Description: The “Jenny and the Bear” story book and Name the Teddy competition, are part of a co-ordinated programme which aims to increase awareness of the effects of secondhand smoke on children and what parents/carers can do to ensure their children are not exposed to its harmful effects.
The programme consists of a story being read to pupils by their class teacher, followed by a classroom activity to agree a name for the bear in the story. The teddy bear names are then entered into a competition and the winners will be awarded a teddy mascot for their class (1 class from each local authority area in GG&C). Letters are sent out to all primary schools in GG&C at the start of the school year with information on how to register for the programme.
The story of the little girl and her teddy offers the opportunity to explore the themes of secondhand smoke, a favourite toy, rewarding positive behaviours and consideration for others. In addition, all children who take part in the programme will be given a booklet version of the story to take home. It is hoped that this will support parents/carers reading to their children and raising awareness of the issues of secondhand smoke within the wider family.
Type: Lesson Plan, Online Resource, Film, Book
Target group: Early
IT/practical requirements: A video version of this story is available as a YouTube link for live streaming
Description: Togther 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 as they experience peer pressure, smoking, drugs and alcohol for the first time.
Liam’s story is about a young boy and his school ates who try to persuade him to smoke to fit in with the crowd and the consequences that follow (smoking, peer pressure, fitting in). The film lasts approximately 15 minutes and can either be watched on its own or as part of the someday series covering other substance misuse topics.
Type: Online resource, Film
Target group: Second Level
IT/practical requirements: Access to the internet required
Description: The Smokefree 4 Me programme is a health education initiative which aims to prevent smoking uptake and encourage young people to make an informed choice to stay smoke free. The Programme is open to all S1 and S2 classes across Greater Glasgow and Clyde.
Classes can take part in the programme in different ways depending on the interests and needs of the pupils as well as the amount of time available in class to undertake activities. The programme is split into five themes:
Theme 1: Health Effects of Smoking
Theme 2: Peer Influence and Decision Making
Theme 3: Smoking and the Law
Theme 4: The Tobacco Industry, Advertising and Promotion
Theme 5: Tobacco, Poverty and the Environment
Each theme has an accompanying lesson plan with background information on the topic, suggested ideas for lesson development and a topical newsletter.
Type: Lesson Plans, Online Resource, Pack
Target group: Third
IT/practical requirements: All secondary schools in Greater Glasgow and Clyde have previously received a hard copy of the pack but please follow the link below for the most recent version with up to date statistics. Some lessons may require IT access in class depending on activities chosen.
Implications for staff: No training required but CPD sessions may be available in each local authority area via your local CPD calendar.
Cost attached: No.
Resource link: Please note: this resource is currently unavailable. Smokefree 4 Me is under review by NHS GGC. A revised version will be linked here once available.
QA Tool: Please note: this resource is currently unavailable. Smokefree 4 Me is under review by NHS GGC. A revised version will be linked here once available.
Trade Winds
Topic: Tobacco
Description: Trade Winds: Learning about Tobacco is an interdisciplinary resource for primary schools and is targeted at P5-P7 pupils (second level).
The pack covers all curriculum areas and is designed to enable children to extend their learning beyond the health impacts of tobacco to a consideration of broader tobacco issues.
The pack is split into 7 topic areas:
Topic A – Setting the Scene
Topic B – History of Tobacco
Topic C – Health Effects of Smoking
Topic D – Secondhand Smoke
Topic E – Cost of Tobacco (Global and Local)
Topic F – Influences on Smoking (Media and Peer Pressure)
Topic G – Extending Children’s Learning Through the Arts
Type: Lesson Plans, Online Resource, Pack
Target group: Second
IT/practical requirements: All primary schools in Greater Glasgow and Clyde have previously received a hard copy of the pack but please follow the link below for the most recent version with up to date statistics. Some lessons may require IT access in class depending on activities chosen.
Implications for staff: No training required but CPD sessions may be available in each local authority area via your local CPD calendar.
Cost attached: No
Resource link: Please note: this resource is currently unavailable. Trade Winds is under review by NHS GGC. A revised version will be linked here once available.
QA Tool: Please note: this resource is currently unavailable. Trade Winds is under review by NHS GGC. A revised version will be linked here once available.
Tobacco-free Secondary Schools
Topic: Tobacco
Description:
By aspiring to be a smoke-free school, schools can support young people to make confident, responsible, effective decisions about their health and wellbeing. There are many different factors that lead young people to smoke and the extent to which smoking is prominent and accepted in the environment around them plays a crucial part. Consistency between what is experienced in the school environment and reinforcing smoke-free messages in the classroom is key.
The pack includes a range of practical tools and resources and is arranged into 2 parts that can be used independently or together:
Part 1 – Guide to becoming a Tobacco-free School
This guide document is intended to support a school through the steps required in order to become a tobacco free school. It explains the background, why it is important and key issues. This guide replaces the previous “Tobacco-free Schools – Helping You Achieve It” guide by Smokefree Services and Ash Scotland.
The guide breaks down the process into 10 steps – and these are laid out in a very practical way that is easy to follow. There is a suite of templates available to guide the schools through the process – these can be found in Appendix 1 and are fully editable Microsoft Word documents.
Part 2 – Tobacco-free Schools Teaching Pack
Secondary pack aligned to Curriculum for Excellence 3rd and 4th level (S1-S3) although reference is also made in the pack to the importance of continuing activity through Senior Phase, for which this material would be suitable.
There are 23 different activities over 10 topic areas. It is not necessary for all activities or topics to be used – teachers are free to “pick and mix”.
Topics covered include:
introducing tobacco
benefits of being smokefree
smoking and health
dealing with peer pressure and building confidence
e-cigarettes and vaping
smoking and mental health
smoking and physical activity
money money money
towards a Smokefree Scotland
cigarettes, plastic and the environment
Type: Lesson Plan(s), Online Resource
Target group: Third, Fourth, Senior phase
IT/practical requirements:
Quit Your Way Smokefree Schools have 1 printed copy of the resource for every secondary school in Greater Glasgow & Clyde. To request your free copy please email: Quityourway.smokefreeschools@ggc.scot.nhs.uk
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
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.
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.
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.
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
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.
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.
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.
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
The West of Scotland Research Ethics Service forms part of the UK wide NHS research ethics service (https://www.hra.nhs.uk/) and applications can be reviewed from across the UK. Applicants are free to apply to any suitably flagged REC in the UK although a local REC is advised. The applicant should book a slot that they are able to attend. The meetings are generally held remotely and instructions for joining the meeting are sent out ahead of time.
The central West of Scotland office is manned by four Research Ethics Committee Managers and Assistants who cover the four West of Scotland Research Ethics Committees.
NHS RECs safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. NHS RECs are entirely independent of research sponsors (that is, the organisations funding and hosting the research) and investigators. This enables them to put participants at the centre of their research. Each year, NHS RECs review around 6,000 research applications. On average, they give an opinion in less than 30 days: well within the maximum allowance of 60 days. Proportionate Review studies are reviewed within a maximum of 21 days.
REC Membership
Each Research Ethics Committee (REC) consists of between seven and 18 volunteer members. At least one-third of the members must be ‘lay’. Lay members are people whose main personal or professional interest is not in a medical research area. The remainder of the committee are expert members, who are specialists including doctors, other healthcare professionals and academics. Membership also includes a category known as ‘lay plus’. This category excludes anyone who has been involved in clinical research other than as a participant. REC members often have the sort of experience which will be useful in scrutinising the ethical aspects of a research proposal. For example, they might be patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background.
Interested in becoming a member of an NHS REC?
Please get in touch with us and we can send you further details and let you know of any local vacancies available. All NHS RECs are established by the UK Health Departments for the purpose of reviewing research applications that fall within our remit as set out in GAfREC.
Different types of REC
There are two main types of RECs:
Recognised RECs
These are recognised by the United Kingdom Ethics Committee Authority (UKECA) for the review of clinical trials of investigational medicinal products (CTIMPs), in accordance with The Medicines for Human Use (Clinical Trials) Regulations.
Authorised RECs
Established under GAfREC but not recognised by UKECA. Authorised RECs can review most research that is not a CTIMP.
In the West of Scotland we have one Recognised REC and three Authorised RECs
Information for applicants
Information to help you define if your research project requires review by a Research Ethics Committee can be found here
Research Application Submission
All researchers wishing to undertake a piece of research within the NHS are required to complete an IRAS form. All guidance and information is contained within the site to allow completion of the IRAS form.
Once you have uploaded all of the study documentation the REC Manager will check and validate the submission. The REC Manager will then issue a validation letter indicating the date and time of the Ethics Meeting and inviting the investigator to attend. The dates and times of all ethics meetings can be found here: https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/
After the meeting the investigator will receive a letter within 10 working days stating the outcome which will be one of four possible decisions:
Final opinion – favourable or unfavourable
Provisional opinion – with request for further information, clarification or revision
No opinion – gone to referee for consultation before opinion given
The national ethics service allows 60 days from the submission of the application to final opinion. Clear guidance is given within the IRAS website for researchers who wish to make an amendment to their application after approval or add extra sites.
Contacts and committee details
Contacts and committee details (dates can vary due to public holidays always check on HRA website)
Committee Details
Meets
Contacts
West of Scotland Research EthicsCommittee 1 WoSREC 1 Recognised Type III Flags: CTIMPs Paediatrics Phase I Patients
Any queries regarding the service or whether an application requires ethical review should be directed to the Scientific Officer / Ethics Manager – Dr Judith Godden
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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.
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.
Useful Links
Please click on the relevant box below to directly access the information.
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.
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.
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
Training is provided in various locations.
Please select the preferred date and venue below to complete the registration form
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.
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.
Click HERE for further informative videos within 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.
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.
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.
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.
We wanted to inform you that all Scottish recruitment data relating to your study/studies from the 1st April 2019 onwards is now visible on the UK Central Portfolio Management System (CPMS).
The benefit of reviewing your Scottish recruitment data within CPMS is for you to be able to confirm your local site data as accurate or not accurate and provide you with the benefits of tracking your recruitment data at all sites across the UK. This will also help provide NHS Research Scotland and the Chief Scientist Office with accurate recruitment data for Scotland.
What is CPMS?
CPMS is a UK platform which collates local study site recruitment information from local portfolio management systems (LPMS). Since the 1st April 2019 our Scottish R&D offices have been collating recruitment information from your local study teams across Scotland and uploading this to our LPMS. We have now established links between our LPMS and CPMS which means you will be able to login, track and view all Scottish recruitment data to your study at each site since the 1st April 2019. You are kindly requested to confirm if this data is accurate or not accurate using the below attached guides. England, Northern Ireland and Wales have already been live with their recruitment data in CPMS since 1st April 2019.
My study has sites only in Scotland
To reduce the burden of confirming a backlog of recruitment since the 1st April 2019, the Chief Scientist Office has agreed for the NIHR to automatically confirm recruitment data on CPMS for your study during the FY 19/20. Any studies which recruited from the 1st April 2020 we would like to request that you access CPMS and confirm recruitment from this date onward on a monthly basis. You can do this using the attached guides.
Recruitment data for your study will continue to upload into CPMS (including zeros for months where a site did not recruit) and we would request that you access, review and confirm or reject the data on a monthly basis as long as your study is open to recruitment. Once your study halts recruitment please inform your lead R&D office so that they can update the study records.
My study has sites in other UK Nations as well as Scotland
If your study has sites in other nations you will be requested to also confirm recruitment from sites in other nations as well as recruitment from Scotland, if you are not already doing so.
To reduce the burden of confirming a backlog of recruitment since the 1st April 2019, the Chief Scientist Office and Health and Care Research Wales have allowed portions of recruitment data to be automatically confirmed. Scottish and Welsh recruitment data for FY 19/20 will be automatically confirmed on your behalf. If you have sites in England you will be asked to complete the backlog of recruitment from 1st April 2019 or when your study opened if this is later.
Recruitment data for your study will continue to upload into CPMS (including zeros for months where a site did not recruit) and we would request that you access, review and confirm or reject the data on a monthly basis as long as your study is open to recruitment. Once your study halts recruitment please inform your lead R&D office so that they can update the study records.
Training and Help
Individuals who can confirm recruitment must be associated with your CPMS study record. Those individuals who are copied in on this email all have associations with the CPMS record to confirm recruitment. If you wish to add another member of your team to perform this function you must contact your local R&D office and inform them that you require a name added to the CPMS record. You can access your study record here https://cpms.nihr.ac.uk/ and use the email which has been used to contact you in this email to login. Attached is also guidance to help you login.
Attached are a quick start guide which provides an overview of how to confirm recruitment and the full Research Activity Confirmation Guidance which provides more detailed information to help you navigate the confirmation process including help on viewing your recruitment and explanations of the differences between nations where they exist.
There are short videos and guidance which can be found by logging into NIHR learn using your CPMS login details.
************************ Many of the R&I team are working remote from our core offices – please use email or Teams as primary method of contact*************************
In order to gain R&I approval as quickly as possible, we advise that you submit to R&I in parallel with your ethics submission. This will allow us to look at your application and progress while under review by the REC.
In order to define the appropriate contact in the R&I Office for your study, please find contact details for your portfolio team here.
Quality is about making an organisation perform for all of their stakeholders, from improving products, services, systems and processes, to making sure that the whole organisation is fit and effective. Quality Management is a never ending pursuit of excellence, striving to ensure all Clinical Trials, Research Studies and Systems within GG&C are not only fit for purpose, but keep improving.
The expected level of Quality for Research and Innovation is that which has been set by all of our Stakeholders as well as external Standards, from Sponsor Staff to Trial Teams, Suppliers to Patients, along with any and all applicable regulatory bodies. It is the responsibility of all staff to strive to meet this level and meet all of the applicable Standards which must be worked to (GCP, UK Policy Framework for Health and Social Care Research, etc). It is the responsibility of the Quality Team to assist everyone in meeting these standards.
The Quality System within Research and Innovation is the vehicle by which this is achieved, a set of controlled procedures are in place and under constant review for improvement and to assure compliance. The Quality Team have a number of activities and areas of influence to ensure this system is working effectively and maintained.
The two main areas of interest for the work of the Quality Team falls in to two main Categories, Quality Assurance(QA) and Quality Control(QC).
Quality Assurance is the “big picture” of Quality and looks to how Quality is baked in to our processes and activities, this is the consideration of how what we do will result in a Quality outcome. Quality Assurance is a proactive approach to achieving quality and is the consideration of what can be achieved before a task is performed, this involves an assessment of the fitness for purpose of a process. For example, QA is the review of the process defining how data is entered or transferred.
Quality Control is then a consideration of the fine detail, this looks at the output of an activity to ensure it meets the required standards, this level of activity is not solely the responsibility of the Quality Team but of all staff involved. Quality Control is the reactive element of Quality, it is the process of checking a completed activity to ensure it is compliant with set processes. For example, QC is the process of confirming that data entered or transferred is correct.
This is a symbiotic relationship and the Quality Control activity will feed in to the Quality Assurance, when an issue is identified through QC, QA will seek to prevent the issue from reoccurring.
The Quality Team are responsible for a number of important activities, a non-exhaustive list of some examples are:
Management of SOPs
Standard Operating Procedures (SOPs) form the backbone of the Quality Management System for R&I, as such their management is vital to ensure efficient, controlled and uniform conduct across all trials. It is the remit of the Quality Department to ensure all SOPs are constructed in accordance to a controlled format, routinely maintained, readily available and appropriately distributed.
This activity involves interaction with every individual who is involved with the content of SOPs, both in their design and in following the content. The quality department engages with owners of the SOPs during regular review periods, to review content and suggest improvements, to distribute to all designated stakeholders and gather evidence of training, compliance and instances of deviation from SOPs as well as identifying gaps in the existing suite of SOPs where new procedures are required. This is an ongoing cycle and feeds in to the continuous development of the department.
Vendor Assessments
For NHSGGC Sponsored or Co-Sponsored CTIMPs that requires an external service, a vendor assessment will be required. Examples include, but not limited to:
Commercial and academic laboratories out with NHSGGC
Bio-repositories
Statistical services
Data management services
Safe Havens
Archiving facilities
IMP manufacturers
In the instance that services are required from an external provider, it is imperative that the provider has been adequately vetted to ensure they can meet the needs of the trial. To this end, the Vendor Assessment process is utilised to ensure that all Vendors used within GG&C trials are capable of what is required of them.
The assessment is based on technical criteria relevant to the facility, in addition to evidence key Sponsor governance requirements such as:
The Quality Department are responsible for conducting Audits across studies and trials within Research and Innovation. This can cover a wide range of different activities, looking at studies and trials and their activities as well as procedures within the Research and Innovation department itself. Audits are a mandatory requirement within Good Clinical Practice and defined as:
“A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”
The Quality Department provide audits as a service which is delivered to other Departments and trial teams. As such, the audits are intended not only to ensure compliance to processes and protocols but to assist those being audited by identifying and removing issues, not only within the area of focus but with associated processes. If improvements can be made to remove waste and streamline activities, Audit is the key mechanism by which this can be achieved. When issues are identified, they can be removed. The audit team will always seek to engage fully with auditees and to form a consensus as those being audited will usually be the subject matter experts. An audit is an opportunity to improve and to influence processes.
It is important to have an accurate understanding of what an audit is, its intended purpose and also what activity takes place that is not considered and audit, generally speaking the separation between Audits, Monitoring, Quality Checks and Inspections are:
What is an Audit?
An Audit is a systematic, documented and independent review of any trial, study or process
An Audit will provide a “snapshot” of a moment in time and confirm “if you are doing what you say/think you are doing”
An Audit is part of sponsor Quality Assurance and feeds into quality systems
What is not an Audit?
Monitoring is a continuous and systematic process throughout the lifetime of the trial conducted by clinical trial monitors not independent of the trial who have not been involved in completing the activity.
Inspections are Independent regulators verifying study data whose primary interest is the protection of the public, e. Medicines and Healthcare products Regulatory Agency (MHRA), Human Tissues Authority (HTA).
Quality Checks are a continuous and systematic process throughout the lifetime of the trial conducted by clinical trial monitors not independent of the trial who have been involved in completing the activity.
Beyond this, the separation between audit activity, Research and Service Evaluation is defined in the following table:
Audit/ Quality Improvement
Research
Service Evaluation
Designed and conducted to produce information to inform delivery of best care
The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.
Designed and conducted solely to define or judge current care.
Designed to answer the question: Does this service reach a predetermined standard?’
Quantitative research – designed to test a hypothesis. Qualitative research – identifies/explores themes following established methodology.
Designed to answer: “What standard does this service achieve or is it complying with best practice?”
Measures against a standard.
Addresses clearly defined questions, aims and objectives.
Measures current service without reference to a standard or best practice.
Involves an intervention in use only (the choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference).
Quantitative research – may involve evaluating or comparing interventions, particularly new ones. Qualitative research – usually involves studying how interventions and relationships are experienced.
Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, standards, best-practice and/or patient preference.
Usually involves analysis of existing data, but may include administration of simple interview or questionnaire
Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care.
Usually involves analysis of existing data but may include administration of interview or questionnaire.
No allocation to Intervention groups: the health professional and patient have chosen intervention before quality improvement.
Quantitative research – study design may involve allocating patients to intervention groups. Qualitative research – uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications.
No allocation to intervention: the health professional and patient have chosen intervention before conducting quality improvement.
For further guidance on and definitions to establish if your project is clinical audit, post market surveillance, service evaluation or research, please refer to:
A large number of the trials Sponsored by Greater Glasgow & Clyde are classed as non Clinical Trial of an Investigational Medicinal Product (non CTIMP), in this instance the Quality Department provides regular training sessions to support the Trial Teams in setting up and maintaining their site file. This is viewed as a preventative measure for Research and Innovation to ensure Trial Teams for Non CTIMPs are adequately trained and able to follow the required SOPs to produce the site file, this will ensure common issues which have been identified through Monitoring and Auditing activity are discussed with Trial Teams to avoid occurrence in future trials. This training session is also a useful opportunity for trial teams to ask for study specific advice on how to navigate study conduct and management at site from set up to close out.
Training Sessions are convened on a regular basis and the list of attendees is generated using standard extracts from the research database and asked to attend by a member of the Governance Team. The sessions are small, informal and friendly, giving researchers a chance to network with their peers, identify study related issues and challenges and participate in group discussions.
The sessions are aimed at individuals employed by NHS GG&C only, who are new to research within the study team; researchers who are Chief Investigator for the first time, or Investigators new to NHS GG&C Sponsored research. Ideally, attendance should be prior to study recruitment. A sample site file index and supporting documentation is also provided prior to the training and study start up, which will be used as the basis for the session.
These sessions cover applicable regulatory frameworks; applications of Good Clinical Practice (GCP); good documentation practice and how each section of the site file index relates to the research. In addition, processes that may also apply to the research are covered, i.e. amendments, study non compliances. Common research audit findings are also discussed as exemplars of study non compliances and strategies discussed on how to avoid them.
Guidance, applicable legislation, responsibilities and principles of good clinical practice for researchers and research teams can be found here:
Develop and Maintain the processes within Quality Management Tool (Q-Pulse)
A standard toolset is utilised by Research and Innovation for a number of activities, the aim of which is to allow these activities to be controlled in a uniform and predictable way to make the access and sharing of information easier for all those involved.
Q-Pulse is a Quality Management System for the control of Audits, Corrective and Preventative Action (CAPAs), Documents, Incident & Occurrences, People and Training. It utilises a number of modules which can be tailored for the specific requirements of all the processes within R&I. The Quality Department are responsible for developing and managing the content of Q-Pulse and generating reports to informing others of what actions are required and when.
Introduction
Pharmacovigilance (PV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
PV is a regulatory requirement for any clinical trial of an investigational medicinal product (IMP) whether the trial is a first in man study of a novel drug or a study investigating how a well understood licensed drug performs in a real world setting.
In addition there are other types of study where vigilance processes are required for example:
Safety reporting is also a regulatory requirement for all clinical investigations of medical devices. Where a non CE marked device (or a CE marked device is used outside of its intended purpose) is used within an investigation there is a requirement to carry out vigilance.
Safety reporting is required within all studies involving human participants; even those that do not involve the use of drugs. Where an intervention or trial specific procedure takes place is important to ensure that the safety of the study in monitored.
About us
The Sponsor Pharmacovigilance Office is part of the Research and Innovation governance team. The Pharmacovigilance and Safety Manager is based within NHS GG&C while PV administration and systems are provided by the Robertson Centre for Biostatistics at the University of Glasgow.
We provide support to researchers from the grant stage of a study, to protocol development, identifying and managing risk from an IMP perspective, overseeing the collection and review of safety data, the processing and administration of Serious Adverse events, monitoring safety data for unexpected events, coding of events, and the preparation of Developmental Safety Update Reports. We ensure that all trials are compliant with the relevant regulatory frameworks on behalf of the lead investigator and Sponsor. The PV office has experience in oncology, cardiovascular, stroke, and many other fields of healthcare.
A risk adapted approach to pharmacovigilance and safety reporting is used to ensure that trials are conducted safely and efficiently while reducing the workload for both sites and investigators where possible.
The Sponsor PV office can help investigators for all studies, not just those involving drugs. We have experience of clinical investigations of medical devices, interventional studies, biomarker studies, and all other forms of healthcare research involving human subjects. We can help you at to assess the level of safety reporting required and aid in the preparation of study protocols. Please get in touch with the PV and Safety Manager should you wish to discuss any aspects of safety reporting.
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