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Substance Misuse PSE Curriculum Pack

Topic: Substance Misuse: drugs (including NPS), alcohol and tobacco

Description: 

Provides teachers with suggested lessons and resources to support delivery of substance misuse lessons as part of the PSE curriculum in Secondary Schools.  Learners will develop their understanding of the use and misuse of a variety of substances including over the counter and prescribed medicines, alcohol, drugs, tobacco, solvents and new psycho active substances.  They will explore and develop their understanding of the impact of risk taking behaviour on their life choices.  Learners are enabled to make informed personal choices with the aim of promoting healthy lifestyles.

S1 Module

  • Lesson 1 – What is a drug
  • Lesson 2 – Sophie’s Story (Alcohol)
  • Lesson 3 – Peer Pressure
  • Lesson 4 – Understanding the school’s policy on drugs

S2 Module

  • Lesson 1 – Drug names and effects
  • Lesson 2 – Drugs and the law
  • Lesson 3 – So what do you think you know about alcohol?
  • Lesson 4 – Why do people use drugs?

S3 Module

  • Lesson 1 – What’s in a unit?
  • Lesson 2 – Helping other people
  • Lesson 3 – Smoking: attitudes, myths and facts
  • Lesson 4 – Choices (NPS)

S4 Module

  • Lesson 1 – Cannabis: the facts
  • Lesson 2 – Risky situations
  • Lesson 3 – Keeping safe – emergency action
  • Lesson 4 – Social implications of substance misuse

S5 Module

  • Lesson 1 – Alcohol and advertising
  • Lesson 2 – Trouble in town
  • Lesson 3 – Alcohol & Drugs, what do you think?
  • Lesson 4 – Scott’s Story (cannabis)

Type: Lesson Plan(s), Online Resource, Film

Target group: Third; Fourth; Senior phase.

IT/practical requirements: None

Implications for staff: None

Resource link: Substance Misuse PSE Curriculum Pack (zip files)

Cost attached: No

QA Tool: PSE Curriculum Pack QA Tool

Alternative resource links (no zip files):

Substance Misuse Primary Education Lesson Plans

Topic: Alcohol Drugs & Tobacco.

Description: The Substance Misuse Education Working Group have created new lesson plans (Early, First and Second Level) which are based on the Substance Misuse Education Resource Pack developed by Educational Services and NHS staff from West Dunbartonshire. A range of activities are provided which include interactive quizzes, paired working and individual learning. Some lesson plans have follow-up activities to further develop children’s learning on the topic. Home activity exercises have been included in some lessons to reinforce learning and promote discussion between parents/carers and their children. Additional lessons will continue to be developed by the Substance Misuse Education Working group in order to create a framework for substance misuse education.

 Early levelP1 lesson 1 – People who help meP1 lesson 2 – Unsafe situations and emergenciesFirst levelP2 lesson 2 – Decision makingP3 lesson 2 – RisksP3 lesson 3 – Decisions, Decisions!P4 lesson 1 – ConsequencesP4 lesson 2 – Peer pressureP4 lesson 3 – MedicinesP4 lesson 4 – What to do in an emergencySecond levelP5 lesson 1 – What are substances part 1: alcohol and tobaccoP5 lesson 2 – What are substances part 2: drugs and solventsP5 lesson 3 – Consequences – Risks and effectsP5 lesson 4 – Doing the right thingP6 lesson 1 – What are drugs part 1: legal drugsP6 lesson 2 – What are drugs part 2: illegal drugsP6 lesson 3 – RisksP7 lesson 1 – Consequences: drugs and the lawP7 lesson 2 – ResponsibilitiesP7 lesson 3 – Antisocial behaviour and substance misuse

Type: Lesson plans, online resource

Target group: Early; First; Second. 

IT/practical requirements: Access to PC and internet required for some lessons.

Implications for staff: None.

Cost attached: No.

Resource link: Substance Misuse Primary Education Lesson Plans (zip files)

QA Tool: Primary Education Lesson Plans QA Tool

As it is

Topic: Alcohol; Drugs.

Description: The AS IT IS DVD is a resource that tackles the issues of gang fighting, territorialism, offending behaviour and substance misuse. The DVD was produced by a partnership of statutory and voluntary agencies based in Glasgow. Accompanying pack was developed by Glasgow Council on Alcohol.  DVD includes interviews with real people and graphic imagery which some people may find disturbing. The resource challenges entrenched thinking by showing how choices made by gang members have impacted in their own and other people’s lives.  Police Scotland advise that the resource is an early intervention toolkit and can be used with P7, S1 & S2 pupils.  This resource will generate discussion and provoke different thinking with all age groups.  It is recommended that parental consent should be obtained if this resource is to be used with persons under the age of 16. It is strongly recommended that staff view the films and teaching aids prior to use.  If additional hard copies are required please contact Inspector Stevie Kinvig, Police Scotland.

Type: Pack.

Target group: Second; Third; Fourth.

IT/practical requirements: Access to DVD Player/PC & Projector to allow DVD to be played.

Implications for staff: The nature of this resource means that staff should review prior to use, young people may have experienced gang fighting & consequences & as a result may require support during and after use of the resource. DVD contains graphic scenes of violence.

Cost attached: No.

Resource link: TBC

QA Tool:

Buzzin

Topic: Drugs.

Description:  Buzzin explores the impact of solvent abuse on the lives of young people living in the fictional town of Duncastle through the use of  a DVD and lesson plans. The resource aims to raise awareness of dangers and effects of volatile substance abuse.

Type: Online resource.

Target group: Third. 

IT/practical requirements: Internet required to download pack and film.

Implications for staff: Pack has a teachers guide included.

Cost attached: No.

Resource link:  http://www.re-solv.org/education-prevention/

QA Tool: Buzzin QA Tool

Drugs Awareness

Topic: Alcohol; Drugs.

Description:  Drug Awareness is an interactive intervention to introduce the risks and effects of legal and illegal drugs with an alcohol and drugs harm reduction focus. The aim is to raise knowledge and awareness of different legal and illegal drugs and highlight the physical, social and emotional effects of drug use/misuse at a secondary school level and ensure pupils have an understanding of the negative consequences of taking drugs. This intervention uses methods that are interactive, current, and engaging for the young people enabling them to discover information and guidance on drugs.

Type: Lesson plan.

Target group: Third.

IT/practical requirements: List of resources required indicated in facilitator’s notes.

Implications for staff: This resource is normally delivered by GCA in schools.

Cost attached: No.

Resource link: Drugs Awareness (zip)   email@glasgowcouncilonalcohol.org

QA Tool:

Choices For Life: Choices (NPS)

The Choices resource was produced prior to the 2016 Psychoactive Substances Act and shows a young person buying NPS from a shop.  This, however, may be a useful discussion point to demystify any beliefs still held that you can legally purchase NPS from a shop or on-line. This does not detract from the wider learning in the film in relation to risky behaviours and substance misuse in general.

Topic: Drugs (New Psychoactive Substances)

Description: The film focuses on Ben as he is faced with a variety of choices around the topic of New Psychoactive Substances (NPS). This is an interactive video drama where learners get to make the choices for Ben and see the consequences. There are a variety of choices that can be selected.  

Type: Online resource, Lesson Plan, Film

Target group: Fourth level, Senior Phase

IT/practical requirements: Access to the internet required 

Implications for staff: None

Cost attached: None

Resource link: 

QA Tool: Choices QA Tool

Sun, sea and safety

Topic: Alcohol; Drugs

Description:  *Resource linked to Fourth Level E’s and O’s, however use is recommended with Senior Phase students* Sun, Sea and Safety is an interactive intervention to increase knowledge of the impact of alcohol on safety whilst abroad taking a harm reduction focus. The aim is to reduce the negative impact of alcohol use/ misuse while abroad and raise awareness of different risky situations and consequences. This intervention uses methods that are interactive, current, age appropriate and engaging for the young people enabling them to discover information and guidance on alcohol.

Type: Lesson plan.

Target group: Senior phase.

IT/practical requirements: List of resources required indicated in facilitator’s notes.

Implications for staff: This resource is normally delivered by GCA in schools.

Resource download link: Sun Sea Safety (zip)   http://www.glasgowcouncilonalcohol.org/contact/

Cost attached: No.

QA Tool: 

Take a Drink

Topic: Alcohol; Drugs

Description: Drama performed by PACE Theatre Company highlighting the dangers of risk taking behaviour to young people, for example, the consequences/situations facing young people under the influence of alcohol and or drugs. The drama follows three characters who attend a party and all have very different experiences due to their excessive alcohol consumption. Follow up workshops are delivered by Glasgow Council on Alcohol to allow discussion about issues raised in the play.  This play is commissioned by NHS GG&C for all Glasgow Secondary Schools at present.  If you are interested in running a similiar project outwith the Glasgow area please contact PACE Theatre Company directly.  Take A Drink 2012 Evaluation Report available on request.

Type: Performance/Drama

Target group: Third; Fourth; Senior phase. 

IT/practical requirements:  Stage area required or large hall depending on audience size. Drama company provide all required equipment including sound equipment.

Implications for staff:  None.

Resource link: http://www.pacetheatre.com

Cost attached: No.

QA Tool:

The Drugs Wheel

Topic: Drugs

Description:  Drugs wheel resource contains up to date names and categories for illegal drugs, new psychoactive substances (drugs formally known as legal highs), solvents and prescription drugs used recreationally.  Can be used to raise awareness during class discussion and the Drugs Wheel game supports young people to work as a group to categorise the drugs.  Could complement a lesson on the effects of drugs. 

Type: Online resource.

Target group: Third; Fourth; Senior phase

IT/practical requirements:  All resources are available for download via the website.  Powerpoint version also available for use on Smart Board.

Implications for staff: None.

Cost attached: No.

Resource link: The Drugs Wheel

QA Tool: QA Tool Drugs – The Drugs Wheel

Young Booze Busters Website

Topic: Alcohol; Drugs; Tobacco.

Description:  Interactive, incentive based information on alcohol, tobacco and other drugs.  This online resource contains information for young people and parents/carers as well as video clips, games, competitions and a link to Becky Booze Buster. Provides information on alcohol.  Additonal information on drugs and tobacco has recently been added.

Type: Online interactive resource.

Target group: Third; Fourth.

IT/practical requirements:  Computer with internet access.  You Tube access required to watch videos.  Link to Becky Booze Busters is via Facebook or email.

Implications for staff: None.

Cost attached: No.

Resource link: http://www.geaap.org     Young Booze Busters

QA Tool: 

Choices For Life Film: Scott’s Story (Drugs-Cannabis)

Topic: Drugs (Cannabis)

Description:  Together with PACE Theatre, Choices for Life have produced a series of dramas “Someday” which are all interlinked. They tell the story of Liam, Sophie and Scott are they experience peer pressure, smoking, drugs and alcohol for the first time and must face the consequences that lead from it. 

Scott’s story is about a young adult who decides to use cannabis to help him cope with stress. The film shows how this choice impacts his life. Explores many of the consequences of cannabis: its effects on relationships, motivation, school work, reliability and drug driving.  The film lasts approximately 15 minutes and can either be watched on its own or as part of the Someday series covering related themes. 

Type: Online resource, Film

Target group: Third Level, Fourth Level, Senior Phase

IT/practical requirements: Access to the internet required 

Implications for staff: None

Cost attached: None

Resource link: 

QA Tool: Scott’s Story QA Tool

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

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

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

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

The role of RECs

The Role of NHS Research Ethics Committees (RECs)

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

REC Membership

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

Interested in becoming a member of an NHS REC?

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

Different types of REC

There are two main types of RECs:

Recognised RECs

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

Authorised RECs

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

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

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

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

 Information for applicants

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

Research Application Submission

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

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

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

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

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

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

Contacts and committee details

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

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

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

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March 2022

Update from Non Medical Prescribing team

Wound management: Discontinuation of  AQUACEL® Ag and AQUACEL® Ag Extra™ dressings and replacement with Aquacel Ag +

In theory no action should be required since previous notification of this has been sent out. However we do continue to note prescribing activity with old non formulary dressing titles prescribed.

 Wound Formulary

Prescribing implications (apart from loss of rebates)

  • “Ordinary” Aquacel flat dressings (not ribbon) are discontinued and Aquacel Extra is the only one available. This information has previously been circulated and should be widely known. We do see this starting to be reflected in prism data.
  • Aquacel Ag as noted is being discontinued and the only range will be formulary Aquacel Ag+ Extra.
  • Over this year as transition takes place clinicians should try not to inadvertently miss out the all-important “+” sign for silver products!  If not prescribed accurately (attached) this could result in the pharmacists contacting NMP to inform them the product has been discontinued and asking for an alternative. This will may cause confusion and risk delays in patients commencing treatment.
  • FYI the “extra” part accounts for greater absorbency potential and sequestering proteases – whereas the  “+” sign for Ag range denotes surfactant has been included.

Please click on the relevant box below to directly access the information.

Prescribing Support

In each of the localities within Glasgow City HSCP, there are support groups available to community nurses who hold the V100, V150 or V300 prescribing qualifications.  Please see the main contact below for each location and feel free to email them to ask for dates and times of meetings you will be able to link in to for support and guidance.

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What to do if you are concerned someone is at risk?

If you are worried that you or someone you know is being harmed, is suffering from neglect, or is being abused, it is important to tell someone. Your report will be treated in confidence. Everyone has a right to be safe.

Make sure they are safe – If immediate help is required phone 999.

During office hours, you can contact Social Care Direct by phone (0141 287 0555) or email socialcaredirect@glasgow.gov.uk.

Outwith office hours you can phone Glasgow and Partners Emergency Social Work Services on 0300 343 1505.

  • For Glasgow City please call 0300 343 1505
  • For Eastwood please call 0141 451 0866
  • For Barrhead please call 0141 800 7850 
  • For East Dumbartonshire please call 0300 343 1505

You can also phone Scottish Police non-emergency on 101.

You can also speak to a health professional (for example your doctor or a health visitor) or the police. They will take your concerns seriously.

If you know or suspect that an adult is being harmed then you need to report your concerns. Don’t assume that someone else has already reported it. The person being harmed or neglected may not be able to report it themselves. Remember, the person who did this may be doing it to others too.

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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