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.
Roles and Responsibilities
Ensure the safety, rights and well-being of trial subjects are protected
Data Integrity
Consent
Protocol Compliance
GCP Compliance
Safety
Delegation of Duties
Training
IMP Management
Documentation
Approvals
Facilities and Equipment
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
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.
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 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
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.
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.
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 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.
Konstantina has a degree in Early Childhood Education with focus on developmental psychology. She followed a paedagogical career until 2017 when she decided to pursue a path in clinical research guided by a passion for facilitating improvement in outcomes for people of all ages.
She has previously worked as trial assistant for the MYRIAD trial, an RCT looking at resilience outcomes in adolescence sponsored by the Department of Psychiatry at the University of Oxford; as data coordinator for the National Perinatal Epidemiology Unit CTU in multicentre neonatal CTIMPs, and as data manager for early and late phase CTIMPs, observational, and biobank trials in the Late Phase Haematology research team at the Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust.
Konstantina joined the Research Governance team as a clinical trial monitor in December 2021 working towards ensuring the scientific and ethical integrity of trials sponsored, and hosted by the Board.
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 640 new research applications in 2024 and have approximately 1000 studies ongoing at any one time.
To ensure consistency of contact, and to help develop an in-depth understanding of therapy area-specific research projects, the NHSGGC Research and Innovation Management office has adopted a ‘portfolio-team’ structure. The portfolio teams form the functional core of Research and Innovation and are comprised of Research Co-ordinators, Research Facilitators, Co-ordinator’s Assistants and clerical support staff.
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.
For information or advice regarding the content of this toolkit, quality assurance process or amendments to resources please contact the SMT working group at:
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.
If you are concerned that a young person requires support with alcohol or substance issues, you should direct them towards an appropriate service.
It is better to contact services now to clarify their referral criteria and procedures, rather than waiting until a young person urgently needs their help!
The Greater Glasgow and Clyde Substance Misuse Education Working Group consists of NHS and Education staff who have worked together to create the ‘Substance Misuse Toolkit’. This online resource contains quality assured substance misuse education resources to support staff working with young people in both education and community settings. Resources include lesson plans, resource packs and relevant websites.
The Substance Misuse Toolkit aims to reduce harm caused by substance misuse by:
Equipping staff with the knowledge and confidence they require to teach pupils about the effects, risks and consequences of substance use by providing them with a range of materials and methodologies.
Encouraging learners to make informed choices about alcohol, drugs and tobacco.
Supporting an age appropriate and inclusive approach to education in relation to substances within the context of a Curriculum for Excellence.
Identifying evidence based resources and approaches and share good practice with staff across the Greater Glasgow and Clyde area.
Ensuring that resources are up to date and fit for purpose.
Ensuring ongoing quality assurance processes are in place to monitor and further develop the site.
Quality Assurance
The Greater Glasgow and Clyde Substance Misuse Education Working Group meets regularly to ensure that resources included within the Substance Misuse Toolkit are evidence based, up to date and of a high standard. The group consults with key stakeholders regarding the accessibility, content, usefulness and areas for improvement.
The Greater Glasgow and Clyde Substance Misuse Education Working Group has developed a quality assurance tool to assess the content of resources against agreed indicators. The tool is consistent with the principles and values of local and national policy including Curriculum for Excellence, GIRFEC and the Greater Glasgow and Clyde Alcohol and Drug Prevention and Education Model. Resources which meet the standards set by this review process are then incorporated into the Substance Misuse Toolkit.
The Quality Assurance Tool Template can be accessedhere.
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.
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
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.
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>
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.
Deadline for submission of applications: Friday 15 August 2025 for 19 August 2025 meeting.
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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
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
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
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
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
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
Guideline 51.008C – Guidance on Types of Non-Compliance and Associated Documentation
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
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
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
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)
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)
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
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
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
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)
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