like to highlight that CSO have implemented a new grants management system .Applicants will be able to submit and manage their applications through all the pre-stage and post award stages through this portal.

For more information about the response mode grant scheme please see our website: Response Mode Research Grants – Open for Applications – Chief Scientist Office or contact Louise Campbell or Alan McNair

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

Applications are Invited for the Endowment Research Facility Investment fund

Purpose of fund:

“Investment in Equipment, Information and Communication Technology CT and physical infrastructure for research facilities and activity”.

Please complete Endowment Funds Block Grant Application Form and submit to michelle.mcdermott@nhs.scot

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

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Quality Manuals
QM-RI-1 – Research and Innovation Quality Manual
  • Author Name: Paul Gribbon
  • Version: 1.0
  • Active Date: 09/11/2023
  • Review Date: 31/12/2024
QM-IN-1 – Innovation Quality Manual
  • Author Name: Elaine O’Neill
  • Version: 1.0
  • Active Date: 18/03/2024
  • Review Date: 31/12/2025
QM-BIO-1 – Biorepository Quality Manual
  • Author Name: Clare Orange
  • Version: 1.1
  • Active Date: 24/04/2024
  • Review Date: 31/12/2025
QM-SH-1 – Safe Haven Quality Manual
  • Author Name: Alison Hamilton
  • Version: 1.0
  • Active Date: 10/10/2023
  • Review Date: 31/12/2024
Chapter 17 – NHS GG&C Clinical Research Facility – Clinical
SOP 17.001 – Adult Emergency Resuscitation Procedures in GCRF
  • Author Name: Naomi Hickey
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.003 – Research Participant’s Clinical Measurements
  • Author Name: Karen Duffy
  • Version: 5.0
  • Active Date: 18/10/2023
  • Review Date: 31/12/2026
  • None
SOP 17.005 – Urinalysis
  • Author Name: Linda Wilson
  • Version: 4.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.006 – Refrigerator and Freezer Unit Use and Monitoring
  • Author Name: Barbara McLaren
  • Version: 5.0
  • Active Date: 04/01/2025
  • Review Date: 31/12/2028
SOP 17.007 – Use of laboratory centrifuge
  • Author Name: Dominic Rimmer
  • Version: 5.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.008 – Recording an Electrocardiograph (ECG)
  • Author Name: Barbara McLaren
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.009 – Obtaining Spirometry Measurements
  • Author Name: Hilary Peddie
  • Version: 5.0
  • Active Date: 27/09/2023
  • Review Date: 31/12/2026
  • None
SOP 17.012 – Obtaining Informed Consent (Adults)
  • Author Name: Helen Hart
  • Version: 6.0
  • Active Date: 28/09/2022
  • Review Date: 31/12/2025
SOP 17.013 – Study Site Coordination and Delivery of an ATIMP Study
  • Author Name: Karen Duffy
  • Version: 1.0
  • Active Date: 20/12/2019
  • Review Date: 31/12/2023
  • Form 17.013A – Clinical Alert Template for Genetically Modified Advanced Therapy IMP
  • Form 17.013B – Inter-site Communication Form for Genetically Modified Advanced Therapy IMP Delivery
SOP 17.015 – Measurement of Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV)
  • Author Name: Barbara McLaren
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.016 – Ambulatory Electrocardiograph Monitoring
  • Author Name: Karen Duffy
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.020 – Monitoring Expiration of Clinical Consumables
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • Form 17.020A – Glasgow Clinical Research Facility Consumable Checklist
SOP 17.025 – Initialising the 24 hour BP monitor
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.026 – Use of Ambulatory Blood Pressure Monitoring Machines
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.027 – Role of GCRF Nurse Coordinator
  • Author Name: Naomi Hickey
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.028 – Management of Hypoglycaemia in adults
  • Author Name: Hilary Peddie
  • Version: 4.0
  • Active Date: 21/07/2023
  • Review Date: 31/12/2026
SOP 17.029 – Management of Anaphylaxis in Adults and Paediatrics
  • Author Name: Naomi Hickey
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.030 – Measuring and Recording Blood Pressure using digital or electronic equipment
  • Author Name: Karen Duffy
  • Version: 4.0
  • Active Date: 24/11/2023
  • Review Date: 31/12/2026
  • None
SOP 17.032 – Return of stock drugs and IMPs
  • Author Name: Barbara McLaren
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • Form 17.032A – Glasgow Clinical Research Facility Spot Check Rota
SOP 17.034 – Storage and management of Medication
  • Author Name: Dominic Rimmer
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.035 – Administration of a Vaccine
  • Author Name: AnneMarie Munro
  • Version: 2.0
  • Active Date: 25/10/2024
  • Review Date: 31/12/2027
  • None
SOP 17.041 – GCRF Management of Samples
  • Author Name: Barbara McLaren
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 17.042 – Paediatric Emergency Resuscitation Procedures in GCRF
  • Author Name: Susanne Cathcart
  • Version: 4.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • Form 17.042A – GCRF QEUH Paediatric Emergency Trolley Checklist
SOP 17.044 – NHS Research Scotland Children s Network SOPs in GCRF
  • Author Name: Susanne Cathcart
  • Version: 3.0
  • Active Date: 29/08/2019
  • Review Date: 31/12/2026
SOP 17.045 – Case Report Form (CRF) Completion
  • Author Name: Dominic Rimmer
  • Version: 4.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.047 – Transfer of the Unwell Research Participant to Acute Care
  • Author Name: Steven Henderson
  • Version: 2.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 17.048 – GCRF Risk Assessment and Mitigation
  • Author Name: Karen Duffy
  • Version: 3.0
  • Active Date: 09/04/2023
  • Review Date: 31/12/2026
SOP 17.052 – Grantbio Shaker-Incubator
  • Author Name: Shona Perry
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.053 – Blood Sampling from a Peripheral Venous Catheter
  • Author Name: Naomi Hickey
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
  • None
SOP 17.055 – Obtaining Informed Consent and Assent (Children)
  • Author Name: Naomi Hickey
  • Version: 1.0
  • Active Date: 02/03/2023
  • Review Date: 31/12/2026
  • None
Chapter 21 – NHS GG&C Pharmacy – Sponsor IMP Management
SOP 21.001 – Review of grant applications with respect to IMP manufacture, distribution and management
  • Author Name: Elizabeth Douglas
  • Version: 3.0
  • Active Date: 26/09/2023
  • Review Date: 31/12/2026
  • Form 21.001A – Summary of Pharmacy and IMP Related Costs (Grants/Support)
  • Form 21.001B – Template Specification for IMP Manufacturing Activity
  • Guideline 21.001A – Generating anticipated pharmacy and IMP related study costs
SOP 21.003 – Sponsor IMP Management and Accountability
  • Author Name: Pamela Surtees
  • Version: 5.0
  • Active Date: 26/09/2023
  • Review Date: 31/12/2026
  • Form 21.003A – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist: Site IMP Management & Accountability Manuals
  • Form 21.003B – NHS GG&C Sponsored/Co-Sponsored Clinical Trials Checklist: Sponsor IMP Management & Accountability Manuals
  • Form 21.003C – IMP Management File Note
  • Form 21.003D – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist:
  • Form 21.003E – NHS GG&C Sponsored/Co-sponsored Clinical Trials Checklist:
  • Guideline 21.003A – IMP Management and Accountability Processes and Documentation
  • Guideline 21.003B – IMP /Study Product management and accountability processes and documentation for Investigator site file
SOP 21.004 – Sponsor Management of IMPs Permanently Stored External to Pharmacy
  • Author Name: Paula Morrison
  • Version: 2.0
  • Active Date: 31/03/2025
  • Review Date: 31/12/2028
  • Form 21.004A – Sponsor IMP Management Risk Assessment Process: Permanent Storage of IMP External to Pharmacy
  • Form 21.004B – IMP Storage Assessment – Permanent Storage of IMP External to Pharmacy
  • Guideline 21.004A – Permanent Storage of IMPs External to Pharmacy: Guidance on Risk Mitigation Strategies
SOP 21.005 – Managing Drug Alerts and Other Urgent Defective Medicine Reports for IMPs and NIMPs in Clinical Trials Sponsored or Co-Sponsored by NHS GG&C
  • Author Name: Elizabeth Douglas
  • Version: 4.0
  • Active Date: 28/09/2023
  • Review Date: 31/12/2026
  • Form 21.005A – Defective Medicines Alert Tracker for Sponsored/Co-sponsored by NHS GG&C
SOP 21.007 – Site-to-site transfer of Investigational Medicinal Products
  • Author Name: Elizabeth Douglas
  • Version: 3.0
  • Active Date: 28/09/2023
  • Review Date: 31/12/2026
SOP 21.008 – Development and approval of labelling text for IMPs and NIMPs
  • Author Name: Pamela Surtees
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • Form 21.008A – NHS GG&C IMP Label Specification Sponsor Approval Form
SOP 21.009 – Expiry Date Monitoring for Study Products Supplied as Part of a Clinical Trial
  • Author Name: Pamela Surtees
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • None
SOP 21.010 – Disposal of Investigational Medicinal Products and other study products
  • Author Name: Pamela Surtees
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • None
SOP 21.011 – Management of temperature deviations and defects in IMPs and NIMPs supplied by Sponsor for clinical trials sponsored or co-sponsored by NHSGGC
  • Author Name: Paula Morrison
  • Version: 4.0
  • Active Date: 26/09/2023
  • Review Date: 31/12/2026
SOP 21.012 – R&I Pharmacy Review Of Sponsored Clinical Trials
  • Author Name: Elizabeth Douglas
  • Version: 4.0
  • Active Date: 10/12/2023
  • Review Date: 31/12/2026
  • Form 21.012A – Technical Agreement, Contract and Work Order Checklist for delegation of IMP responsibilities
  • Form 21.012B – R&I Pharmacy Task Tracker
  • Form 21.012C – Sponsor Risk Assessment for IMP Delivery from Participating Study Site to Participant s Home
  • Guideline 21.012A – R&I pharmacy review of sponsored clinical trials
SOP 21.013 – Testing of Emergency Unblinding System for Blinded research
  • Author Name: Elizabeth Douglas
  • Version: 3.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.013A – Emergency Unblinding Test Plan (Non-Automated Process)
  • Form 21.013B – Record of IVRS/IWRS systems review for emergency unblinding
SOP 21.014 – Sponsor Investigational Medicinal Product Management Document Control Process
  • Author Name: Paula Morrison
  • Version: 4.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.014A – Sponsor Pharmacy Investigational Medicinal Product (IMP) Management Document Control Log
SOP 21.016 – R&I Pharmacy Site Initiation Training
  • Author Name: Pamela Surtees
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.016A – NHS GG&C Sponsored/Co-sponsored Study product Checklist: Site Pharmacy Initiation Training Form
  • Guideline 21.016A – R&I Pharmacy Study Product Management Training for sites
SOP 21.017 – Regulatory approval of IBs not submitted for approval by commercial partner
  • Author Name: Paula Morrison
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • None
SOP 21.018 – Sponsor Pharmacy Review of Study Amendments
  • Author Name: Angela Carruth
  • Version: 2.0
  • Active Date: 25/01/2024
  • Review Date: 31/12/2027
SOP 21.019 – Reconciliation of Study Product at site or study close out
  • Author Name: Pamela Surtees
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.019A – Pharmacy Study Product Reconciliation Check
SOP 21.020 – Periodic review/end of Trial Management File check for studies Sponsored, Co-Sponsored or facilitated by NHSGGC
  • Author Name: Pamela Surtees
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.020A – Checklist for periodic review/end of trial TMF(Section 10) check for studies Sponsored, Co-Sponsored or facilitated by NHSGGC
SOP 21.023 – IVRS/IWRS IMP management specification development, testing & training
  • Author Name: Elizabeth Douglas
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.023A – IVRS/IWRS Specification for Drug Supply Management System(s)
  • Form 21.023B – IXRS Drug Supply Management Acceptance Testing Approval & Training
  • Form 21.023C – IXRS User Acceptance Testing Tracker
SOP 21.024 – Management of shelf-life extension for IMPs for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
  • Author Name: Elizabeth Douglas
  • Version: 1.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 21.024A – Site IMP Labelling Form
  • Guideline 21.024A – Detailed guidance on IMP date extension process for research Sponsored by NHSGGC or Co-Sponsored by NHSGGC & UoG or when NHSGGC are UK Lead or Coordinating Centre for another Sponsor
SOP 21.025 – Management of Dose Escalation in Early Phase IMP/ATIMP Clinical Trials
  • Author Name: Elizabeth Douglas
  • Version: 2.0
  • Active Date: 26/05/2025
  • Review Date: 31/12/2028
SOP 21.026 – Investigational Medicinal Product Dossier requirements for Sponsored and Co-Sponsored CTIMPs
  • Author Name: Elizabeth Douglas
  • Version: 1.0
  • Active Date: 31/07/2025
  • Review Date: 31/12/2028
  • Form 21.026A – Template Simplified Investigational Medicinal Product Dossier
  • Form 21.026B – Template UK IMP Supply Chain
SOP 21.027 – Development and Maintenance of an Investigator s Brochure for IMP/ATIMPs owned by Co-Sponsor
  • Author Name: Elizabeth Douglas
  • Version: 1.0
  • Active Date: 29/07/2025
  • Review Date: 31/12/2028
  • None
Chapter 22 – NHS GG&C Pharmacy – Hosted CTIMP
SOP 22.001 – Defects in Clinical Trial Supplies
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • None
SOP 22.002 – Recall of Clinical Trial Supplies
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • None
SOP 22.003 – Clinical Trial Training for Pharmacy Staff
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • None
SOP 22.006 – Development and maintenance of the Pharmacy Dispensing and Study Management Procedure for studies hosted by NHSGGC
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 17/05/2024
  • Review Date: 31/12/2027
  • Form 22.006A – Pharmacy Dispensing & Study Management Procedure
  • Form 22.006B – Pharmacy Dispensing and Study Management Procedure Change Control Log
SOP 22.007 – Receipt and release of IMPs and NIMPs on delivery to pharmacy sites
  • Author Name: Maria Nygren
  • Version: 7.0
  • Active Date: 25/11/2024
  • Review Date: 31/12/2027
  • Form 22.007A – IMP Quarantine and Tracking Release record (Pharmacy – Excluding New Deliveries)
  • Form 22.007B – Storage Location Log (Pharmacy)
  • Form 22.007C – IMP Quarantine Release Record (Pharmacy New deliveries only)
SOP 22.008 – Temperature monitoring for IMPs and other medicines involved in research
  • Author Name: Eliza Valentine
  • Version: 6.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.008A – Clinical Trials Temperature Monitoring Record (Ambient Temperature)
  • Form 22.008B – Temperature Deviation Alert Summary
  • Form 22.008C – Annual Temperature Mapping Exercise
  • Form 22.008D – Commissioning Temperature Mapping Exercise
  • Guideline 22.008A – Environmental monitoring for IMPs and other medicines involved in research: temperature monitoring
  • Guideline 22.008B – Standards for Refrigerators and Freezers and Temperature Monitoring Equipment for Clinical Trials
  • Guideline 22.008C – Temperature Mapping for Refrigerators and Freezers used to Store IMPs and Other Medicines Involved in Research
  • Guideline 22.008D – Kelsius Temperature Monitoring System
  • Guideline 22.008E – Process for configuring data loggers for mapping and commissioning of refrigerators and freezers and monitoring temperatures external to pharmacy
SOP 22.009 – Dispensing and accuracy checking for clinical trial supplies
  • Author Name: Jennifer McAughtrie
  • Version: 4.0
  • Active Date: 26/05/2022
  • Review Date: 31/12/2027
SOP 22.010 – Managing participant returns for clinical trials
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • Form 22.010A – Pharmacy Clinical Trial Returned Medication Log
SOP 22.011 – Disposal and destruction of clinical trial related pharmaceutical waste
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.011A – Destruction of clinical trial supplies log (Pharmacy)
  • Form 22.011B – NHSGGC Statement of clinical trial supplies destruction policy
  • Form 22.011C – Clinical Trials Supplies Returns to Sponsor Log (Pharmacy)
  • Guideline 22.011A – Disposal of clinical trial drugs back to Sponsor
  • Guideline 22.011B – Destruction of clinical trial related pharmaceutical waste
SOP 22.012 – Emergency unblinding of treatment allocation in clinical trials
  • Author Name: Ramis Qureshi
  • Version: 4.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.012A – Emergency Unblinding of Assigned Treatment
SOP 22.013 – Managing storage of IMPs and NIMPs external to pharmacy
  • Author Name: Sharon Grant
  • Version: 7.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
  • Form 22.013A – Assessment to Support IMP Management External to Pharmacy
  • Form 22.013B – Local procedures for the management of IMPS and other medicines as part of a clinical trial
  • Guideline 22.013A – Short term and long term management of IMPs and NIMPs external to pharmacy
SOP 22.014 – Transfer of IMPs/NIMPs in clinical trials
  • Author Name: Sharon Grant
  • Version: 5.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
SOP 22.015 – Continuous pharmaceutical input to research involving medicines
  • Author Name: Jennifer McAughtrie
  • Version: 4.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
SOP 22.016 – NHSGGC Pharmacy Clinical Trials Site File
  • Author Name: Kirsty McLeish
  • Version: 3.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.020 – Collation of workload information for pharmacy clinical trials services in NHSGGC
  • Author Name: Kirsty McLeish
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.021 – Pharmacy authorisation process for clinical trials hosted by NHSGGC
  • Author Name: Kirsty McLeish
  • Version: 5.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.022 – Pharmacy review of clinical trials hosted by NHSGGC
  • Author Name: Kirsty McLeish
  • Version: 5.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • Form 22.022A – Pharmacy Clinical trials set-up tracking form
  • Form 22.022B – Checklist for Pharmacy Review of Study Protocol for Clinical Trials hosted by NHSGGC
  • Form 22.022C – Key Sponsor and Local Study Contacts for Pharmacy
  • Form 22.022D – NHSGGC Clinical Trials Pharmacy Pro-forma
  • Form 22.022G – Prescription Form
  • Form 22.022H – Master Site Level Accountability Log
  • Guideline 22.022A – Process for Pharmacy Review of Studies hosted by NHSGGC
  • Guideline 22.022B – Documentation Review and Requirements for Clinical Trials that are Hosted within NHSGGC
SOP 22.023 – Re-labelling of clinical trial medicines for expiry date extension
  • Author Name: Linda Taylor
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.024 – Use of hospital stock for clinical trials
  • Author Name: Sharon Grant
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.025 – Expiry date monitoring of clinical trial medicines
  • Author Name: Ramis Qureshi
  • Version: 6.0
  • Active Date: 26/02/2025
  • Review Date: 31/12/2028
SOP 22.026 – Closure of a clinical trial pharmacy process
  • Author Name: Karen Montgomery
  • Version: 5.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.027 – Managing monitoring visits and subsequent reports
  • Author Name: Karen Montgomery
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
SOP 22.028 – Labelling of IMPs and NIMPs in Clinical Trials that are hosted by NHSGGC
  • Author Name: Maria Nygren
  • Version: 5.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • Guideline 22.028A – Labelling of IMPs and NIMPs in Clinical Trials Hosted by NHSGGC
SOP 22.030 – Role of NHSGGC Pharmacy Clinical Trial Services: an overview
  • Author Name: Kirsty McLeish
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.031 – Role of pharmacy services in support of trials that are hosted by NHSGGC: an overview
  • Author Name: Kirsty McLeish
  • Version: 4.0
  • Active Date: 28/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.033 – Incident reporting for pharmacy clinical trials
  • Author Name: Maria Nygren
  • Version: 4.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.034 – Management of controlled drug IMPs within pharmacy sites
  • Author Name: Kirsty McLeish
  • Version: 3.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.035 – Clinical trial information provided to site on-call pharmacists
  • Author Name: Ramis Qureshi
  • Version: 3.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • Form 22.035A – Clinical Trial Information Provided to Site On-Call Pharmacists
SOP 22.037 – Tracking and Release of IMPs placed into quarantine post delivery at pharmacy sites
  • Author Name: Linda Taylor
  • Version: 3.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.038 – Introduction To Genetically Modified Organism (GMO) Products Within Clinical Trials
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • Guideline 22.038A – Introduction to Genetically Modified Product (GMO) in Clinical Trials
SOP 22.039 – Cleaning The Aseptic Room And Isolator Used To Prepare Genetically Modified Organism Products (GMO)
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.040 – Safe Handling Of Spillage, Personal Contamination or Injury Involving Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.041 – Aseptic Preparation of Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.042 – Personal Protective Equipment (PPE) To Be Worn When Handling Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.043 – Environmental Monitoring Of The Isolator And Room Used To Prepare Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.044 – Transportation Of Genetically Modified Organism (GMO) Products
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.045 – Safe Handling Of Genetically Modified Organism (GMO) Products Waste
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.046 – Remote Provision of Professional Check of Clinical Trial Prescriptions
  • Author Name: Jennifer McAughtrie
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.047 – Processing of clinical trial prescriptions scanned to pharmacy
  • Author Name: Ramis Qureshi
  • Version: 2.0
  • Active Date: 21/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.048 – Pharmacy authorisation process for studies involving Advanced Therapy Investigational Medicinal Products (ATIMPs)
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.049 – Pharmacy process for receipt and transfer of Advanced Therapy Investigational Medicinal Products (ATIMPs)
  • Author Name: Martin Ball
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • None
SOP 22.050 – Recording Pharmacy Clinical Trial Activity for Income Generation
  • Author Name: Angela Carruth
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
Chapter 23 – NHS GG&C Pharmacy – Hosted Non-CTIMPs
SOP 23.001 – Role of Pharmacy Services in Support of Other Clinical Research within NHSGGC: an Overview
  • Author Name: Kirsty McLeish
  • Version: 3.0
  • Active Date: 28/06/2024
  • Review Date: 31/12/2027
  • None
Chapter 50 – NHS GG&C General
SOP 50.009 – Project Numbering
  • Author Name: Kirsty Theron
  • Version: 5.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
SOP 50.010 – Project Data Entry on SReDA
  • Author Name: Radek Penar
  • Version: 7.0
  • Active Date: 22/04/2025
  • Review Date: 31/12/2028
SOP 50.011 – Setting up and Maintaining Research and Innovation project files (for R&I office approvals)
  • Author Name: Kirsty Theron
  • Version: 5.0
  • Active Date: 09/06/2023
  • Review Date: 31/12/2026
SOP 50.013 – Setup and maintenance of training files: NHS
  • Author Name: Nicola Thomson
  • Version: 5.0
  • Active Date: 04/03/2025
  • Review Date: 31/12/2028
SOP 50.016 – Trial of New Processes Within NHSGGC R&I
  • Author Name: Paul Gribbon
  • Version: 5.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
SOP 50.017 – Research & Innovation Document Management
  • Author Name: Paul Gribbon
  • Version: 5.0
  • Active Date: 14/05/2025
  • Review Date: 31/12/2028
  • None
SOP 50.019 – Independent Stakeholder Assessment
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
SOP 50.020 – eCRF User Acceptance Testing (Glasgow Clinical Trials Unit)
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • None
SOP 50.021 – Participant recruitment sourcing and recording
  • Author Name: Radek Penar
  • Version: 2.0
  • Active Date: 08/05/2024
  • Review Date: 31/12/2027
  • None
SOP 50.022 – Preparation and Maintenance of Terms of Reference
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
SOP 50.023 – Management of SOPs within NHS GG&C R&I
  • Author Name: Paul Gribbon
  • Version: 1.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
SOP 50.024 – Management of the Central Portfolio Management System
  • Author Name: Radek Penar
  • Version: 1.0
  • Active Date: 29/08/2023
  • Review Date: 31/12/2026
SOP 50.025 – Quality Check of Project Entries on SReDA
  • Author Name: Radek Penar
  • Version: 1.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
  • None
SOP 50.026 – Internal QC checks of Scottish Research Database Application (SReDA)
  • Author Name: Radek Penar
  • Version: 4.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
  • None
SOP 50.027 – Service Level and Operational Level Agreements
  • Author Name: Paul Gribbon
  • Version: 1.0
  • Active Date: 25/10/2024
  • Review Date: 31/12/2027
  • None
Chapter 51 – NHS GG&C Sponsor R&I
SOP 51.001 – Protocol Development for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 7.0
  • Active Date: 21/08/2025
  • Review Date: 31/12/2028
  • None
SOP 51.002 – Participant Information Sheet and Consent Forms: Design and Approval
  • Author Name: Louise Ner
  • Version: 6.0
  • Active Date: 30/06/2025
  • Review Date: 31/12/2028
  • Guideline 51.002A – Participant Information Sheet and Informed Consent Form Guidelines
SOP 51.003 – Peer review
  • Author Name: Maureen Travers
  • Version: 4.0
  • Active Date: 02/11/2022
  • Review Date: 31/12/2025
SOP 51.004 – Risk Assessment
  • Author Name: Maureen Travers
  • Version: 5.0
  • Active Date: 18/01/2022
  • Review Date: 31/12/2025
SOP 51.005 – R&I – End of study procedures
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
  • None
SOP 51.007 – Identifying a Sponsor organisation
  • Author Name: Louise Ner
  • Version: 6.0
  • Active Date: 01/09/2025
  • Review Date: 31/12/2028
  • Form 51.007A – International Site Questionnaire
  • Form 51.007B – NHSGGC and University of Glasgow Co-Sponsor Letter
  • Form 51.007C – NHSGGC Sponsor Letter
  • Form 51.007D – Responsibilities delegated to the Chief Investigator for CTIMP Trials Co-Sponsored by the University of Glasgow and NHS GG&C
  • Form 51.007E – Responsibilities delegated to the Chief Investigator for CTIMP Trials Sponsored by NHS GG&C
SOP 51.008 – Handling non-compliance with Good Clinical Practice (GCP) and/or the trial protocol in clinical research sponsored, co-sponsored or hosted by NHS Greater Glasgow and Clyde
  • Author Name: Caroline Watson
  • Version: 4.0
  • Active Date: 19/04/2022
  • Review Date: 31/12/2025
SOP 51.009 – Notification of Serious Breaches of Good Clinical Practice or the Trial Protocol for Clinical Trials of Investigational Medicinal Products and non-CA marked Medical Devices
  • Author Name: Caroline Watson
  • Version: 5.0
  • Active Date: 25/11/2024
  • Review Date: 31/12/2027
SOP 51.010 – Preparation and Review of Grant Applications and Costs
  • Author Name: Heather Flanagan
  • Version: 5.0
  • Active Date: 24/07/2023
  • Review Date: 31/12/2026
  • Form 51.010A – NHS Project Costs for Non-commercial Research
  • Form 51.010D – Grant with potential non CA/CE marked medical device – Checklist
  • Form 51.010E – R&I Study Strategic Plan
  • Guideline 51.010A – Guidelines for identifying category of research funding organisation
SOP 51.011 – University of Glasgow and NHS Greater Glasgow and Clyde Co-Sponsorship Agreement
  • Author Name: Maureen Travers
  • Version: 4.0
  • Active Date: 10/04/2021
  • Review Date: 31/12/2024
  • Form 51.011A – Short Letter CTA CI Employer
  • Form 51.011C – Proforma for signing of Non-Commercial Funded Clinical trial Agreement
SOP 51.014 – Preparation and submission of IRAS forms
  • Author Name: Maureen Travers
  • Version: 4.0
  • Active Date: 02/11/2022
  • Review Date: 31/12/2025
  • None
SOP 51.015 – Assessment of Vendors
  • Author Name: Paul Gribbon
  • Version: 5.0
  • Active Date: 10/04/2024
  • Review Date: 31/12/2027
SOP 51.016 – Preparation and Maintenance of a Trial Master File
  • Author Name: Liz Anne Lewsley
  • Version: 6.0
  • Active Date: 05/08/2025
  • Review Date: 31/12/2028
SOP 51.017 – Registration of research projects on public databases
  • Author Name: Heather Flanagan
  • Version: 4.0
  • Active Date: 26/07/2023
  • Review Date: 31/12/2026
  • None
SOP 51.019 – Sponsor End of study procedures
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 22/04/2025
  • Review Date: 31/12/2028
SOP 51.020 – Sponsor Regulatory Green Light
  • Author Name: Liz Anne Lewsley
  • Version: 4.0
  • Active Date: 29/04/2024
  • Review Date: 31/12/2027
  • Form 51.020A – Sponsor CTIMP Regulatory Green Light Letter
  • Form 51.020B – Sponsor Oversight Checklist For Issuing RGL
SOP 51.021 – Review and Approval of Amendments for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 5.0
  • Active Date: 10/04/2024
  • Review Date: 31/12/2027
SOP 51.022 – Research & Innovation Data & Administration tasks
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 29/08/2023
  • Review Date: 31/12/2026
SOP 51.023 – Sponsor process for an IDMC
  • Author Name: Liz Anne Lewsley
  • Version: 5.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
SOP 51.024 – Archiving Essential Documents from Clinical Research Process for a GGC Sponsored/Co Sponsored CTIMP and/or CIMD
  • Author Name: Heather Flanagan
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
  • Form 51.024A – Essential Documents for Archiving Archiving Checklist (for CTIMPs)
  • Form 51.024E – Trial Archiving Oversight
SOP 51.025 – Archiving Essential Documents from Clinical Research Process for a Sponsored Non CTIMP
  • Author Name: Maureen Travers
  • Version: 1.0
  • Active Date: 04/12/2018
  • Review Date: 31/12/2023
  • Form 51.025A – Essential Documents for Archiving – Archiving Checklist (for Non-CTIMPs)
SOP 51.028 – NHS Laboratory samples for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow or hosted by NHSGGC.
  • Author Name: Lynsey Gillespie
  • Version: 5.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
  • Form 51.028A – Categorising Laboratory Tests undertaken within Research Projects Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
SOP 51.029 – Writing Study Specific Laboratory Manuals for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Lynsey Gillespie
  • Version: 4.0
  • Active Date: 05/03/2024
  • Review Date: 31/12/2027
SOP 51.030 – Writing Sample Handling Manuals for Sites Participating in Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Lynsey Gillespie
  • Version: 3.0
  • Active Date: 25/01/2024
  • Review Date: 31/12/2027
SOP 51.031 – Corrective and Preventative Action Plan Management
  • Author Name: Paul Gribbon
  • Version: 2.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
  • None
SOP 51.033 – Research Imaging for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow (UoG)
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 03/09/2020
  • Review Date: 31/12/2023
  • Form 51.033A – Categorising Imaging Tests undertaken within CTIMPS Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow
  • Form 51.033B – MRI Site Survey Template
  • Form 51.033C – CT Site Survey Template
SOP 51.034 – Writing a Trial Specific Research Imaging Manual for Sites Participating in CTIMP Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and University of Glasgow (UoG)
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 03/09/2020
  • Review Date: 31/12/2023
SOP 51.035 – Design and Development of CRFs/eCRFs in CTIMPs and Clinical Investigations
  • Author Name: Marc Jones
  • Version: 1.0
  • Active Date: 02/11/2022
  • Review Date: 31/12/2025
  • None
SOP 51.036 – Trial Steering Committee for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow
  • Author Name: Heather Flanagan
  • Version: 2.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
  • Form 51.036A – Letter of Invitation to TSC member GG&C sole Sponsor
  • Form 51.036B – Letter of Invitation to TSC member GG&C/UoG co-sponsor
SOP 51.037 – Storage and Transfer of Laboratory Data for Clinical Trials and Investigations Sponsored by NHS Greater Glasgow & Clyde (NHS GG&C) or Co-Sponsored by NHS GG&C & University of Glasgow
  • Author Name: Marc Jones
  • Version: 1.0
  • Active Date: 03/03/2022
  • Review Date: 31/12/2028
  • None
SOP 51.040 – Study Handover for Research Sponsored by NHSGGC or Co-Sponsored by NHSGGC and the University of Glasgow
  • Author Name: Louise Ner
  • Version: 1.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
  • None
Chapter 52 – NHS GG&C Hosted R&I
SOP 52.001 – Obtaining NHS Management Approval Non-commercial
  • Author Name: Karen Chase
  • Version: 4.0
  • Active Date: 27/06/2025
  • Review Date: 31/12/2028
SOP 52.002 – Obtaining NHS Management Approval for Commercial Studies
  • Author Name: Ross Nicol
  • Version: 4.0
  • Active Date: 09/06/2023
  • Review Date: 31/12/2026
SOP 52.003 – R&I Review of Amendments
  • Author Name: Ruth Pink
  • Version: 5.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
SOP 52.004 – R&I Contract Development and Review
  • Author Name: Ross Nicol
  • Version: 5.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
SOP 52.005 – Review of Research Passport and issuing of Honorary Research Contracts/Letters of Access
  • Author Name: Rozanne Suarez
  • Version: 5.0
  • Active Date: 08/05/2024
  • Review Date: 31/12/2027
  • Form 52.005A – Letter Template – Honorary Research Contract
  • Form 52.005B – Letter Template – Letter of Access
  • Form 52.005C – Letter Template – Letter of Access (Staff Studies Only)
  • Form 52.005D – Letter Template – Letter of Access (NHS to NHS)
SOP 52.007 – Authorisations for NHS resource use in R&D submissions
  • Author Name: Karen Chase
  • Version: 3.0
  • Active Date: 18/03/2020
  • Review Date: 31/12/2023
  • Form 52.007A – Imaging Research – Research Trial Imaging Details
  • Form 52.007B – Sample email of notification to Head of Clinical Department or Clinical Service Manager
SOP 52.009 – Validation of Project Submissions for R&I Management Approval: NHS
  • Author Name: Shanice White
  • Version: 4.0
  • Active Date: 09/06/2023
  • Review Date: 31/12/2026
SOP 52.013 – Process for approving studies and trials involving a Genetically Modified Organism (GMO)
  • Author Name: Caroline Watson
  • Version: 2.0
  • Active Date: 28/09/2023
  • Review Date: 31/12/2026
SOP 52.014 – Archiving Essential Documents from Clinical Research Process for Hosted Research
  • Author Name: Radek Penar
  • Version: 2.0
  • Active Date: 06/10/2025
  • Review Date: 31/12/2028
SOP 52.015 – Phase I First in Human Committee Review Process
  • Author Name: Emma Whitelaw
  • Version: 2.0
  • Active Date: 20/12/2023
  • Review Date: 31/12/2026
SOP 52.017 – Process for Local Review of Non-Commercial, Hosted, Multi-Centre and Single-Centre PR Studies with NHS Staff as Participants
  • Author Name: Euan Rennie
  • Version: 1.0
  • Active Date: 09/09/2025
  • Review Date: 31/12/2028
  • None
Chapter 53 – NHS GG&C Sponsor Governance
SOP 53.001 – Handling Urgent Safety Measures for Clinical Trials for Investigational Medicinal Products and non-CA marked Medical Devices
  • Author Name: Caroline Watson
  • Version: 4.0
  • Active Date: 10/04/2024
  • Review Date: 31/12/2027
  • None
SOP 53.002 – The Handling of Poor Quality and Fraud in Clinical Research
  • Author Name: Caroline Watson
  • Version: 4.0
  • Active Date: 07/05/2022
  • Review Date: 31/12/2028
  • Form 53.002A – Reporting of fraud in clinical trials of an investigational medicinal product not identified as a serious breach of GCP
SOP 53.003 – Temporary halt or early termination of clinical trials of investigational medicinal products
  • Author Name: Caroline Watson
  • Version: 4.0
  • Active Date: 25/01/2024
  • Review Date: 31/12/2027
  • None
SOP 53.004 – Monitoring Clinical Research – Site Monitoring Visit
  • Author Name: Sheila Mcgowan
  • Version: 7.0
  • Active Date: 29/10/2024
  • Review Date: 31/12/2027
SOP 53.005 – GCP Audit of Research studies and systems supporting research
  • Author Name: Paul Gribbon
  • Version: 7.0
  • Active Date: 18/02/2022
  • Review Date: 31/12/2025
SOP 53.006 – Monitoring Handover Checklist Process
  • Author Name: Sheila Mcgowan
  • Version: 3.0
  • Active Date: 09/08/2025
  • Review Date: 31/12/2028
  • Form 53.006A – Research & Innovation Monitoring Handover Checklist
SOP 53.007 – Unblinded Monitoring Process
  • Author Name: Sheila Mcgowan
  • Version: 2.0
  • Active Date: 12/06/2022
  • Review Date: 31/12/2025
  • None
SOP 53.008 – Accompanied and Training Visit Process
  • Author Name: Sheila Mcgowan
  • Version: 2.0
  • Active Date: 03/09/2023
  • Review Date: 31/12/2026
SOP 53.009 – Preparation and Maintenance of a Clinical Trial Monitoring File
  • Author Name: Sheila Mcgowan
  • Version: 3.0
  • Active Date: 09/08/2025
  • Review Date: 31/12/2028
  • None
SOP 53.010 – Monitoring Clinical Research Preparation and Management of a Monitoring Plan
  • Author Name: Emma Moody
  • Version: 2.0
  • Active Date: 18/06/2024
  • Review Date: 31/12/2027
  • Form 53.010A – Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Medical Device Investigation
  • Form 53.010B – NHSGGC Monitoring Risk Assessment
  • Form 53.010C – Research & Innovation Monitoring Plan Tracking Log
SOP 53.011 – Sponsor Source Data Requirements and Guidance
  • Author Name: Sheila Mcgowan
  • Version: 2.0
  • Active Date: 01/08/2025
  • Review Date: 31/12/2028
  • None
SOP 53.012 – Monitoring Clinical Research Site Close Out Monitoring visit
  • Author Name: Emma Moody
  • Version: 2.0
  • Active Date: 09/08/2025
  • Review Date: 31/12/2028
SOP 53.013 – Monitoring Clinical Research For Cause Monitoring Visit
  • Author Name: Emma Moody
  • Version: 1.0
  • Active Date: 25/08/2022
  • Review Date: 31/12/2025
  • None
SOP 53.014 – External Sponsor Monitoring Arrangement
  • Author Name: Sheila Mcgowan
  • Version: 1.0
  • Active Date: 29/04/2024
  • Review Date: 31/12/2027
  • Form 53.014A – External Sponsor Monitoring Process Arrangement
SOP 53.015 – Monitoring Clinical Research – Site Compliance Visit
  • Author Name: Sheila Mcgowan
  • Version: 1.0
  • Active Date: 29/10/2024
  • Review Date: 31/12/2027
  • None
Chapter 55 – NHS GG&C Pharmacovigilance
SOP 55.001 – Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit)
  • Author Name: Marc Jones
  • Version: 8.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
SOP 55.002 – Preparation and Submission of the Development Safety Update Report
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 10/09/2019
  • Review Date: 31/12/2026
  • Form 55.002A – Development Safety Update Report (DSUR) Template
  • Form 55.002B – DSUR Investigator Checklist
  • Guideline 55.002A – PV Office Creation and submission of Development Safety Update Reports
SOP 55.004 – Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 06/09/2023
  • Review Date: 31/12/2026
SOP 55.005 – Initial Review and Management of Updates to Reference Safety Information
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 18/11/2021
  • Review Date: 31/12/2027
SOP 55.006 – Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
  • Author Name: Marc Jones
  • Version: 5.0
  • Active Date: 18/11/2021
  • Review Date: 31/12/2027
  • Form 55.006A – SmPC Tracker for Sponsored/Co-Sponsored Clinical Trials
  • Form 55.006B – IB Tracker for Sponsored/Co-Sponsored Clinical Trials
  • Form 55.006C – SmPC Update Monitor Form
  • Guideline 55.006A – Summary of Product Characteristics (SmPC) & Investigator s Brochure Checks
SOP 55.007 – Safety Reporting in Clinical Trials of Medical Devices of Non CE Marked Medical Devices or CE Marked Devices Used Outside of their Intended Purpose (Sponsored and Hosted Clinical Investigations)
  • Author Name: Marc Jones
  • Version: 2.0
  • Active Date: 19/07/2018
  • Review Date: 31/12/2025
  • Guideline 55.007A – PV Office Processing for Clinical Investigations of Non CE Marked medical Devices
SOP 55.015 – Sponsor Pharmacovigilance Data
  • Author Name: Marc Jones
  • Version: 4.0
  • Active Date: 06/07/2024
  • Review Date: 31/12/2027
SOP 55.016 – Sponsor IB Assessment
  • Author Name: Paula Morrison
  • Version: 1.0
  • Active Date: 05/09/2022
  • Review Date: 31/12/2025
  • None
SOP 55.017 – Sponsor Quality Control of SAEs Processed by the Pharmacovigilance Office
  • Author Name: Marc Jones
  • Version: 2.0
  • Active Date: 26/02/2025
  • Review Date: 31/12/2028
Chapter 56 – NHS GG&C Sponsor Project Management Unit
SOP 56.001 – Site Set up – Green for Go Process
  • Author Name: Lynsey Gillespie
  • Version: 8.0
  • Active Date: 22/05/2024
  • Review Date: 31/12/2027
SOP 56.002 – Project Management Trial Set-up
  • Author Name: Lynsey Gillespie
  • Version: 5.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
SOP 56.003 – Project Management: Managing an Active Trial
  • Author Name: Lynsey Gillespie
  • Version: 5.0
  • Active Date: 28/06/2024
  • Review Date: 31/12/2027
SOP 56.004 – Project Management Trial Site Close-Out
  • Author Name: Lynsey Gillespie
  • Version: 3.0
  • Active Date: 21/08/2023
  • Review Date: 31/12/2026
SOP 56.007 – Project Management Site Capability Assessment
  • Author Name: Lynsey Gillespie
  • Version: 2.0
  • Active Date: 18/08/2023
  • Review Date: 31/12/2026
Chapter 57 – NHS GG&C Clinical Research Facility – Administration
SOP 57.001 – Managing a Monitoring Visit
  • Author Name: Helen Hart
  • Version: 9.0
  • Active Date: 28/09/2022
  • Review Date: 31/12/2025
SOP 57.002 – Management of paper health records
  • Author Name: Kate Smith
  • Version: 4.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 57.003 – GCRF Internal Audit
  • Author Name: Helen Hart
  • Version: 4.0
  • Active Date: 10/10/2023
  • Review Date: 31/12/2026
SOP 57.004 – GCRF Booking, Admission and Discharge of Research Participants
  • Author Name: Kate Smith
  • Version: 3.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
SOP 57.005 – GCRF Hosted Study Documentation and Data Management
  • Author Name: Helen Hart
  • Version: 4.0
  • Active Date: 08/03/2023
  • Review Date: 31/12/2026
SOP 57.006 – GCRF Principal Investigator Responsibilities
  • Author Name: Helen Hart
  • Version: 3.0
  • Active Date: 28/09/2022
  • Review Date: 31/12/2025
SOP 57.007 – GCRF Communications
  • Author Name: Helen Hart
  • Version: 5.0
  • Active Date: 25/03/2025
  • Review Date: 31/12/2028
SOP 57.008 – External Audit and Inspection
  • Author Name: Helen Hart
  • Version: 3.0
  • Active Date: 17/11/2023
  • Review Date: 31/12/2026
  • Form 57.008A – External Audit/Inspection Notification Checklist
  • Form 57.008B – External Audit/Inspection Document Request
  • Form 57.008C – External Audit/Inspection Scribe Template
  • Form 57.008D – External Audit/Inspection Document Tracker
  • Form 57.008E – External Audit/Inspection CAPA Tracker
SOP 57.010 – Study Planning, Set-up and Start-up
  • Author Name: Helen Hart
  • Version: 4.0
  • Active Date: 13/05/2024
  • Review Date: 31/12/2027
SOP 57.011 – GCRF Study Management
  • Author Name: Helen Hart
  • Version: 3.0
  • Active Date: 24/11/2023
  • Review Date: 31/12/2026
SOP 57.012 – GCRF Security and Access
  • Author Name: Kate Smith
  • Version: 3.0
  • Active Date: 23/06/2023
  • Review Date: 31/12/2026
  • None
SOP 57.014 – GCRF Support of Early Phase Clinical Trials
  • Author Name: Patricia Clark
  • Version: 1.0
  • Active Date: 20/12/2018
  • Review Date: 31/12/2023
SOP 57.016 – EDGE Clinical Research Management System
  • Author Name: Kirsty McAinsh
  • Version: 2.0
  • Active Date: 19/10/2023
  • Review Date: 31/12/2026
Chapter 58 – NHS GG&C Clinical Research Imaging Facility
SOP 58.001 – CRIF QEUH Adult Emergency Resuscitation Procedures
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
SOP 58.002 – CRIF QEUH Paediatric Emergency Resuscitation Procedures
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • None
SOP 58.004 – Clinical Research Involving Imaging
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 21/08/2023
  • Review Date: 31/12/2026
SOP 58.005 – CRIF Risk Assessment and Risk Mitigation
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • Form 58.005A – Clinical Research Imaging Facility Study Risk Assessment Form
SOP 58.006 – Reporting of Research Images
  • Author Name: Tracey Hopkins
  • Version: 3.0
  • Active Date: 21/08/2023
  • Review Date: 31/12/2026
SOP 58.008 – CRIF QEUH Controlled Access
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • Form 58.008A – CRIF MRI Researcher Entitlement & Authorisation Application Form
  • Guideline 58.008A – CRIF Researcher MRI Entitlement and Authorisation Guidelines
SOP 58.009 – CRIF Study Data and Document Management
  • Author Name: Tracey Hopkins
  • Version: 1.0
  • Active Date: 23/11/2023
  • Review Date: 31/12/2026
  • None
Investigator SOPs

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

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

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