************************ 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 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:
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 Improvement
Research
Service Evaluation
Designed and conducted to produce information to inform delivery of best care
The 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 questionnaire
Usually 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:
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:
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.
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 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.
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 September 2024. The virtual course will be based on exam topics and endeavour to reproduce the spirit of previous courses, while taking advantage of the strengths of virtual platforms.
The course fee is £750
When the course if 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.