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Research and Innovation

The NHSGGC Biorepository is an invaluable resource for clinical research, providing access to a wide range of human tissue samples including surplus materials from diagnostic and surgical procedures.  We can also provide access, with appropriate governance in place, to pathology archive specimens.

Through close collaboration with all clinical departments we source fully-consented surplus tissue and other materials in order to fulfil the need for these in studies requiring human tissue.

Each anonymised sample is associated with a limited set of clinical and demographic data held by the Biorepository.  If necessary the scope of these data can be expanded upon through our close collaboration with the NHSGGC Safe Haven.

As part of the NRS Biorepository network we provide streamlined access to anonymised samples and associated data Scotland-wide.

For Researchers

The NHSGGC Biorepository, as part of the NRS Biorepository Network, aims to provide researchers with efficient access to a wide range of high-quality and well-characterised tissue for use in research. You can download our latest user manual here (pdf).

We are independently accredited to oversee governance on collection, storage and release of biological materials obtained from informed, consenting patients for use in medical research.

A streamlined pathway supports researchers in obtaining tissue samples and discussing the design and costing of projects across a range of clinical specialties:

  • Autoimmune & Inflammation
  • Hepatology
  • Oral & Dental
  • Cancer
  • Mental Health Studies
  • Orthopaedics
  • Cardiovascular
  • Metabolic & Endocrine
  • Paediatrics
  • Dermatology
  • Microbiology
  • Regenerative Medicine
  • Diabetes
  • Musculoskeletal
  • Renal
  • Gastroenterology
  • Neurology
  • Reproductive Health
  • Haematology
  • Opthalmology
  • Respiratory

It is important that you contact us as soon as possible at the start of your research discussions to ensure that we can assist you with your requirements and deliver on time for your needs.

Click here to access the application website or find our contact information below.

For Patients

Why do researchers need access to my surplus tissue?

First, it is important for you to know that when we talk about surplus tissue we mean anything that is left over from your routine medical care – no extra procedures are ever involved in obtaining ‘surplus tissue’.

Doctors and scientists need human tissue for medical research. Research is any activity that aims to discover new facts about a disease. It includes things like looking down a microscope and analysing proteins, DNA and other molecules in the tissue.

The tissue you donate may be used in all these aspects of research. In addition your tissue may be used in research with animals to model disease processes and in the creation of cell lines where your cells could be grown and cared for in a laboratory for multiple experiments possibly over months and years.

If samples are collected at different stages of a disease, it helps to understand how a disease or problem starts or develops. They can also try out different drugs and tests on the tissue. They may find new medicines or treatments. They may also find new ways of diagnosing a disease earlier.

It is important to highlight to you that any research that uses this tissue will conform to strict UK guidelines and regulations.

How can I get involved in research/clinical trials?

The research on your tissue will normally have nothing to do with your own care or treatment.  However, if any information might be of use in your current care or treatment, the doctors looking after you may discuss with you how it could be used to guide your treatment. This may include inviting you to join a medical research trial of new treatments. You would be provided with full information of any new treatments and free to decide whether or not to take part.

How does the Biorepository get consent to use my tissue?

When you come into hospital or attend a clinic you will be asked if you agree to let your surplus tissue to be used for medical research. Your wishes will be recorded electronically. In some cases, this may involve surplus tissue taken earlier in your care.

Can I change my mind?

You can change your mind at any time. You don’t need to give a reason.  However, if you change your mind after your operation, some of your tissue may already have been used for research.

How do I find more?

If you need more information you can ask your doctor or nurse, or find our contact information below.

Complains Procedure

We endeavour to provide a good service. Our complaints policy and procedure reflects NHS Greater Glasgow and Clyde’s commitment to welcoming all forms of feedback, including complaints, and using them to improve services, to address complaints in a person-centred way and to respect the rights of patients, families and staff involved. It will support our staff to resolve complaints and to conduct thorough and fair investigations so that we can make compassionate, yet evidence-based decisions, on the facts of the case.

Should you have any comments, suggestions, cause for concern or complaints about the service you receive from the Biorepository, please contact the Biorepository Manager.

Contact Us

In the first instance please contact:

Managers

Address

NHSGGC Biorepository
Level 3, Laboratory Medicine Building
Queen Elizabeth University Hospital
1345 Govan Road
Glasgow, G51 4TY

Useful Links

The West of Scotland Research Ethics Service forms part of the UK wide NHS research ethics service (https://www.hra.nhs.uk/) and applications can be reviewed from across the UK.  Applicants are free to apply to any suitably flagged REC in the UK although a local REC is advised.  The applicant should book a slot that they are able to attend.  The meetings are generally held remotely and instructions for joining the meeting are sent out ahead of time.

The central West of Scotland office is manned by four Research Ethics Committee Managers and Assistants who cover the four West of Scotland Research Ethics Committees.

A list of all contact details and the meeting and submission dates can be found here:   https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/

In Scotland the REC Service is managed regionally across four Health Boards.  The Health Board is the appointing authority for each REC.  All NHS RECs in the UK work within the guidelines detailed in Governance Arrangements for Research Ethics Committees (20thJuly 2021)   https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/

The role of RECs

The Role of NHS Research Ethics Committees (RECs)

NHS RECs safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. NHS RECs are entirely independent of research sponsors (that is, the organisations funding and hosting the research) and investigators. This enables them to put participants at the centre of their research. Each year, NHS RECs review around 6,000 research applications. On average, they give an opinion in less than 30 days: well within the maximum allowance of 60 days. Proportionate Review studies are reviewed within a maximum of 21 days.

REC Membership

Each Research Ethics Committee (REC) consists of between seven and 18 volunteer members. At least one-third of the members must be ‘lay’. Lay members are people whose main personal or professional interest is not in a medical research area. The remainder of the committee are expert members, who are specialists including doctors, other healthcare professionals and academics.  Membership also includes a category known as ‘lay plus’. This category excludes anyone who has been involved in clinical research other than as a participant. REC members often have the sort of experience which will be useful in scrutinising the ethical aspects of a research proposal. For example, they might be patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background.

Interested in becoming a member of an NHS REC?

Please get in touch with us and we can send you further details and let you know of any local vacancies available. All NHS RECs are established by the UK Health Departments for the purpose of reviewing research applications that fall within our remit as set out in GAfREC.

Different types of REC

There are two main types of RECs:

Recognised RECs

These are recognised by the United Kingdom Ethics Committee Authority (UKECA) for the review of clinical trials of investigational medicinal products (CTIMPs), in accordance with The Medicines for Human Use (Clinical Trials) Regulations.  

Authorised RECs

Established under GAfREC but not recognised by UKECA.  Authorised RECs can review most research that is not a CTIMP.   

Many RECs are fagged to look at particular types of research and these flags can be seen here;  https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/

During the online booking process you will be directed to an appropriately flagged REC if this is required; https://www.hra.nhs.uk/about-us/committees-and-services/online-booking-service/

In the West of Scotland we have one Recognised REC and three Authorised RECs 

 Information for applicants

Information to help you define if your research project requires review by a Research Ethics Committee can be found here

Research Application Submission

All researchers wishing to undertake a piece of research within the NHS are required to complete an IRAS form. All guidance and information is contained within the site to allow completion of the IRAS form.

Once the application is ready for submission i.e. complete with electronic authorisations etc.  Please follow the current guidance on online submission; https://www.hra.nhs.uk/about-us/committees-and-services/online-booking-service/

Once you have uploaded all of the study documentation the REC Manager will check and validate the submission.  The REC Manager will then issue a validation letter indicating the date and time of the Ethics Meeting and inviting the investigator to attend.  The dates and times of all ethics meetings can be found here: https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/

After the meeting the investigator will receive a letter within 10 working days stating the outcome which will be one of four possible decisions:

  • Final opinion – favourable or unfavourable
  • Provisional opinion – with request for further information, clarification or revision
  • No opinion – gone to referee for consultation before opinion given

The national ethics service allows 60 days from the submission of the application to final opinion. Clear guidance is given within the IRAS website for researchers who wish to make an amendment to their application after approval or add extra sites.

Contacts and committee details

Contacts and committee details  (dates can vary due to public holidays always check on HRA website)

Committee DetailsMeetsContacts
West of Scotland Research Ethics Committee 1 WoSREC 1 Recognised Type III Flags: CTIMPs Paediatrics Phase I Patients1st Tuesday of the month 9am-12pm
WestofScotland.ResearchEthicsCommittee1@ggc.scot.nhs.uk
West of Scotland Research Ethics Committee 3 WoSREC3 Authorised Flags: QualitativeResearch 4th Thursday of the month, 2-5pm WestofScotland.ResearchEthicsCommittee3@ggc.scot.nhs.uk
West of Scotland Research Ethics Committee 4 WoSREC4 Authorised Flags: Device Trials, Tissue Banks, Research Databases & Paediatrics1st Friday of each month 12-3pm WestofScotland.ResearchEthicsCommittee4@ggc.scot.nhs.uk
West of Scotland Research Ethics Committee 5 WoSREC5 Authorised Flags: Paediatrics 3rd Wednesday of each month 2-5pm WestofScotland.ResearchEthicsCommittee5@ggc.scot.nhs.uk

Any queries regarding the service or whether an application requires ethical review should be directed to the Scientific Officer / Ethics Manager – Dr Judith Godden 

We wanted to inform you that all Scottish recruitment data relating to your study/studies from the 1st April 2019 onwards is now visible on the UK Central Portfolio Management System (CPMS).

The benefit of reviewing your Scottish recruitment data within CPMS is for you to be able to confirm your local site data as accurate or not accurate and provide you with the benefits of tracking your recruitment data at all sites across the UK. This will also help provide NHS Research Scotland and the Chief Scientist Office with accurate recruitment data for Scotland.

What is CPMS?

CPMS is a UK platform which collates local study site recruitment information from local portfolio management systems (LPMS). Since the 1st April 2019 our Scottish R&D offices have been collating recruitment information from your local study teams across Scotland and uploading this to our LPMS. We have now established links between our LPMS and CPMS which means you will be able to login, track and view all Scottish recruitment data to your study at each site since the 1st April 2019.  You are kindly requested to confirm if this data is accurate or not accurate using the below attached guides.  England, Northern Ireland and Wales have already been live with their recruitment data in CPMS since 1st April 2019. 

My study has sites only in Scotland

To reduce the burden of confirming a backlog of recruitment since the 1st April 2019, the Chief Scientist Office has agreed for the NIHR to automatically confirm recruitment data on CPMS for your study during the FY 19/20. Any studies which recruited from the 1st April 2020 we would like to request that you access CPMS and confirm recruitment from this date onward on a monthly basis. You can do this using the attached guides.

Recruitment data for your study will continue to upload into CPMS (including zeros for months where a site did not recruit) and we would request that you access, review and confirm or reject the data on a monthly basis as long as your study is open to recruitment. Once your study halts recruitment please inform your lead R&D office so that they can update the study records.

My study has sites in other UK Nations as well as Scotland

If your study has sites in other nations you will be requested to also confirm recruitment from sites in other nations as well as recruitment from Scotland, if you are not already doing so.

To reduce the burden of confirming a backlog of recruitment since the 1st April 2019, the Chief Scientist Office and Health and Care Research Wales have allowed portions of recruitment data to be automatically confirmed.  Scottish and Welsh recruitment data for FY 19/20 will be automatically confirmed on your behalf. If you have sites in England you will be asked to complete the backlog of recruitment from 1st April 2019 or when your study opened if this is later.

Recruitment data for your study will continue to upload into CPMS (including zeros for months where a site did not recruit) and we would request that you access, review and confirm or reject the data on a monthly basis as long as your study is open to recruitment. Once your study halts recruitment please inform your lead R&D office so that they can update the study records.

Training and Help

Individuals who can confirm recruitment must be associated with your CPMS study record. Those individuals who are copied in on this email all have associations with the CPMS record to confirm recruitment. If you wish to add another member of your team to perform this function you must contact your local R&D office and inform them that you require a name added to the CPMS record. You can access your study record here https://cpms.nihr.ac.uk/ and use the email which has been used to contact you in this email to login. Attached is also guidance to help you login.

Attached are a quick start guide which provides an overview of how to confirm recruitment and the full Research Activity Confirmation Guidance which provides more detailed information to help you navigate the confirmation process including help on viewing your recruitment and explanations of the differences between nations where they exist.

There are short videos and guidance which can be found by logging into NIHR learn using your CPMS login details.

************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact *************************

In order to gain R&I approval as quickly as possible, we advise that you submit to R&I in parallel with your ethics submission. This will allow us to look at your application and progress while under review by the REC.

In order to define the appropriate contact in the R&I Office for your study, please find contact details for your portfolio team here.

Quality Assurance

Quality is about making an organisation perform for all of their stakeholders, from improving products, services, systems and processes, to making sure that the whole organisation is fit and effective. Quality Management is a never ending pursuit of excellence, striving to ensure all Clinical Trials, Research Studies and Systems within GG&C are not only fit for purpose, but keep improving.

The expected level of Quality for Research and Innovation is that which has been set by all of our Stakeholders as well as external Standards, from Sponsor Staff to Trial Teams, Suppliers to Patients, along with any and all applicable regulatory bodies. It is the responsibility of all staff to strive to meet this level and meet all of the applicable Standards which must be worked to (GCP, UK Policy Framework for Health and Social Care Research, etc). It is the responsibility of the Quality Team to assist everyone in meeting these standards.

The Quality System within Research and Innovation is the vehicle by which this is achieved, a set of controlled procedures are in place and under constant review for improvement and to assure compliance. The Quality Team have a number of activities and areas of influence to ensure this system is working effectively and maintained.

The two main areas of interest for the work of the Quality Team falls in to two main Categories, Quality Assurance(QA) and Quality Control(QC).

Quality Assurance is the “big picture” of Quality and looks to how Quality is baked in to our processes and activities, this is the consideration of how what we do will result in a Quality outcome. Quality Assurance is a proactive approach to achieving quality and is the consideration of what can be achieved before a task is performed, this involves an assessment of the fitness for purpose of a process. For example, QA is the review of the process defining how data is entered or transferred.

Quality Control is then a consideration of the fine detail, this looks at the output of an activity to ensure it meets the required standards, this level of activity is not solely the responsibility of the Quality Team but of all staff involved. Quality Control is the reactive element of Quality, it is the process of checking a completed activity to ensure it is compliant with set processes. For example, QC is the process of confirming that data entered or transferred is correct.

This is a symbiotic relationship and the Quality Control activity will feed in to the Quality Assurance, when an issue is identified through QC, QA will seek to prevent the issue from reoccurring.

The Quality Team are responsible for a number of important activities, a non-exhaustive list of some examples are:

  • Management of SOPs

Standard Operating Procedures (SOPs) form the backbone of the Quality Management System for R&I, as such their management is vital to ensure efficient, controlled and uniform conduct across all trials. It is the remit of the Quality Department to ensure all SOPs are constructed in accordance to a controlled format, routinely maintained, readily available and appropriately distributed.

This activity involves interaction with every individual who is involved with the content of SOPs, both in their design and in following the content. The quality department engages with owners of the SOPs during regular review periods, to review content and suggest improvements, to distribute to all designated stakeholders and gather evidence of training, compliance and instances of deviation from SOPs as well as identifying gaps in the existing suite of SOPs where new procedures are required. This is an ongoing cycle and feeds in to the continuous development of the department.

  • Vendor Assessments

For NHSGGC Sponsored or Co-Sponsored CTIMPs that requires an external service, a vendor assessment will be required.   Examples include, but not limited to:

  • Commercial and academic laboratories out with NHSGGC
  • Bio-repositories
  • Statistical services
  • Data management services
  • Safe Havens
  • Archiving facilities
  • IMP manufacturers

In the instance that services are required from an external provider, it is imperative that the provider has been adequately vetted to ensure they can meet the needs of the trial. To this end, the Vendor Assessment process is utilised to ensure that all Vendors used within GG&C trials are capable of what is required of them.

The assessment is based on technical criteria relevant to the facility, in addition to evidence key Sponsor governance requirements such as:

  • GCP compliance
  • Robust Quality Management System
  • Internal Audits and SOPs
  • Relevant and up to date training
  • Safety Reporting
  • Data Protection Processes
  • Reporting of non-compliance

For further information, please contact via: RAndDVendorAssessment@ggc.scot.nhs.uk

  • Audit

The Quality Department are responsible for conducting Audits across studies and trials within Research and Innovation. This can cover a wide range of different activities, looking at studies and trials and their activities as well as procedures within the Research and Innovation department itself. Audits are a mandatory requirement within Good Clinical Practice and defined as:

“A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”

The Quality Department provide audits as a service which is delivered to other Departments and trial teams. As such, the audits are intended not only to ensure compliance to processes and protocols but to assist those being audited by identifying and removing issues, not only within the area of focus but with associated processes. If improvements can be made to remove waste and streamline activities, Audit is the key mechanism by which this can be achieved. When issues are identified, they can be removed. The audit team will always seek to engage fully with auditees and to form a consensus as those being audited will usually be the subject matter experts. An audit is an opportunity to improve and to influence processes.

It is important to have an accurate understanding of what an audit is, its intended purpose and also what activity takes place that is not considered and audit, generally speaking the separation between Audits, Monitoring, Quality Checks and Inspections are:

What is an Audit?

  • An Audit is a systematic, documented and independent review of any trial, study or process
  • An Audit will provide a “snapshot” of a moment in time and confirm “if you are doing what you say/think you are doing”
  • An Audit is part of sponsor Quality Assurance and feeds into quality systems

What is not an Audit?

  • Monitoring is a continuous and systematic process throughout the lifetime of the trial conducted by clinical trial monitors not independent of the trial who have not been involved in completing the activity.
  • Inspections are Independent regulators verifying study data whose primary interest is the protection of the public, e. Medicines and Healthcare products Regulatory Agency (MHRA), Human Tissues Authority (HTA).
  • Quality Checks are a continuous and systematic process throughout the lifetime of the trial conducted by clinical trial monitors not independent of the trial who have been involved in completing the activity.

Beyond this, the separation between audit activity, Research and Service Evaluation is defined in the following table:

Audit/ Quality ImprovementResearchService Evaluation
Designed and conducted to produce information to inform delivery of best careThe attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.Designed and conducted solely to define or judge current care.
Designed to answer the question: Does this service reach a predetermined standard?’Quantitative research – designed to test a hypothesis. Qualitative research – identifies/explores themes following established methodology.Designed to answer: “What standard does this service achieve or is it complying with best practice?”
Measures against a standard.Addresses clearly defined questions, aims and objectives.Measures current service without reference to a standard or best practice.
Involves an intervention in use only (the choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference).Quantitative research – may involve evaluating or comparing interventions, particularly new ones. Qualitative research – usually involves studying how interventions and relationships are experienced.Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, standards, best-practice and/or patient preference.
Usually involves analysis of existing data, but may include administration of simple interview or questionnaireUsually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care.Usually involves analysis of existing data but may include administration of interview or questionnaire.
No allocation to Intervention groups: the health professional and patient have chosen intervention before quality improvement.Quantitative research – study design may involve allocating patients to intervention groups. Qualitative research – uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications.No allocation to intervention: the health professional and patient have chosen intervention before conducting quality improvement.

For further guidance on and definitions to establish if your project is clinical audit, post market surveillance, service evaluation or research, please refer to:

http://www.hra-decisiontools.org.uk/research/

  • Non CTIMP training

A large number of the trials Sponsored by Greater Glasgow & Clyde are classed as non Clinical Trial of an Investigational Medicinal Product (non CTIMP), in this instance the Quality Department provides regular training sessions to support the Trial Teams in setting up and maintaining their site file. This is viewed as a preventative measure for Research and Innovation to ensure Trial Teams for Non CTIMPs are adequately trained and able to follow the required SOPs to produce the site file, this will ensure common issues which have been identified through Monitoring and Auditing activity are discussed with Trial Teams to avoid occurrence in future trials. This training session is also a useful opportunity for trial teams to ask for study specific advice on how to navigate study conduct and management at site from set up to close out.

Training Sessions are convened on a regular basis and the list of attendees is generated using standard extracts from the research database and asked to attend by a member of the Governance Team. The sessions are small, informal and friendly, giving researchers a chance to network with their peers, identify study related issues and challenges and participate in group discussions. 

The sessions are aimed at individuals employed by NHS GG&C only, who are new to research within the study team; researchers who are Chief Investigator for the first time, or Investigators new to NHS GG&C Sponsored research. Ideally, attendance should be prior to study recruitment. A sample site file index and supporting documentation is also provided prior to the training and study start up, which will be used as the basis for the session.

These sessions cover applicable regulatory frameworks; applications of Good Clinical Practice (GCP); good documentation practice and how each section of the site file index relates to the research.  In addition, processes that may also apply to the research are covered, i.e. amendments, study non compliances.  Common research audit findings are also discussed as exemplars of study non compliances and strategies discussed on how to avoid them.

Guidance, applicable legislation, responsibilities and principles of good clinical practice for researchers and research teams can be found here:

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

For further information, please contact via: RAndDAudit@ggc.scot.nhs.uk

  • Develop and Maintain the processes within Quality Management Tool (Q-Pulse)

A standard toolset is utilised by Research and Innovation for a number of activities, the aim of which is to allow these activities to be controlled in a uniform and predictable way to make the access and sharing of information easier for all those involved.

Q-Pulse is a Quality Management System for the control of Audits, Corrective and Preventative Action (CAPAs), Documents, Incident & Occurrences, People and Training. It utilises a number of modules which can be tailored for the specific requirements of all the processes within R&I. The Quality Department are responsible for developing and managing the content of Q-Pulse and generating reports to informing others of  what actions are required and when.

Pharmacovigilance and Safety Reporting: NHS Greater Glasgow and Clyde

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.

Roles and Responsibilities
Ensure the safety, rights and well-being of trial subjects are protectedData IntegrityConsentProtocol Compliance
GCP ComplianceSafetyDelegation of DutiesTraining
IMP ManagementDocumentationApprovalsFacilities 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 

Dr Caroline Watson – Research Governance Manager

Caroline.watson@ggc.scot.nhs.uk  Mobile – 07899595682

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.

  • Dr Margaret Fegen

Margaret.fegen@ggc.scot.nhs.uk   Mobile – 07813533000

Margaret’s career began as a nurse, training as an RGN in the former Royal Alexandra Hospital in Paisley which was part of the then Argyll and Clyde Health Board. Having worked as a Staff Nurse in an Acute Medical Ward, she then went to Glasgow to train in peri-operative nursing at The Southern General Hospital. She gained her  first sisters post at the newly established Ross Hall Hospital which offered valuable experience due to the diverse and specialised surgeries that took place there,  as well as the opportunity to work in other UK leading hospitals such as The Harley Street Clinic in London, The Princess Margaret Hospital in Windsor and The Alexandra Hospital in Cheadle. After around 10 years at Ross Hall she went back to NHS GG&C, Gartnavel Hospital, to run a theatre mainly focussing on Urology, with some ENT and vascular. During this time she completed intensive training in Advanced Life Support. After a career break, and due to her intense curiosity about the scientific investigation of health and disease, Margaret attended university full-time completing a BSc in Applied Bioscience before going on to complete a PhD in cellular biology studying the inflammatory effects of obesity on knee osteoarthritis. While writing her thesis, she secured a post as Research Coordinator within NHS GG&C R&D department for the CRUK funded Clinical Trials. This post resulted in gaining experience in the regulatory requirements with which to set up and support Clinical Trials, while serving as a basis for the transition to her role with the Governance team as Clinical Trial Monitor.

  •   Konstantina Komninidou

Konstantina.Komninidou@ggc.scot.nhs.uk

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 – 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 R&I 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 R&I office in Scotland, we received in excess of 620 new research applications in 2021 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 R&I Management office has adopted a ‘portfolio-team’ structure. The portfolio teams form the functional core of R&I and are comprised of Research Co-ordinators, Research Facilitators, Co-ordinator’s Assistants and clerical support staff.

Research and Clinical Innovation Strategy

The 5 core strategic objectives of the Research and Clinical Innovation Strategy are to:

  1. Deliver world leading quality research and innovation which will directly impact on and improve patient-centred care within Glasgow, Scotland and globally
  2. To fully embed a research and innovation culture within NHSGGC
  3. Further promote patient and public engagement and participation in clinical research and innovation
  4. Optimise our use of informatics and real world data through collaboration regionally, Nationally and globally with NHS partners, industry and academia
  5. Actively support innovation and early adoption (or early rejection) of novel medicines and devices at scale, nationally and internationally.

To achieve these objectives, NHSGGC recognises:

  • The value of our strong academic partnership with University of Glasgow within the Glasgow Health Sciences Partnership (GHSP) and the important role of our clinical academics in delivering clinical research within NHSGGC
  • Our close academic collaboration with Strathclyde University, Glasgow Caledonian, West of Scotland and Stirling University within the West of Scotland Health Sciences Network and others across Scotland & Nationally
  • The key role of research & innovation governance in ensuring that research and innovation areas conducted to high scientific, ethical & financial standards
  • The expanding role of our nurses, pharmacists, allied health professionals, translational scientists and associated academic partnerships in clinical research and as principal investigators
  • Our areas of current strength and research expertise
  • Our close collaboration with other boards both within the NHS Research West Node, the West of Scotland Health Sciences Network and other NHS boards across Scotland
  • Collaboration and close working with e-Health and Medical Physics within the West of Scotland
  • The value of existing and new key research partnerships through NHS research Scotland, local and national charities, trusts and voluntary organisations
  • The role of research and innovation to drive evidence based practice.

Further Information

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 NHS GG&C and its partners.