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NIHR BRC Imaging Network Meeting Abstract Advert

Description: NIHR BRC Imaging Network Meeting – Abstract deadline extended to 19th January National Institute for Health and Care Research (NIHR) Biomedical Research
Url: /Media/Southampton-Clinical-Research/Downloads/NIHR-BRC-Imaging-Network-Meeting-Abstract-Advert.pdf

Lay Abstract Help Sheet (2024)

Description: TOP TIPS FOR WRITING A LAY SUMMARY A lay summary should provide an overview of your research that uses clear, plain language to communicate to a non-specialist audience. Lay summaries can make your findings accessible to a wider audience and broaden the impact of your research. KNOW YOUR AUDIENCE People who read your summary will be interested in your research but are not necessarily specialists. For example, imagine pitching your summary to: • a policy steering committee/MP • a family member over a family get-together • A-level students at a career day. Remember, your summary should get your message across with minimum effort from the reader. TELL THE STORY What do you need to say? Outline your summary by answering: Who, What, Where, When, Why, and How? How will you say it? • Avoid technical jargon and uncommon abbreviations unless absolutely necessary – if you have to use them provide a clear explanation. • Avoid scientific symbols and notations (e.g. ‘<’, ‘Σ’) – not everyone will know what they mean. • Use the first person and active voice. For example, say ‘we will look at how cells change’ rather than ‘how cells change will be looked at’. • Use positive, and not negative sentences. For example, say ‘We plan to repeat the tests once’, rather than ‘We do not plan to repeat tests more than once’. • Use person-centred language, rather than focusing on circumstance, illness, or disability. For example: ‘people with a disability/illness’ is preferable to ‘the disabled/invalids’; a person ‘has cerebral palsy’ rather than ‘is a victim of cerebral palsy’. • Use analogies to explain complex ideas – but remember to keep them relatable, e.g. link to an everyday activity. • Avoid complicated English or uncommon words. Examples include archaic language (e.g. amidst, whilst), and verb choices such as ‘conducted’ used in place of the simpler ‘done’. 1 • Have a title that is short, clear, relevant, and reader friendly. It is your first chance to catch the reader’s attention. What’s the bigger picture? • Cover the ‘so what?’ factor. Put your research into context for the reader – state the potential non-academic impact and benefits to society. For example, state how many people suffer from condition x, or ‘We spend £xx million on xx drugs’. • Include a ‘summary within a summary’: one final sentence which explains what the key findings are and why they are important. MAKE IT AN EASY READ • Keep your sentence length to an average of 20 words. • Try to stick to one main idea in a sentence, and avoid complicated sentence structure (e.g. lots of semicolons). • Check your summary for readability using software tools: o Hemingway Editor App o The Writer readability checker GET FEEDBACK • Read the summary aloud to yourself – this can help you check if there’s a logical flow of ideas. • Ask a non-scientist to read your summary to see if they understand it. STICK TO THE WORD LIMIT Keep within the 150 word limit as indicated in the conference abstract submission guideline. Adapted from: https://www.wiley.com/network/societyleaders/research-impact/how-towrite-a-lay-summary-for-your-research 2
Url: /Media/Southampton-Clinical-Research/Downloads/Lay-Abstract-Help-Sheet-2024.pdf

Lay Abstract Help Sheet (2024)

Description: TOP TIPS FOR WRITING A LAY SUMMARY A lay summary should provide an overview of your research that uses clear, plain language to communicate to a non-specialist audience. Lay summaries can make your findings accessible to a wider audience and broaden the impact of your research. KNOW YOUR AUDIENCE People who read your summary will be interested in your research but are not necessarily specialists. For example, imagine pitching your summary to: * a policy steering committee/MP * a family member over a family get-together * A-level students at a career day. Remember, your summary should get your message across with minimum effort from the reader. TELL THE STORY What do you need to say? Outline your summary by answering: Who, What, Where, When, Why, and How? How will you say it? * Avoid technical jargon and uncommon abbreviations unless absolutely necessary – if you have to use them provide a clear explanation. * Avoid scientific symbols and notations (e.g. ‘<’, ‘Σ’) – not everyone will know what they mean. * Use the first person and active voice. For example, say ‘we will look at how cells change’ rather than ‘how cells change will be looked at’. * Use positive, and not negative sentences. For example, say ‘We plan to repeat the tests once’, rather than ‘We do not plan to repeat tests more than once’. * Use person-centred language, rather than focusing on circumstance, illness, or disability. For example: ‘people with a disability/illness’ is preferable to ‘the disabled/invalids’; a person ‘has cerebral palsy’ rather than ‘is a victim of cerebral palsy’. * Use analogies to explain complex ideas – but remember to keep them relatable, e.g. link to an everyday activity. * Avoid complicated English or uncommon words. Examples include archaic language (e.g. amidst, whilst), and verb choices such as ‘conducted’ used in place of the simpler ‘done’. 1 * Have a title that is short, clear, relevant, and reader friendly. It is your first chance to catch the reader’s attention. What’s the bigger picture? * Cover the ‘so what?’ factor. Put your research into context for the reader – state the potential non-academic impact and benefits to society. For example, state how many people suffer from condition x, or ‘We spend £xx million on xx drugs’. * Include a ‘summary within a summary’: one final sentence which explains what the key findings are and why they are important. MAKE IT AN EASY READ * Keep your sentence length to an average of 20 words. * Try to stick to one main idea in a sentence, and avoid complicated sentence structure (e.g. lots of semicolons). * Check your summary for readability using software tools: * Hemingway Editor App * The Writer readability checker GET FEEDBACK * Read the summary aloud to yourself – this can help you check if there’s a logical flow of ideas. * Ask a non-scientist to read your summary to see if they understand it. STICK TO THE WORD LIMIT Keep within the 150 word limit as indicated in the conference abstract submission guideline. Adapted from: https://www.wiley.com/network/societyleaders/research-impact/how-to- write-a-lay-summary-for-your-research 1
Url: /Media/Southampton-Clinical-Research/Downloads/Lay-Abstract-Help-Sheet-2024.docx

The Hospital Communication book

Description: The Hospital Communication Book Helping to make sure people who have difficulties understanding and /or communicating get an equal service in hospital Talking clearly Using Signing Visual Impairment Hearing loss Developed on behalf of The Learning Disability Partnership Board in Surrey Using Pictures and Symbols Introduction and Contents This communication book has been developed on behalf of The Learning Disability Partnership Board in Surrey. The Partnership Board funded the Access To Acute Hospitals Project which aimed to help make sure that people with a learning disability had the right support when they used acute hospital services. The biggest barrier to people receiving the right support was found to be communication. This book aims to help hospital staff in 2 ways, and contains 2 sections. • Section 1 - To give acute hospital staff basic information about the communication needs people may have • Section 2 - To be a practical communication tool people can use to help communicate together. Section 1 - Information Pages • Page 3 - Communicating with speech • Page 4 - Supporting people with visual impairments • Page 5 - Supporting people with a hearing loss • Page 6 - Using Signing • Page 7 - Examples of useful signs • Page 8 - Using photos, pictures, and symbols These pages aim to explain some of the key communication issues for people with learning disabilities. Also to give you advice and practical tips on how to communicate clearly with people with learning disabilities, and other people who may have difficulties communicating. Section 2 - The Picture, Symbol, Photo Toolkit • Page 9 - Drinks • Pages 16, 17, 18 - Procedures • Page 10 - Food • Pages 19 & 20 - Body parts • Page 11 - People • Page 21 - Full Body • Page 12 - Personal things • Page 22 - Nil by Mouth • Page 13 - Personal care • Page 23 - Places • Page 14 - Symptoms • Page 24 - When Do I Go Home ? • Page 15 - Degree of Pain These are practical pages of pictures you can use to offer people choices, explain to people what is going to happen, and help them to communicate to you. Please read page 8 before using the pictures with people as this gives important advice on how to use them. Bear in mind not everyone will be able to recognise the meaning of all the pictures. They can help to back up what you are saying, and clue people in. We are keen that you use this book in anyway you feel can improve a person’s experience whilst in hospital. You may find it useful to photocopy some of the pages to use seperately. For example the ‘Nil by Mouth’ page can be copied to be displayed above a person’s bed. To respect the copyright of Rebus, PCS, Makaton, Change Picturebank and Photosymbols graphics please do not reproduce these pages for any other purposes. The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Widgit Rebus symbols used with permission from Widgit Software Tel: 01223 425558 Many thanks to the Building Links Group from Bentley Day service for helping to choose the symbols used. Page 2 Communicating Clearly with Speech We usually talk too fast People don’t understand all the words we use It takes more time for many people to process the words they hear. This is true for many people with a learning disability. And also true for all people when they are feeling anxious Use everyday words wherever you can. Use short simple sentences. Have only one idea in a sentence. You may have a much larger vocabulary than the person you are communicating with Use very Literal Language When people are talking to us we understand much of their meaning by their tone and body language. Also, we often talk using abstract phrases rather than accurate words. Look at these phrases. I’ll give you a bell later The doctor’s doing her rounds He can’t see the wood for the trees Some people will be less skilled at interpreting abstract language. They take a more literal meaning from words, and can get confused. Some people with a learning disability may only pick up key words in a sentence. This means they may only take in one, two, or three words of your sentence. For example : Unfortunately due to complications it‛s not possible for you to go home yet, we may know more tomorrow home tomorrow It’s important to make sure the person has understood the main idea of your message DON’T SHOUT - IT’S RUDE, AND DOESN’T HELP COMPREHENSION !!!! Using gestures helps Gestures and facial expressions give visual clues about the meaning of what you are saying, as well as slowing down the pace of your speech The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 3 Supporting People with Visual Impairments There are around 23,000 people in the UK who have a severe loss of both sight and hearing. About 200,000 have less serious dual sensory loss. “In the UK 17,000 people with sight problems use a white cane. Another 5000 use guide dogs. There are many more who need help with their everyday living”. Be aware how you explain things. We often talk in a very visual way. For example when asked where the toilet is “the green door on the right” is not a helpful answer! If you are physically shown you can work the route out for yourself. To make hand writing more legible, choose a dark felt tip pen and write neatly using thicker strokes. Be aware that some people have good vision in a limited area so would be ok with smaller print. Avoid clutter! Try to minimise the risk of someone tripping over things It’s important to take the time to tell people where the important things are like toilets, call buttons, and drinks. People may need a bit of time before they are confident. It can help people to have a bed near a landmark in the room, say a bed at the end rather than in the middle. Good lighting is important. A clip on reading lamp may be useful for a person to have. A magnifying glass may be useful to have around the ward for people who have a visual impairment to use to read. Be aware that people have a variety of sight difficulties and a magnifier may not meet their needs. Encourage people to bring in their own magnifier. Menus and food are a very common difficulty for people with sight problems in hospital People will often have difficulty reading and ticking the menus as they are usually printed in very small writing. Read the menu out for someone or enlarge in on the photocopier if someone reads large print. Meals may be left on a tray, on a table, which is out of reach near the end of the bed. Someone who has a visual impairment may not see the meal and miss their food. It’s important that staff take the time to describe to the person what is happening & where things are. The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 4 Supporting People with a Hearing Loss Firstly, establish how the deaf person communicates. If they are asking you a question using their voice, it is safe to assume that they will be expecting to lip-read your reply. • Face the person directly, if you look away the deaf person cannot see your lips. • Speak clearly at a normal pace. Do not shout • Make sure you have good light on your face so the person can see your features and read your lips easily. • Use whole sentences rather than one word replies lip-reading is 70% guess work and many words look the same. Using sentences gives contextual clues. • Be patient, if you are asked to repeat something try changing the sentence slightly, it may make it easier to understand. • Do not give up, if you cannot make yourself understood then try writing it down or drawing what you mean. • If the person is a sign language user, they will probably still expect to have to try to lip-read your reply. Very few hearing people sign, and deaf people are used to trying to communicate with hearing people. • Use gestures to help explain what you are saying. Use gestures, point, mime to help explain what you are saying. E.g. Show a cup and ask what they want to drink. Mime driving a car to ask if you can give them a lift. Point to objects to give clues, or point to give directions. Show size and shape with your hands • Use facial expressions to help convey meaning. • Fingerspelling - Deaf people usually fingerspell names, places, and unusual words. If the person has a learning disability and a hearing loss then please note this general advice about hearing loss, but also allow for the person’s learning disability see advice on page 3. The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 5 Using Signing To Support Speech The main benefit of using signing with speech is that it makes communication visual. People can see what you are saying as well as hearing it. People then have more ways of understanding the message. On the following page we have included diagrams of a few signs you may find useful on a hospital ward. These are signs for things not easily represented by a picture or symbol. It’s best to use the symbols where you can Some signs have an arrow which shows you the direction to move your hand. The double headed arrow here means up and down. A more specific action is explainied in writing. To explain that you are going for a drive you might say ‘we are going in the car’ as it keeps the language simple. The limitation of signing is that, as with speech, when you stop signing the message is gone and relies on the person’s memory. British Sign Language (BSL) Is a full visual language used by many deaf people to communicate. Not everyone who signs uses the full BSL. Some people use signs to support the words they are speaking. Many people who aquired a hearing loss later in life use signing in this way. A deaf person may need the support of an interpretor. Contact your local Deaf Services Team Makaton Signing Makaton is a language programme integrating speech, manual signs, and graphic symbols. Many people with a learning disability use Makaton. Key words are signed. We are going to the shop in the car. You only sign the bold words. Contact Makaton for advice on training. Their website is www.makaton.org The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 6 Some Useful Makaton Signs Eat Drink Yes No Toilet House - often used for home Please Thank You Sleep Pain Good Bad Please Note : These signs are for illustration. People learn Makaton signing in groups supported by Makaton representatives. Please go to www.makaton.org.for more information The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 7 Using Photos, Pictures, and Symbols Photos, Pictures and symbols can help people to: Understand Information Many people with a learning disability do not read, and some people find it hard to understand when you explain things. Pictures can help get your message across. Tell you what they need Some people with a learning disability do not communicate verbally. Some people ‘s speech can be hard to understand. Pictures can help them get their message across Make choices Many people find it hard to make choices in their head. Having pictures to look at helps. One benefit of using pictures is that they are permanent. Once you stop speaking or signing you rely on the person’s memory. The symbols we have included on the next few pages may help you to communicate more clearly with a wide range of people. Many people who have a learning disability will be familiar with some symbols Symbols are simple line drawings car that represent a word headache Note of Caution A picture, photo, or symbol is only a 2 dimensional representation of an object or idea. Not all people with a learning disability will take a meaning from a picture, photo, or symbol. Some people have a very profound disability and do not use pictures and symbols at all. Using an object, like a cup or a gown, can help to explain what you’re saying. Many symbols look like what they represent - others are more abstract. If you can’t easily tell what a symbol represents other people will struggle too, and will need help. Remember that many people won’t be able to read the word underneath. Some people will understand the symbol for car easily but may struggle with headache which is more abstract. Symbols and Signing Not everyone who uses signing will be familiar with symbols and not everyone who understands symbols will understand signing. Some people will use a mixture of both. The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 8 Symbols of Drinks Tea Coffee Milk Hot Chocolate Fizzy Drink Squash Milkshake The Hospital Communication Book Water Juice Developed on behalf of The Learning Disability Partnership Board in Surrey Sugar Lemon Orange Blackcurrant Red Fruits Lime Page 9 Symbols of Foods Dinner Sandwich Fruit Sweets Pudding Yoghurt Chocolate Cake Cereal The Hospital Communication Book Toast Biscuit Developed on behalf of The Learning Disability Partnership Board in Surrey Crisps Page 10 Symbols of People Nurse Doctor Mum Dad Staff Specialist Brother Sister Partner The Hospital Communication Book Grandad Grandma Developed on behalf of The Learning Disability Partnership Board in Surrey Friend Page 11 Symbols of Personal Things Glasses Hearing Aid Clothes Nightclothes Phone Book Money Radio Wheelchair Walking Frame Walking Stick The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Shoes & slippers Page 12 Personal Care Symbols Shower Wash Bath Hairwash Toilet Shave Brush teeth Brush hair Sanitary wear The Hospital Communication Book Dressing Gown Toiletries Developed on behalf of The Learning Disability Partnership Board in Surrey Make up Page 13 Symbols of Symptoms Hot Cold Headache Dizzy Backache Tummy Ache Sore throat Chest Pain Constipation The Hospital Communication Book Diarrhoea Tired Developed on behalf of The Learning Disability Partnership Board in Surrey Sick Page 14 Degree of Pain Happy OK In Pain Bad pain The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 15 Symbols of Procedures Weight Dressing Bandages Plastercast Temperature Tablets Medicine 75 Sling Mouth care The Hospital Communication Book Nail care Pulse Developed on behalf of The Learning Disability Partnership Board in Surrey Blood Pressure Page 16 Symbols of Procedures Scan Drip Canula Catheter ultrasound scan Endoscopy Sigmoidoscopy EEG Heart Monitor / ECG The Hospital Communication Book Naso-gastric tube Urine Test Developed on behalf of The Learning Disability Partnership Board in Surrey Operation Page 17 Symbols of Procedures Blood Test Stitches Blood test X ray Suppository Chair Enema Symbols for Moving Injection The Hospital Communication Book Injection Don’t walk Stay in bed Developed on behalf of The Learning Disability Partnership Board in Surrey Page 18 Body Parts Head Eyes Ear Mouth Tooth Neck Shoulder Arm Elbow The Hospital Communication Book Hand Chest Developed on behalf of The Learning Disability Partnership Board in Surrey Breasts Page 19 Body Parts Back Tummy Hips Bottom Penis Vagina Leg Knee Nose The Hospital Communication Book Foot Toe Developed on behalf of The Learning Disability Partnership Board in Surrey Finger Page 20 Full Body Front The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Back Page 21 Nil By Mouth No Drink No Food The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 22 Symbols of Places Ward Home Transport TV Room Cafe Chapel Garden Day Centre Shop Newspapers and Magazines Flowers Snacks The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Drink Page 23 When do I go home ? Monday Tuesday Wednesday Thursday Friday Saturday Sunday 7 nights 6 nights 5 nights 4 nights 3 nights 2 nights H1 onmighet The Hospital Communication Book Developed on behalf of The Learning Disability Partnership Board in Surrey Page 24
Url: /Media/UHS-website-2019/Docs/For-patients/The-Hospital-Communication-book.pdf

BRC EDI Prize Application Form_November 2025

Description: BRC EDI Prize Application Form Please complete the form and submit to brc-applications@uhs.nhs.uk by 12:00 midday on Monday, 12th January. Please note that the word limits are indicative only. You do not need to write exactly to the limit. Project team details Lead applicant name(s) Job title(s) Organisation Contact email of lead applicant(s) List of Collaborators (if any) Project details Project title Start date End date Abstract: Brief description of project and its impact (250 words) Project goal and objectives Describe the background for your project, what you hope to achieve and why it is important? (max 500 words) Project activities and timeline Give a breakdown of all the activities/methods you will undertake to achieve your project goals (max 750 words) Inclusion, ethical and PPIE Considerations Describe what considerations you have given to PPIE, ethics and Inclusion in both the development of this project and its implementation. (max 500 words) Expected impact Outline the expected short-term outputs and outcomes, as well as long-term impact of the project and how these will be measured (max 500 words) Any additional information about your project (max 250 words) Total amount requested If requesting more than £2000, please provide justification for costs here (500 words) Budget breakdown (Please check this with your R&D departments) References
Url: /Media/Southampton-Clinical-Research/Downloads/BRC-EDI-Prize-Application-Form-November-2025.docx

Caroline Grabau, adult senior research sister

Description: NIHR Southampton Clinical Research Facility Auto Generated Title Caroline provides nursing leadership and support to four adult nursing teams ensuring that all adult research studies are set up and implemented in the facility according to standards and timelines. Email: Caroline.grabau@uhs.nhs.uk Leading adult nursing Caroline works with investigators, R&D and the research support team to review incoming adult studies, assessing their feasibility and overseeing the set up and implementation of these studies in the facility. Appointed adult senior research sister in 2015, she coordinates the day-to-day management of the three adult facility research nursing teams and the nursing team for the NIHR Biomedical Research Centre for Nutrition. She ensures appropriate cover and skill mix for the smooth running of research projects and supports nurses delivering the research projects. She also collaborates with other senior nurses within the facility to enhance nursing practice and strategy. Raising the profile of clinical research Caroline is a member of the UKCRF Network Experimental Medicine Nurses Group and collaborates with other members to raise the profile of clinical research nursing across the whole study pathway and in all clinical settings. Caroline also sits on the UHS nursing and midwifery practice groups and the UHS Medication Safety Group, providing a research nursing voice at these meetings and feeding back practice issues to the CRF. Career Caroline qualified as a registered nurse in 1996, obtaining her BSc Hons degree in 2012. She worked predominately in the field of coronary care nursing both in the UK and New Zealand, before joining the facility as a research nurse in 2012. Since working in research, she has been lead nurse for phase 1 vaccine studies and has also worked on rheumatology studies, neurological trauma, orthopedic, nutrition, Alzheimer and Hypertension studies. In 2012, Caroline was joint nominated for UHS Hospital Heroes research individual/team of the year for her work on a nutrition study. Due to Caroline ’ s background in cardiac medicine she was also the facility resus link nurse and her work on developing a program of emergency scenario testing afforded her the opportunity to be a joint author for two posters and abstracts that were displayed at both the NIHR Meeting and UKCRF Network Meetings in 2013.
Url: /ClinicalResearchinSouthampton/Our-people/Clinical-research-facility-people/Caroline-Grabau-adult-senior-research-sister.aspx

BEACON protocol v8.0 07Mar2023 signed

Description: A randomised phase IIb trial of BE AC v izumab added to Temozolomide O ± Irin tecan for children with N refractory/relapsed euroblastoma Version 8.0 dated 07-Mar-2023 Dinutuximab beta amendment Coordinating Sponsor: Sponsor Protocol Number: CAS Code: EudraCT Number: ISRCTN Reference Number: ITCC Number: Roche Study Reference Number: Email: University of Birmingham RG_ 11-087 BN2008 2012-000072-42 40708286 032 MO28245 beacon@trials.bham.ac.uk This application is supported by the facilities funded through Birmingham Science City: Translational Medicine Clinical Research Infrastructure and Trials Platform, an Advantage West Midlands (AWM) funded project which forms part of the Science City University of Warwick and University of Birmingham Research Alliance. BEACON-Neuroblastoma Protocol_vn 8.0_vd 07Mar2023 Page1 of 157 BEACON-Neuroblastoma Trial Protocol AMENDMENTS The following amendments and/or administrative changes have been made to this protocol since the implementation of the first approved version Amendment Date of number amendment Protocol version number Type of amendment SA 1 29-Jan-2013 2.0 Substantial Amendment N/A 23-Apr-2013 2.0a Non-Substantial Amendment N/A 01-Jul-2013 2.0b Non-Substantial Amendment Summary of amendment Introduction of the recommendation of weekly monitoring of blood counts for all patients receiving irinotecan. Addition of planned vaccination with live vaccination to exclusion criteria and prohibited medications section. ITCC Number has been corrected. Roche Study Reference Number and ISRCTN Reference Number have been added. Contact details for Plasma & Tumour Angiogenesis-Related Biomarkers have been amended. Table numbers have been corrected. Addition of guidance for research bone marrow sampling in Schedule of Activities table and sections 7.4.2.2 and 7.5.2. Addition of paragraph to sections 7.2, 7.6.1 – 7.6.4 detailing arrangements for handling dose modifications for Irinotecan + Temozolomide for patients receiving Bevacizumab. Discontinuation rules for osteonecrosis of the jaw and eye disorders added to table 13 in section 7.6.4. Correction to table number references in section 7.6.3. Clarification made in section 13.4.1 concerning Planned Interim Analysis. SA 3 06-Oct-2014 4.0 Substantial Amendment Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators. Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5. Amendment to exclusion criteria in Trial Synopsis and section 4.2. Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up. Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 3 of 157 BEACON-Neuroblastoma Trial SA 4 06-Oct-2014 4.0 SA 5 30-Jul-2015 5.0 Substantial Amendment Substantial Amendment Protocol Option to fax emergency randomisation removed. Telephone only in section 6.2 Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age. Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2. Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1 Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4. Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates. Changes to section 9.1 regarding reporting of laboratory adverse events. Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11. Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3. Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3. Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1. Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6 Addition of Trial Management Group meeting frequency in section 14.4. Changes to the wording of irinotecan randomisation in section 13.4.2. Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11. Reference to the National Coordinating Centres has been changed to National CoSponsor throughout. Reference to Sponsor has been changed to Coordinating Sponsor. Change of Chief Investigator to Professor Pamela Kearns. Change of Principal Investigator at Royal Marsden Hospital to Dr Sucheta Vaidya. No changes made to the Protocol version. Chief Investigator and UK Lead Investigator changed to Dr Lucas Moreno Switzerland details added Schedule of events table amended for End Of Treatment clarity BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 4 of 157 BEACON-Neuroblastoma Trial N/A 23-Sep-2015 5.0a SA 6 16-Jan-2019 6.0a Protocol Topotecan added to the study as a new trial question and 2 new randomisation arms. The following sections are amended accordingly: Synopsis (Primary Objectives, sample size, Trial Duration, Trial therapy) Section 1 Background and rationale (Trial rationale) Section 3 Trial design (Randomisation) Section7.1 and 7.2 Treatment details Section7.6.1 Dose modifications Table 6 amended, Tables 11 and 12 added Section 8.4 Pharmaceutical Information Section 13 Statistical considerations The following changes were made to the Eligibility: Inclusion criteria – further details regarding birth control Exclusion criteria – Defined wash out period following prior IMP according to IMP half-life or 14 days. Lifestyle guidelines - further details regarding birth control Section 7.6 Dose modifications Figure 1 – reference to “chemo” changed to Temozolomide/Irinotecan/Topotecan” for clarity Section 8.2.4 Reference to “chemo” removed for clarity Section 7.6.4 AEs requiring Bevacizumab discontinuation – additional AEs added following Bevacizumab IB v22 Addendum Additional mRNA and exploratory sampling. Non-Substantial Amendment Substantial amendment The requirement for confirmatory scans was removed from the Schedule of Activities and Response assessment section 7.4.3. Lead Investigator for France amended to Dr Marion Gambart Minor wording corrections and clarifications Schedule of events table corrected Introduction of two new treatment arms (dinutuximab beta) for additional 64 patients Addition of eligibility criteria, schedule of events, treatment details, duration, cross over and dose modification details for new dinutuximab beta arms Adaptation of objectives, trial design, supporting treatment, pharmaceutical information and statistical consideration sections with new, relevant information. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 5 of 157 BEACON-Neuroblastoma Trial N/A 11-Apr-2019 6.0b SA 7 07-Feb-2020 7.0 SA 22 07-Mar-2023 8.0 Protocol Non-Substantial Amendment Substantial Amendment Substantial Amendment Minor wording corrections and clarifications Version amended from 6.0 to 6.0a to add. Additional rationale to update typographical errors.) Trial Synopsis: Clarification of recruitment targets Clarification of Section 10 title: “Dinutuximab beta and topotecan randomisations” Clarification that not all biological studies will be open at any one time (Section 10.2 and 15.5) Minor wording corrections and clarifications Urgent Safety Measure – implemented on 28th January 2020 Closure of Temozolomide (T) and Dinutuximab beta and Temozolomide (dBT) arms with immediate effect. Section 1.1 Background Section 1.2.3 Benefit Risk assessment Section 3.1 Randomisation Section 10 Headings changed Section 10.3 Trial therapy Update of contact details Change of definition of End of Trial (Section 21). Protocol previously defined two stages of end of trial (6 months after last patient completes treatment and 12 months after last data capture after 5 years follow up). This has been combined into one End of Trial definition: 6 months after last patient last visit (i.e. after 5 years follow up) Also addition of option to email SAE form (Section 18.2.1.2) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 6 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL PERSONNEL Chief Investigator: Co-Investigators: Exploratory Biomarkers Dr Lucas Moreno Dr. Lucas Moreno, MD, PhD Director Paediatric Oncology & Haematology Division Vall d’Hebron Barcelona Hospital Campus Passeig de la Vall d’Hebron, 119-129, 08035, Barcelona, Spain  +34 93 489 3000  +34 93 489 4060  lucas.moreno@vhebron.net Professor Keith Wheatley Professor of Clinical Trials Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 415 9119  k.wheatley@bham.ac.uk Dr Juliet Gray Associate Professor and Consultant in Paediatric Oncology Southampton Children’s Hospital Tremona Road Southampton SO16 6YD  +44 (0) 790 1507929  juliet.gray@uhs.nhs.uk Dr Gudrun Schleiermacher Senior Scientist Institute Curie 26 rue d'Ulm 75248 Paris cedex 05 France  +33 (0)1 56 24 45 50  +33 (0)1 56 24 66 30  gudrun.schleiermacher@curie.net Professor Louis Chesler Paediatric Tumour Biology Team Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0) 208 722 4035 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 7 of 157 BEACON-Neuroblastoma Trial Protocol  louis.chesler@icr.ac.uk Functional Imaging Study: Professor Andrew Peet Institute of Child Health University of Birmingham Whittall Street Birmingham, UK B4 6NH  +44 (0) 121 333 8234  +44 (0) 121 333 8241  a.peet@bham.ac.uk Dr Dow-Mu Koh Consultant Radiologist in Functional Imaging Royal Marsden Hospital Downs Road, Sutton, Surrey, UK SM2 5PT  +44 (0) 208 6613857  dow-mu.koh@icr.ac.uk Professor Martin Leach Co-Director, Cancer Research UK and EPSRC Centre for Cancer Imaging, Director, NIHR Clinical Research Facility Deputy Head, Division of Radiotherapy and Imaging Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0 208 661 3338  Martin.Leach@icr.ac.uk Molecular Monitoring mRNA Study: Professor Sue Burchill Leeds Institute of Cancer & Pathology St. James University Hospital Beckett Street Leeds, UK LS9 7TF  +44 (0) 113 206 5873  +44 (0) 113 242 9886  S.A.Burchill@leeds.ac.uk Professor Walter Gregory Clinical Trials Research Unit (CTRU) University of Leeds Clinical Trials Research House 71-75 Clarendon Road Leeds LS2 9PH  +44 (0) 113 343 1489  +44 (0) 113 343 1471 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 8 of 157 BEACON-Neuroblastoma Trial Protocol Trial Statistician: Trial Coordinator & Trial Office: Randomisation Service: SAE Reporting:  W.M.Gregory@leeds.ac.uk Miss Grace Holt Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 8328  +44 (0)121 414 3700  G.C.Holt@bham.ac.uk Miss Punam Mistry Children’s Cancer Trials Team Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  beacon@trials.bham.ac.uk Provided by the CRCTU at the University of Birmingham Randomisation should be performed by sites online at: https://www.cancertrials.bham.ac.uk/BEACONLive In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on: 0800 371 969 or +44 (0)121 414 3366 SAEs should be faxed to the BEACON-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK  + 44 (0)121 414 9520 or +44 (0)121 414 3700 National Coordinating Investigators: Austria – Lead Investigator: Prof Dr Ruth Ladenstein St. Anna Children’s Hospital and CCRI /Studies and Statistics Department for Integrated Research and Projects (S²IRP) Kinderspitalgasse 6, Zimmermannplatz 10 A-1090 Vienna Austria +43-1-40470-4750  +43-1- 40470- 7430  ruth.ladenstein@ccri.at BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 9 of 157 BEACON-Neuroblastoma Trial Belgium Lead Investigator: Prof Genevieve Laureys Ghent University Hospital 9000 Ghent De Pinterlaan 185 Belgium  +32 93 32 34 48  genevieve.laureys@uzgent.be Denmark – Lead Investigator: Dr Karsten Nysom Dept. of Paediatrics & Adolescent Medicine Rigshospitalet Blegdamsvej 9 DK2100 Copenhagen Denmark  +45 35 45 08 09  +45 35 45 50 55  Karsten.nysom@regionh.dk France – Lead Investigator: Dr Marion Gambart Unité d'Hémato-Oncologie Hôpital des Enfants 330, avenue de Grande Bretagne TSA 70034 31059 Toulouse Cedex France  +33 (0)5 34 55 86 11  +33 (0)5 34 55 86 12  gambart.m@chu-toulouse.fr Germany - Lead Investigator: Dr. Simone Hettmer Zentrum für Kinder- und Jugendmedizin UNIVERSITÄTSKLINIKUM FREIBURG Mathildenstr. 1, 79106 Freiburg Germany  +49 761 270-43000  +49 761 270-45180  simone.hettmer@uniklinik-freiburg.de Ireland – Lead Investigator: Dr Cormac Owens Our Lady’s Children’s Hospital Crumlin Road, Crumlin Dublin 12 Ireland  +35314096659  +35313453041  Cormac.owens@olchc.ie Protocol BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 10 of 157 BEACON-Neuroblastoma Trial Protocol Italy – Lead Investigator: Dr. Aurora Castellano U.O.Oncoematologia Ospedale Pediatrico Bambino Gesù Pzza S. Onofrio 4 00165 Roma Italy +39 06 68592957-2678  +39 06 68592826  aurora.castellano@opbg.net Netherlands – Lead Investigator: Dr. C Michel Zwaan Erasmus Medical Center Sophia’s Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam +31 (0) 10 703 6691  +31(0) 10 703 6681  c.m.zwaan@erasmusmc.nl Spain – Lead Investigator: Dr. Victoria Castel Instituto de Investigación Sanitaria Unidad de Oncología Pediátrica Hospital Universitario La Fe Bulevar Sur, S/N 46026 Valencia Spain +34 963862758 Ext 50040  +34 963494416  castel_vic@gva.es Switzerland – Lead Investigator: Dr. Nicolas Gerber University Children’s Hospital, Steinwiesstrasse 75, CH-8032 Zurich, Switzerland +41 44 266 31 17  +41 44 266 34 61  Nicolas.gerber@kispi.uzh.ch UK – Lead Investigator: Dr Lucas Moreno Honorary Research Fellow University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  lucas.moreno@vhebron.net, lmorenom@ext.cnio.es BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 11 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL SYNOPSIS Title A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial Trial Design A phase II, randomised, open label, international multicentre 3x2 factorial trial. The dinutuximab beta amendment did utilise a 2x2 factorial design it will now be a simple two-way randomisation. Objectives Primary: - To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan + temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma - To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma - To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma (“topotecan randomisation”) - To test whether dinutuximab beta added to a backbone chemotherapy regimen (temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma (“dinutuximab beta randomisation”) Secondary: - To evaluate the safety of the regimens Tertiary: - To undertake preliminary evaluation of the changes in magnetic resonance imaging (MRI) derived functional imaging biomarkers of angiogenesis - To undertake preliminary evaluation of the role of circulating mRNA levels for tyrosine hydroxylase (TH), paired-like homeobox 2b (PHOX2B) and doublecortin (DCX) as prognostic/predictive biomarkers in this refractory/relapsed setting - To undertake a preliminary evaluation of the role of tumour molecular profiles in blood and archival tumour tissue profiles as prognostic and predictive biomarkers - To undertake a preliminary evaluation of biomarkers of response to anti-GD2 therapy (Fc/KIR polymorphisms, Antibody Dependant Cell-Mediated Cytotoxicity (ADCC) and Anti-Drug Antibodies (ADAs) and of dinutuximab beta pharmacokinetics (PK) Outcome Measures Primary Endpoint: - Best response (Complete Response [CR] or Partial Response [PR]) [1] at any time during the first 6 cycles of trial treatment - For the bevacizumab part 2 only: Progression-free survival (PFS) Secondary Endpoints: - Safety of the regimens: Incidence and severity of Adverse Events (AE)s - PFS - Overall survival (OS) - Event-free survival (EFS) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 12 of 157 BEACON-Neuroblastoma Trial Protocol Exploratory/Tertiary Endpoints: - Changes in (MRI) derived functional imaging biomarkers of angiogenesis measured by quantitative dynamic contrast enhanced (DCE) MRI: primary biomarkers will be the transfer constant Ktrans [min-1] and initial area under the gadolinium uptake curve from 0 to 60 seconds (IAUGC60, mM Gd min) and secondary biomarkers will be tumour apparent diffusion coefficient (ADC, 10-6 cm2 s-1), native T1 and T2 relaxation times (ms) and transverse relaxation rate R2* - Changes in circulating mRNA levels for TH, PHOX2B and DCX in bone marrow and blood samples - Pilot descriptive study of angiogenesis and neuroblastoma markers that may include O6methylguanine-methyltransferase (MGMT) status, immunohistochemistry and immunofluorescence markers on tumour samples (such as microvessel density (MVD), CD31, Ki67, NRP1, VEGFR-1, VEGFR-2, C-KIT), DNA/RNA extraction from tissue sections for tumour mutation screening and tumour expression profiling - A preliminary correlation of the different biomarkers [Fc/KIR polymorphisms, Antibody – Dependent Cellular Toxicity (ADCC), and Anti-Drug Antibodies (ADAs)] will be made with parameters of anti-tumour activity (response rate, PFS and OS). PK parameters (dinutuximab beta trough levels) for this chemo-immunotherapy regimen will be described. Patient Population Children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma. Sample Size Approximately 224 patients, including 160 for the bevacizumab randomisation and 64 for the dinutuximab beta amendment. Trial Duration 8 years of patient recruitment, 5 years of patient follow up BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 13 of 157 BEACON-Neuroblastoma Trial Protocol Abbreviations ADA ANTI-DRUG ANTIBODIES ADCC ANTIBODY – DEPENDENT CELL-MEDIATED CYTOTOXICITY AE ADVERSE EVENT AESI ADVERSE EVENT OF SPECIAL INTEREST AFSAPPS COMPETENT AUTHORITY FOR FRANCE ALT ALANINE AMINOTRANSFERASE ANC ABSOLUTE NEUTROPHIL COUNT APPT ACTIVATED PARTIAL THROMBOPLASTIN TIME ASCT AUTOLOGOUS STEM CELL TRANSPLANTATION AST ASPARTATE AMINOTRANSFERASE AUC AREA UNDER THE CURVE AR ADVERSE REACTION BIT BEVACIZUMAB + IRINOTECAN + TEMOZOLOMIDE ARM BM BONE MARROW BP BLOOD PRESSURE BSA BODY SURFACE AREA BT BEVACIZUMAB + TEMOZOLOMIDE ARM BTTo BEVACIZUMAB + TEMOZOLOMIDE + TOPOTECAN ARM CI CHIEF INVESTIGATOR CIs CONFIDENCE INTERVALS COG CHILDREN’S ONCOLOGY GROUP CNS CENTRAL NERVOUS SYSTEM CR COMPLETE RESPONSE CRF CASE REPORT FORM CR UK CANCER RESEARCH UK CRCTU CANCER RESEARCH UK CLINICAL TRIALS UNIT (UNIVERSITY OF BIRMINGHAM) CRN CLINICAL RESEARCH NETWORK CSR CLINICAL STUDY REPORT CT COMPUTERISED TOMOGRAPHY CTC COMMON TERMINOLOGY CRITERIA CTCAE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS CXR CHEST X-RAY dBT DINUTUXIMAB BETA + TEMOZOLOMIDE ARM dBTTo DINUTUXIMAB BETA + TEMOZOLOMIDE + TOPOTECAN ARM DCX DOUBLECORTIN DLT DOSE LIMITING TOXICITY DMC DATA MONITORING COMMITTEE DNA DEOXYRIBONUCLEIC ACID ECHO ECHOCARDIOGRAM ECOG EASTERN COOPERATIVE ONCOLOGY GROUP EFS EVENT FREE SURVIVAL EMA EUROPEAN MEDICINES AGENCY ERDC ELECTRONIC REMOTE DATA CAPTURE EOT END OF TREATMENT FFPE FORMALIN-FIXED PARAFFIN EMBEDDED GCP GOOD CLINICAL PRACTICE G-CSF GRANULOCYTE COLONY STIMULATING FACTOR BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 14 of 157 BEACON-Neuroblastoma Trial Protocol GFR GM-CSF GGT GP GPOH HR IB ICF ICH IMP INR INRC INRG INSS IRF ISF IT ITCC IV MGMT MIBG MHRA MRD MRI MSKCC MTD MYCN NANT NCI NCS NR OS OTC PCP PD PFS PHOX2B PI PIS PK PMA PRES PO PPTP PR REC RECIST RNA GLOMERULAR FILTRATION RATE GRANULOCYTE-MONOCYTE COLONY STIMULATING FACTOR GAMMA-GLUTAMYL TRANSPEPTIDASE GENERAL PRACTITIONER GERMAN SOCIETY FOR PAEDIATRIC ONCOLOGY & HAEMATOLOGY HEART RATE INVESTIGATOR BROCHURE INFORMED CONSENT FORM INTERNATIONAL CONFERENCE ON HARMONISATION INVESTIGATIONAL MEDICINAL PRODUCT INTERNATIONAL NORMALISED RATIO INTERNATIONAL NEUROBLASTOMA RESPONSE CRITERIA INTERNATIONAL NEUROBLASTOMA RISK GROUP INTERNATIONAL NEUROBLASTOMA STAGING SYSTEM INSTITUTIONAL REVIEW BOARD INVESTIGATOR SITE FILE IRINOTECAN + TEMOZOLOMIDE ARM INNOVATIVE THERAPIES FOR CHILDREN WITH CANCER INTRAVENOUS O6-METHYGUANINE METHYLTRANSFERASE META-IODO-BENZYL-GUANIDINE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MINIMAL RESIDUAL DISEASE MAGNETIC RESONANCE IMAGING MEMORIAL SLOAN KETTERING CANCER CENTRE MAXIMUM TOLERATED DOSE MYELOCYTOMATOSIS VIRAL RELATED ONCOGENE NEW AGENTS FOR NEUROBLASTOMA THERAPY NATIONAL COORDINATING INVESTIGATOR NATIONAL CO-SPONSOR NO RESPONSE OVERALL SURVIVAL OVER THE COUNTER PNEUMOCYSTIS CARNI PNEUMONITIS PROGRESSSIVE DISEASE PROGRESSION FREE SURVIVAL PAIRED-LIKE HOMEOBOX2B PRINCIPAL INVESTIGATOR PATIENT INFORMATION SHEET PHARMACOKINETICS POPULATION-MODELLING ANALYSIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ORALLY PAEDIATRIC PRECLINICAL TESTING PROGRAM PARTIAL RESPONSE RESEARCH ETHICS COMMITTEE RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS RIBONUCLEIC ACID BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 15 of 157 BEACON-Neuroblastoma Trial Protocol RTKI RT-qPCR SAE SAR SCT SD SFOP SIOPEN SNP SPC SUSAR SWFI T TH TMA TMG TSC TTo TVD UAR UKCCSG ULN VTE VEGF VGPR WMA RECEPTOR TYROSINE KINASE INHIBITORS REVERSE TRANSCRIPTASE QUANTITATIVE POLYMERASE CHAIN REACTION SERIOUS ADVERSE EVENT SERIOUS ADVERSE REACTION STEM CELL TRANSPLANT STABLE DISEASE FRENCH SOCIETY OF PAEDIATRIC ONCOLOGY INTERNATIONAL SOCIETY PAEDIATRIC ONCOLOGY EUROPEAN NEUROBLASTOMA GROUP SINGLE NUCLEOTIDE POLYMORPHISM SUMMARY OF PRODUCT CHARACTERISTICS SUSPECTED UNEXPECTED SEVERE ADVERSE REACTION STERILE WATER FOR INJECTION TEMOZOLOMIDE ARM TYROSINE HYDROXYLASE TISSUE MICROARRAY TRIAL MANAGEMENT GROUP TRIAL STEERING COMMITTEE TEMOZOLOMIDE + TOPOTECAN ARM TOPOTECAN, VINCRISTINE & DOXORUBICIN UNEXPECTED ADVERSE REACTION UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP UPPER LIMIT OF NORMAL VENOUS THROMBO-EMBOLISM VASCULAR ENDOTHELIAL GROWTH FACTOR VERY GOOD PARTIAL RESPONSE WORLD MEDICAL ASSOCIATION FORMULAE Mosteller formula: BSA (m²) = BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 16 of 157 BEACON-Neuroblastoma Trial Protocol Table of Contents Trial Synopsis ...................................................................................................................................... 12 Title .................................................................................................................................................... 12 Trial Design ........................................................................................................................................ 12 Objectives .......................................................................................................................................... 12 Outcome Measures............................................................................................................................ 12 Patient Population .............................................................................................................................. 13 Sample Size ....................................................................................................................................... 13 Trial Duration...................................................................................................................................... 13 Abbreviations ..................................................................................................................................... 14 1. Background and Rationale ............................................................................................................. 22 1.1 Background............................................................................................................................ 22 1.1.1 Background for the dinutuximab beta amendment............................................................ 28 1.2 Trial Rational.......................................................................................................................... 29 1.2.1 Justification for design ....................................................................................................... 29 1.2.2 Rationale for patient population ......................................................................................... 30 1.2.3 Benefit-risk assessment .................................................................................................... 31 1.2.4 Rationale for the selected backbone schedules: Temozolomide, irinotecan + temozolomide and temozolomide + topotecan .............................................................................. 31 1.2.5 Rationale for dosing schedule of bevacizumab................................................................. 32 1.2.6 Rationale for evaluating chemo-immunotherapy in the BEACON-Neuroblastoma Trial... 32 1.2.7 Rationale for dosing schedule of dinutuximab beta........................................................... 33 1.2.8 Rationale for the use of biomarker studies ........................................................................ 34 1.3 Relevance and future importance ......................................................................................... 35 2. Objectives and Outcome Measures ............................................................................................. 36 2.1 Objectives .............................................................................................................................. 36 2.2 Outcome Measures ............................................................................................................... 37 3. Trial Design ..................................................................................................................................... 37 3.1 Randomisation....................................................................................................................... 37 3.2 Duration of treatment............................................................................................................. 38 3.3 Frequency and duration of follow-up ..................................................................................... 38 4. Eligibility.......................................................................................................................................... 39 4.1 Lifestyle guidelines ................................................................................................................ 39 5. Schedule of activities..................................................................................................................... 39 6. Screening and Consent ................................................................................................................. 40 6.1 Informed Consent .................................................................................................................. 40 6.2 Screening............................................................................................................................... 41 7. Trial Entry........................................................................................................................................ 42 7.1 Procedure for online patient randomisation........................................................................... 42 7.2 Emergency Randomisation ................................................................................................... 42 8. Treatment Details ........................................................................................................................... 43 8.1 Definition of Investigational Medicinal Products (IMPs) ........................................................ 43 9. Bevacizumab randomisation......................................................................................................... 43 9.1 Eligibility criteria for the bevacizumab randomisation............................................................ 43 9.1.1 Inclusion criteria for the bevacizumab randomisation ....................................................... 43 9.1.2 Exclusion criteria for the bevacizumab randomisation ...................................................... 44 9.2 Schedule of activities for the bevacizumab randomisation ................................................... 45 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 17 of 157 BEACON-Neuroblastoma Trial Protocol 9.3 Trial Therapy (bevacizumab randomisation) ......................................................................... 49 9.3.1 Bevacizumab randomisation trial treatment ...................................................................... 49 9.4 Treatment Schedule..................................................................................................................... 51 9.4.1 Day 1 of Cycle 1 ................................................................................................................ 51 9.4.2 Day 1 of subsequent cycles............................................................................................... 51 9.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12) ........................................................ 52 9.4.4 End of Treatment ............................................................................................................... 52 9.4.5 Treatment Duration............................................................................................................ 52 9.5 Dose Modifications for the bevacizumab randomisation ....................................................... 53 9.5.1 Dose Modifications for AEs due to chemotherapy - for the bevacizumab randomisation. 56 9.5.2 Bevacizumab – Infusion-related Reaction/Infusional Site Extravasation Management Guidelines ...................................................................................................................................... 62 9.5.3 Bevacizumab - Treatment Delays ..................................................................................... 63 9.5.4 Bevacizumab - Discontinuation ........................................................................................ 64 9.5.5 Bevacizumab - Toxicity Management guidelines .............................................................. 65 9.6 Central Venous Access Device (CVAD)................................................................................ 67 10 Dinutuximab beta and topotecan randomisations...................................................................... 68 10.1 Eligibility for the dinutuximab beta randomisation ................................................................. 68 10.1.1 Inclusion criteria for the dinutuximab beta randomisation ............................................. 68 10.1.2 Exclusion criteria for the dinutuximab beta randomisation ............................................ 69 10.2 Schedule of events for the dinutuximab beta and topotecan randomisations....................... 70 10.3 Trial therapy (dinutuximab beta and topotecan randomisations) .......................................... 74 10.3.1 Dinutuximab beta and topotecan trial treatment................................................................ 75 10.4 Treatment Schedule .............................................................................................................. 76 10.4.1 Day 1 of Cycle 1 ............................................................................................................ 76 10.4.2 Day 1 of subsequent cycles........................................................................................... 76 10.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12 on chemotherapy only) ............... 77 10.4.4 End of Treatment ........................................................................................................... 77 10.4.5 Treatment Duration............................................................................................................ 78 10.4.6 Cross-over ......................................................................................................................... 78 10.5 Dose Modifications – dinutuximab beta and topotecan randomisations ............................... 79 10.5.1 Dose modifications for dinutuximab beta specific toxicities .......................................... 79 10.5.2 Dose modifications for haematological toxicity.............................................................. 81 10.5.3 Dose modifications for hepatic toxicity .......................................................................... 82 11 Treatment Compliance................................................................................................................... 84 12 Supportive Treatment .................................................................................................................... 84 12.1 Nausea and Vomiting ............................................................................................................ 84 12.2 Growth Factors ...................................................................................................................... 84 12.3 Fever and neutropenia .......................................................................................................... 84 12.4 Blood products....................................................................................................................... 84 12.5 Pneumocystis jirovecii pneumonia (PJP) prophylaxis ........................................................... 84 12.6 Management of side effects caused by non-selective NSAIDs as cyclooxygenase (COX) type I and II inhibitors ......................................................................................................................... 84 12.7 Supportive care during Dinutuximab beta infusion................................................................ 85 12.7.1 Pain Management.......................................................................................................... 85 12.7.2 Prevention of dinutuximab beta related infusion reactions............................................ 86 13 Concomitant Medication................................................................................................................ 87 14 Assessments .................................................................................................................................. 87 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 18 of 157 BEACON-Neuroblastoma Trial Protocol 14.1 Response assessment .......................................................................................................... 88 15 Biomarkers...................................................................................................................................... 88 15.1 Blood sampling safety ........................................................................................................... 88 15.2 MRI-derived functional imaging biomarkers of angiogenesis................................................ 90 15.3 Molecular monitoring mRNA.................................................................................................. 90 15.4 Neuroblastoma exploratory biomarker analyses ................................................................... 90 15.5 Sample Collection.................................................................................................................. 92 15.5.1 Peripheral blood samples .............................................................................................. 92 15.5.2 Bone Marrow Samples .................................................................................................. 92 15.5.3 Archival tumour samples ............................................................................................... 92 16 Patient Follow Up ........................................................................................................................... 93 16.1 Patient Withdrawal................................................................................................................. 93 17 Pharmaceutical Information .......................................................................................................... 94 17.1 Definition of Investigational Medicinal Product ...................................................................... 94 17.2 Bevacizumab ......................................................................................................................... 94 17.2.1 Bevacizumab - Drug Supply .......................................................................................... 94 17.2.2 Bevacizumab - Ordering ............................................................................................... 94 17.2.3 Bevacizumab - Formulation, Packaging and Labelling ................................................. 94 17.2.4 Bevacizumab - Preparation and Dispensing ................................................................. 95 17.2.5 Compatibility information ............................................................................................... 95 17.2.6 Bevacizumab - Administration ....................................................................................... 95 17.2.7 Bevacizumab – Accountability....................................................................................... 96 17.2.8 Bevacizumab - Destruction............................................................................................ 96 17.3 Cyclophosphamide ................................................................................................................ 96 17.4 Dinutuximab beta................................................................................................................... 96 17.5 Irinotecan ............................................................................................................................... 96 17.5.1 Irinotecan - Drug Supply ............................................................................................... 96 17.5.2 Irinotecan - Formulation, Packaging and Labelling ....................................................... 96 17.5.3 Irinotecan - Preparation and Dispensing ....................................................................... 97 17.5.4 Compatibility information ............................................................................................... 97 17.5.5 Irinotecan - Administration ............................................................................................. 97 17.6 Temozolomide ....................................................................................................................... 97 17.6.1 Temozolomide – Drug Supply ....................................................................................... 97 17.6.2 Temozolomide - Formulation, Packaging and Labelling ............................................... 97 17.6.3 Temozolomide - Administration ..................................................................................... 97 17.7 Topotecan.............................................................................................................................. 98 17.7.1 Topotecan - Drug Supply.............................................................................................. 98 17.7.2 Topotecan - Formulation, Packaging and Labelling ..................................................... 98 17.7.3 Topotecan - Preparation and Dispensing ..................................................................... 98 17.7.4 Topotecan - Compatibility information ........................................................................... 98 17.7.5 Topotecan - Administration........................................................................................... 99 18 Adverse Event Reporting .............................................................................................................. 99 18.1 Reporting Requirements........................................................................................................ 99 18.1.1 Adverse Events (AE) ..................................................................................................... 99 18.1.2 AESIs of Bevacizumab .................................................................................................. 99 18.1.3 Serious Adverse Advents (SAE).................................................................................... 99 18.1.4 Reporting period .......................................................................................................... 100 18.2 Reporting Procedure ........................................................................................................... 100 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 19 of 157 BEACON-Neuroblastoma Trial Protocol 18.2.1 Site............................................................................................................................... 100 18.2.2 Trial Office ................................................................................................................... 102 18.2.3 Reporting to the Competent Authority and main Research Ethics Committee ........... 102 18.2.4 Investigators ................................................................................................................ 102 18.2.5 Data Monitoring Committee ......................................................................................... 102 18.2.6 Manufacturer of Investigational Medicinal Product...................................................... 102 19 Data Handling and Record Keeping ........................................................................................... 103 19.1 Data Collection .................................................................................................................... 103 19.2 Archiving .............................................................................................................................. 103 20 Quality Management .................................................................................................................... 103 20.1 Site Set-up and Initiation ..................................................................................................... 103 20.2 On-site Monitoring ............................................................................................................... 104 20.3 Central Monitoring ............................................................................................................... 104 20.4 Audit and Inspection ............................................................................................................ 104 20.5 Notification of Serious Breaches ......................................................................................... 104 21 End of Trial Definition .................................................................................................................. 105 22 Statistical Considerations ........................................................................................................... 105 22.1 Trial Design.......................................................................................................................... 105 22.2 Definition of Outcome Measures ......................................................................................... 106 22.2.1 Primary ........................................................................................................................ 106 22.2.2 Secondary.................................................................................................................... 106 22.2.3 Exploratory/Tertiary ..................................................................................................... 106 22.3 Sample Size......................................................................................................................... 106 22.4 Interim and Main Analyses of Outcome Measures.............................................................. 108 22.4.1 Planned Interim Analyses ............................................................................................ 108 22.4.2 Main Analysis............................................................................................................... 108 22.5 Stopping Guidelines ............................................................................................................ 110 23 Trial Organisational Structure..................................................................................................... 110 23.1 Coordinating Sponsor .......................................................................................................... 110 23.2 Co-Sponsor Centres ........................................................................................................... 110 23.3 Relationship of trial committees........................................................................................... 112 23.4 Trial Management Group..................................................................................................... 112 23.5 Trial Steering Committee ..................................................................................................... 112 23.6 Data Monitoring Committee................................................................................................. 112 23.7 Finance ................................................................................................................................ 113 23.8 NIHR CRN Portfolio ............................................................................................................. 113 24 Ethical Considerations ................................................................................................................ 113 25 Confidentiality and Data Protection ........................................................................................... 114 26 Insurance and Indemnity ............................................................................................................. 115 27 Publication Policy ........................................................................................................................ 116 28 Reference List............................................................................................................................... 117 Appendix 1 – WMA Declaration of Helsinki .................................................................................... 124 Appendix 2 - Definition of Adverse Events ..................................................................................... 127 Appendix 3 - Common Toxicity Criteria Grading ........................................................................... 129 Appendix 4 – RECIST Criteria 1.1 .................................................................................................... 130 Appendix 5 – Tumor Response at Metastatic Soft Tissue and Bone Sites (Park et al. 2017) ... 133 Appendix 6 - CURIE & SIOPEN scoring methods for neuroblastoma ......................................... 134 Appendix 7 – Temozolomide Dosing............................................................................................... 136 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 20 of 157 BEACON-Neuroblastoma Trial Protocol Appendix 8 – Blood Pressure Levels by Age and Height Percentile for Children and Adolescents ....................................................................................................................................... 139 Appendix 9 – Height for Age Chart - Girls ...................................................................................... 144 Appendix 10 – Height for Age Chart - Boys.................................................................................... 149 Appendix 11 – Lansky and Karnofsky/ECOG Scales .................................................................... 154 Appendix 12 – Tanner Staging ......................................................................................................... 156 Appendix 13 – Clinical studies of anti-GD2 therapies in combination with chemotherapy ...... 157 LIST OF TABLES Table 1 - Second line chemotherapy regimens tested in phase II in relapsed or refractory neuroblastoma since 2000 ..........
Url: /Media/UHS-website-2019/Docs/PaediatricOncology/beacon-protocol-v8.0-07mar2023-signed.pdf

ETD Funding Call - application form 2024

Description: NIHR Southampton BRC Education, Training and Career Development Fund Application Form Applicant details Full name Email Mobile no Contact address Current position Since Higher degree (if appropriate) Since School and faculty or Clinical division and specialty Supervisor’s / line manager’s name Supervisor’s / line manager’s title Supervisor’s / line manager’s email Who is your primary employer? This is the organisation name which reflects in your payslip. Please choose only one option. This information is used for financial purposes only. Staff member UoS Staff member UHS If you are not employed by UoS or UHS, but are currently pursuing a qualification via UoS, please select the option below. Student UoS Other (details) Summary of request Total funding cost When will the funding be used? Latest date funding can be received Breakdown of funding requested (max £1,000). Please mention additional sources of funding if relevant. Justification Please explain briefly (maximum 250 words) why the funding is required and how it will be used. You may wish to include the following: • How you are contributing to the BRC’s research • The BRC theme(s) with which your research aligns • The SMART objectives with which your research aligns • How this funding will improve the care of patients in the future • How the funding will contribute to your future research and/ or career • A brief description of your training or development need and how this funding will help meet it • What funding is already in place (if any) • Justification for the cost (attach quotes or evidence of abstract acceptance if applicable) Previous BRC support Please provide details of any previous support from the BRC that you have received. Include the outcome of this support (e.g. “£250 for course that provided knowledge to undertake a systematic review, published last year”, “presented poster at international conference”, “preliminary data for external grant application”, etc). For all outputs please confirm that NIHR BRC was acknowledged. Title of previous support Date of previous support Nature of the award(s) (e.g. course fees, travel support) Outcome of award(s) (e.g. list of poster presentations or publications, explanation of how your work has improved) Signatures Successful applicants agree to: • Be prepared to support the BRC in line with their circumstances and skills (e.g., give a short talk at a BRC training meeting, organise a BRC training meeting). • Acknowledge the BRC on all publications and presentations resulting from this funding. The BRC must be informed of all such research outputs. • Provide feedback on how this funding opportunity has impacted your learning and development. • Spend the funding in line with the timeframe stipulated on the award letter. Applicant’s signature Date Supervisor’s / line Date manager’s signature
Url: /Media/Southampton-Clinical-Research/Downloads/ETD-Funding-Call-application-form-2024.pdf

ETD Funding Call - application form

Description: NIHR Southampton BRC Education, Training and Career Development Fund Application Form Applicant details Full name Email Mobile no Contact address Current position Since Higher degree (if appropriate) Since School and faculty or Clinical division and specialty Supervisor’s / line manager’s name Supervisor’s / line manager’s title Supervisor’s / line manager’s email Who is your primary employer? This is the organisation name which reflects in your payslip. Please choose only one option. This information is used for financial purposes only. Staff member UoS Staff member UHS If you are not employed by UoS or UHS, but are currently pursuing a qualification via UoS, please select the option below. Student UoS Other (details) Summary of request Total funding cost When will the funding be used? Latest date funding can be received Breakdown of funding requested (max £1,000). Please mention additional sources of funding if relevant. Justification Please explain briefly (maximum 250 words) why the funding is required and how it will be used. You may wish to include the following: • How you are contributing to the BRC’s research • The BRC theme(s) with which your research aligns • The SMART objectives with which your research aligns • How this funding will improve the care of patients in the future • How the funding will contribute to your future research and/ or career • A brief description of your training or development need and how this funding will help meet it • What funding is already in place (if any) • Justification for the cost (attach quotes or evidence of abstract acceptance if applicable) Previous BRC support Please provide details of any previous support from the BRC that you have received. Include the outcome of this support (e.g. “£250 for course that provided knowledge to undertake a systematic review, published last year”, “presented poster at international conference”, “preliminary data for external grant application”, etc). For all outputs please confirm that NIHR BRC was acknowledged. Title of previous support Date of previous support Nature of the award(s) (e.g. course fees, travel support) Outcome of award(s) (e.g. list of poster presentations or publications, explanation of how your work has improved) Signatures Successful applicants agree to: • Be prepared to support the BRC in line with their circumstances and skills (e.g., give a short talk at a BRC training meeting, organise a BRC training meeting). • Acknowledge the BRC on all publications and presentations resulting from this funding. The BRC must be informed of all such research outputs. • Provide feedback on how this funding opportunity has impacted your learning and development. • Spend the funding in line with the timeframe stipulated on the award letter. Applicant’s signature Date Supervisor’s / line Date manager’s signature
Url: /Media/Southampton-Clinical-Research/Downloads/ETD-Funding-Call-application-form.pdf

Institutional information_2022-23_final

Description: Institutional information – key facts for inclusion as appropriate Support statements must be personal to your application to avoid the same document being submitted for different people from the same source. The NIHR have fed back that they expect tailored and personal statements of organisational support so, if you use some of the text below, it needs to be refined to connect with your own situation, context, focus of project, career to date and plans for the future. You should also check with the relevant NIHR infrastructure in advance of submission that they are happy to support you and/or be mentioned in your submission as in some cases the NIHR (and other funders) will email the infrastructure director following your submission to confirm they support your application. Brief information that describes research excellence of both organisations pertinent to your proposal is generally required. Start with your substantive employer, and then weave in the honorary organisation. Work up as a Word document in conjunction with your supervisor. Submit to relevant School, Faculty and/or Trust division/care group/department to the named person who will confirm participation on the system and may, for some schemes, have to make the final submission on behalf of the host institution. This might be the Faculty Associate Dean for Research, Deputy Head of School (Research) or relevant Head of Department or Care Group. They should review, augment and discuss the text with you, as necessary. University – generic information You are not expected to use all of this generic information. Recent feedback from the NIHR says they really don’t want reams of text extolling the virtues of the institution, but rather it should be personalised to the applicant and the project. Think carefully how you demonstrate the excellence of your chosen academic partner in your chosen area of research. The University of Southampton’s outstanding research and impact has been recognised in the Research Excellence Framework (REF 2021) results. Research by 1,412 Southampton academics – comprising 3,227 research outputs, 104 impact case studies, and 25 environment statement. Ninety-two per cent of the University’s research has been classed as ‘world leading’ (4*) or ‘internationally excellent’ (3*), placing Southampton in the top 10 per cent of submitting institution and ranked seventh among universities that submitted to more than one Unit of Assessment (‘non-specialist’ universities) across the sector. The University of Southampton is a founding signatory of the Athena SWAN Charter. The University holds a Silver Athena SWAN award (attained in 2016) and is seeking Gold. The University of Southampton Doctoral College provides a focal point for the training and development of researchers across the university who are enrolled on a PhD programme. In addition, the Centre for Higher Education Practice (CHEP) provides opportunities for the academic professional development of all staff, (research and education), particularly through access to references and resources. UK league table rankings ➢ 13th overall and 2nd for Physiotherapy with 14 subject areas in the top 10 in The Complete University Guide 2023 ➢ 16th in The Times and The Sunday Times Good University Guide 2023 ➢ 16th overall and 1st for Electronic and Electrical Engineering, and Physiotherapy - with a total of 13 of subject areas in the top 10 in The Guardian University Guide 2023 International league table rankings ➢ 77th in the QS World University Rankings (2022) ➢ Three subjects in the global top 50, according to QS World University Rankings by Subject 2021: Nursing (9); Statistics & Operational Research (33); Geology (50) ➢ Also in the top 100 globally, according to QS World University Rankings by Subject 2021: Archaeology, Civil & Structural Engineering; Earth & Marine Sciences; Electrical & Electronic Engineering (62nd out of 503); Geography; Geophysics; Mechanical, Aeronautical & Manufacturing Institutional information_2022-23_final -1- Engineering (75th out of 500); Medicine (88th out of 650); Physics & Astronomy (66th out of 601); Psychology and Social Policy & Administration ➢ 108th in the Times Higher Education (THE) World University Rankings 2023 and 12th among UK universities listed. Explore the full World University Rankings and UK Best Universities ➢ 11th in Times Higher Education's (THE) 'Golden Age' universities 2020 - the top 200 institutions founded as universities between 1945 and 1967. Southampton is second among the UK universities featured. Learn more at timeshighereducation.com Student satisfaction The National Student Survey (NSS) gathers feedback from mainly final-year undergraduates about their time in UK universities. Highlights from the NSS 2020 results include: ➢ 84.7% of our students were satisfied with the overall quality of their course ➢ 84.5% of our students were satisfied with the teaching on their course ➢ 85.8% of our students were satisfied with the learning resources provided by the University ➢ 89.3% of our students agreed that staff were good at explaining things ➢ 87.7% of our students agreed that their course was intellectually stimulating Knowledge Exchange Framework (KEF2) The University of Southampton’s outstanding business and public engagement has been recognised in the second Knowledge Exchange Framework (KEF2). The University’s strengths in public engagement, business partnerships, IP commercialisation and entrepreneurial activities – including graduate start-ups – have been recognised as amongst the best in England. Southampton achieved a top rating (‘very high engagement’) in four of seven areas of assessment: ‘Working with business’, ‘Working with the public and third sector’, ‘Intellectual Property and commercialisation’ and ‘Public and community engagement’. Southampton achieved the second highest rating ('high engagement’) in the other three areas: ‘Research partnerships’, ‘Local growth and regeneration’ and ‘CPD and graduate start-ups’. These results place Southampton at or above the average in all perspectives amongst the cluster of 17 very large, research-intensive and broad-discipline English universities. In partnership with University Hospital Southampton A foundation of its success has been the strong partnership between the University of Southampton and University Hospital Southampton. The relationship draws strength from the very best of Southampton’s basic science research in biomedicine, psychology, social sciences, electronics and computer science and mathematics and allows us to continually pursue excellence in health and social care research, education and professional practice. University Research group This is by far the most important bit. Describe the research group/department and key people in it who will support the fellowship holder, how the research project and person will be aligned with this focus and expertise, describe any facilities and resources available and what ‘support’ you will get from group, e.g. seminars, departmental meetings, being part of doctoral and post-doctoral community. School of Health Sciences Generic information The School of Health Sciences in the Faculty of Environmental and Life Sciences is internationally acknowledged as the leading centre for research in Nursing, Allied Health Professions, and Health Sciences Institutional information_2022-23_final -2- in the UK. Nursing at the University of Southampton is ranked fifth in the world and second in the UK (QS rankings 2022). The Complete University Guide (2022) ranks Occupational Therapy at Southampton as third in the UK and Physiotherapy as first. The School delivers world-leading health and care research to improve the health and wellbeing of the people of Wessex, the UK and beyond. All aspects of the School’s research environment were judged in REF 2021 to be conducive to producing research of world-leading quality and enabling outstanding impact in terms of its vitality and sustainability. The panel noted clear and concise strategic direction of research, particularly in clinical partnerships, sustainability and ongoing development of international collaborations. 93% of our research outputs were judged to be of internationally excellent or world-leading quality in terms of originality, significance and rigour. 80% of research impact case studies submitted were judged to have led to outstanding impact in terms of their reach and significance. These excellent results confirm our position as a leading research-intensive School. The School’s research strategy is based on strong links with the NHS and other healthcare organisations in collaboration with leading figures from a range of clinical professions, and research. Our research also helps to prepare the healthcare leaders of the future feeding into the School’s educational and enterprise programmes, and vice versa, giving our students the opportunity to work with cutting-edge research teams, in four research groups: Active Living; Health Needs; Fundamental Care and Health Work. https://www.southampton.ac.uk/healthsciences/research/index.page Clinical academic development Our Health Sciences academics have a long history and leading track record in nurturing and supporting nurses, midwives and AHPs (NMAHPs) across the entire career trajectory from pre-doctoral to senior investigator, within a strong culture of inter-disciplinary research. We have a leading role with the NIHR ARC Wessex and within the School of Health Sciences are strongly committed to supporting a range of fellowships (e.g. NIHR, Diabetes UK, Versus Arthritis UK, UKRI, Wellcome, ESRC). From 2014 to 2021, we have extended and expanded our post-doctoral clinical academic capacity for NMAHPs (45 awards: Senior Investigators, Senior Fellowships, Advanced Fellowships, Senior Clinical Lectureship, Clinical Lectureship) and 51 NIHR, ARC and School/Trust partnership funded clinical academic PGR students have been awarded. Since 2006, we have supported many internships and NIHR funded MRes studentships (108 awards, to 2021), successfully building capacity in research knowledge as a pre doctoral pipeline. XXX will benefit from career development support specific to non-medical clinical academic career pathways. They will participate as part of our larger clinical academic team of senior researchers, Early Career Researchers and PhD students in additional activities that focus career development. They will also work alongside the established multidisciplinary researchers housed in the clinical academic facility, funded through URKI and EU projects e.g. EU Marie Curie Integrated Training Network ‘STINTS’. The purpose-built facility provides open plan research space, conference rooms and specialist laboratories to support research (including a biomechanics laboratory, imaging facilities and a CAT2 biochemistry lab). For inclusion in Doctoral fellowship applications: In addition to the Doctoral College training focused on transferable skills and employability, we offer a Health Sciences doctoral training programme. This consists of the taught component of the MRes, with modules focused on clinical and health research, specifically design & methods, conducting research, planning research, quantitative and qualitative methods from the clinical and health research perspective. In addition, we run regular PGR student forum sessions which provide more in-depth discussion on topics requested by the students, for example ethics and approvals, patient and public involvement. Finally, students are invited to attend the Health Sciences seminar series and have opportunities to present via their research groups. Faculty of Medicine Generic information The Faculty of Medicine leads innovative learning and discovery for better health across the life course. The Faculty aims to establish its reputation as an internationally recognised Medical School (placed =71st in the 2022 QS global subject rankings), and to secure its place as one of the UK’s leading Medical Schools, building upon three distinctive features: our strong partnership with the local NHS (particularly University Hospital Institutional information_2022-23_final -3- Southampton NHS Foundation Trust - UHS) to deliver translational research and equip the next generation of doctors to work in a rapidly‐changing environment; collaborations at the life sciences interface with engineering, mathematics, computing, chemistry and nanotechnology; and exploitation of the enterprise agenda to maximise the impact of our education and research. Our research will focus on four key approaches: • Combining basic mechanistic and clinical research to deliver internationally-leading research and resultant outputs • Early clinical translation, utilising and fostering links with the NHS • Interdisciplinary collaborations, through the UoS Institute for Life Sciences (IfLS) • Enterprise and innovation Our research falls within five key themes: • Cancer Sciences • Healthy Ageing and Multi-Morbidity • Infection and Microbial Science • Developmental Sciences and Regenerative Medicine • Population Science Supporting these themes are five cross-cutting research methodology platforms that guide investment in equipment, core facilities and technical support: • Cell Biology & Chemistry of Life • Immunology • Clinical Trials & Experimental Medicine • Systems Biology • Data Science We are proud to host research centres/units which are fully integrated within the Faculty and our strategy. These are: • The Centre for Cancer Immunology and the NIHR CRUK Experimental Cancer Medicine Centre (ECMC) • Southampton Centre for Biomedical Research incorporating the NIHR Southampton Biomedical Research Centre (BRC) and the NIHR Southampton Clinical Research Facility (CRF) • NIHR Wessex Applied Research Centre (ARC) • NIHR School for Primary Care Research • NIHR and Cancer Research UK Southampton Clinical Trials Unit • MRC Lifecourse Epidemiology Centre (MRC LEC) • Versus Arthritis-MRC National Centre of Excellence for Musculoskeletal Health and Work The Faculty also has three major enterprise units, which are pivotal in Faculty activities. These are the the School of Healthcare Enterprise and Innovation, The NIHR Research Design Service South Central and the Clinical Informatics Research Unit (CIRU). Clinical academic development The Southampton Clinical Academic Training Scheme (SoCATS) brings together the Faculty of Medicine and Health Education England-Wessex (HEE-W) to support the development our Specialised Foundation Programme (SFP) trainees, Academic Clinical Fellows (ACFs) and Clinical Lecturers (CLs). SFP trainees involved with research are provided with monthly training throughout year 1 on research methods. There is a four-month rotation in year 2 for an academic placement with hands-on research. Institutional information_2022-23_final -4- ACFs and CLs can access a wide range of training opportunities (research methodology, epidemiology, statistics, etc.) to support their development. Trainees can also access workshops on scientific writing, abstract writing, poster presentations, supervisory skills and research impact. Professional development workshops include time management, leadership skills, building/managing research teams, public engagement, and teaching skills. Mentoring for clinical academic trainees is facilitated via the Faculty Mentoring Scheme. ACFs and CLs can access funding to attend conferences to disseminate their research findings, as well as other research related events. Financial support is available to fund training to support academic development. As a result of the rigorous scientific training received many of our former or current ACFs and CLs have made significant discoveries in their field of research and have published these findings in international journals. This includes publications in Lancet, Nature Medicine, Nature Genetics, British Medical Journal, Lancet Oncology, Lancet Infectious Diseases, Lancet Diabetes and Endocrinology, Proceedings of the National Academy of Sciences USA, Gut, American Journal of Respiratory and Critical Care Medicine, Journal of Allergy and Clinical Immunology, Journal of the National Cancer Institute, Cancer Research, Clinical Cancer Research, Brain, Blood, and many other reputable journals. Career progression through fellowships is supported via three Fellowship Champions and six Fellowship Mentors based within the Faculty. The University Research and Innovation Services team provide bespoke advice and assistance with fellowship and grant applications. Since the inception of our Integrated Academic Training programme over 100 NIHR funded ACFs have completed their ACF with the majority continuing research once their post has come to an end. We have an excellent track record of CLs being awarded intermediate or advanced fellowships, including Career Development Fellowships (NIHR, MRC, Pathological Society, Fulbright Scholarship), Postdoctoral Fellowships (NIHR, Wellcome Trust) and Clinician Scientist/Advanced Clinician Scientist Fellowships (CRUK, MRC). SoCATS has a network of Academic Leads who can provide information specific to their specialty. Details of academic leads can be obtained via our SoCATS website (https://www.southampton.ac.uk/socats/index.page). NOTE – Further information on SoCATS can be found on our website and Intranet site (UoS login required). Transferable Skills Programme, peer support and wider university participation Our transferable skills programme provides a wide range of training opportunities for our Postgraduate Research Students, Postdoctoral Researchers, and clinical academic trainees. The programme has been developed in line with the national Researcher Development Framework. It includes a range of workshops, varying from one hour to one day in duration covering topics including abstract and poster presentations, scientific writing, presentation skills, mentoring and interview skills. A range of online training materials are also available. Postgraduate research students are represented on many University and Faculty committees. They are encouraged to raise issues or make suggestions through their representatives. Students enrolling at the start of the academic year benefit from interacting with staff and other PGR students at the induction day and subsequent FoM training programmes. Opportunities for further meetings are provided throughout the year via this training programme and also by attending School seminars and biannual student fora. Institutional information_2022-23_final -5- UHS Trust – generic information Again you don’t have to use all of this – refer to relevant areas as needed and specific to context of your own research and situation. So if you are doing research that aligns with expertise and focus of the BRC for example, mention that, and what the BRC will offer in terms of support and development. University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England, with a staff of 13,000 with a turnover of more than £1bn (2020-21). It provides hospital services for 1.9 million people living in Southampton and southern Hampshire and specialist services including neurosciences, respiratory medicine, cancer, cardiovascular, obstetrics and specialist children’s services to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. UHS gained foundation trust status on 1 October 2011. Every year, our staff see more than 650,000 people at outpatient appointments, deal with 150,000 attendances in the emergency department, and treat around 160,000 inpatients and day patients, including over 75,000 emergency admissions. In addition, the Trust delivers more than 100 outpatient clinics across the south of England to keep services local for patients. Research is an integral part of University Hospital Southampton’s mission to constantly improve and be able to offer better care to our patients. The Trust’s Research Strategy (2017-2022) “Research for All”, and UHS Clinical Strategy (2020-2025) lay out the Trust vision that research is fundamental to everything we do, embedded in the delivery of care. One of the UK’s largest University Hospitals, UHS is overall fourth highest recruiting NHS Trust for recruitment and complex weighted recruitment: 246,135 participants have been recruited into CRN portfolio studies from 2008-2022 (46,129 recruited to interventional studies; 7846 to commercial studies, ranking UHS as 7th nationally). Between 2009-2021, participation in interventional trials increased from 3% to 30% of overall annual recruitment activity. To date, UHS has opened 4512 portfolio studies and is top NHS Trust nationally for number opened. For 2021-22 specifically, UHS was ranked 8th for overall recruitment, 3rd for complexity weighted recruitment, and 10th for commercial recruitment, with 14,567 participants in both CoVID and non-CoVID research. The University of Southampton (UoS) and University Hospital Southampton NHS Foundation Trust’s (UHS) research partnership extends from fundamental laboratory based science, through joint management of large-scale, externally funded translational research infrastructure, to collaborative implementation of research interventions into practice. The partnership has in place a strategic agreement and robust governance designed to govern and contract for their frequent research collaboration. The partnership is realised through a combination of joint strategic investment, a physical University presence within the Trust at Southampton General Hospital and a collaborative approach to working. This essential base for the University at the heart of the NHS ensures it is positioned to undertake timely and relevant research into service provision and intervention, informed by collaboration with clinical colleagues at the forefront of NHS practice. The two institutions seek to foster a collaborative approach to research, through joint working arrangements, the sharing of best practice, and regular operational and strategic steering groups, in an administrative, academic and clinical context. UHS is committed to developing a culture of inclusion, diversity and belonging. The ‘Actionable Allyship’ programme is being rolled out across all staff, encouraging confidence to have positive discussions around all aspects of inclusion and belonging, and to challenge microaggressions and inequalities in the moment. Additional health and wellbeing support measures for staff were implemented in response to the COVID-19 pandemic, including designation of a wellbeing guardian on the board of directors. The Clinical Informatics Research Unit has achieved much in the field of health service data research and has developed the EDGE Clinical Research Management system enabling investigators nationwide to manage their clinical research data optimally. The Trust has a dedicated grants team who can provide advice and support on aspects such as managing the research grant, looking after the budget and developing an annual report of progress. Institutional information_2022-23_final -6- Material on your clinical department Ask your supervisors and other senior academics who are in the dept and clinical mentors to support this section. Describe the ethos, culture and research and innovation strengths of particular dept and the Trust as a clinical centre of excellence. Mention if, for example, there are seminars or research group meetings that you can access. Also, the presence of medical academic clinical fellows, other nurse/AHP clinical academics and medical senior investigators who will support and encourage. Southampton NIHR infrastructure – generic information If your research is aligned with the BRC or the NIHR ARC Wessex make sure you talk to the training lead of the relevant bit of BRC (Nutrition – Mark Johnson, Respiratory – Karl Staples, Cross cutting themes of behavioural, antimicrobial and data science – Kay Mitchell), or NIHR ARC (Alison Richardson, Director of NIHR ARC Wessex) and they can help you add text about ‘trainee’ support as relevant to your area of focus. Embedded in the heart of the hospital is the NIHR Clinical Research Facility (CRF) (2022-2027 award £10.5m) which has facilitated over 1850 studies in 31 specialities, hosting over 161,000 participant visits since 2001. Here, early phase studies can be delivered safely in either the inpatient or outpatient setting. Within the CRF is a dedicated laboratory for processing and storing of study related samples with full barcode tracking. A satellite CRF Vaccine Hub was established in 2020 in response to the COVID-19 pandemic that, together with the main site, supported over 8800 visits across 11 COVID vaccine studies in 2020-21 and the ACCORD/AGILE national early phase platforms. The Southampton Clinical Trials Unit is an NIHR support funded and Cancer Research UK core funded UKCRC registered CTU with expertise in the design, conduct and analysis of clinical trials and other well designed studies. Since August 2013 the SCTU has recruited over 10,000 patients into trials, coordinated over 50 studies, and driven major advances in cancer areas including urology, breast, gastro-intestinal and thoracic oncology , and lymphoma and non-cancer areas including primary care and respiratory medicine. Wessex Investigational Sciences Hub (WISH) laboratory is a Good Laboratory Practice regulated immunology laboratory with genomics and molecular microbiology facilities. Part NIHR funded, it is a quality-regulated research environment and is approved by several external governance bodies. It hosts the CR UK Experimental Cancer Medicine Centre, unique in the UK for its focus on immunotherapy and immunomonitoring, in addition to the Wessex NHS Genomic Medicine Centre. The NIHR Southampton Biomedical Research Centre (BRC) (£25m award 2022-2027) brings together five themes (Nutrition, Lifecourse and Metabolism, Respiratory and Allergy, Data health and Society, Microbiology, Immunology and Infection and Perioperative and Critical Care), two core partners (University Hospital Southampton and University of Southampton) and a network of collaborations across Wessex, the UK and internationally. Our vision is to enhance health and quality-of-life by improving resilience to disease, injury and the consequences of ageing across the lifecourse through translation of world-class experimental medicine combined with our seven foundational principles of focus, integration, democratisation, personcentredness, inclusivity, collaboration and efficiency. NIHR Applied Research Collaboration Wessex (ARC) (original award 2019-2024, £9m, since increased, plus £7.5m ECR dementia research) is a partnership between the NHS, three universities, charities, local authorities, and other organisations within the Wessex region. The ARC Wessex programme of research addresses four areas related to the health and social care needs of our community: Ageing & Dementia, Healthy Communities, Long term Conditions, Workforce & Health Systems alongside a Mental Health hub. Academic career development forms a central component of the ARC Wessex strategy to develop the research skills and talents of the ARC Wessex community and make a substantial contribution to fostering a world class research environment in applied health and social care research. XXX will become a member of our Academy (200+ members) which offers a diverse and collaborative network by which we pool resources to support a variety of events, regular ‘check-in’ meetings and have set up on-line resources and top tips for Academy members to remain connected throughout the course of their awards and beyond. The University of Southampton’s Primary Care Research Centre is a member of the NIHR School for Primary Care Research (SPCR). NIHR research schools are national collaborations between leading academic centres that fund research in primary care, public health and social care. This new phase of the SPCR has an explicit Institutional information_2022-23_final -7- aim to strengthen the primary care research sector more broadly, covering sectors such as community nursing and pharmacy as well as general practice. Funding of £22 million started in April 2021 for a five year period. The NIHR Research Design Service South Central provides research design and methodological support to researchers, including qualitative research, health economics and PPI capabilities. The RDS also delivers training including an annual NIHR focussed grant application workshop. Sited at Southampton General Hospital, the region covers Southampton, Portsmouth and Oxford. These centres amount to significant NIHR investment and come together to form the supporting pillars of the Southampton clinical research partnership. Southampton Academy of Research (SoAR) - generic information SoAR is Southampton’s university/Trust partnership’s pan professional hub for health-related research career training and development. The existence of the Academy is evidence of how seriously the Trust is committed to research capacity building. SoAR supports the development of policies relevant to researcher career development across the Trust/University partnership to ensure both parties work in ways that meet the NIHR principles and obligations statement. SOAR benefits The applicant (name) will be able to take advantage of the resources and support offered by the Academy, which includes: • Engagement with other early career researchers, across professions and disciplines, facilitated by named Early Career Research Champions. • Access to a named Academic Career Development Lead for career advice and support. • Short, free training courses addressing practical researcher development skills such as writing pathways to impact statements, writing quality papers, networking and influencing strategies. • Access to a competitive training and education fund for support to attend conferences or access specific training courses. • A winter and summer school of addressing aspects like time management, collaboration, researcher well-being. • A quarterly newsletter including training, fellowship and development opportunities. • Support to source an appropriate mentor. • Support to navigate and problem solve any challenges that might arise in working across the Trust/university interface. • Drop-in sessions for information and advice on career development. Institutional information_2022-23_final -8- APPENDIX Example support statements 1. With kind permission of Alasdair Munro: I am delighted to support Alasdair Munro’s application for a Clinical Research Training Fellowship and will provide senior mentorship during the duration of the award. Alasdair is an ideal candidate for an NIHR training fellowship which will be conducted using equipment provided by the new £2.8 M. NIHR antimicrobial resistance capital award to Southampton. He gained a first-class honours degree from the University of Southampton and was an outstanding student. Alasdair has progressed rapidly and seamlessly through the clinical training pathway, gaining a national training number in paediatric medicine and his MRCPCH. He has demonstrated a clear interest in clinical academic medicine since his medical student project where he excelled in a project requiring complex data analysis. He has been self-motivated in conducting clinical research projects that he has published while in clinical training posts, including in the area of real-world diagnostics. He was appointed against strong competition for his current post as NIHR Clinical Research Facility fellow, and has impressed us greatly. In his current post, Alasdair has shown great energy and ability, leading on the set up of complex noncommercial and commercial phase 1 trials of antibiotics and new vaccines. He has taken an interest in biofilm infections and diagnostic technologies, writing a review and working across Faculties to put his Fellowship proposal together. This clinical feasibility study will translate a new imaging solution for diagnosing resistant bacteria in biofilms, which fits very well with his clinical training and interest in diagnostics. Alasdair has developed the proposal himself, working with his supervisors to carry out a PhD aligning with both the current national/global priority area of preventing antimicrobial resistance and to current expertise and interfaculty work at the University of Southampton, Southampton BRC/CRF and National Biofilm Innovation Centre. Alasdair will be supported by an excellent supervisory team at the University of Southampton, each an emerging leader in their respective fields. Saul Faust is Director of the NIHR Clinical Research Facility who leads the Faculty of Medicine and BRC input to the National Biofilm Innovation Centre (NBIC). Jeremy Webb is an international authority on pseudomonal biofilms who is co-chief investigator NBIC, itself hosted by the University of Southampton. Sumeet Mahajan is a global academic leader in Raman spectroscopy and engineering. This Fellowship will give Alasdair an excellent training in cutting edge technologies and interdisciplinary research that can be widely applied to address human disease. We clearly need to mentor and develop such translational clinical scientists to harness the potential of emerging technologies. Alasdair’s strong academic background and stage in his clinical training makes him an ideal candidate for an NIHR Clinical Doctoral Fellowship to develop such skills. 2. With kind permission of Andrew Bates: We first became aware of Andrew during his work at Royal Bournemouth Hospital. He took responsibility for delivering our Fit4Surgery portfolio, recruiting significant participant numbers with exceptional commitment, desire and dedication. Andrew secured an HEE/NIHR Internship award, further establishing our partnership as we hosted his research placement during this successful and productive programme. We quickly understood his potential and valuing his contributions, we developed a 12-month secondment. He has become an integral member of the Critical Care Research team, so we have been delighted to appoint him on a permanent basis, as research manager. This is a Clinical Academic Post. He is developing a translational clinical service and managing a team of junior research staff. We are committed to supporting a 50:50 clinical: fellowship role. With our support, we feel he has the attributes and desire to forge a leading clinical academic career within this exemplar service. Institutional information_2022-23_final -9- Given his extensive experience of research delivery and management, we gave serious consideration to steering Andrew towards a doctoral training programme. On reflection, we felt that developing Andrew’s individual research identity and relevant methodological skills would be better served through the PCAF level award. Andrew’s PCAF programme will be hosted by a partnership between University Hospital Southampton and University of Southampton. This established research partnership has enabled the Southampton Academy of Research to harness the potential of our health-related research workforce, driving the next generation of clinical discoveries and supporting them to advance knowledge and improve care. While keeping his primary hospital contract, Andrew will gain access to training, facilities and networking opportunities at the University, via an extension of his established honorary contract. The Faculty of Medicine and School of Health Sciences will collaborate with the NIHR Southampton Biomedical Research Centre, Critical Care Research Area, to ensure that he receives the highest quality of support. The School of Health Sciences is internationally acknowledged as the leading centre for research in Nursing, Allied Health Professions, and Health Sciences in the UK, with a strong track record with NIHR personal awards. The School’s aim is to build and sustain world-leading applied health research that will lead to real improvements in health care. Research environment and research impact were both rated world-leading (4*) in REF 2014. The School has an excellent reputation for cutting edge multidisciplinary research based on strong links with the NHS and other healthcare organisations. The research strategy is aimed at generating the highest quality research and making a real difference to people’s lives. The Faculty of Medicine leads innovative learning and discovery for better health across the life course and is an internationally recognised Medical School (placed in the top 100 in 2014 in the QS global subject rankings). To secure our place as one of the UK’s leading Medical Schools, we are building upon three distinctive features: our strong partnership with the local NHS providers, to deliver translational research and equip the next generation of healthcare professionals to work in a rapidly-changing environment; collaborations at the life sciences interface with technology; and exploitation of the enterprise agenda to maximise the impact of our education and research. The Faculty’s transferable skills programme will provide a wide range of training opportunities for Andrew. The programme has been developed in-line with the Vitae Researcher Development Framework. It includes a range of workshops including scientific writing, presentation skills, mentoring and interview skills. The Critical Care Research team is a group of clinicians and clinical scientists engaged in research to meet key unmet needs in critical illness across the life-course, with particular attention to the acute patient pathway, of which Andrew has vast clinical, teaching and now research experience. Fit4Surgery is a world-leading clinical and research programme, aiming to improve patient outcome throughout their surgical journey. Leadership from internationally renowned Professors, Mike Grocott, Sandy Jack and Denny Levett with whom Andrew already has close working relationships, will provide a fertile environment for his PCAF and subsequent research career development, in this, his chosen field for research. We believe that the quality of his clinical academic support is assured, not just by our institutional track record in delivering research and supporting clinical academic development, but also by the quality of his confirmed supervisor/ mentorship team. Andrew’s principal academic mentor is Associate Professor Steve Wootton. Dr Wootton is the infrastructure and training lead of NIHR Southampton Biomedical Research Centre and a member of the NIHR Trainees Coordinating Centre. He has played a leading role in the design and delivery of principal national educational initiatives. He has successfully supervised to completion 18 PhD and 4 MD students. He will take primary responsibility for ensuring that, post-PCAF, Andrew is equipped to deliver the highest quality of application for the NIHR Doctoral Fellowship Programme. Dr Chloe Grimmett is an NIHR post-doctoral fellow, working out of University of Southampton School of Health Sciences. She has a strong research track record. With established expertise in qualitative methodology, she will support Andrew’s key methodological training need. Her support ensures the involvement and collaboration of the FoHS. As an NIHR award holder, Chloe will mentor Andrew’s progression through this career pathway. Institutional information_2022-23_final - 10 - Kay Mitchell is a critical care nurse researcher with significant personal research output and experience in promotion of clinical academic careers for healthcare professionals. She is a founder member of Southampton Academy of Research a research partnership which is focussed on developing an integrated approach to training and career development. Andrew will be welcomed into this network, provided with key training and networking opportunities. Kay is a newly appointed 70@70 Senior Nurse Leader, leaving her as a perfectly placed mentor to develop Andrew’s PCAF programme to doctoral fellowship and beyond. We have been consistently impressed with the quality of Andrew’s work, driven by hard-work and determination to forge a successful clinical academic career. This is matched by our determination to support this aspiration. We feel confident that our collaborative efforts will result in Andrew delivering a successful fellowship and subsequent progression through the HEE / ICA programme. Institutional information_2022-23_final - 11 -
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