Staff Resources & Support

Introduction

Pharmacovigilance (PV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

PV is a regulatory requirement for any clinical trial of an investigational medicinal product (IMP) whether the trial is a first in man study of a novel drug or a study investigating how a well understood licensed drug performs in a real world setting.

In addition there are other types of study where vigilance processes are required for example:

Safety reporting is also a regulatory requirement for all clinical investigations of medical devices. Where a non CE marked device (or a CE marked device is used outside of its intended purpose) is used within an investigation there is a requirement to carry out vigilance.

Safety reporting is required within all studies involving human participants; even those that do not involve the use of drugs. Where an intervention or trial specific procedure takes place is important to ensure that the safety of the study in monitored.

About us

The Sponsor Pharmacovigilance Office is part of the Research and Innovation governance team. The Pharmacovigilance and Safety Manager is based within NHS GG&C while PV administration and systems are provided by the Robertson Centre for Biostatistics at the University of Glasgow.

We provide support to researchers from the grant stage of a study, to protocol development, identifying and managing risk from an IMP perspective, overseeing the collection and review of safety data, the processing and administration of Serious Adverse events, monitoring safety data for unexpected events, coding of events, and the preparation of Developmental Safety Update Reports.  We ensure that all trials are compliant with the relevant regulatory frameworks on behalf of the lead investigator and Sponsor. The PV office has experience in oncology, cardiovascular, stroke, and many other fields of healthcare.

A risk adapted approach to pharmacovigilance and safety reporting is used to ensure that trials are conducted safely and efficiently while reducing the workload for both sites and investigators where possible.

The Sponsor PV office can help investigators for all studies, not just those involving drugs. We have experience of clinical investigations of medical devices, interventional studies, biomarker studies, and all other forms of healthcare research involving human subjects. We can help you at to assess the level of safety reporting required and aid in the preparation of study protocols. Please get in touch with the PV and Safety Manager should you wish to discuss any aspects of safety reporting.

ICH GCP defines monitoring as “the act of overseeing a clinical trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Good Clinical practice, SOPs and relevant regulatory requirements”

 The GG&C monitors purpose is to ensure and verify 

• The rights and well-being of human subjects are protected
• The reported trial data are accurate, complete, and verifiable from source documents
• The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

The clinical trial monitors (CTMs) are sponsor representatives who review and update monitoring procedures, attend trial specific meetings, ensure compliance and consistency to regulatory and local procedures, and review protocol deviations. CTMs are appropriately trained and have the knowledge to escalate protocol deviations and identify serious breaches of GCP.  The CTMs assist with risk assessments and implement a trial specific monitoring risk assessment. The specific monitoring risk assessment aids the monitoring plan development.   CTMs ensure patient safety on trials is upheld, reviewing SAEs and identifying unreported SAEs and in the identification and analysis of repeated trends within trials.

Our team is made up of highly experienced individuals with varying backgrounds from nursing, science undergraduates and post graduates in addition to NHS and commercial backgrounds.

Due to the continually evolving nature of clinical trials and the recent global COVID-19 pandemic, new processes had to be rapidly developed and put in place to ensure ongoing oversight for new and existing clinical trials within our portfolio.  Remote and central monitoring processes were utilised whilst minimising the burden on site staff as far as possible.  All monitoring plans were reviewed to ensure compliance and addendums added to document any changes that were required.

The types of visit we conduct – Site Compliance, Routine monitoring, Close Out and For Cause visits.

CTMs generate a visit report using the Q-Pulse database to manage actions raised during visits and ensure any non-compliances are rectified and recorded appropriately.

Services and Support Provided

• Monitoring of Sponsor / host-sponsored CTIMPs, High-risk non-CTIMPs, and device trials
• Non-commercial and commercial monitoring
• Building a relationship between sites and sponsor
• Identification of trends within a study (e.g. lab results being missed, deviations, issues with the study, site staff etc.)
• Input into risk assessment
• Identification of serious breaches
• Feedback regarding site and non-compliance issues
• Site training – protocol, eCRF completion

When to Get Us Involved

• Grant application – Costings
• During the start-up /set-up – Budgets/funding, logistics of the source data, feasibility
• Risk assessment – Early input for development of the monitoring plan
• During the study – Amendments, safety issues, database issues, etc.
• End of study – Close-out activities

What monitoring is?	What monitoring isn’t?
Collection and analysis of information to track progress in a clinical trial.	Evaluation of any type including process evaluation
Critical to ensure the safety, rights and wellbeing of trial patients are upheld.	Audits and inspections
Risk assessment defines level of monitoring based on objective, purpose, design, complexity, blinding, size and endpoints of the trial and is an ongoing process defined by amendments, site problems or other assessments.	It does not usually occur just once. (unless a company has approached the monitors for a one time visit, which is agreed at the start)
Ongoing occurrence throughout the clinical trial determined by the risk assessment and monitoring plan.	Quality Assurance
Helps in order to identify trends and patterns in data, report deviations and non-compliances

Dr Caroline Watson – Research Governance Manager

Caroline.watson@ggc.scot.nhs.uk

The Governance Manager has worked within the research department for almost 20 years and manages the Governance team with the aim to ensure that there is an environment of support and regulatory compliance to ensure safety of research participants and high quality research.   

Caroline has a degree and PhD in Biochemistry and undertook a post doctoral research fellowship before joining Industry where she designed and developed a novel drug and medical devices for the market.  She has several patented technologies and the products are on the market.

As a senior manager in the NHS Caroline has in addition to managing the Governance team, a specific role in Trial Sponsorship, leading on MHRA inspections, Quality Assurance and Risk Management.

Governance has a major role in overseeing and supporting research and the manager chairs a number of governance and sponsor committees and has been responsible for setting up other Governance committees while generating the assessments and documentation required for them.   This has included risk assessments for Phase I First In Human (FIH) trials, research involving Genetically Modified organisms as well as the processes to oversee trials during the COVID-19 pandemic.  Caroline is also a key member of committees overseeing GCP for trials hosted by NHS GG&C.

The manager is also responsible for the management of non-compliances and serious breaches of GCP which arise in trials or systems supporting research.

Paul Gribbon- QA Manager  

Paul.Gribbon@ggc.scot.nhs.uk  Mobile – 07977716315

The Quality Manager within Research and Innovation is Paul Gribbon, he has been in post with R&I since August 2019. Prior to this he has worked as a Quality Assurance Manager as part of a large Quality Team within a multi-national Engineering company primarily working in the defence sector. In his previous role he has gained several years’ experience developing and implementing new processes, toolsets and systems of work. Some of this work has included the development of a Non-Conformance system and process, a new system for the management and planning of Audits as well as the management of any resulting Corrective and Preventative Actions to name a few.

Eileen McCafferty – Research Audit Facilitator

Eileen.McCafferty2@ggc.scot.nhs.uk  Mobile – 07773 203 214

Eileen McCafferty has been employed with NHS GG&C for almost 40 years. A background in ward nursing and ward management allowed further developmental opportunities out with the clinical setting. This included secondments to clinical audit then clinical effectiveness and within research as a research nurse and clinical event monitor, before taking up post as Research Audit Facilitator within R&I in 2003.  Eileen was a founder member of the NHS GG&C Clinical Research Forum, founder member and steering group member of the Scottish Research Nurse and Coordinators Network and is a current member and past co Chair of the National Academic Research Quality Assurance  group.

Dr Marc Jones- Pharmacovigilance and Safety Manager

Marc.Jones@ggc.scot.nhs.uk   Mobile – 07989 470505

The PV and Safety Manager has worked within R+I Governance since 2016. He has a degree in pharmacology and a PhD in molecular biology and biochemistry. Following an academic career in basic research focussed on molecular engineering he changed focus to work in clinical trials.  He began his clinical trials career at the Leeds Clinical Trials Research Unit in 2008. During his time at Leeds he gained a wide range of experience in all aspects of clinical trials but with a particular focus on pharmacovigilance, central monitoring, and data management. He has experience in oncology trials, biomarker discovery and validation studies, hepatology trials, clinical investigations of medical devices, and cardiovascular trials.

Dr Sheila McGowan- Lead Clinical Trial Monitor

Sheila.mcgowan2@ggc.scot.nhs.uk  Mobile – 07812733044

The Lead Clinical Trial monitor has a degree in Immunology and Pharmacology, and completed a PhD and post-doctoral in Immunology. After leaving academia to pursue clinical research she joined a commercial Clinical Research Organisation. During her time at the CRO she trained and passed their Clinical Research Foundation Programme and achieved awards in delivering quality monitoring and building relationships with sites. Following promotion to senior positions she decided to change focus and join the NHS, working at the CRUK Clinical Trials unit bringing her commercial knowledge to the role and the processes. Sheila took up the position of Lead Clinical Trial Monitor within Research and Innovation and has blended her academic and commercial background to monitoring and auditing. Over 13 years working in clinical research has allowed her to experience various opportunities and situations to learn and expand her knowledge in order to deliver and drive to achieve quality within the monitoring team and as a sponsor representative.

Clinical Trial Monitors

• Emma Moody

Emma.Moody@ggc.scot.nhs.uk  Mobile – 07855108909

After obtaining a Nursing degree at Glasgow Caledonian University, Emma spent a number of years as a Staff Nurse however, after many years of twelve hour shifts, she decided it was time for a change. With a longstanding interest in research she applied for a Clinical Trial Coordinator position at The New Victoria Hospital, it became apparent with such a small staff ratio and over twenty oncology trials to manage, her nursing degree could be put to good use. Her role was changed to Cancer Research Nurse where she worked mainly in haematology oncology trials and her love of all things haematology grew. Emma studied for a Masters degree at Stirling University and wrote her dissertation on a chemotherapy application using a mobile phone for symptom control in haematology chemotherapy patients. Over nine years at the New Victoria has given Emma the experience and expertise of managing clinical trials at site level to take on her role as Clinical Trial Monitor.

• Amanda Lynch

Amanda.Lynch@ggc.scot.nhs.uk Mobile  – 07811518145

Amanda Lynch has been employed with NHS for over 19 years. A background in hospital pharmacy as a Pharmacy Technician working in various areas. This included aseptic pharmacy, oncology, ward level dispensary and primary care. This allowed to further develop undertaking HNC in pharmacy management and development and checking qualifications. Then moved into a Clinical Trial Coordinator role, gaining a wide range of experience in all aspects of oncology clinical trials before taking up post as an Academic Clinical Trial Monitor in 2023.

•   Louise Dinnett

Louise.Dinnett2@nhs.scot

Louise developed an interest in clinical trials whilst working as a student within the then Research and Development Department during her Speech and Language Pathology degree. Once her degree was completed she took up a post as clinical trial coordinator at the Beatson for 6 years working on haemato-oncology trials. From this Louise then progressed in the role of clinical trial monitor at the GO CTU for 9 years working primarily on pancreatic, gynaecology and colorectal trials. This then led to a move to the role of clinical trial monitor in R&I in 2026.

• Emma Whitelaw – Governance Facilitator

Emma.Whitelaw@ggc.scot.nhs.uk  Mobile – TBC

Emma Whitelaw has been employed with NHS GG&C for almost 18 years. She has been in the Governance Facilitator post since October 2020. Prior to this she was part of the R&I Project Management Unit for 10 years as a Project Assistant helping run Clinical Trials from Start to Finish.

She currently supports the Governance Manager and team with

• Administration, audit and inspections.
• Manages and administers the Phase 1 First in Human Committee for the chair Prof Jim McCaul.
• Administers the GHSP Regulatory Affairs Group chaired by Prof Rob Jones.
• Administers the Sponsor Governance meetings with CRUK
• Supports the administration of the CTIMP oversight committee

Emma also carries out some remote close out admin, file reviews and mini audits for the clinical trials monitoring  team.

Emma will help with availability of the governance team and  the person to contact for advice on documentation and process for the committees.

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

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

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

As the busiest Research and Innovation office in Scotland, we received in excess of 630 new research applications in 2025 and have approximately 1000 studies ongoing at any one time.

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

Research and Innovation Strategy

Research and Innovation Teams

Further Information and Resources

Course Dates

Monday 19th – Friday 23rd January 2026

The course will be held over Zoom, and directed at trainees who have passed the Part I exam, and are preparing to sit their Part II exam in March 2026. The virtual course will be based on exam topics and endeavour to reproduce the spirit of previous courses, whilst taking advantage of the strengths of virtual platforms. 

The course fee is £900

When the course is fully subscribed, a waiting list will be held from which, trainees will be offered cancellations/withdrawal.

*Bank details provided on request.

Register Your Interest

To register interest, please fill out the application form. 

If you require any further information or have any questions regarding the course please send email to: dorothy.stobie@nhs.scot 

Substance Misuse Toolkit Working Group

For information or advice regarding the content of this toolkit, quality assurance process or amendments to resources please contact the SMT working group at: 

substancemisuse.toolkit@ggc.scot.nhs.uk     

Education Establishments

Advice and Support 

If you are concerned that a young person requires support with alcohol or substance issues, please follow your organisation’s own policies and procedures and discuss with senior management.

There may be additional local support services available within your area. Please contact substance misuse working group for more information if you are unaware of these.

substancemisuse.toolkit@ggc.scot.nhs.uk     

Youth Organisations

Advice and Support

If you are concerned that a young person requires support with alcohol or substance issues, you should direct them towards an appropriate service.

It is better to contact services now to clarify their referral criteria and procedures, rather than waiting until a young person urgently needs their help!

• Aye Mind (Digital Well Being Tool for Young People)

• Alcohol and Drug Recovery Service (ADRS)
• Alcohol and Drug Recovery Service (ADRS) Information Booklet ( also in other languages)
• Sandyford Centre
• Scottish Families Affected by Drugs and Alcohol
• Quit Your Way (NHS Greater Glasgow & Clyde)
• Email: Substance Misuse Toolkit Working Group
• Youth Health Services  (Glasgow City)

The Greater Glasgow and Clyde Substance Misuse Education Working Group consists of NHS and Education staff who have worked together to create the ‘Substance Misuse Toolkit’. This online resource contains quality assured substance misuse education resources to support staff working with young people in both education and community settings. Resources include lesson plans, resource packs and relevant websites.

The Substance Misuse Toolkit aims to reduce harm caused by substance misuse by:

• Equipping staff with the knowledge and confidence they require to teach pupils about the effects, risks and consequences of substance use by providing them with a range of materials and methodologies.
• Encouraging learners to make informed choices about alcohol, drugs and tobacco.
• Supporting an age appropriate and inclusive approach to education in relation to substances within the context of a Curriculum for Excellence.
• Identifying evidence based resources and approaches and share good practice with staff across the Greater Glasgow and Clyde area.
• Ensuring that resources are up to date and fit for purpose.
• Ensuring ongoing quality assurance processes are in place to monitor and further develop the site.

Quality Assurance

The Greater Glasgow and Clyde Substance Misuse Education Working Group meets regularly to ensure that resources included within the Substance Misuse Toolkit are evidence based, up to date and of a high standard. The group consults with key stakeholders regarding the accessibility, content, usefulness and areas for improvement.

The Greater Glasgow and Clyde Substance Misuse Education Working Group has developed a quality assurance tool to assess the content of resources against agreed indicators. The tool is consistent with the principles and values of local and national policy including Curriculum for Excellence, GIRFEC and the Greater Glasgow and Clyde Alcohol and Drug Prevention and Education Model. Resources which meet the standards set by this review process are then incorporated into the Substance Misuse Toolkit.

The Quality Assurance Tool Template can be accessed here.

Policy Context

The need to support children and young people to make positive choices about alcohol, drugs and tobacco has been highlighted by a number of national and local policy documents. Substance Misuse Education is a priority within the Greater Glasgow and Clyde Alcohol and Drug Prevention & Education Model and is a Health & Wellbeing organiser within Curriculum for Excellence. Getting it Right for Every Child (GIRFEC) ensures that wellbeing is central to all of our work in meeting children and young people’s needs.

Further information on the policy context can be found here.

NHS Research Scotland definition

Research Governance concerns setting standards to improve research quality and safeguard the public. It involves enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring lessons are learned and preventing poor performance and misconduct.

A broad range of regulations, principles and standards of good practice exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.

Research governance applies to everyone connected to healthcare research including Chief investigators, health care professionals, researchers, and support staff.

Introduction

Research Governance is essential for the conduct of research on humans and encompasses regulations, good practices, and world- wide collaboration to create an environment ensuring safety of the participants while conducting the studies and trials and the collection and analysis of data to quality standards.

The Research Governance team at NHS Greater Glasgow and Clyde is a support department to researchers and teams and is made up a range of highly qualified individuals such as PhD level scientists with research and Industrial experience, an engineer, auditors and monitors with key skills in QA, clinical trials, Industry, medical devices, drug development, Intellectual property and safety. 

The team provide Sponsor support starting from the grant stage of a study, to protocol development, to assessing vendors, to identifying and managing risk and overseeing the conduct of the study, to managing non-compliances, protocol deviations and serious breaches of GCP.  This activity covers hundreds of sites across the UK and internationally as NHS GG&C and Glasgow University researchers lead on worldwide research.

The QA team carry out GCP audits, a requirement of the Clinical Trial Regulations, engage with third parties to audit our own activities and provide a Quality system for the production and maintenance of SOPS incorporating all of the departments involved in research e.g. Imaging, safehaven, Bio repository.

The team activity is inspected by the MHRA during Regulatory Sponsor inspections.  The Governance manager is a lead for these inspections involving all departments and other organisations.  Together with the QA manager they manage the outcomes of inspections and ensure that the findings are addressed.

The Team are also responsible for the oversight of other  studies such as surgical, medical devices and hosted studies including commercial and other academic led studies.  Due to limited resources this is managed by assessing risk and focusing on areas which may potentially pose safety or quality issues. 

During the 2020 COVID-19 pandemic the team led the development and implementation of a process to oversee safety of research participants still taking part in sponsored clinical research led by NHSGGC and its partners.

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

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

Who are we?

• Dr Katriona Brooksbank: Innovation Champion 
• Sophie Bagnall: Industry Collaboration project manager
• Elaine O’Neill: Industry Collaboration project manager

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

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 27^th 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. 

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Applications are Invited for the Endowment Research Facility Investment fund

Purpose of fund:

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

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

Deadline for submission of applications: Thursday 28 May 2026 for 2 June 2026 meeting.