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 560 new research applications in 2023 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 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.
On the 20th of October the HRA have announced a partnership with ISRCTN, which will enable automatic registration of clinical trials.
Registering studies before the first participant is recruited is one of the pillars of research transparency, it reduces research waste and prevents duplication. A key commitment they make in the Make it Public strategy is to register trials on behalf of sponsors. The aim is to ease the burden on sponsors and help to make transparency easy and the norm.
The Research Pharmacy clinical trials team work to ensure all patients participating in clinical trials derive maximum benefit and minimum harm from their medicines. We also strive to achieve a high quality, effective and efficient service at all times. The team is spread across NHSGGC with bases in the Research and Innovation office and across PPSU Acute and Mental Health sites in NHSGGC.
What can the Pharmacy Clinical Trials Service do for you?
The service has a dual role providing support to investigators and members of the research study team on medicines related aspects of research and clinical trials in addition to dispensing medicines for study subject and patient use. The Pharmacy Clinical Trials Service also works in tandem with the R&I department.
Pharmacy Q&A
Does Pharmacy need to be involved in my research?
Yes, Pharmacy review all clinical trials and research studies where medicines are used. This will ensure the proposed study meets standards around the management of medicines in research e.g. they are the appropriate quality and the study meets the requirements of NHS GG&C Safe and Secure Handling of Medicines Policy.
What does Pharmacy do?
Pharmacy services in NHSGGC work in tandem with the Research and Innovation (R&I) department, reviewing all clinical trials to ensure the appropriate standards for conducting research involving medicines are met and also that the study is clinically appropriate and operationally viable. As part of the review process, the Pharmacy Clinical Trials Team will liaise with fellow staff e.g. Quality Assurance, Aseptic Services, Clinical Pharmacists and Lead Directorate Pharmacists, whereupon satisfactory completion of the review, Pharmacy approval is given and forms part of the R&I management approval process. Where NHSGGC are sponsor or co-sponsor for a clinical trial, Pharmacy will assist you from the very early stages of preparing your protocol, assisting you with your medicines related aspects of regulatory applications and setting up your study. Pharmacy can also help prepare the necessary documentation and assist you with IMP management processes at all stages from receipt into Pharmacy to administration to the patient. For all other clinical trials, Pharmacy work to facilitate multi-site clinical trials as a single working stream and provide information and training to you and your study Team to ensure the trial meets the appropriate standards. We also have close links with Pharmacy clinical trial colleagues throughout Scotland via the Clinical Trial Special Interest Group (CTSIG), sharing best practices in developing our service. A very visible part of the Pharmacy contribution to clinical trials and research is in the dispensing of medicines to patients or study subjects. Pharmacy work to Standard Operating Procedures (SOPs) and have processes in place to deal with problems such as temperature deviations or medicine defects. Medicines are generally dispensed from the local hospital pharmacy where the patient is attending for their study visits. All pharmacy sites in NHSGGC currently provide or have the potential to provide local services to support research.
What happens if my clinical trial does not come under the clinical trial regulations but still involves medicines?
R&I work closely with Pharmacy to ensure you are given the best advice.
What can I do to help obtain Pharmacy approval for my study?
In order to help ensure your trial receives Pharmacy approval as quickly as possible, you should approach R&I and Pharmacy in the early planning stages. Pharmacy staff will often need to ask some follow-up questions and it is very helpful if researchers keep in contact with Pharmacy staff and update them on their progress and proposed start dates.
What is the procedure if my study involves multiple sites within NHSGGC?
A system of single pharmacy review and approval is in development for multi-site clinical trials within NHSGGC. If you are aware your study is going to run over two or more sites, you should contact the R&I-Pharmacy Team in the first instance.
Who should I contact if I have a query with my clinical trial?
The first point of call should be your local site Pharmacy Clinical Trials Team contact, alternatively, for a general query, you can contact the R&I-Pharmacy Team.
What will it cost for Pharmacy Clinical Trial Services?
Pharmacy work closely with R&I Finance to estimate the cost of undertaking a research project. Pharmacy Clinical Trials Services are required to charge for their involvement in all commercial clinical trials. Depending on funding, Pharmacy support service such as dispensing may be free-of-charge to researchers undertaking non-commercial research. However, real costs incurred such as manufacturing costs and the cost of additional medicines over standard care need to be met out of the study funding.
Do I need to notify Pharmacy if I have received a protocol amendment?
Pharmacy should receive notification of protocol amendments by R&D, however, investigators are often responsible for ensuring all relevant staff have access to the correct study protocol. It would be helpful if you verified this with the local Pharmacy site. If you need advice relating to the potential impact of your amendment on pharmacy, you should contact your site Pharmacy Clinical Trials Team or the R&I-Pharmacy Team if your clinical trial involves multiple sites or is sponsored/co-sponsored by NHSGGC.
What qualifications, skills and experience do Pharmacy have in research and clinical trials?
The Pharmacy Clinical Trial Teams throughout NHSGGC are composed from a mix of Pharmacists, Pharmacy Technicians and Pharmacy Support Workers. In addition to each staff group’s professional and vocational qualifications, all pharmacy clinical trial staff undergo regular Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) training. Many of our staff have significant experience of working within research and clinical trials over a number of years.
How do Pharmacy Services link in with research and innovation?
The R&I-Pharmacy Team are based in the R&I Management office at the Western Infirmary. This team forms the central hub of communication between R&I and the wider Pharmacy Clinical Trials service. Communication is also conducted directly between R&I and the Pharmacy sites as necessary.
What should I do when my research study or clinical trial is nearing an end?
It is helpful if you let Pharmacy know when you are planning to stop recruiting new patients and/or when patients have completed active treatment involving medicines. This can help Pharmacy ensure they have sufficient supplies to the end of the study in the most cost-effective way. It is standard practice for the Pharmacy file to be archived with the investigators file and arrangements will need to be made with your local Pharmacy Clinical Trials Team.
I am planning a study involving medicines that will be sponsored or co-sponsored by NHSGGC, what do I do?
If you are planning a new clinical trial or research where medicines are used then you should contact the relevant R&I co-ordinator in the first instance. The co-ordinator will then alert the R&I-Pharmacy Team who will work with you to develop the IMP management processes for your clinical trial and liaise with the relevant site Pharmacy Teams.
What is an IMP?
IMP stands for Investigational Medicinal Product and is the special term used for medicines when they are studied as part of a clinical trial or used as part of a study protocol. Any medicines used within a clinical trial or research study must be of an appropriate quality and this is governed by UK/EU legislation. A key role of Pharmacy is to ensure the medicines used within research are always of a suitable standard for administration to study subjects.
Can Pharmacy help me with my research proposal?
Yes, Pharmacy will work closely with R&I to assist you with the design and IMP related aspects of your protocol. In addition, we can provide assistance with prescription forms and accountability logs.
How do I source my IMP?
The R&I-Pharmacy Team will be able to assist you with sourcing IMPs and any other medicines that may be required. Pharmacy work very closely with the Regional Quality Assurance service (RQA) and the Pharmacy Production Unit (PPU) based at the Western Infirmary, Glasgow. PPU are licensed by the MHRA to prepare many different types of medicines for use in a clinical trial. If PPU are unable to meet the requirements for your study, then the R&I-Pharmacy Team will be able to advise/organise alternative arrangements.
I am planning a study involving medicines that will be hosted within NHSGGC, what should I do?
If the clinical trial is to be run at only one site within NHSGGC, you should contact the site Pharmacy as soon as possible. However, Pharmacy will not undertake a formal review for approval or begin setting up your study until notified by R&I. If the clinical trial is to be run over two or more sites within NHSGGC, contact the R&I-Pharmacy Team as soon as possible.
Research often involves new MR imaging techniques, and optimisation of these techniques is essential before they can be successfully applied in clinical studies. The CRIF Approval Group is responsible for reviewing and approving requests for access to the research scanners for technical development and proof of principle MR research projects. Researchers requesting optimisation of imaging study protocols will complete a CRIF Development Application Form and submit to CRIF Approval Group. The CRIF ApprovalGroup will assess both the scientific aspects of the protocol as well as conduct an ethical review under delegated authority from the main REC. The CRIF Approval Group meet monthly.
Clinical Research Imaging Facility (CRIF) Approval Group
Delegated by West of Scotland Research Ethics Committee
Expected meeting date: Monthly – Usually the last Tuesday every month
Meeting Duration: 1-2 hours
Volume of activity: maximum of 3 imaging development applications considered per meeting
Location: Online
We have an opportunity for those interested in health research and ethics. Research Ethics Committee members are volunteers who review new research projects taking place in the UK from an ethical viewpoint, protecting patients and the public while promoting good ethical research. The West of Scotland Research Ethics Service is currently seeking to recruit a new member, either Expert or Lay to support the Clinical Research Imaging Facility (CRIF) Approval Group, which specifically reviews studies that are developing new scanning techniques with MRI. Since March 2020 meetings have been conducted virtually (currently via Microsoft Teams), which allows us to expand our membership outside of the Glasgow area and avoid travel.
The committee reviews research applications and gives an opinion as to whether the research is ethical. The position can be highly rewarding and covers a diverse range of research topics. Projects are focused on developing scanning techniques and may involve healthy volunteers as well as patients. You should expect to spend approximately 2 hours per month at meetings and some additional time in preparatory work. Meetings provide an opportunity to interact with researchers and discuss proposals. REC members receive training in ethical review and have opportunities to debate challenging ethical issues.
The work is voluntary and involves reading submissions prior to the meeting and attending a monthly meeting of the CRIF Approval Group (there are usually about 11 meetings in the year). Training is provided.
Meetings are generally scheduled for the last Tuesday afternoon each month, approximately 2-4pm, but may vary depending on availability of members.
Members may also be involved in follow-on work, which is generally conducted via email.
The MRI Research Team at Queen Elizabeth University Hospital is looking for volunteers to undergo an MRI scan so that we can test and optimise new techniques before they are used in clinical research studies.
The Research and Innovation Finance team actively contributes to the delivery of clinical research and innovation projects, working closely with research teams, coordinators and project managers to:
Secure funding for research and innovation projects in line with ACORD national research costing guidelines
Provide robust financial management of research and innovation contracts – typically milestone or recruitment driven
Provide timely financial advice and business support to research active professionals across NHSGGC.