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Staff Resources & Support

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To access the New Community Webpage simply CLICK HERE

Basic Life Support
Continence
District Charge Nurse – Day 2 Introduction to MicroStrategy

Day 2 – Will look at Microstrategy Clinical Quality Indicators – SSKINS, MUST & Cauti

All sessions will start 1:00pm prompt 

All sessions will now be delivered via MSTeams, Please access link below to attend. No need to book a place.

EQUIP-U

Training is provided by the staff within EQUIP-U, currently conducted via MS Teams, however, this may change with the current regulations. Please check details upon booking.

To Book or join waiting list please click HERE

HICC/PICC Care

Maintenance sessions are carried out periodically throughout the year, depending on demand. If you find there are no dates available, please contact the PDN team via email to find out more.

Important Note

Prior to booking, please ensure you have the support of your Line Manager to attend as these are carried out in the afternoon.

Next dates for these sessions are listed below and will be held within the QEUH.

To book onto the training session, simply click on the preferred date below.

Thursday 28th September

Monday 30th October

23rd November

18th December

Hypoglycaemia Management
Leg Ulcer Management
Record Keeping

Record Keeping Sessions

Currently, sessions are On – Demand, which means you can access the training online at anytime.

Record Keeping for District Nursing

All Staff within District Nursing (bands 3 – 7) are expected to undertake this training annually and ensure their competence within record keeping.  Any additional record keeping support can be accessed by emailing David.McCrohon@ggc.scot.nhs.uk

There are 3 steps to completing this training.

1) Watch the on-demand video

2) Read and understand the ‘Standards for Professional Record Keeping’ policy

3) Sign the declaration that you have completed both of the above.

If you have not completed all 3 steps, this may flag your name to indicate training incomplete.

Record Keeping

Step 1

You should now access the on-demand Record Keeping training video here.

Topics covered include : 

  • Principles of good Record Keeping
  • Excellence in Care
  • Expectations from DN staff
  • Nursing Assessments 
  • Risk Assessing
  • Care Planning
  • Specialist Forms (wound charts, leg ulcer pathways, waterlows etc)
  • Recording visits
  • White Cards
  • Agile Working

Step 2

Staff should familiarise themselves with this policy and understand what is expected of them in relation to Record Keeping within the organisation.

Step 3

This will be shared with your Nurse Team Leader and can be used for Revalidation and CPD purposes.

Safer Sharps

Welcome to the Safe Use of Clinical Sharps training page.

Sol Care Needles

With the introduction of the new Insulin syringes within Community, please ensure you access the training material provided below.

Below is the relevant important information for Sol-Care Insulin Safety Syringe. Please read the material below prior to using the instruments.

Should you have any further concerns or questions please do not hesitate to contact the Practice Development Team.

Completing your safer sharps training

There are 5 key components to this training that must be completed prior to using any sharps devices within the clinical environment.

  1. All community nursing staff should first access and complete the below Learnpro modules
  • GGC: Managing Skin Care for Responsible Persons
  • Management of Needlestick & Similar Injuries
  • Prevention & Management of Occupational Exposure

2. You must read the Safer Sharps Policy and sign to confirm you understand your roles and responsibilities with your Nurse Team Leader.

3. You must access the Safe Use of Clinical Sharps theory video

(This can only be accessed via an NHS device).

4. You must complete the practical demonstration with your line manager (Nurse Team Leader, District Charge Nurse, Treatment Room Coordinator).

5. Once you have completed Steps 1-4, you must now fill out this online form to evidence your training.  

SCIT app

What is SCIT?

Secure Clinical Image Transfer

The Secure Clinical Image transfer (SCIT) app is the approved method for capturing clinical photographs securely on a registered mobile device in acute and community settings.

The SCIT is an application of which is located on your professional mobile phone. Patients images are taken and immediately transferred to the server, when this occurs the images are no longer accessible from the mobile phone.

To apply for the SCIT app please click HERE

The images can be viewed within 24 hours on Clinical Portal or the Medical Image Manager (M.I.M) software

What is M.I.M?

Medical Image Manager

Medical Image Manager is a purpose-built database solution which allows healthcare professionals to access clinical photographs at workstations in their clinic or ward, using a simple web browser. Medical Image Manager enables all users’ access to the relevant image, in the relevant place, at the relevant time to support patient care. The system has been fully implemented within the acute hospitals of NHS Greater Glasgow and Clyde, and now welcomed by community nursing.

Accessing your patients images

Access can be via M.I.M or/and Clinical Portal.

Via Clinical Portal: Within your patient record, from the list noted on the left, click on “images”, you will see a drop down box appear, click on “photographs”. From this you will access all photographs captured by all services for your patient.

Via M.I.M:

When Applying for the M.I.M software please download and complete the required form, please note this cannot be completed and sent electronically, it must be signed by your Nurse Team Leader and sent to the correct department for approval. To apply for M.I.M please click HERE.

Training Material

Please familiarise yourself with the useful information below.

Venepuncture

Venepuncture training is offered from Acute, therefore practical session is given within the Royal Infirmary, Glasgow.

Prior to booking onto the training, please read the information provided below:

LearnPro (mandatory prior to training)

Practitioners must complete the NHSGGC 157: Venepuncture and Cannulation e-learning module on NHS LearnPro.

Failure to complete this before attending training will result in practitioner being refused entry and asked to book once this has been completed.

Practical Training

  • Practitioners attend a 2 hour practical workshop (this is not a drop-in session). Sessions available are:
  • Venepuncture only
  • Cannulation only
  • Venepuncture and cannulation

All staff wishing to attend this training must have approval from their Line Manager as the Nominator.

Places for these workshops are booked by completing the Nomination form and emailing to practicedevelopmentnominations@ggc.scot.nhs.uk.

Click Here to access the form.

Practitioners must work in an area where there is a clinical need for the skill.

Competency Assessment

A 2 month period of supervised practice and competency assessment follows attendance at the practical session.

Individuals are not deemed competent until they have received their completion certificate from Practice Development.

It is the responsibility of the individual to review and maintain their competence thereafter.

Competency booklets will be supplied during the training session.

Completed competency booklets should be emailed to practicedevelopment.enquiries@ggc.scot.nhs.uk

Important

If practitioners have already completed venepuncture training and achieved competence in another health board, and are able to provide documentary evidence of this, they should contact Practice Development to confirm this training and competence is transferrable to NHSGGC.

These practitioners should still complete supervised practice using the NHSGGC venepuncture competency book.

A copy of this completed booklet, signed off by your line manager, should be kept in appropriate training files at local level as evidence.

They should also access and complete the NHSGGC 157 venepuncture and cannulation module on NHS LearnPro.

LearnPro – MUST

This training is for Glasgow City HSCP for ALL Community Nursing Staff

New to LearnPro is the following modules.

These modules are for all community staff, it is expected that these modules are completed in full by 31st May.

See below for the New Modules available:

  • GGC:270 An Overview of Malnutrition.
  • GGC:271 Assessing Risk of Malnutrition
  • GGC:273 Food First Strategies – Community.

To access these, please log in to your LearnPro account below. 

Mandatory Training Requirements for all Community Staff Members

As part of your role, you are required to complete all relevant statutory and mandatory training via Learnpro. 

Below is a full list of all statutory & mandatory LearnPro modules you must complete.  Theses should be prioritised and must be completed within the first 12 weeks of your employment.

Accordion item 1

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:

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

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

Audit

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

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

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

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

What is an Audit?

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

What is not an Audit?

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

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

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

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

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

Non CTIMP training

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

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

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

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

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

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

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

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

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

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

Introduction

Pharmacovigilance (PV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

PV is a regulatory requirement for any clinical trial of an investigational medicinal product (IMP) whether the trial is a first in man study of a novel drug or a study investigating how a well understood licensed drug performs in a real world setting.

In addition there are other types of study where vigilance processes are required for example:

Safety reporting is also a regulatory requirement for all clinical investigations of medical devices. Where a non CE marked device (or a CE marked device is used outside of its intended purpose) is used within an investigation there is a requirement to carry out vigilance.

Safety reporting is required within all studies involving human participants; even those that do not involve the use of drugs. Where an intervention or trial specific procedure takes place is important to ensure that the safety of the study in monitored.

About us

The Sponsor Pharmacovigilance Office is part of the Research and Innovation governance team. The Pharmacovigilance and Safety Manager is based within NHS GG&C while PV administration and systems are provided by the Robertson Centre for Biostatistics at the University of Glasgow.

We provide support to researchers from the grant stage of a study, to protocol development, identifying and managing risk from an IMP perspective, overseeing the collection and review of safety data, the processing and administration of Serious Adverse events, monitoring safety data for unexpected events, coding of events, and the preparation of Developmental Safety Update Reports.  We ensure that all trials are compliant with the relevant regulatory frameworks on behalf of the lead investigator and Sponsor. The PV office has experience in oncology, cardiovascular, stroke, and many other fields of healthcare.

A risk adapted approach to pharmacovigilance and safety reporting is used to ensure that trials are conducted safely and efficiently while reducing the workload for both sites and investigators where possible.

The Sponsor PV office can help investigators for all studies, not just those involving drugs. We have experience of clinical investigations of medical devices, interventional studies, biomarker studies, and all other forms of healthcare research involving human subjects. We can help you at to assess the level of safety reporting required and aid in the preparation of study protocols. Please get in touch with the PV and Safety Manager should you wish to discuss any aspects of safety reporting.

ICH GCP defines monitoring as “the act of overseeing a clinical trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Good Clinical practice, SOPs and relevant regulatory requirements”

 The GG&C monitors purpose is to ensure and verify 

  • The rights and well-being of human subjects are protected
  • The reported trial data are accurate, complete, and verifiable from source documents
  • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

The clinical trial monitors (CTMs) are sponsor representatives who review and update monitoring procedures, attend trial specific meetings, ensure compliance and consistency to regulatory and local procedures, and review protocol deviations. CTMs are appropriately trained and have the knowledge to escalate protocol deviations and identify serious breaches of GCP.  The CTMs assist with risk assessments and implement a trial specific monitoring risk assessment. The specific monitoring risk assessment aids the monitoring plan development.   CTMs ensure patient safety on trials is upheld, reviewing SAEs and identifying unreported SAEs and in the identification and analysis of repeated trends within trials.

Our team is made up of highly experienced individuals with varying backgrounds from nursing, science undergraduates and post graduates in addition to NHS and commercial backgrounds.

Due to the continually evolving nature of clinical trials and the recent global COVID-19 pandemic, new processes had to be rapidly developed and put in place to ensure ongoing oversight for new and existing clinical trials within our portfolio.  Remote and central monitoring processes were utilised whilst minimising the burden on site staff as far as possible.  All monitoring plans were reviewed to ensure compliance and addendums added to document any changes that were required.

The types of visit we conduct – Site Compliance, Routine monitoring, Close Out and For Cause visits.

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

CTMs generate a visit report using the Q-Pulse database to manage actions raised during visits and ensure any non-compliances are rectified and recorded appropriately.

Services and Support Provided

  • Monitoring of Sponsor / host-sponsored CTIMPs, High-risk non-CTIMPs, and device trials
  • Non-commercial and commercial monitoring
  • Building a relationship between sites and sponsor
  • Identification of trends within a study (e.g. lab results being missed, deviations, issues with the study, site staff etc.)
  • Input into risk assessment
  • Identification of serious breaches
  • Feedback regarding site and non-compliance issues
  • Site training – protocol, eCRF completion

When to Get Us Involved

  • Grant application – Costings
  • During the start-up /set-up – Budgets/funding, logistics of the source data, feasibility
  • Risk assessment – Early input for development of the monitoring plan
  • During the study – Amendments, safety issues, database issues, etc.
  • End of study – Close-out activities
What monitoring is?What monitoring isn’t?
Collection and analysis of information to track progress in a clinical trial.  Evaluation of any type including process evaluation
Critical to ensure the safety, rights and wellbeing of trial patients are upheld.Audits and inspections
Risk assessment defines level of monitoring based on objective, purpose, design, complexity, blinding, size and endpoints of the trial and is an ongoing process defined by amendments, site problems or other assessments.It does not usually occur just once. (unless a company has approached the monitors for a one time visit, which is agreed at the start)
Ongoing occurrence throughout the clinical trial determined by the risk assessment and monitoring plan.Quality Assurance
Helps in order to identify trends and patterns in data, report deviations and non-compliances 

Dr Caroline Watson – Research Governance Manager

Caroline.watson@ggc.scot.nhs.uk

The Governance Manager has worked within the research department for almost 20 years and manages the Governance team with the aim to ensure that there is an environment of support and regulatory compliance to ensure safety of research participants and high quality research.   

Caroline has a degree and PhD in Biochemistry and undertook a post doctoral research fellowship before joining Industry where she designed and developed a novel drug and medical devices for the market.  She has several patented technologies and the products are on the market.

As a senior manager in the NHS Caroline has in addition to managing the Governance team, a specific role in Trial Sponsorship, leading on MHRA inspections, Quality Assurance and Risk Management.


Governance has a major role in overseeing and supporting research and the manager chairs a number of governance and sponsor committees and has been responsible for setting up other Governance committees while generating the assessments and documentation required for them.   This has included risk assessments for Phase I First In Human (FIH) trials, research involving Genetically Modified organisms as well as the processes to oversee trials during the COVID-19 pandemic.  Caroline is also a key member of committees overseeing GCP for trials hosted by NHS GG&C.

The manager is also responsible for the management of non-compliances and serious breaches of GCP which arise in trials or systems supporting research.

Paul Gribbon- QA Manager  

Paul.Gribbon@ggc.scot.nhs.uk  Mobile – 07977716315

The Quality Manager within Research and Innovation is Paul Gribbon, he has been in post with R&I since August 2019. Prior to this he has worked as a Quality Assurance Manager as part of a large Quality Team within a multi-national Engineering company primarily working in the defence sector. In his previous role he has gained several years’ experience developing and implementing new processes, toolsets and systems of work. Some of this work has included the development of a Non-Conformance system and process, a new system for the management and planning of Audits as well as the management of any resulting Corrective and Preventative Actions to name a few.

Eileen McCafferty – Research Audit Facilitator

Eileen.McCafferty2@ggc.scot.nhs.uk  Mobile – 07773 203 214

Eileen McCafferty has been employed with NHS GG&C for almost 40 years. A background in ward nursing and ward management allowed further developmental opportunities out with the clinical setting. This included secondments to clinical audit then clinical effectiveness and within research as a research nurse and clinical event monitor, before taking up post as Research Audit Facilitator within R&I in 2003.  Eileen was a founder member of the NHS GG&C Clinical Research Forum, founder member and steering group member of the Scottish Research Nurse and Coordinators Network and is a current member and past co Chair of the National Academic Research Quality Assurance  group.

Dr Marc Jones- Pharmacovigilance and Safety Manager

Marc.Jones@ggc.scot.nhs.uk   Mobile – 07989 470505

The PV and Safety Manager has worked within R+I Governance since 2016. He has a degree in pharmacology and a PhD in molecular biology and biochemistry. Following an academic career in basic research focussed on molecular engineering he changed focus to work in clinical trials.  He began his clinical trials career at the Leeds Clinical Trials Research Unit in 2008. During his time at Leeds he gained a wide range of experience in all aspects of clinical trials but with a particular focus on pharmacovigilance, central monitoring, and data management. He has experience in oncology trials, biomarker discovery and validation studies, hepatology trials, clinical investigations of medical devices, and cardiovascular trials.

Dr Sheila McGowan- Lead Clinical Trial Monitor

Sheila.mcgowan2@ggc.scot.nhs.uk  Mobile – 07812733044

The Lead Clinical Trial monitor has a degree in Immunology and Pharmacology, and completed a PhD and post-doctoral in Immunology. After leaving academia to pursue clinical research she joined a commercial Clinical Research Organisation. During her time at the CRO she trained and passed their Clinical Research Foundation Programme and achieved awards in delivering quality monitoring and building relationships with sites. Following promotion to senior positions she decided to change focus and join the NHS, working at the CRUK Clinical Trials unit bringing her commercial knowledge to the role and the processes. Sheila took up the position of Lead Clinical Trial Monitor within Research and Innovation and has blended her academic and commercial background to monitoring and auditing. Over 13 years working in clinical research has allowed her to experience various opportunities and situations to learn and expand her knowledge in order to deliver and drive to achieve quality within the monitoring team and as a sponsor representative.

Clinical Trial Monitors

  • Emma Moody

Emma.Moody@ggc.scot.nhs.uk  Mobile – 07855108909

After obtaining a Nursing degree at Glasgow Caledonian University, Emma spent a number of years as a Staff Nurse however, after many years of twelve hour shifts, she decided it was time for a change. With a longstanding interest in research she applied for a Clinical Trial Coordinator position at The New Victoria Hospital, it became apparent with such a small staff ratio and over twenty oncology trials to manage, her nursing degree could be put to good use. Her role was changed to Cancer Research Nurse where she worked mainly in haematology oncology trials and her love of all things haematology grew. Emma studied for a Masters degree at Stirling University and wrote her dissertation on a chemotherapy application using a mobile phone for symptom control in haematology chemotherapy patients. Over nine years at the New Victoria has given Emma the experience and expertise of managing clinical trials at site level to take on her role as Clinical Trial Monitor.

  • Amanda Lynch

Amanda.Lynch@ggc.scot.nhs.uk Mobile  – 07811518145

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 Komninidou

Konstantina.Komninidou@ggc.scot.nhs.uk

Konstantina has a degree in Early Childhood Education with focus on developmental psychology. She followed a paedagogical career until 2017 when she decided to pursue a path in clinical research guided by a passion for facilitating improvement in outcomes for people of all ages.

She has previously worked as trial assistant for the MYRIAD trial, an RCT looking at resilience outcomes in adolescence sponsored by the Department of Psychiatry at the University of Oxford; as data coordinator for the National Perinatal Epidemiology Unit CTU in multicentre neonatal CTIMPs, and as data manager for early and late phase CTIMPs, observational, and biobank trials in the Late Phase Haematology research team at the Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust.

Konstantina joined the Research Governance team as a clinical trial monitor in December 2021 working towards ensuring the scientific and ethical integrity of trials sponsored, and hosted by the Board.

  • Emma Whitelaw – Governance Facilitator

Emma.Whitelaw@ggc.scot.nhs.uk  Mobile – TBC

Emma Whitelaw has been employed with NHS GG&C for almost 18 years. She has been in the Governance Facilitator post since October 2020. Prior to this she was part of the R&I Project Management Unit for 10 years as a Project Assistant helping run Clinical Trials from Start to Finish.

She currently supports the Governance Manager and team with

  • Administration, audit and inspections.
  • Manages and administers the Phase 1 First in Human Committee for the chair Prof Jim McCaul.
  • Administers the GHSP Regulatory Affairs Group chaired by Prof Rob Jones.
  • Administers the Sponsor Governance meetings with CRUK
  • Supports the administration of the CTIMP oversight committee

Emma also carries out some remote close out admin, file reviews and mini audits for the clinical trials monitoring  team.

Emma will help with availability of the governance team and  the person to contact for advice on documentation and process for the committees.

The Research and Innovation Service in NHS Greater Glasgow and Clyde operates to support researchers in the NHS and academia. It has multiple roles including offering consultancy and advice, providing Management Approval and aiding in the achievement of a successful conclusion to research projects.

Our goal is to release the potential to world class clinical studies across the region, and to play our part in enabling Scotland to grow as an internationally competitive location for medical research.

The 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 640 new research applications in 2024 and have approximately 1000 studies ongoing at any one time.

To ensure consistency of contact, and to help develop an in-depth understanding of therapy area-specific research projects, the NHSGGC Research and Innovation Management office has adopted a ‘portfolio-team’ structure. The portfolio teams form the functional core of Research and Innovation and are comprised of Research Co-ordinators, Research Facilitators, Co-ordinator’s Assistants and clerical support staff.

Research and Innovation Strategy

Research and Innovation Teams

Further Information and Resources

Course Dates

Monday 19th – Friday 23rd August 2024

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.

*Bank details provided on request.

Register Your Interest

To register interest, please fill out the application form

If you require any further information or have any questions regarding the course please send email to: dorothy.stobie@ggc.scot.nhs.uk 

Substance Misuse Toolkit Working Group

For information or advice regarding the content of this toolkit, quality assurance process or amendments to resources please contact the SMT working group at: 

substancemisuse.toolkit@ggc.scot.nhs.uk     

Education Establishments

Advice and Support 

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.

substancemisuse.toolkit@ggc.scot.nhs.uk     

Youth Organisations

Advice and Support

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!