Any research taking place in NHS GG&C that doesn’t fit the definition of NHS GG&C Sponsored or Commercially Funded and Sponsored, would be considered to be NHS GG&C Hosted (i.e. All Non Commercial studies that aren’t Sponsored by NHS GG&C). This includes all studies that are academically led by another health board, trust or academic institution (not NHS GG&C and or the University of Glasgow)
All multicentre clinical, health and social care Research and Innovation studies in Scotland require to be submitted to the NHS Research Scotland Permissions Coordinating Centre (NRSPCC) at gram.nrspcc@nhs.scot NRSPCC will upload multicentre studies onto the shared Scottish R&D web based database and make them available to participating Health Boards for review and approval and will ensure single centre studies are available to the relevant R&D office.
All research teams are encouraged to submit their application for NHS R&D management approval in parallel with their application for an ethics committee opinion, as this will help expedite the R&D management approval process
To find the appropriate contact in the R&I Hosted Team for your study, please use the Info Path document available here.
Contact Details
Study Type
Ionising Radiation for combined review of clinical trial of an investigational medicinal product Ionising Radiation and Devices form for combined review of combined trial of an investigational medicinal product and an investigational medical device Clinical investigation or other study of a medical device Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
Disease Area
A & E, Trauma & Emergencies Critical Care Ear, Nose and Throat (ENT) Haematology (Oncology only) Medical Genetics Mental Health (Includes Adolescent Psychiatry, Alcohol/Drugs Misuse, Adult Mental Health, Psychological Medicine/ Clinical Psychology, Family Psychiatry, Forensic Psychiatry and Learning Disability) Neurology (Non Stroke) (Includes Dementia, Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache) Obstetrics, Gynaecology and Midwifery Oncology Ophthalmology Oral and Dental Health (Includes Oral Medicine, Dentistry/Community Dentistry and Dentistry – Restorative) Pathology.
Hosted Facilitator
Ms Sandi Conway – Research Facilitator sandi.conway@ggc.scot.nhs.uk 0141 314 0221 Line Manager: Dr George Bakirtzis
Anaesthetics Cardiology Cardiovascular & Exercise Medicine Dermatology Diabetes Gastroenterology Haematology (Non Oncology) Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy) Hepatology Infectious Diseases Includes Infectious Diseases, Microbiology, Virology) Metabolic and Endocrine) (Includes Dietetics, Metabolic Disease and Human Nutrition) Orthopaedics Public Health (Includes Occupational Health, Sexual Health, Reproductive Health and Family Planning) Physiotherapy Renal and Urology Rheumatology Respiratory Medicine Stroke Surgery
Mrs Karen Puglisevich Chase Research Facilitator Karen.Chase@ggc.scot.nhs.uk 0141 314 0222 Line Manager: Mr Ross Nicol
Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology Study involving qualitative methods only Study limited to working with human tissue samples (or other biological samples) and data (specific project only) Study limited to working with data (specific project only) Research tissue bank or Research database Patient Information Centres (PIC) Basic Science Study involving procedures with human participants
NHSGGC supports the conduct of high-quality commercially Sponsored and Funded research, which allows patient the opportunity to access novel medicines. NHS GG&C currently has the highest volume of Commercial research in Scotland
To find the appropriate contact in the R&I Commercial Team for your study, please use the Info Path document available here.
You can also find contact details for the Commercial Team here
All multicentre clinical, health and social care Research and Innovation studies in Scotland require to be submitted to the NHS Research Scotland Permissions Coordinating Centre (NRSPCC) at gram.nrspcc@nhs.scot NRSPCC will upload multicentre studies onto the shared Scottish R&D web based database and make them available to participating Health Boards for review and approval and will ensure single centre studies are available to the relevant R&D office.
The following links offer more information on the Commercial research approval process in NHS GG&C:
Cardiology Cardiovascular & Exercise Medicine Diabetes Gastroenterology Haematology (Non Oncology) Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy) Haepatology Infectious Diseases (Includes Infectious Diseases, Microbiology, Virology and Bacteriology) Metabolic and Endocrine (Includes Dietetics, Metabolic Disease and Human Nutrition) Orthopaedics Public Health (Includes Occupational Health, Sexual Health and Family Planning) Physiotherapy Renal and Urology Rheumatology Respiratory Medicine Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
NHS GG&C has responsibility to ensure that there are appropriate governance arrangements in place for any commercially funded research, thus ensuring that:
The interests and safety of patients enrolled in trials are protected in all eventualities
All trials are fully costed and that the costs are properly recovered
Maximum benefit is provided to the investigator and to the board
The interests of both the investigator and the board are protected in the event of Intellectual Property arising out of research
Any external regulatory, ethical and financial approvals are obtained
Any risks (liabilities) are properly considered and minimised
The board presents a thoroughly professional approach in its dealings with industry.
In order to ensure Governance of commercial projects, all studies must receive Management approval. Only protocols and trials approved by the R&I Management Office will be covered by the appropriate insurance or NHS indemnity arrangements and the Board will not accept liability for any activity that has not been approved. This website contains a practical guide to help you navigate the R&I process and highlights key steps required to get your research project up and running
Initial R&I Contact and Document Request
Investigators
If you have been approached to participate in a commercial research study your first port of call should be your Research Co-ordinator. The Co-ordinator will be able to advise on the steps required to get up and running, and will take over negotiations over fees and contracts with the company concerned. With your help the Co-ordinator should be able to manage the approval process from start to finish.
Companies
If you would like to run a study within NHS GG&C please contact the relevant Research Co-ordinator who will be able to advise on the best way to submit an R&I application.
Documents
In order to gain R&I approval as quickly as possible, we advise that you submit to R&I as early as possible. We are happy to receive documents as they become available, this will allow us to look at your application and progress quickly. The very minimum we require to start our process is a copy of the protocol and proposed budget.
Engage Support Departments
Once we have identified what support departments will be involved in the study we can contact the relevant personnel for confirmation of costs and approval for research to be conducted within the department
Project Costing
Once a copy of the protocol has been submitted to R&I the Research Co-ordinator can begin costing the project. Costs associated with a research project are calculated on the staff time required and on the allocated price for procedures. The Research Co-ordinator will usually work closely with the research team to ensure that time required to complete the study is accurately captured. The project costing is then sent to R&I finance and the investigator for approval. If required, the Research Co-ordinator can negotiate fees with the commercial company
Commercial Contracts and Agreements
Before any commercial study can proceed within NHS GG&C a written agreement between the Board and the commercial company should be signed by both parties. Contracts should only be negotiated by Research Co-ordinators and are signed by an R&I director. The agreement should define the following:
Scope of work
Acceptable payment arrangements
Important issues such as the right to publish results
Protection of confidential information
Indemnification of third parties.
To help facilitate timely completion of the appropriate contractual documentation, the Association of British Pharmaceutical Industry (ABPI) and the Department of Health have developed, and published, a model Clinical Trials Agreement (mCTA) as a standard contractual framework for commercial trials involving NHS patients. To incorporate slight differences in Scottish Law and policy, a revised mCTA for use in Scotland has been developed. All legal agreements between the Board and commercial companies should be governed by the laws of Scotland.
The Sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage, monitor and finance a study. For any research that takes place in the context of the NHS in Scotland, there must be a Sponsor. Normally, the Sponsor will be one of the organisations taking the lead for particular aspects of the arrangements for the study. The sponsor may be the Chief Investigator’s employing organisation, the lead organisation providing healthcare, or the main funder.
R&I Management Approval is no longer provided by the Glasgow Sponsored Team, this is now provided by another R&I Systems Team member, independently of the Sponsor Co-ordinator
The Sponsor Team provide information and support to researchers from study inception right up to the point of issuing R&I Management Approval. The Sponsor Team can offer guidance in the following areas:
Study Planning and Design
Grant applications and study costings
Any required study specific permissions and approvals (e.g. Ethics Approval, MHRA etc.)
Study set-up support (e.g. making contact with appropriate support departments such as R&I Pharmacy and Imaging)
Study documentation development (including study protocol, patient information and consent forms etc.)
Sponsor confirmation and assistance with any contracts and/or agreements
If you wish NHSGGC to Sponsor your study (or Co-Sponsor with the University of Glasgow), you should contact the R&I Sponsor Team as early as possible.
To find the appropriate contact in the R&I Sponsor Team for your study, please use the Info Path document available here.
You can also find the contact details for the Sponsor Team below.
The interactive Sponsor Team SOP Roadmapgives further information on the Sponsor process in NHSGGC.
Sponsor Team Contacts
Study Type
Ionising Radiation for combined review of clinical trial of an investigational medicinal product Ionising Radiation and Devices form for combined review of combined trial of an investigational medicinal product and an investigational medical device Clinical investigation or other study of a medical device Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
Disease Area
Critical Care Dermatology Ear, Nose and Throat (ENT) Medical Genetics Mental Health (Includes Adolescent Psychiatry, Alcohol/Drugs Misuse, Adult Mental Health, Psychological Medicine/ Clinical Psychology, Family Psychiatry, Forensic Psychiatry and Learning Disability) Neurology (Non Stroke) (Includes Dementia, Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache) Ophthalmology Pathology Stroke.
Ms Brittany Graham Senior Research Administrator Brittany.Graham@ggc.scot.nhs.uk 0141 314 4011 Line Manager: Mrs Barbara Ross.
Study Type
Disease Area
Sponsor Co-ordinator
Administrative Support
As above
Anaesthetics Cardiology (Colin Berry and John McMurray team led) Cardiovascular & Exercise Medicine Diabetes Heath Services and Delivery Research (Includes Biochemistry, Immunology, Clinical and Medical Physics, Radiology, Nuclear Medicine and Homeopathy) Haepatology Infectious Diseases (Includes Infectious Diseases, Microbiology, Virology and Bacteriology) Metabolic and Endocrine (Includes Dietetics, Metabolic Disease and Human Nutrition) Physiotherapy Public Health (Includes Occupational Health, Sexual Health, Reproductive Health and Family Planning) Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
Mrs Kirsty Theron Senior Research Administrator Kirsty.Theron@ggc.scot.nhs.uk 0141 314 4011 Line Manager: Dr Maureen Travers
As above
Paediatrics and Neonatal Gastroenterology Orthopaedics Rheumatology A & E, Trauma & Emergencies Haematology (Non Oncology and Oncology) Oral and Dental Health Cardiology (John Cleland team led) Obstetrics, Gynaecology and Midwifery Renal and Urology Respiratory Medicine
Mrs Kirsty Theron Senior Research Administrator Kirsty.Theron@ggc.scot.nhs.uk 0141 314 4011 Line Manager: Ms Joanne McGarry
Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology Study involving qualitative methods only Study limited to working with human tissue samples (or other biological samples) and data (specific project only) Study limited to working with data (specific project only) Research tissue bank or Research database Patient Information Centres (PIC) Basic Science Study involving procedures with human participants
As the busiest R&I office in Scotland, the NHSGGC R&I Team received in excess of 560 new research applications in 2023 and have approximately 1000 studies ongoing at any one time.
There are 3 teams working within the Systems Team structure:
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.
Complaints 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.
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. Researchers can 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.
Complaints 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.
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.
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.
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 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 Details
Meets
Contacts
West of Scotland Research EthicsCommittee 1 WoSREC 1 Recognised Type III Flags: CTIMPs Paediatrics Phase I Patients
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 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.