Congratulations, your research study has Management Approval! What happens next? R&I will ensure that all research studies are carried out in line with national guidelines as described in the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and other relevant government legislation.
Once R&I has issued Management Approval the Investigator is authorised to proceed with the research study. R&I is then responsible for research management and governance of the research study and will require updates on recruitment, study progress and will approve all study amendments throughout the lifetime of the study
NHSGGC responsibilities
Once R&I approval has been issued NHS GG&C has responsibility for:
- Ensuring investigators perform pharmacovigilance to required regulatory timelines as dictated by government legislation (CTIMPS only)
- Ensuring research teams are working to GCP standards as required by the EU Directive and Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended) (CTIMPS only)
- Following the trial to completion and ensuring regulatory requirements are met for the termination and final reports are submitted to ethics and/or the regulatory authority
- Capturing publication and dissemination, service benefits and other key research outputs
Multi-site Studies Where a research study is being extended to sites outwith GG&C to other NHS organisations, R&I will generate multi-site agreements which set out the responsibility of each party. R&I regularly organise international trials which have global sites round the world, e.g. U.S.A, Australia, France and Japan.
Monitoring R&I has a responsibility to monitor research studies conducted on its premises under ICH-GCP, the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and the Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended).
Investigator responsibilities
The Investigator is responsible for the conduct of the research study. As a condition of Management Approval the following information is required to be submitted to R&I during the lifespan of the project:
Investigator Site File All research studies must have a site file to aid in document storage and management of the research study. The site file should contain all essential documents required to be stored at site and retained for five years following the study end (CTIMPS only). Please download an Investigator Site File template here.
Progress Reports The Chief Investigator (CI) must submit an annual progress report each year to Ethics. More information can be found at National Research Ethics Committee (NRES). R&I must also be supplied with a copy of the report made to ethics and the Principal Investigator (PI) must inform R&I when the study ends.
Safety SAE Reporting (CTIMPS only) CTIMPS sponsored by NHS GG&C or co-sponsored with The University of Glasgow The PI should ensure that all members of the research team are familiar with GCTU SOPs for Pharmacovigilance available here. Further information on the SAE/SUSAR reporting procedure and services provided by the PV office including assistance with the preparation and submission of Annual Safety Reports are available here.
CTIMPs hosted by NHS GG&C Adverse events must be recorded, assessed and reported as specified in the study protocol. SUSAR Reports and Annual Safety Reports must be provided to R&I as per the conditions of Management Approval. Further information available here
Safety Reporting (Research other than CTIMPs) The NRES has specific reporting requirements for safety reporting in research other than CTIMPs. Details are available here
Amendments
Amendments made to any study specific documentation must be reported to ethics, the MHRA (if the research study is a CTIMP or medical device) and R&I. The NRES require changes to studies to be reported with those deemed substantial to be approved. Guidance on whether an amendment is substantial or non-substantial can be found here. Please submit the following documentation to R&I to ensure management Approval of your study is still valid:
- Copy of the Notification of Amendment form sent to ethics
- Copy of the favourable opinion of the amendment from ethics
- Copies of all documentation listed in the amendment favourable opinion letter received from ethics
- Copy of amendment approval letter from the MHRA (only required for CTIMP or medical device).
Once the above documents have been satisfactorily reviewed by R&I you will receive an email confirming R&I Approval is still valid
************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact *************************
The R&I team aim to provide a comprehensive support service throughout the duration of the project from inception to submission of final report. With this in mind, it is important that you contact the appropriate R&I portfolio team as early as possible.
New academic studies (including student projects): please provide a brief summary of the background to the study along with a draft protocol.
Ongoing academic studies at other sites: if you would like to participate in a study sponsored by another Board or Trust, please provide a copy of the current study protocol and contact details of the study Co-ordinator.
Researchers should be aware there is a separate research review process for projects requiring access to social work service users, social work staff or social work data in relation to social care and community health services falling under Glasgow City Health and Social Care Partnership, further information available here.
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. Please refer to this flow diagram for additional information on specific aspects of your R&I application.
Is your project research?
Research is defined as: ‘..an attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods’ As R&I approval is required for all research studies it is important to know if your project can be classed as research or not.
- Research must be systematic and follow a series of predefined steps defined in a protocol
- Research must be well organised and undergo rigorous planning, including performing an in-depth literature review and evaluation of questions to be answered
- The scientific definition of research generally states that a variable must be manipulated, although case studies and purely observational science do not always comply with this.
This table should help you decide if your project is research. Should you be unsure, please do not hesitate to contact the R&I office who will be happy to advise. For projects classed as clinical audit or service evaluation, the clinical effectiveness team can provide specialist support and advice.
Data Handling Measures
Interim data handling procedures can be found here
Developing your protocol
Study protocols, patient information leaflets and patient consent forms should be prepared in standard templates (below) and should be date and version controlled.
When developing your protocol click here for a few key elements that you should consider
Once you have developed a full draft of your Protocol, Patient Information Sheets, Consent Forms and IRAS forms you should ask your Research Co-ordinator to review and provide some comments. Co-ordinators can advise on the level of detail required in each of the documents and can check for consistency between them.
Identify a sponsor
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 health research study covered by the Research Governance Framework, it is for the sponsor to be satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management, monitoring and financing. 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. NHS GG&C can act as sponsor in the following situations:
- A study where the CI is an NHS GG&C employee
- A study involving NHS GG&C patients, staff or resources.
For more information on study sponsorship, please contact your Research Co‑ordinator.
Clinical Trials
For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution, company or organisation) who takes responsibility for the initiation management and financing (or arranging the financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials) Regulations 2004. Following appropriate risk assessment, NHS GG&G may act as sponsor on a trial where the Chief Investigator is an employee of NHS GG&C. Where the Chief Investigator is an employee of the University of Glasgow, NHS GG&C and the University may act as co-sponsor. Clinical trials sponsored by NHS GG&C should be formally adopted by and run by standards outlined by the Glasgow Clinical Trials Unit (CTU) standard operating procedures (SOPs).
Will your study generate intellectual property?
The Greater Glasgow Health Board Policy on the Management of Intellectual Property can be found here
Pharmacovigilance
Pharmacovigilance ensures the safety, quality and efficacy of medicines and healthcare products. The Scottish Executive Health Department Research Governance Framework for Health and Community Care (Second Edition, 2006) further defines the responsibilities in clinical trials and in other research carried out in Scotland. In CTIMPs sponsored by NHS Greater Glasgow and Clyde or co-sponsored with the University of Glasgow, the delivery of pharmacovigilance activity within the CTIMP is delegated to the Chief Investigator (CI). However, the ultimate responsibility and accountability for pharmacovigilance remains with the sponsor. The Pharmacovigilance Office facilitates and ensures compliance with this responsibility and provides central coordination of pharmacovigilance activity within the Glasgow Clinical Trials Unit.
Pharmacovigilance Office
Glasgow Clinical Trials Unit Robertson
Centre for Biostatistics
Boyd Orr Building
University of Glasgow
Glasgow G12 8QQ
Tel: +44(0)141 330 4744
Fax: +44(0)141 357 5588
Web: Can be accessed here
Pharmacovigilance Enquiries: pharmacovig@glasgowctu.org
Research facing primary care
A useful guide to research in a Primary Care setting is available here.
Good clinical practice
All researchers are required to adhere to the relevant legislation, frameworks and principles and take responsibility for ensuring any staff and students involved in research are familiar with the appropriate requirements. To achieve working to this level, the Good Clinical Practice Training for Staff Involved in Clinical Research policy outlines the expectation for staff and students to attend Good Clinical Practice (GCP) training, which is integral to the research experience and culture within NHS GG&C. Each person involved in a clinical trial must receive training in GCP appropriate to their roles and responsibilities.
The NHS GG&C Good Clinical Practice Training for Staff Involved in Clinical Research policy document is available here.
To book a GCP course (1/2 day or full day) please follow the links below:
Published information data transparency
Document is available here
Research activity confirmation
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).
Managed recovery process
A National process is currently underway to identify interventional, multi-site clinical research studies that are both urgent and should benefit from the support of NIHR CRN, NHS research Scotland, and R&I to fully recruit and/or close in the next year. Chief Investigators will be contacted directly if their projects have been selected by the funder for the managed recovery process. There is no intention that this process will result in any pause or withdrawal of support for studies active within NHS GG&C.
(https://www.nihr.ac.uk/documents/guidance-on-the-managed-recovery-of-the-uk-clinical-research-portfolio/27749 _
Since July 2020, NHS GG&C have initiated a local process for restarting all studies paused due to COVID-19. Locally, work continues to ensure that all studies are able to return to normal recruitment activities. In addition to local efforts and participating in the UK Managed Recovery Process we will continue to prioritise (please note the order does not indicate priority levels):
- NHS GGC locally sponsored/co-sponsored studies and in particular those involving early career researchers who have limited time to complete their funded clinical research.
- Studies that include routine standard of care as an option
- On going “urgent public health COVID-19” studies (e.g., Oxford-Astra/Zeneca, Novavax, Valneva and COV-BOOST vaccine trials; OCTAVE and SIREN etc)
************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact *************************
Research affects us all; many of the technologies and therapies that we associate with the delivery of a modern health service have their origin in research. Therefore, research is essential to developing the evidence base for the successful promotion and protection of health and well-being and to modern and effective health and social services.
By its very nature, research can involve an element of risk, both in terms of return on investment and sometimes for the safety and well-being of research participants. Therefore proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and community care. Glasgow has a long history of groundbreaking research that has resulted in real benefits to patients around the globe.
The team at R&I are keen to foster this spirit and offer extensive support to new and experienced researchers
Research & Innovation
NHS Greater Glasgow & Clyde
Ward 11, Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
About Us
Who Are We?
‘A multidisciplinary team promoting, co-ordinating and facilitating all aspects of high quality research within NHS Greater Glasgow & Clyde’
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 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 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, Research Administrators and clerical support staff.
The teams work together to support and encourage investigators and manage the R&I process from concept to approval and final report. Specifically, Research Co-ordinators and Facilitators act as an ‘advocate’ for the researcher and balance the administrative burden associated with clinical research against regulatory requirements.
Where to Find Us?
The R&I Management office is situated at Dykebar Hospital, Paisley.
Our postal address is:
Research & Innovation
NHS Greater Glasgow & Clyde
Ward 11, Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Contact Us
Portfolio 1
Dr George Bakirtzis Commercial Research Coordinator 0141 314 0225 Randdsystems.PF1@ggc.scot.nhs.uk
Ms Sandi Conway Research Facilitator 0141 314 0221 Randdsystems.PF1@ggc.scot.nhs.uk
Ms Kelly Cochrane Research Administrator 0141 314 0229
Portfolio 2
Mr Ross Nicol Commercial Research Coordinator 0141 314 0221
Mrs Karen Puglisevich Chase Research Facilitator 0141 314 0222
Ms Oumaima Abakar Ismail Research Administrator (NHS GG&C Hosted & Commercial studies) 0141 314 0217
Portfolio 3
Mrs Ruth Pink Commercial Research Coordinator 0141 314 0217
Ms Natalie Phillips Research Administrator 0141 314 0216
Low Risk Non Commercial NHSGGC Hosted
Ms Rozanne Suarez Senior Research Administrator (Line manager – Mrs Ruth Pink)
Mr Euan Rennie Senior Research Administrator (Line Manager – Mr Ross Nicol)
Sponsor Portfolio
Ms Nicola Jensen Academic Research Co-ordinator 0141 314 4001
Mrs Louise Ner Academic Research Co-ordinator 0141 314 4011
Dr Maureen Travers Academic Research Coordinator 0141 314 4012
Dr Alison Hamilton Academic Research Co-ordinator 0141 314 4414
Ms Shanice Thomas Senior Research Administrator 0141 314 4011
Mrs Kirsty Theron Senior Research Administrator 0141 314 4011
Mr Adam Wade Research Facilitator 0141 314 4172
Audit & Monitoring
Mrs Eileen McCafferty Audit Facilitator 0141 314 4429
Dr Sheila McGowan Lead Clinical Trials Monitor 0141 314 4414
Emma Moody Clinical Trials Monitor 0141 314 4485
Amanda Lynch Clinical Trials Monitor 0141 314 4414
Emma Whitelaw Governance Research Facilitator 0141 314 4429
Paul Gribbon Quality Assurance Manager
Research Pharmacy
Dr Samantha Carmichael Lead Pharmacist 0141 314 0232
Dr. Elizabeth Douglas Clinical Trials Pharmacist 0141 314 4073
Ms Paula Morrison Senior Pharmacist Clinical Trials – Oncology 0141 314 4019
Mrs. Pamela Surtees Lead Pharmacy Technician Clinical Trials 0141 314 4083
Ms Angela Carruth Pharmacy Facilitator 0141 314 4081 / 0141 211 3319
Pharmacovigilance Office
Dr Marc Jones Trial Safety Manager 0141 314 4434
Admin Pharmacovigilance Administrator
R&I Director
Prof Julie Brittenden R&I Director 0141 314 0327
R&I Managers
Ms Chloe Cowan Senior R&I Manager 0141 314 0233
Dr Caroline Watson Research Governance Manager 07899 595 682
Dr Melissa Robert R&I Systems Manager 0141 314 4125
Dr Samantha Carmichael Lead Pharmacist 0141 314 0232
Ms Michelle McDermott Management Secretary 0141 314 0327
R&I Information Officer
Mr Radek Penar Information Officer 0141 314 0226
NRS Performance Manager
Mr Graeme Piper NRS Performance Manager 0141 314 0230
Ms Islay Morrison Research Administrator 0141 314 0230
R&I Approval Process
What is R&I approval?
R&I approval provides permission for a study to commence within NHS Greater Glasgow & Clyde (NHSGGC) and is required for all research studies involving NHS patients, their tissues or information, or studies involving NHS staff participating by virtue of their profession.
R&I approval ensures that the legal obligations of the board, outlined in the Research Governance Framework (2nd edition, 2006), are met and is issued following a formal review of the project by designated staff. In addition, R&I approval provides insurance/indemnity for research projects under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS) and is a condition of ethical favourable opinion. The Research Governance Framework can be found here
The R&I approval process ensures:
- An appropriate study sponsor is identified
- The scientific quality of the proposal (as required)
- That there is a favourable ethical opinion from an appropriate REC
- Appropriate regulatory authorisations are in place
- Appropriate risk/benefit analysis
- Provisions for appropriate insurance/indemnity
- The financial and resource implications of the study are assessed
- Appropriate trial registration
- All researchers have substantive or honorary NHS GG&C contracts
- All researchers are adequately qualified
- Support department approval
- Formal agreements or contracts with external bodies meet the requirements of the Board.
All research conducted within the NHS must have R&I Management Approval
Who provides R&I approval?
Commercial
Commercial research is defined as research that is funded and sponsored by a commercial organisation. A study is defined as industry sponsored and funded if a commercial company has developed the study protocol and is fully funding the additional costs of hosting the trial within the NHS. These trials must be supported by a Clinical Trials Agreement and appropriate indemnification.
The Co-ordinators for Commercial research in NHSGGC are:
Click here for further information on Commercial Research, including details on the specific therapy areas covered by each Portfolio Team
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Non Commercial NHSGGC Sponsored
A ‘sponsor’ is defined as – an individual or organisation that takes on responsibility for confirming there are proper arrangements in place to initiate, manage, monitor and finance a study. Sponsors must also ensure that appropriate indemnity is in place before research begins.
The Co-ordinators for Non Commercial research Sponsored by NHSGGC are:
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Low Risk Non Commercial NHSGGC Sponsored
We have deemed “low risk” studies to be all Study Types from the IRAS Form that are:
- 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
Click here for further information on NHS GG&C Sponsored Research, including details on the specific therapy areas covered by each Portfolio Team
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Non Commercial NHSGGC Hosted
For all Non Commercial studies that aren’t Sponsored by NHSGGC, the Research Facilitators will be:
Click here for further information on NHS GG&C Hosted Research, including details on the specific therapy areas covered by each Portfolio Team
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Low Risk Non Commercial NHSGGC Hosted
We have deemed “low risk” studies to be all Study Types from the IRAS Form that are:
- 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
Ms Rozanne Suarez Senior Research Administrator (Line manager – Mrs Ruth Pink)
Mr Euan Rennie Senior Research Administrator (Line Manager – Mr Ross Nicol)
Commercial therapy areas
Portfolio 1
Co-ordinator: Dr George Bakirtzis
- Haematology (Oncology only)
- Medical Genetics
- Oncology
- Pathology
Network: Cancer
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Portfolio 2
Co-ordinator: Mr Ross Nicol
- 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)
Networks: Cardiovascular; Diabetes; Infectious Diseases; Stroke; Musculoskeletal Health;
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Portfolio 3
Co-ordinator: Mrs Ruth Pink
- A&E, Injuries and Emergencies
- Anaesthetics
- Critical Care
- Dermatology
- Ear, Nose and Throat (ENT)
- 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 Parkinson’s Disease, Multiple Sclerosis, Epilepsy, Migraine & Headache)
- Paediatrics
- Obstetrics, Gynaecology and Midwifery
- Ophthalmology
- Oral and Dental Health (Includes Oral Medicine, Dentistry/Community Dentistry and Dentistry – Restorative)
- Stroke
Networks: DEnDRON; Mental Health; Children’s Research Network
Non commercial NHSGCC sponsored therapy areas
Sponsor Co-ordinator: Ms Nicola Jensen (for ALL Oncology and CRUK co-ordinated Oncology studies)
Networks: Cancer; NRS Non- Malignant Haematology
- Haematology
- Ophthalmology
- Oncology
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Sponsor Co-ordinator: Dr Alison Hamilton
Networks / Speciality Group: Stroke; NRS Renal Speciality Group; Cardiovascular;
- Renal and Urology
- Cardiology (Colin Berry and John McMurray team led)
- Cardiovascular & Exercise Medicine
- Metabolic and Endocrine (Includes Dietetics, Metabolic Disease and Human Nutrition)
- Stroke
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Sponsor Co-ordinator: Dr Maureen Travers
Networks: Dental; NRS Oral & Dental Specialty Group; ENT; Cardiovascular Diabetes; Musculoskeletal Health;
- Anaesthetics
- Dermatology
- Diabetes
- Ear, Nose and Throat (ENT)
- Gastroenterology
- Medical Genetics
- Oral and Dental Health* (Includes Oral Medicine, Dentistry/Community Dentistry, Restorative Dentistry and Paediatric Dentistry)
- Orthopaedics
- Public Health (Includes Occupational Health, Sexual Health, Reproductive Health and Family Planning)
- Rheumatology
- Respiratory Medicine
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Sponsor Co-ordinator: Mrs Louise Ner
Networks: NRS Trauma and Emergencies; Infectious Diseases; Mental Health; Children’s Research Network;
- A & E, Trauma and Emergencies
- Critical Care
- 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)
- 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
- Paediatrics and Neonatal
- Physiotherapy
- Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
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Based on disease area for:
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Low Risk Non Commercial NHSGGC Sponsored
Research Facilitator: Mr Adam Wade
We have deemed “low risk” studies to be all Study Types from the IRAS Form that are:
- 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
Networks:
Non commercial NHSGGC hosted therapy areas
Portfolio 1
Research Facilitator: Ms Sandi Conway
- A & E, Injuries and 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
Network: Cancer; DEnDRON; Mental Health; Children’s Research Network
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Portfolio 2
Research Facilitator: Mrs Karen Puglisevich Chase
- 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)
- 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, Reproductive Health and Family Planning)
- Physiotherapy
- Renal and Urology
- Rheumatology
- Respiratory Medicine
- Stroke
- Surgery (Includes Burns, Plastic Surgery, Cardiothoracic Surgery and Vascular Surgery)
Networks: Cardiovascular; Diabetes; Infectious Diseases; Stroke; Children’s Research Network; Musculoskeletal Health
Referral to Clinical Genetics / Consent
More information coming soon…
Protection of Personal Information
More information coming soon…
Patient Information Leaflets
More information coming soon…
Useful Links
More information coming soon…
Management
Head of Service for Laboratory Genetics
Paul Westwood, Consultant Clinical Scientist
Tel: 0141 354 9312
Email: paul.westwood@ggc.scot.nhs.uk
Deputy Head of Service for Laboratory Genetics
Rachael Ellis, Consultant Clinical Scientist
Tel: 0141 354 9331
Email: rachael.ellis@ggc.scot.nhs.uk
Germline
Germline Programme Manager
Therese Bradley, Principal Clinical Scientist
Tel: 0141 354 9311
Email: therese.bradley@ggc.scot.nhs.uk
Senior Scientific Staff
Vera Cerqueira, Principal Clinical Scientist
Tel: 0141 354 9287
Email: vera.cerqueira@ggc.scot.nhs.uk
Jonathan Grant, Principal Clinical Scientist
Tel: 0141 354 9316
Email: jonathan.grant@ggc.scot.nhs.uk
Somatic
Somatic Programme Manager
Claire McKeeve, Principal Clinical Scientist
Tel: 0141 354 9288
Email: claire.mckeeve2@ggc.scot.nhs.uk
Senior Scientific Staff
Sandra Chudleigh, Principal Clinical Scientist
Tel: 0141 354 9110
Email: sandra.chudleigh@ggc.scot.nhs.uk
Avril Morris, Principal Clinical Scientist
Tel: 0141 354 9324
Email: avril.morris@ggc.scot.nhs.uk
Technical
Technical Programme Manager
Fiona Morgan, Principal Clinical Scientist
Tel: 0141 354 9408
Email: fiona.morgan3@ggc.scot.nhs.uk
Laboratory Manager
Donna Reid
Tel: 0141 232 7978
Email: donna.reid2@ggc.scot.nhs.uk
Development Manager
Niamh Mannion
Tel: 0141 354 9323
Email: niamh.mannion@ggc.scot.nhs.uk
Compliance
Feedback
We are committed to continual improvement and value your feedback. If you have any positive or negative experiences you want to share, please contact our Compliance and Resource Programme Manager or Quality Manager.
To log a formal complaint, please refer to the NHS Scotland complaints procedure.
Instructional courses at Canniesburn have been running since 1972.
Over the years these have been refined to give the maximum ‘hands on’ exposure to each participant.
For further information and to apply online, choose one of the course options below.
The reporting of accidents and incidents within NHSGGC will enable the safety performance of the organisation to be monitored and allow statistics relative to the accidents and incidents occurring to be compiled. These statistics will provide information about the hazards that employees, patients, visitors and others encounter on Division premises and ensure that suitable precautions can be taken to minimise these hazards and prevent a recurrence of an incident that has already caused or could potentially cause injury.
The incident report is a primary tool for collecting data about an incident, analysing the data and translating the information into a strategy for change.
Definitions
Incident
Any unplanned event that has resulted in, or could result in, injury or ill health to people, damage to or loss of property, plant or materials. This would apply to all people on hospital property including patients, staff and visitors. This definition takes account of the usual accident where personal injury results, and of near miss reporting where an incident could have resulted in injury and includes any act of non-consensual physical violence or verbal abuse.
Near Miss
As a result of chance or intervention the outcome could have lead to harm but on this occasion it did not. Reporting a near miss is just as important as reporting an actual incident. Near misses indicate difficulties that may be due to incorrect or missing procedures being in place. It is important that these are recorded. Although staff may only see an isolated incident within their area, this may have wider implications.
If you wish to report an incident, please click here. (Only available when logged into NHSGGC)
RIDDOR Reporting
Reportable incidents
Incidents fall into the following categories:
- Death
- Specified injury
- 8 stated categories of Occupational Diseases
- A dangerous occurrence
- over 7 day injury to an employee
- Death or major injury to a person not at work.
Specified Injuries
The list of ‘specified injuries’ in RIDDOR 2013 includes:
- A fracture, other than to fingers, thumbs and toes
- Amputation of an arm, hand, finger, thumb, leg, foot or toe
- Permanent loss of sight or reduction of sight
- Crush injuries leading to internal organ damage
- Serious burns (covering more than 10% of the body, or damaging the eyes, respiratory system or other vital organs)
- Scalpings (separation of skin from the head) which require hospital treatment
- Unconsciousness caused by head injury or asphyxia
- Any other injury arising from working in an enclosed space, which leads to hypothermia, heat-induced illness or requires resuscitation or admittance to hospital for more than 24 hours.
Reportable Occupational Diseases
This includes:
- Carpal tunnel syndrome
- Severe cramp of the hand or forearm
- Occupational dermatitis
- Hand-arm vibration syndrome
- Occupational asthma
- Tendonitis or tenosynovitis of the hand or forearm
- Any occupational cancer
- Any disease attributed to an occupational exposure to a biological agent.
NB Where an employee who sustains a high risk needlestick injury subsequently sero-converts to a reportable disease, a RIDDOR Reportable Disease report will require to be submitted in addition to the report of the Dangerous Occurrence
Dangerous occurrences
These are certain, specified ‘near-miss’ events (incidents with the potential to cause harm.) Not all such events require reporting. There are 27 categories of dangerous occurrences that are relevant to most workplaces, for example:
- The collapse, overturning or failure of load-bearing parts of lifts and lifting equipment
- Plant or equipment coming into contact with overhead power lines
- Explosions or fires causing work to be stopped for more than 24 hours
- An employee is injured by a sharp known to be contaminated with a blood borne virus.
Over seven day injuries
Only when they occur at work – over seven day injuries, not counting the day of the accident but including weekends and rest-days, which result in an employee being away from work or unable to do their normal duties for more than seven days (including non-working days).
Injuries to non-workers
If the accident occurred at a hospital, the report only needs to be made if the injury is a ‘specified injury’ (see above).
Additional documents
Overview
Staff can be identified as being lone workers if their working activities involve periods of time where they are without any kind of close or direct supervision, or in contact with any other colleagues. The NHSGGC Policy on Lone Working provides further guidance on identifying lone workers.
When a manager identifies that they have staff who are lone workers, a risk assessment is required to identify the risks involved and any measures to control the risks. Guidance on undertaking a lone worker risk assessment can be found in the NHSGGC Lone Worker Policy. There are many potential control measures, of which one is the lone worker support service, currently provided by Reliance Protect.
This service uses a specialist Lone Worker Device. If the lone worker’s safety is compromised, they can discreetly use the device to summon support and/or emergency assistance.
This service should only be considered after undertaking a lone worker risk assessment in conjunction with the guidance provided within the NHSGGC Lone Worker Policy. If the Lone Worker Support Service is identified as a potential control measure, this should be discussed and agreed with the appropriate budget holder who will be paying for the service.
If the services require additional lone worker devices please contact the Health & Safety Service in the first instance.
Guidance
Guidance
Guidance presentation used during training for using the Lone Worker Support Identicom Device.
An escalation protocol outlines how a service will use the lone worker support service and details what to do in the event an alert is raised by a lone worker. An example protocol is provided here.
Champions Training
These sessions are for those identified by managers as staff who will provide support and help with managing the use of the Dedicated Lone Worker Devices issued by Reliance Protect. Training sessions, further information and nominations are available on request.
Escalation form
How to…
Access refresher training for using your lone worker device
Contact Reliance Protect on – Training@reliancehightech.co.uk – with your name, email address and device serial number
Make changes to lone worker details associated with a device
Changes to details associated with a device – all changes should be notified directly to Reliance Protect’s customer service department using servicedesk@reliancehightech.co.uk or 0800 840 7121 (Option 1). This includes changes to a lone workers personal details, for example, car registration, personal mobile; or work details, for example, work mobile phone or managers details. Both the lone work and the manager named at the top of the escalation form associated with the group can make these changes.
Make changes to escalation form details
Changes to escalation form details associated with a lone working group should be notified directly to Reliance Protect’s customer service department using to servicedesk@reliancehightech.co.uk or 0800 840 7121 (Option 1). This includes changes to lone workers on the form and contact details of any of the escalation point. The manager named at the top of the escalation form associated with the group can make these changes. Any requests must include the email addresses of any persons that the change relate to.
Make changes/additions to managers
Changes associated with an escalation form should be notified directly to Reliance Protect’s customer service department using servicedesk@reliancehightech.co.uk or 0800 840 7121 (Option 1). The Manager named at the top of the escalation form receives the monthly reports directly from Reliance Protect and can make changes to the form. The manager can add additional ‘managers’ to the group/escalation form. Any requests must include the email addresses of any persons that the change relate to.
When a lone worker leaves employment
When a lone worker leaves employment, the device should be retained by the manager and re-assigned to their replacement. Reliance Protect should be contacted directly to inform them of this change to both the lone workers details associated with the device and the escalation form. Contact Reliance Protects customer service department using servicedesk@reliancehightech.co.uk or 0800 840 7121 (Option 1)
I need a replacement part/accessory for the device
For example, a new pin, lanyard or charger. These are available at extra cost and should be ordered from Reliance High Tech using a non-stock order form. Ensure the order form is clearly marked ‘Lone Worker device accessory’ and the supplier is ‘Reliance High Tech’.
For further information, contact Health and Safety through the internal email system or through the main HR contact number 0141 278 2700.
Respiratory Protection (FFP3 Masks)
FFP3 Masks
The need for FFP3 Mask (oral nasal disposable mask respiratory protection) to be worn is identified through clinical risk assessment. The mask is used to protect against respiratory borne pathogens. To use these masks, relevant staff must be ‘face fit tested’ to ensure that they can achieve a suitable face fit of the mask and that it operates at the required efficiency.
The following documentation is used specifically in relation to face fit testing:
A list of current FFP3 mask fitters as of 3rd December 2020 is available here (only accessible to staff on NHS network).
Checking for an FFP3 fit test record
After checking, if you believe a fit test record is not on eESS that should be, please contact the Health and Safety Service: wig-movhan736@ggc.scot.nhs.uk.
FFP3 Mask Supply
Prior to the onset of COVID-19, NHSGGC fit tested to 3 masks – Alpha Solway 3030V and S-3V; and, the 3M 1863+. In early March 2020, significant challenges to worldwide supplies of FFP3 disposable masks occurred and as a result a number of different FFP3 masks were sourced and introduced.
The following document gives an overview of the masks that have been issued by procurement during this period for face fit testing against:
FFP3 Mask Model Overview – updated 20th May 2020
Changes to mask availability due to the above, is likely to continue to occur during the next few months of 2020 and as such the Face Fit Test flow chart below identifying which masks should be fit tested against and are available, will be updated regularly
Fit Test Rec
- At the point of fit test, the fit tester will complete an eForm. **You will need the persons Payroll, eESS or NI Number to use this form**
- Guidance for completing the eForm.
- On completing the fit test, the record will be emailed to both the testee and the tester for reference and record keeping
- Fit test records will be uploaded on a regular basis to eESS OLM. The record can be found within a course entitled ‘PPE – FFP3 Mask’ in the Health and Safety category and viewed by both the testee and their direct line manager.
Guidance Documents
Guidance including for donning and fit checking an FFP3 mask is provided below:
Powered Air-Purifying Respirators (PAPR)
A Powered Air-Purifying Respirator (PAPR) is a type of respirator used to safeguard workers against contaminated air. PAPR consists of headgear and a fan which takes air from the surrounding environment, passes it through a filter and delivers it through a hose to the users face via the hood.
Within NHSGGC the need for respiratory protection to be worn is identified through clinical risk assessment. The first choice control measure is an FFP3 mask to which staff must be face fit tested, to ensure a tight seal is achievable. Staff will only be considered for PAPR if no available FFP3 masks are suitable for them and they are required to undertake / work in Aerosol Generating procedures/environments.
If you have been identified as requiring PAPR you will require to undertake learning, complete a self assessment and be competency assessed by GGC PAPR trainers, to ensure you are competent to Don, Operate, Doff, Decontaminate and Maintain/Manage the system. If you are assessed as competent to use PAPR safely, you will be enabled to use the system during AGP work activities. PAPR must be stored at your place of work.
The head gear will always be specific to you, however the rest of the system, fan unit, hose, belt, battery and charger may be used by multiple people. Arrangements for how and where to store the PAPR and the designated areas to put on and take off the system will be explained to you by your line manager prior to you using the equipment for AGP activities.
Training in PAPR will be specific to the PAPR system you will be issued, that is, after the training you will only be able to use the specific make and model you have been trained on and issued with.
Additional Documentation
8000 PAPR
Infection Prevention and Control
Checklists
A step by step guide relating to the management process, including how to use the documentation below, for staff who have received training in the use of PAPR within NHSGGC, can be found here
- Pre-use checklist – this must be completed and signed prior to every use of the PAPR system and kept within the box where the PAPR is stored – ** Updated 28th Jan 2021**
- Filter change record – filters are valid for 1 month after opening. The date of opening must be recorded on this record and kept within the box where the PAPR is stored.
- Monthly checklist – this must be kept with the pre-use checklist and completed every month when the PAPR has not been used
- Box Poster – This poster should be completed and stuck to the box that contains the PAPR unit.