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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
Url: /Media/UHS-website-2019/Docs/PaediatricOncology/beacon-protocol-v8.0-07mar2023-signed.pdf

Registering New Studies into the CRF

Description: SCBR University Hospitals Southampton NHS Foundation Trust Standard Operating Procedure for Accepting Registering New Projects Studies into the Southampton NIHR Wellcome Trust Clinical Research Facility(CRF) SOP Number: SCBR/GEN/V31/264 Version Number & Date: V3, 21 Sep 2018V2, 23 May 2016 Superseded Version Number & Date: V2, 23 May 2016V1, 25 Jun 2014 Author: Filipa MartinsStephen Saich Designation: CRF Clinical Research Project Manager Authorised By: Kim Lee Designation: Acting Senior QA Lead, SCBR Expert Authorisation: Designation: Contact Details: Revision Chronology Version Number Date Changes Author, Designation Authorisation, Designation V1 Jun 2014 First written Susan Caddy, Education Lead Chris Blackwell, Senior QA Lead V2 May 2016 Changes on the process of registration of new projects. Changes on responsibilities of individual teams. Filipa Martins, Clinical Research Project Manager Kim Lee Acting Senior QA Lead V3 Sep 2018 Changes to the process of registration of new projects. Changes on responsibilities of individual teams. Changes to the New Projects Meeting format. Stephen Saich, Clinical Research Project Manager Kim Lee Acting Senior QA Lead TRAINING AND IMPACT ASSESSMENT Training needs identified? No Details: No specific training needs have been identified for this procedure. Associated competency assessment required? No Details: No competency assessment has been identified for this procedure. Impact on other SOPs etc? No Details: The formalisation of this procedure does not have a direct impact on the content of any existing SOPs Impact on existing studies identified? No Details: The formalisation of this procedure does not have any impact on existing studies. TRAINING AND IMPACT ASSESSMENT Training (please add “X” to table below as the appropriate training for this SOP) Read and acknowledge on Q Pulse Research Education Agenda Face-to-face training session Associated competency assessment Other If other, please specify. Further Details regarding the documentation of the training: Impact on other SOPs etc? Yes / No (delete as appropriate) Details: Impact on existing studies identified? Yes / No (delete as appropriate) Details: (if it is identified that the SOP will not be introduced retrospectively to apply to existing studies, please state this) 1. Background The Southampton NIHR Wellcome Trust Clinical Research Facility (CRF) is a multi-user facility for supporting clinical research. The CRF has a vital role in facilitating clinical research in a safe and efficient working environment that respects the rights, safety and well-being of research participants and investigators, whilst ensuring that regulatory standards are met. All studies must be registered and formally accepted by the CRF prior to using any of the CRF/BRU/BRC staff, clinical or laboratory facilities. Registering studies ensures that the CRF can maintain oversight of research activities within the CRF, and provide the appropriate levels of support. 2. Purpose This SOP ensures that the full process for registration and acceptance of research studies into the CRF is formalised and documented. 3. Scope This SOP applies to all members of staff who are involved in the process of accepting new projects into the CRF. This includes the CRF Directors and members of the New Projects Team. 4. Responsibilities CRF Directors The CRF Directors hold overall responsibility for the acceptance of studies into the CRF. New Projects Team Members of the New Projects Team are responsible for attending the CRF New Projects meetings. They are also responsible for the review of all study applications, and for giving input in accordance with their role. If actions are allocated to individual members of the New Projects Team following a meeting, then they are responsible for completing these and feeding back at the next New Projects meeting. Specific responsibilities within the New Projects team: 1. New Project ReporterChair The member of staff reporting a new study to the New Projects Meeting isNew Projects Chair is responsible for reviewing the appropriate study documents and the Trial Assessment fForm. CRF Registration Fo The Chair will advise the New Projects Team on the support that has been requested and will lead discussion on whether the support requested is feasible.rm, and for writing a report which they present to the New Projects Team. 2. CRF Project Management Team The Project Management Team are responsible for ensuring that all the appropriate documentation and approvals are in placeis available prior to review by the New Projects Team, and for ensuring that these documents are checked and deemed complete before being passed to the New Project Reporter.meeting record sheets and study information is kept up to date. They are also responsible for the administration duties that are involved with this procedure, and for providing administrative support to the New Project team. 5. Procedure The process for accepting new studies into the CRF can be seen in Appendix A: Flowchart for Accepting New Projects into the CRF. Study submission to the CRF: Investigators wishing to use the CRF to support their research studies must complete a Southampton NIHR Wellcome Trust CRF Registration Form (Available on the CRF website and as SCBR/FORMS/076) and submit to the CRF Project Management Team via the generic email account for study registrations (crf@uhs.nhs.uk). This form clearly indicates the study phase.make this known to the R&D facilitator / divisional research manager setting up their study. On receiving information that an investigator wishes to request support from the CRF for the delivery of their study, the R&D facilitator / divisional research manager should notify the CRF Clinical Research Project Manager or CRF Assistant Project Manager of this request. A copy of the completed trial assessment form should be made available for CRF New Projects Team review. Management of study submissionsCRF support requests: The email account is managed by the CRF Project management team. Upon receipt of Registration Formthe Trial Assessment Form, the CRF Project Management Team will ensure that all registration formsforms are completed correctly and resolve any initial queries that may arise upon study submissioninitial study review. They will then seek to obtain all relevant/additional documents. As a minimum the necessary documents are: * Study Protocol * Consent form * Participant Information sheet(s) * REC application (REC form) and approval status * UHS R&D application (SSiF) and approval status * EPSC Risk Assessment and Dose Escalation Procedures form (if applicable) - Phase I studies only - and approval status Once these documents have been obtained, the Project Management Team will arrange for the study to be discussed at the next New Projects Meeting.The Project Management Team will also ensure that the logistics, CRF resources and finance agreements are in place prior to discussion at the New Projects meeting. Queries and progress status will be discussed in more detailed at the fortnightly CRF Feasibility and study set-up meeting (SCBR/DOC/009: Terms Of Reference CRF Feasibility And Study Set-Up Meeting). Once it has been verified that registrations are complete, the registration documents will be passed to the New Project Reporter. The member of staff who will be the New Project Reporter is determined by the study discipline, and is clarified further in the document Reporter Allocation for New Projects Meeting which can be found on Q-Pulse (SCBR/FORMS/078). The New Project Reporter will review the registration documents and write a report using the New Project Reporter Review Form, which is incorporated in the CRF registration form. The content of this will then be presented at the New Projects Meeting. New Projects Meeting: The New Projects Meeting is separated into two separate meetings, each occurring fortnightly. Studies that require CRF nurse delivery will be discussed at a fortnightly meeting, and studies requesting CRF room and/or lab support only will be discussed at the alternate fortnightly meeting. takes place typically on a weekly basis, and tThe members of the New Projects Team consist of Senior Nursing Staff, CRF Project Management TeamStaff, the Senior QA Lead, Education Lead, and representation from the CRF Lab Team, PPI Officer, Clinical Trials Pharmacy, R&D Communications, CRF Research Fellows and CRF Operations Team. Further details of meetings, membership can be found in the CRF New Projects Meeting Terms of Reference. The CRF Project Management Team will send an email to all the key members of the New Projects team, stating which studies will be discussed, three working days prior to the meeting. The template for this email can be found in Appendix B. The New Projects Meeting will be formally minuted using the appropriate the template New Projects Meeting Record Sheet (SCBR/FORMS/134: CRF New Projects Meeting Record Sheet – CRF Delivered, SCBR/FORMS/135: CRF New Projects Meeting Record Sheet – Room & Lab only07)7). A meeting record sheet will be completed for each study that is discussed. Discussion will be documented using this meeting record sheet. Queries / actions will also be documented and responses will be provided to the New Projects Team remotely, for feedback at the next meeting.This includes a list of the members of the New Projects Team present, the studies that have been reviewed, the outcome of the meeting (i.e.- study accepted or not), any clarifications required prior to acceptance, and the subsequent answers to any queries. Following presentation of the report by the New Project reporter, discussion of the study and requests for CRF facilities and staff, any training needs, QA issues etc will be discussed and documented on the New Projects Meeting Record Sheet. Any clarifications required before study acceptance (and the associated actions needed) will be documented on the New Projects Meeting Record Sheet. If the New Projects Team require any clarification or the resolution of issues prior to their acceptance, then actions should be allocated to the relevant individual in the study team or members of the New Projects Team for completion and feed back at the next New Projects meeting. Assuming that the issues have been resolved satisfactorily,y, the New Projects Team will accept the study. The study can be accepted at this meeting prior to R&D approval being in place. When a study is accepted by the New Projects Meeting then this will be documented and signed off on the New Projects Meeting Record Sheet. Two Meeting Record Sheets will be used, one for CRF nurse delivered studies and another for CRF room and/or lab use only. and signed off on the New Projects Reporter Review Form. Final sign-off / acceptance of studies into the CRF When a study is accepted by the New Projects Team, the registration documents will be given to the Project Management Team to be forwarded to one of the Directors for their review. The study can be sent to the directors prior to R&D approval being in place. Should the Directors have any queries or require any further clarification, these should be directed to the relevant member of staff and addressed accordingly. Queries and issues that have been raised by the Directors (and the associated responses) should be documented by means of a File Note which should be attached to the New Projects Review Form. Following directors signature, the Project Management Team will ensure that the study has R&D approval prior to final acceptance of the study, a signed acceptance letter is sent by the Directors to the study PI, lead nurse & R&D facilitator / divisional research manager – this letter indicates final sign off of the study registration and acts as the CRF’s confirmation that they have the capacity and capability to support the study. (SCBR/DOC/011: CRF Registration Acceptance Letter) Phase I studies registering to use the CRF The CRF Project Management Team is informed by the R&D department of any Phase I studies that are due to take place in the Trust. This process is described in detail on the CRF feasibility and study set-up meeting terms of reference. (SCBR/DOC/009: Terms of Reference CRF Feasibility and Study Set-up Meeting) Any Phase I study that wishes to register with the CRF must also submit an EPSC Risk Assessment form to the CRF Project Management team – via the generic email CRFPhase1@uhs.nhs.uk. The process for EPSC review is set out in the following SOP: Early Phase Safety Committee Review (SCBR/GEN/263). Following approval by the EPSC, the completed risk assessment and Dose Escalation Procedures form (SCBR/FORMS/079, if applicable) should be passed to the Project Management Team for distribution to the New Projects Reporter Chair (alongside all other registration documents), prior to review final sign off by the New Projects Team. Phase 1 studies that are yet to receive EPSC approval will not be sent to the directors for sign off until approval is in place. 6. List of abbreviations/ Definitions CRF = NIHR Wellcome Trust Clinical Research Facility EPSC = Early Phase Safety Committee PIS = Participant Information Sheet 7. Related documents SCBR/FORMS/076: Southampton NIHR Wellcome Trust CRF Registration Form SCBR/FORMS/077: New Projects Meeting Record Sheet SCBR/FORMS/078: Reporter allocation for new projects meeting SCBR/FORMS/134: CRF New Projects Meeting Record Sheet - CRF Delivered SCBR/ FORMS/135: CRF New Projects Meeting Record Sheet - Room & Lab Only SCBR/GEN/263: Review of Phase I Studies by the CRF’s Early Phase Safety Committee (EPSC) EPSC Risk Assessment Form SCBR/FORMS/079: Dose Escalation Procedures form SCBR/DOC/006: Terms of reference CRF New Projects Meeting SCBR/DOC/009: Terms of reference CRF Feasibility and study set-up meeting SCBR/DOC/011: CRF Registration Acceptance Letter 8. References n.a. 9. Appendices Appendix A: Flowchart for Accepting New Projects into the CRF APPENDIX B: New Projects Briefing email Guidelines Appendix A: Flowchart for Accepting New Projects into the CRF APPENDIX B: New Projects Briefing Email Guidelines This email needs to be sent 34 working days prior to the meeting taking place. Key contacts ReporterLead Nurse: AllocatedThe allocated lead nurse reporters for studies due to be discussed at the meeting will be asked to attend the meeting to provide further information and respond to queries (see reporter allocation for new projects meeting doc) Nursing: Senior Nurse ManagerCRF Matron, BRC and Phase 1 Matron, Matron Research & Development, Adult/paediatric/ BRU/BRC and Trust-wide Senior Sisters & Team Leaders or delegate QA: Senior QA Lead Education: Education lead or delegate Facilities: Operations Manager and Assistant Operations Managers Project Management team Pharmacy: Generic email (clinicaltrials@uhs.nhs.uk) Laboratory: Lab Manager or delegate Other clinical staff: CRF Research Fellows PPI Officer R&D Communications R&D Facilitator / Divisional Research Manager Other staff might be added if relevant for projects that are being discussed at the meeting. Email needs to contain the following information: Subject New project meeting - <insert date for the meeting> Content Meeting Date & Time: DD/MM/YY Meeting Venue: <insert room name> New studies to be reviewed: 1. <RHM NUMBER>, Short Title, CRF Support Requested, Allocated to <insert name of reporter> 2. <RHM NUMBER>, Short Title, CRF Support Requested, Allocated to <insert name of reporter> 3. <RHM NUMBER>, Short Title, CRF Support Requested, Allocated to <insert name of reporter> (...) Studies in follow up to be discussed: 1. <RHM NUMBER>, Short Title, Allocated to <insert name of reporter> 2. <RHM NUMBER>, Short Title, Allocated to <insert name of reporter> 3. <RHM NUMBER>, Short Title, Allocated to <insert name of reporter> (...) THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR ENSURING IT IS THE CURRENT VERSION For control copy, please contact the QA Lead Do not make unauthorised copies SCBR/GEN/V23/264 Page 8 of 10
Url: /Media/Southampton-Clinical-Research/CRF-templates/Registering-New-Studies-into-the-CRF.docx

UHS complaint against The Sunday Times upheld by press watchdog

Description: The Independent Press Standards Organisation (IPSO) recently upheld a complaint made by the trust about an article printed in The Sunday Times.
Url: /AboutTheTrust/Newsandpublications/Latestnews/2018/July-2018/UHS-complaint-against-The-Sunday-Times-upheld-by-press-watchdog.aspx

ACCORD-2 example sub-protocol

Description: CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TITLE PAGE Master Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Sub-protocol Number: ACCORD-2-002 Sub-protocol for Candidate Agent: Bemcentinib Study Phase: 2 Sponsor Name: University Hospital Southampton NHS Foundation Trust Legal Registered Address: Southampton General Hospital Level E, Laboratory & Pathology Block, SCBR - MP138 Tremona Road Southampton SO16 6YD, UK Regulatory Agency Identifying Number(s): EudraCT: 2020-001736-95 IRAS Number: 282769 RHM Number: Date of Sub-protocol: 22 April 2020 Version: Protocol Amendment 01 Caution: In accordance with cardiac exclusion criteria, in particular Exclusion 13, drugs known to cause QT prolongation should be discontinued/replaced, with sufficient time (5 half-lives) for washout. Patients in these categories of potential risk should be discussed directly by telephone with BerGenBio: Prof Hani Gabra, BerGenBio Chief Medical Officer: +44 7810 576112 Dr Akil Jackson, BerGenBio Medical Director: +44 7810 575037 Final, 22 April 2020 1 CONFIDENTIAL Sponsor Signatory: ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Professor Tom Wilkinson MA Cantab MBBS PhD FRCP Professor of Respiratory Medicine and Honorary NHS Consultant Physician 22/04/2020 Date Final, 22 April 2020 2 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TABLE OF CONTENTS TABLE OF FIGURES.............................................................................................................4 PROTOCOL AMENDMENT HISTORY .............................................................................5 1.0 SUB-PROTOCOL SUMMARY .................................................................................6 1.1 Overview of Sub-protocol................................................................................6 1.2 Schedule of Activities .......................................................................................8 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 .........................................................................................................12 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro..........................13 2.2 Dose Justification for Bemcentinib...............................................................14 2.3 Human Experience from Trials in Cancer Patients ...................................16 3.0 STUDY POPULATION ............................................................................................18 3.1 Eligibility Criteria ..........................................................................................18 4.0 STUDY ASSESSMENTS AND PROCEDURES ....................................................19 4.1 Efficacy Assessments .....................................................................................19 4.2 Safety Assessments.........................................................................................19 4.2.1 Adverse Events ..................................................................................20 4.2.2 Clinical Safety Laboratory Assessments ...........................................20 4.3 Pharmacokinetic Assessments ......................................................................20 4.4 Pharmacodynamic Assessments ...................................................................20 5.0 STUDY TREATMENT .............................................................................................21 5.1 Conclusions and Risk Benefit Statement .....................................................21 5.2 Bemcentinib Drug Administration ...............................................................21 5.3 Dose Modifications and Toxicity Management ...........................................22 5.4 Prohibited Concomitant Medications ..........................................................22 5.5 Study Drug Information................................................................................22 5.5.1 Study Medication...............................................................................22 5.5.2 Bemcentinib Storage, Dispensing, and Destruction ..........................23 6.0 REFERENCES...........................................................................................................24 7.0 APPENDICES ............................................................................................................26 Appendix 1 Abbreviations ...................................................................................26 Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index ..........................................................................................27 Final, 22 April 2020 3 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator ................................................................28 Figure 1 Figure 2 Figure 3 TABLE OF FIGURES Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells .............................14 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) .....................................................15 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients .............................................................................................................16 Final, 22 April 2020 4 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) PROTOCOL AMENDMENT HISTORY Protocol amendment 01 (dated 22 April 2020) replaces the original sub-protocol for bemcentinib (dated 20 April 2020). The amendment incorporates the following main changes: • A change of Sponsor, from BerGenBio ASA to University Hospital Southampton NHS Foundation Trust, with a corresponding change to the named Sponsor signatory. • Addition of exclusion criterion for clinically significant hypokalaemia. • Clarification that for the exclusion criterion of inability to swallow capsules, administration via nasogastric tube is permitted. • Clarification that the physical examination at screening includes height and weight (this is part of the Master Protocol). • Addition of samples for cytokine analysis and PBMC phenotyping on the Schedule of Activities (this is part of the Master Protocol). • Removal of specific blood volumes from the Schedule of Activities. • Clarified that analysis of inflammatory cytokines is part of the Master Protocol. • Clarification regarding known adverse events for bemcentinib. Final, 22 April 2020 5 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.0 SUB-PROTOCOL SUMMARY 1.1 Overview of Sub-protocol Bemcentinib is a small molecule AXL kinase inhibitor developed by BerGenBio ASA (the candidate agent owner) which has demonstrated potent and selective inhibition of AXL in biochemical and cell-based kinase inhibition assays. AXL is a recognised therapeutic target for the treatment of cancer. AXL regulates cancer cell survival and immunosuppressive modulatory effects, particularly in driving immunosuppressive features of the innate immune compartment in the tumour microenvironment, including activation of the myeloid derived suppressor cells, the M2 macrophage state, and suppressor regulatory dendritic cells that inhibit activated T cell function. Further, AXL is an important negative regulator of type I interferon (IFN) responses that are important for anti-cancer treatments. Bemcentinib is currently being developed for the treatment of cancer, particularly in non-small cell lung carcinoma, acute myeloid leukaemia (AML), myelodysplastic syndrome, and other cancers. The AXL receptor mediates entry of enveloped viruses such as Zika and Ebola through “apoptotic mimicry”. Phosphatidylserine (PS) on the viral envelope is tethered to AXL by its bound ligand, growth arrest-specific 6 (GAS6), leading to viral internalisation. Viruses also activate AXL signal transduction that antagonises anti-viral type-I IFN responses. Preclinical data show that AXL-mediated internalization and IFN suppression may extend to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and that bemcentinib can inhibit coronavirus entry and replication. The hypothesis is therefore that bemcentinib is a potentially effective treatment for COVID-19 disease. Additionally the Sponsor’s understanding of the mechanism supports testing the hypothesis that bemcentinib may be an effective preventive/prophylactic therapy for COVID-19. This sub-protocol describes the approach for study conduct of the bemcentinib arm within the ACCORD-2 multicentre, Phase 2 adaptive randomisation platform study to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised patients. Key differentiating features of this sub-protocol include the following: (a) Bemcentinib is an oral 100-mg capsule, recommended Phase 2 dose (RP2D) is 200 mg given once daily, following a loading dose (400 mg) given once daily for 3 days. Although the Master Protocol plans for 15 days of treatment, this sub-protocol can provide up to 21 days of bemcentinib treatment if required for patients. (b) A specific eligibility criterion has been added to exclude patients based on electrocardiogram (ECG) QT interval on screening above 450 msec (a lower exclusion limit than that stated in the Master Protocol, 500 msec), as well as significant cardiac comorbidity. Any concomitant medication with QT prolongation risk must be stopped at screening and direct discussion between the investigator and Sponsor Medical Monitors will allow support in risk management. Serial ECG measurements have been added in Final, 22 April 2020 6 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) order to pragmatically monitor any QT interval change with bemcentinib, coupled to a sparse pharmacokinetic (PK) sample schedule, in the hospitalised COVID-19 population. Within the clinical development programme to date, over 286 patients have been treated without any observed cardiac adverse events (AEs). (c) Translational and pharmacodynamic (PD) sampling is included in this protocol. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. (d) Selected secondary endpoints from the Master Protocol will be considered as key secondary endpoints for the purposes of this sub-protocol. Final, 22 April 2020 7 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.2 Schedule of Activities Screening Baseline Day (± Window) ELIGIBILITY Informed consent Demographics Relevant medical historyb Review SARS-CoV-2 diagnostic tests Inclusion and exclusion criteria STUDY INTERVENTION Randomisation Administration of bemcentinibc Treatment with SoC STUDY PROCEDURES Clinical frailty score Diagnostic imaging (X-ray and/or computed tomography) Physical examination (including presenting symptoms, height, weight) Targeted physical examination (focused on lung auscultation) Day -1 or Day 1 Day 1 X X X X X X Days 1-3 400 mg loading daily X X X X Daily Until Hospital Discharge X 200 mg maintenance X X Day 15a (±2 days) X Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Final, 22 April 2020 8 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Vital signs, including oral temperature, pulse rate, blood pressure, respiratory rate, SpO2 Clinical assessmentse Targeted medication review (including use of vasopressors) Adverse event evaluation Disease-related co-infection evaluation (including microbiologic/infectious agent assessment/results; bacteria, viral, fungi) Survival status Blood gases and FiO2 at worst PO2f 12-lead ECGg SAFETY LABORATORY Haematology, chemistry, liver function tests, coagulationh Pregnancy test for females of childbearing potential RESEARCH LABORATORY Blood (SST) for exploratory inflammatory cytokine analysis Blood (sodium heparin tube) for PBMC phenotypingl Day -1 or Day 1 X X Xi Xi Day 1 Xd Xd Xd X X X X X Xd,j X X Daily Until Hospital Discharge X X X X X X X See schedule belowg Days 3, 5, 8, 11 (all ±1 day) if hospitalised Day 8 Day 8 Day 15a (±2 days) X X X X X X Xk X X Day 29a (±3 days) X X X X X Xk X X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) X X X X Final, 22 April 2020 9 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Day -1 or Day 1 Day 1 Daily Until Hospital Discharge Day 15a (±2 days) Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Blood (EDTA) for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Oropharyngeal/nasal swab for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Saliva for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Blood (SST) for SARS-CoV-2 serology research (host response) X Day 8 X X X Blood (PAXGENE) for transcriptome analysis (host genome)m X Day 8 X Blood (EDTA) host genome (host DNA)m X Mid-turbinate nasal swab viral genomem X Blood samples for PD and translational studiesn X See schedule belown X X X PK samplingn X See schedule belown X ECG=electrocardiogram; EDTA=ethylenediaminetetraacetic acid; FiO2=fraction of inspired oxygen; PBMC=peripheral blood mononuclear cell; PCR=polymerase chain reaction; PD=pharmacodynamic; PK=pharmacokinetic; PO2=partial pressure of oxygen; RT PCR=reverse transcription polymerase chain reaction; SARS-CoV-2= severe acute respiratory syndrome coronavirus 2; SoC=standard of care; SpO2=oxygen saturation; SST=serum separator tube. a These visits will be performed even if a patient has already been discharged. If discharged prior to scheduled visit, in-person visits are preferred, but recognising that quarantine and other factors may limit the patient’s ability to return to the clinic, these visits may be conducted by telephone or with a home visit by study staff. For visits conducted by telephone, it will not be possible to perform some scheduled assessments (eg, vital signs). The Day 29 assessments will also be performed, where possible, for patients who discontinue the study prematurely. b Medical history includes estimated date and time of first symptoms and number of co-morbidities (eg, respiratory, cardiovascular, metabolic, malignancy, endocrine, gastrointestinal, immunologic, renal). Final, 22 April 2020 10 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) c Although the Master Protocol plans for 15 days treatment, this sub protocol can provide up to 21 days bemcentinib treatment if required for patients. Bemcentinib should be taken once per day, in the morning, on an empty stomach with water. Patients should not consume anything other than water for at least 1 hour after taking study drug. d Baseline assessments should be performed prior to study drug administration. e Includes ordinal score, National Early Warning Score 2 (NEWS2), oxygen requirement, noninvasive or invasive ventilator requirement, including start and stop of low- or high-flow oxygen supply or of any form of ventilation etc. f If done as part of SoC, blood gases results to be fully recorded with date and time. g ECG to coincide with selected PK and PD sampling timepoints, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. h For parameters, see Master Protocol i Laboratory tests performed in the 48 hours prior to enrolment will be accepted for determination of eligibility. j Any laboratory tests performed as part of routine clinical care within the specified visit window can be used for safety laboratory testing. k Additional safety laboratory evaluations to be performed on Days 15 and 29 only if patient is still hospitalised. l Samples collected for immediate laboratory processing and frozen storage. m Samples collected dependent on capacity of study centre, need for reduced study burden on staff, and potentially limited access to patients. n Procedures for the collection, processing, storage and shipment of the PK and PD samples will be provided in the Study Laboratory Manual. Sample collection to coincide with the ECGs, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. Final, 22 April 2020 11 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 Nonclinical in vitro and in vivo data suggest that bemcentinib might be useful for the treatment of early SARS-CoV-2 infection for which no medical countermeasures are currently approved, and support testing the efficacy of bemcentinib treatment among hospitalised adults with COVID-19. The AXL receptor tyrosine kinase promotes the infection of a wide range of enveloped viruses including pox-, retro-, flavi-, arena-, filo-, and alpha-viruses (Shimojima 2006, Brindley 2011, Meertens 2012, Dowall 2016, Meertens 2017). AXL increases viral infection through two mechanisms: 1) enhanced viral entry through “apoptotic mimicry”; and 2) suppression of anti-viral type I IFN responses. The AXL receptor and related receptors (Tyro3 and MerTK, collectively TAM) are important for the clearance of apoptotic cells (efferocytosis) by macrophages (Lemke 2019). Enveloped viruses co-opt this mechanism to expand tropism and enhance viral entry. GAS6, the AXL ligand, binds PS exposed on the surface of the viral envelope, tethering the viral particle to the AXL receptor and promoting uptake by phagocytosis. This mechanism of viral entry, based on PS exposure, is common to most enveloped viruses and is termed viral “apoptotic mimicry” (Mercer 2008, Bhattacharyya 2013). Binding of the viral particle to GAS6-AXL potently activates signal transduction through its tyrosine kinase domain to suppress type I IFN signalling and facilitate viral replication (Bhattacharyya 2013, Meertens 2017). AXL expression is induced by inflammation and serves as an innate immune checkpoint. AXL signalling suppresses viral-induced IFN responses via suppressor of cytokine signalling (SOCS)1/3, leading to increased viral replication in infected cells and decreased anti-viral defences of neighbouring cells (Huang 2015, Chen 2018, Strange 2019). Consequently, Axl-null mice are resistant to Zika pathogenesis likely due to a combination of reduced virus entry and enhanced IFN responses (Hastings 2019), indicating a potential role for AXL inhibitors as therapeutics during viral infection. Therapeutic AXL receptor inhibition ameliorated pulmonary pathology resulting from primary viral infection in experimental models, indicating an important role for AXL within the lung (Shibata 2014). During primary respiratory syncytial virus (RSV) infection, AXL inhibition increased the number of IFNg–producing T cells and natural killer (NK) cells, suppressed RSV replication and whole lung levels of interleukin (IL)-4 and IL-13. Also, the lethal effect of intrapulmonary H1N1 infection inflammation was reduced by AXL inhibition. AXL inhibition in infected mice increased the number of IFN-b–producing macrophages and dendritic cells and suppressed neutrophil infiltration. Final, 22 April 2020 12 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Bemcentinib is a clinical-stage, oral, selective small molecule AXL kinase inhibitor with well documented anti-viral effects in several systems. Bemcentinib is reported to block dengue, Ebola and Zika virus infections in several cell types including epithelial, fibroblast, endothelial, neuronal and myeloid cell types in in vitro cell culture and organoid systems. Bemcentinib treatment is associated with increased IFN signalling and reduced viral replication (Dowall 2016, Meertens 2017, Strange 2019). During the 2013/2014 Ebola virus (EBOV) outbreak, bemcentinib was 1 of 60 compounds evaluated by Public Health England as an experimental therapy for EBOV, using its Biosafety Containment Level 4 facilities at Porton Down. Bemcentinib 200 mg/kg/day starting 6 hours post viral challenge protected 1/6 EBOV infected guinea pigs from weight loss and early mortality in an 18-day in vivo mortality study (Dowall 2016), compared with 1/6 untreated animals surviving to Day 18 but exhibiting weight loss during the observation period. The authors concluded that bemcentinib may have had some protective effect in this model. 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro Professor Wendy Maury, University of Iowa, conducted a preliminary analysis of the anti-viral effects of bemcentinib on SARS-CoV-2 in a Vero E6 cell line. As shown in Figure 1, bemcentinib incubation starting 1 hour prior to virus inoculation potently inhibited SARS-CoV-2 infection of Vero E6 cells in a dose-dependent manner. Other studies using vesicular stomatitis virus pseudotyped with SARS-CoV spike protein and a mouse betacoronavirus (mouse hepatitis virus [MHV]) showed that bemcentinib may both inhibit uptake and activate the IFN-mediated antiviral gene, ISG15, to control viral infection. SARS-CoV-2 cell tropism is likely to include PS dependent viral uptake and may target critical immune cell populations (eg, macrophages, dendritic cells) that produce IFN and mobilize anti-viral immunity. Importantly, delayed IFN signalling is characteristic of pathogenic human betacoronaviruses and correlates with disease severity in animal models, suggesting that early intervention with IFN-activating treatment may provide therapeutic benefit (Channappanavar 2016). Thus, AXL targeting is expected to attenuate SARS-CoV-2 pathogenesis both by limiting viral uptake and promoting innate antiviral immunity. Final, 22 April 2020 13 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 1 Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells Vero E6 cells (60,000) in a 48-well format were incubated (1 hour) with bemcentinib prior to addition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (MOI 0.0005). Cells were lysed at 24 hours and viral load was analysed by quantitative reverse transcription polymerase chain reaction (RT-PCR) for spike protein gene expression as normalized to the housekeeping gene Cyclophilin. W.Maury et al., unpublished results Importantly, recent data that differentiate SARS-CoV-2 from severe acute respiratory syndrome (SARS) have emerged that support the hypothesis that AXL may have a more dominant role in SARS-CoV-2 infection, and therefore that bemcentinib may have specifically a more important role to play in inhibiting this viral infection: • SARS-CoV-2 has similar replication kinetics to SARS-CoV, but demonstrates differential sensitivity to type I interferon treatment (One of 2 mechanisms of action of Bemcentinib through AXL inhibition) (Lokugamage 2020). • Structural analysis of the spike (S) protein of SARS-CoV-2 showed that its S protein has weaker binding to the angiotensin converting enzyme (ACE)2 receptor on human cells compared with strong affinity of human SARS coronavirus (Dong 2020) – supporting the large magnitude effect we have observed for inhibition of viral replication using clinically appropriate doses of bemcentinib in ACE2 receptor +ve cells. 2.2 Dose Justification for Bemcentinib Bemcentinib’s antiviral action stems from a cellular effect, inhibiting AXL kinase to prevent viral attachment and intracellular viral replication (through maximisation of the early type-I interferon rather than a direct antiviral action). From estimates of pooled data, the half maximal inhibitory concentration (IC50) at 24 hours for bemcentinib inhibition of viral load is approximately 140 nM and the approximate concentration required for 90% of maximum inhibition (IC90) is 650 nM. This broadly corresponds to cancer cell data demonstrating high Final, 22 April 2020 14 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) potency of bemcentinib to inhibit AXL. This high potency is reflected in translational data from clinical trials that demonstrate that at the RP2D steady state, AXL kinase is completely inhibited in myeloblasts from AML patients on bemcentinib (Figure 2). Clinically, at RP2D, AXL kinase target demonstrates complete kinase inhibition (Figure 2), thus the maximal possible antiviral effect with this mechanism of action is accessed at the current clinical dose. Clinically, frequent monotherapy complete responses are observed in AML at RP2D (Figure 2). Bemcentinib PK exhibits a prolonged enteral absorptive phase which overlaps with prolonged elimination kinetics after the second dose, to proportionately reduce peak-to-trough difference in plasma concentration-time profile, over a 24-hour dose interval, resulting in smooth steady state without noticeable peak to trough variation (Figure 3). Thus, at the clinical RP2D it is predicted that bemcentinib would be a highly potent antiviral against SARS-CoV-2, and potentially as efficacious as its main use an anticancer therapeutic. Figure 2 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) C=cycle; D=day; Pat=patient Final, 22 April 2020 15 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 3 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients Bemcentinib is given orally as 100-mg capsules. Early clinical development in oncology patients identified the RP2D; dose administration of bemcentinib in this study will utilise the same dosing regimen, ie, a loading dose (400 mg) given once daily for 3 days followed by a maintenance dose of 200 mg once daily. Planned duration of bemcentinib treatment is for a total of 15 days, with the possibility of extension to 21 days for in-patients, at the discretion of the clinical investigator. In preclinical and Phase 1 clinical studies, it was shown that systemic exposure to bemcentinib increased dose proportionately. The terminal half-life was 45.6 to 88.7 hours in man. Modelling of the PK data from this study indicated that the most effective approach to rapidly achieving steady state is to administer 3 daily loading doses followed by a lower daily maintenance dose. 2.3 Human Experience from Trials in Cancer Patients Experience has been gained in the use of bemcentinib in the treatment of many types of cancer (including over 286 patients treated with AML, lung cancer, breast cancer, melanoma, and pancreatic cancer) in Phase 2 clinical studies. This has helped to define the safety profile, recommended dose and schedule as a monotherapy (Loges et al 2018). The safety profile of bemcentinib, initially ascertained in normal human volunteers is tolerable and allows monotherapy approaches as well as combinations with chemotherapy (low dose cytosine arabinoside or with docetaxel), targeted therapy (epidermal growth factor receptor inhibitors) and immunotherapy (pembrolizumab). Bemcentinib is given as two oral capsules once daily (200 mg) following three daily 400 mg loading doses, to achieve steady state. Its principal significant AEs are a low incidence of diarrhoea (28% , with 6% Grade 3/4), asymptomatic QT prolongation (6% Grade 3/4), asthenia, and nausea at the RP2D (Loges et al 2018). Many patients have received bemcentinib without untoward effects for over 2 years at full dose. In particular, there were no QTc related cardiac sequelae observed with either monotherapy or combination therapy in over 286 cancer patients, including elderly multimorbid patients (as presented in the Investigator’s Brochure). Evidence of monotherapy efficacy has been Final, 22 April 2020 16 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) documented in heavily pre-treated patients with AML. Complete response rates of approximately 40% have been observed in AXL expressing AML patients (Loges et al 2018), indicating on-target potency and specificity of bemcentinib as a monotherapy, through complete inhibition of the AXL kinase target. Treatment was well tolerated by most subjects, including the frail elderly. Bemcentinib was well tolerated when combined with pembrolizumab, demonstrating synergy with programmed cell death-1 (PD-1) antagonists through targeting of AXL-dependent immune suppressive mechanisms (M2 macrophages, suppressor dendritic cells, regulatory T cells, and myeloid derived suppressor cells). Collectively, bemcentinib mediated activation of innate immunity within the tumour microenvironment synergizes with immune checkpoint therapy (Krebs et al 2019). Final, 22 April 2020 17 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 3.0 STUDY POPULATION 3.1 Eligibility Criteria Overall inclusion and exclusion criteria are presented in Sections 5.1 and 5.2 of the Master Protocol, respectively. Additional exclusion criteria that are specific to the sub-protocol are as follows: 12. Inability to swallow capsules (administration via nasogastric tube is permitted) 13. Current treatment with any agent known to cause QT prolongation. See Appendix 2 for list of relevant medications. The treatment can be discontinued, with sufficient time (5 half-lives) for washout, to allow inclusion of the patient. 14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) > 450 ms 15. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once. 16. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. 17. Previous bowel resection that would interfere with drug absorption Final, 22 April 2020 18 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.0 STUDY ASSESSMENTS AND PROCEDURES In addition to the study assessments and procedures described in Section 8.0 of the Master Protocol, assessments specific to the sub-protocol will be performed as described in the following sections. The Schedule of Activities (SoA) for this sub-protocol is presented in Section 1.2. 4.1 Efficacy Assessments Efficacy assessments will be included as per the Master Protocol. The following endpoints, secondary endpoints in the Master Protocol, will be considered as key secondary endpoints for the purposes of this sub-protocol: Table 1. Bemcentinib Sub-protocol Specific Key Objectives and Endpoints Objectives • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • To evaluate the number of oxygen-free days. • To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. • To evaluate SARS-CoV-2 viral load. • To evaluate SARS-CoV-2 viral load. Endpoints • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). Exploratory studies will define the role of PD biomarkers. Exploratory endpoints relate to the translational plan. 4.2 Safety Assessments For ECG assessments see the SoA (Section 1.2). Timing of the PK and PD evaluations will be matched to the ECG assessments. Final, 22 April 2020 19 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.2.1 Adverse Events 4.2.1.1 Adverse Events from Indications Under Investigation Bemcentinib is a relatively safe investigational therapeutic agent. A few patients may experience tiredness and gastrointestinal disturbance (nausea, diarrhoea). Occasionally there may be some changes to blood tests relating to liver function (transaminitis) and some changes on ECG tracing (QT prolongation). These AEs are temporary and lasting only a few days. 4.2.1.2 Adverse Events of Special Interest (AESI) Not applicable. 4.2.1.3 Disease-related Events and/or Disease-related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events Not applicable. 4.2.2 Clinical Safety Laboratory Assessments See Master Protocol for the list of clinical laboratory tests to be performed for this sub-protocol, and the SoA (Section 1.2) for the timing and frequency. 4.3 Pharmacokinetic Assessments Venous blood samples for PK analysis will be collected according to the SoA (Section 1.2). The samples will be analysed for plasma bemcentinib and additionally for bemcentinib metabolites (to be defined). Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. Plasma samples for determination of bemcentinib concentration will be analysed by BerGenBio’s Bioanalytical Services vendor using the validated liquid chromatography with tandem mass spectrometry method. 4.4 Pharmacodynamic Assessments Blood samples for PD analysis will be collected according to the SoA (Section 1.2) and stored for future analysis in both the bemcentinib arm and the control arm. The samples will be analysed for soluble AXL, GAS6 (which could be predictive, PD, and mechanism biomarkers and hence require comparison with control group not receiving bemcentinib), and other blood proteins. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. This analysis will be in addition to the inflammatory cytokine analysis detailed in the Master Protocol. Final, 22 April 2020 20 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.0 STUDY TREATMENT 5.1 Conclusions and Risk Benefit Statement Bemcentinib has shown in vitro evidence of antiviral effect against SARS-CoV-2 infection at concentrations below those achieved at the proposed dose regimen for use in this trial. This dose matches the RP2D derived from multiple studies in various cancer populations. Treatment at this dose in 286 patients over a range of 6 weeks up to 2 years demonstrates that monotherapy or combination is largely well tolerated; therefore short term administration (15 to 21 days) in the context of hospitalized patients with SARS-CoV-2 infection is anticipated to be well tolerated. A non-severe, asymptomatic effect on QTc interval has been noted. Regular ECG/continuous ECG monitoring is included in the clinical trial enabling early identification of prolonged QTc and early stopping rules given the high morbidity and potential mortality of SARS-CoV-2 in hospitalised patients, there is a favourable balance of potential benefit: risk in the proposed clinical investigation of bemcentinib treatment for COVID-19 within the context of this clinical trial. 5.2 Bemcentinib Drug Administration Bemcentinib will be administered as a 400 mg oral loading dose on Days 1, 2, and 3, followed by 200 mg once-daily oral maintenance dose for 15 days with the possibility of extension to 21 days for in patients at the discretion of the clinical investigator. Bemcentinib should be taken once per day, in the morning after an overnight fast. Tablets should be taken with 100 mL water. Patients should not consume anything other than water for at least 1 hour after taking study drug. Final, 22 April 2020 21 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.3 Dose Modifications and Toxicity Management Note: this modified guidance has been added to the Investigators’ Brochure under relevant section of treatment of COVID-19 Event Recommended Bemcentinib Dose Modification Estimated creatinine clearance decreases Study medication should be withheld until estimated creatinine by more than ≥50% from baseline clearance returns to baseline ALT or AST increases to > 5 ULN Study medication should be withheld until ALT and AST returns to baseline Dose Modification of Bemcentinib Daily Dose for QTc Prolongation QTcF Recommended Bemcentinib Dose Modification > 501 ms 1st occurrence Discontinue permanently Ventricular arrhythmia 1st occurrence Discontinue permanently ALT=alanine aminotransferase; AST=aspartate aminotransferase; QTcF= QTc interval according to Fridericia correction; ULN=upper limit of normal Notes: Serum calcium, magnesium and potassium should be measured regularly whilst receiving bemcentinib; all abnormal results should be corrected; check for use of concomitant medication that are associated with QT prolongation. 5.4 Prohibited Concomitant Medications Administration of bemcentinib is contraindicated in patients requiring treatment with concomitant medications known to prolong QTc interval and promote Torsade de Points (TdP) listed in Appendix 2. Patients already in receipt of such medications should be excluded unless medications are discontinued and a sufficient wash out period is allowed prior to starting bemcentinib. Medicines with both cytochrome P450 (CYP) 3A4 and TdP liabilities are particularly hazardous and their concomitant use is a reason for exclusion of patients. Concomitant medications that are CYP3A4 substrates are not reasons for exclusion of patients, however they should be discontinued or used with caution. Treatment with histamine receptor 2 inhibitors (cimetidine, ranitidine) or protein pump inhibitors (omeprazole) is permitted provided that administration is in the evening. 5.5 Study Drug Information 5.5.1 Study Medication The drug product is presented in a single strength: 100 mg bemcentinib in size 0, Swedish Orange hydroxypropyl methylcellulose capsules for oral administration. Bemcentinib capsules Final, 22 April 2020 22 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) consists of a wet granulated blend of 40% drug substance with standard excipients (lactose monohydrate, microcrystalline cellulose, crospovidone, polyvinylpyrrolidone, colloidal silicon dioxide, and magnesium stearate). Bemcentinib has been manufactured according to appropriate Good Manufacturing Practice standards. Bemcentinib capsules are packaged in 50-mL white opaque round high density polyethylene bottles containing 22 capsules. The bottles are closed with opaque 32-mm child-resistant screw caps and sealed with tamper-resistant tape. Refer to the current version of the Bemcentinib Investigational Medicinal Product Dossier/Investigator’s Brochure for additional information on the physical, chemical and pharmaceutical properties of bemcentinib. 5.5.2 Bemcentinib Storage, Dispensing, and Destruction Bemcentinib will be shipped to the participating site by PCI Pharma Services, UK, and must be stored at the site in a secure location under ambient temperature conditions (<25°C). Accountability for study treatment is the responsibility of the Investigator. The Investigator/designee must ensure that the bemcentinib will only be dispensed to patients in accordance with the dosing instructions in this protocol. Study staff should refer to the Bemcentinib Pharmacy Manual for specific instructions regarding the handling, storage, dispensing and destruction of bemcentinib. Final, 22 April 2020 23 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 6.0 REFERENCES Bhattacharyya S, Zagórska A, Lew ED, et al. Enveloped viruses disable innate immune responses in dendritic cells by direct activation of TAM receptors. Cell Host Microbe 2013;14:136-47. Brindley MA, Hunt CL, Kondratowicz AS, et al. Tyrosine kinase receptor Axl enhances entry of Zaire ebolavirus without direct interactions with the viral glycoprotein. Virology 2011;415:83-94. Channappanavar R, Fehr AR, Vijay R, et al. Dysregulated Type I Interferon and Inflammatory Monocyte-Macrophage Responses Cause Lethal Pneumonia in SARS-CoV-Infected Mice. Cell 2016;19:181-93. Chen J, Yang YF, Yang Y, et al. AXL promotes Zika virus infection in astrocytes by antagonizing type I interferon signalling. Nat Microbiol 2018;3(3):302-9. Dong N, Yang X, Ye L, Chen K, Chan EW, Chen S. Genomic and protein structure modelling analysis depicts the origin and pathogenicity of 2019-nCoV, a new coronavirus which caused a pneumonia outbreak in Wuhan, China [version 2; peer review: 1 not approved]. F1000Research 2020, 9:121 (https://doi.org/10.12688/f1000research.22357.2) Dowall SD, Bewley K, Watson RJ, et al. Antiviral Screening of Multiple Compounds against Ebola Virus. Viruses 2016;8(11). pii:E277. Hastings AK, Hastings K, Uraki R, et al. Loss of the TAM Receptor Axl Ameliorates Severe Zika Virus Pathogenesis and Reduces Apoptosis in Microglia. iScience 2019;13:339-50. Huang MT, Liu WL, Lu CW, et al. Feedback regulation of IFN-αβ signalling by Axl receptor tyrosine kinase modulates HBV immunity. Eur. J. Immunol. 2015;45:1696-705. Krebs M et al. A phase II study of bemcentinib (BGB324), a first-in- class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis. SITC 2019, oral presentation in High Impact Clinical Trials session. Lemke G. How macrophages deal with death. Nat Rev Immunol. 2019;19(9):539-49. Loges S et al. Comprehensive Analysis of the Dose Escalation, Expansion and Correlates in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS ASH 2018, presentation. Lokugamage KG, Hage A, Schindewolf C, Rajsbaum R, Menachery VD. SARS-CoV-2 is sensitive to type I interferon pretreatment. bioRxiv preprint doi: https://doi.org/10.1101/2020.03.07.982264.Meertens L, Carnec X, Lecoin MP, et al. The TIM Final, 22 April 2020 24 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) and TAM Families of Phosphatidylserine Receptors Mediate Dengue Virus Entry. Cell Host Microbe 2012;12(4):544-57. Meertens L, Labeau A, Dejarnac O, et al. Axl mediates ZIKA virus entry in human glial cells and modulates innate immune responses. Cell Rep 2017;18(2):324-33. Mercer J, Helenius A. Vaccinia virus uses macropinocytosis and apoptotic mimicry to enter host cells. Science 2008;320(5875):531-5. Shibata T, Habiel DM, Coelho AL, Kunkel SL, Lukacs NW, Hogaboam CM. Axl Receptor Blockade Ameliorates Pulmonary Pathology Resulting from Primary Viral Infection and Viral Exacerbation of Asthma. J Immunol. 2014;192(8):3569-81. Shimojima M, Takada A, Ebihara H, et al. Tyro3 family-mediated cell entry of Ebola and Marburg viruses. J Virol. 2006;80(20):10109-16. Strange DP, Jiyarom B, Pourhabibi Zarandi N, et al. Axl promotes Zika virus entry and modulates the antiviral state of human Sertoli cells. mBio 2019;10(4):e01372-19. Final, 22 April 2020 25 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 7.0 APPENDICES Appendix 1 Abbreviations Abbreviation ACE AE AML BP CYP EBOV ECG GAS6 IC50 IC90 IFN IL MHV NK NYHA PD PD-1 PK PS QTcF RP2D RSV SARS SARS-CoV-2 SoA SOCS TAM TdP Definition Angiotensin-converting enzyme Adverse event Acute myeloid leukaemia Blood pressure Cytochrome P450 Ebola virus Electrocardiogram Growth arrest-specific 6 Half maximal inhibitory concentration Concentration required for 90% of maximum inhibition Interferon Interleukin Mouse hepatitis virus Natural killer New York Heart Association Pharmacodynamic Programmed cell death-1 Pharmacokinetic Phosphatidylserine QTc interval according to Fridericia correction Recommended Phase 2 dose Respiratory syncytial virus Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Schedule of Activities Suppressor of cytokine signalling Tyro3, AXL, MerTK Torsade de Points Final, 22 April 2020 26 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index For any concomitant medication, please check the following website for the drug’s Torsades de Pointes (TdP) risk: https://crediblemeds.org/oncosupport/. Drugs with known (TdP) risk are reason for EXCLUSION. For drugs with a conditional risk, please review the product label and correct any abnormalities, eg, hypokalaemia. Common medication Associated with a Risk of QT Prolongation and TdP – USE PROHIBITED AS CONCOMITANT MEDICATION t½ less than 6 hours Azithromycin 2-4 hours$ Clarithromycin 3-4 hours$ Cocaine 0.6 – 1.3 hours$ Droperidol 2 hours$ Erythromycin 2 hours$ Ondansetron 3 hours$ Procainamide 2.5-4.75 hours$ Terfenadine 3.5 hours** t½ between 6 – 12 hours Cisapride 10 hours ** Disopyramide 6.7 hours$ Ketoconazole 3 – 10 hours$ Moxifloxacin 12 hours$ Quinidine 6 hours **$ Voriconazole 6 hours$ t½ greater than 12 hours Amiodarone 50 days$ Astemizole 24 hours ** Chloroquine 1-2 months$ Citalopram 35 hours$ Escitalopram 30 hours$ Fluconazole 30 hours$ Haloperidol 15 – 27 hours$ Methadone 25 – 55 hours$ Petamidine 10 – 14 days$ **also CYP3A4 substrates $ also TdP risk Pimozide 55 hours ** Sotalol 10 – 20 hours$ Thioridazine 21 – 24 hours$ Sensitive CYP3A4 Substrates With A Narrow Therapeutic Margin THESE MEDICATIONS SHOULD BE DISCONTINUED BEFORE ENROLMENT t½ less than 6 hours t½ between 6 – 12 hours t½ greater than 12 hours alfentanyl 90-111 minutes dihydroergotamine & ergotamine 2 hours Fluticasone 3 – 8hours Terfenadine 3.5 hours astemizole 7 – 9 hours cisapride 12 hours cyclosporine 8.4 hours Fentanyl 8 – 10 hours quinidine 6 hours tacrolimus (FK506) 12 hours pimozide 55 hours sirolimus 63 hours Woosley RL, Heise CW , Gallo T, Tate J, Woosley D and Romero KA, www.CredibleMeds.org, QTdrugs List, [14Apr2020], AZCERT, Inc. 1822 Innovation Park Dr., Oro Valley, AZ 85755 Final, 22 April 2020 27 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator PROTOCOL TITLE: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients SUB-PROTOCOL NO: ACCORD-2-002 SUB-PROTOCOL FOR CANDIDATE AGENT BEMCENTINIB VERSION: Amendment 01 This sub-protocol is a confidential communication of the Sponsor. I confirm that I have read this sub-protocol, I understand it, and I will work according to this sub-protocol, in conjunction with the Master Protocol for the overall platform study. I will also work consistently with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and the applicable laws and regulations. Acceptance of this document constitutes my agreement that no unpublished information contained herein will be published or disclosed without prior written approval from the Sponsor. Instructions to the Investigator: Please SIGN and DATE this signature page. PRINT your name, title, and the name of the study centre in which the study will be conducted. Return the signed copy to the Contract Research Organization/Sponsor. I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Signature of Investigator: Printed Name: Investigator Title: __________________________ ___________________________ ___________________________ Date: ________ Name/Address of Centre: ___________________________ ___________________________ ___________________________ Final, 22 April 2020 28
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How to contact the bronchiectasis service - patient information

Description: This flyer contains information about the Southampton bronchiectasis service.
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Charitable Funds Committee ToR May 2023

Description: Charitable Funds Committee Terms of Reference Date Issued: Review Date: Document Type: 25 May 2023 May 2024 Committee Terms of Reference Version: 6 Contents Paragraph 1 2 3 4 5 6 7 8 9 10 Role and Purpose Constitution Membership Attendance and Quorum Frequency of Meetings Conduct and Administration of Meetings Duties and Responsibilities Accountability and Reporting Review of Terms of Reference and Performance and Effectiveness References Appendices Appendix A Committee and Reporting Structure Page 2 2 2 3 3 3 3 4 5 5 Page 6 Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. Page 1 of 7 1. Role and Purpose 1.1 The Charitable Funds Committee (the Committee) is responsible for exercising the functions of University Hospital Southampton NHS Foundation Trust (UHS or the Trust), as sole corporate trustee of Southampton Hospital Charity (registered charity number 1051543) (the Charity), including overseeing the management and monitoring of charitable funds on behalf of the Trust. 1.2 The Committee provides the board of directors of the Trust (the Board) with a means of assurance regarding the administration of the Charity in accordance with applicable legislation. 1.3 The duties and responsibilities of the Committee are more fully described in paragraph 7 below. 2. Constitution 2.1 The Committee has been established by the Board. The Committee has no executive powers other than those set out in these terms of reference. It is supported in its work by other committees established by the Board and other committees and groups as shown in Appendix A. 2.2 The Committee is authorised by the Board to investigate any activity within its terms of reference. It is authorised to seek any information it requires from any member of staff and all members of staff are directed to cooperate with any request made by the Committee. 2.3 In carrying out its role the Committee is authorised to seek reports and assurance from executive directors and managers and will maintain effective relationships with the chairs of other Board committees to understand their processes of assurance and links with the work of the Committee. 2.4 The Committee is authorised to obtain external legal or other independent professional advice if it considers this necessary, taking into consideration any issues of confidentiality and the Trust’s standing financial instructions. 3. Membership 3.1 The members of the Committee will be appointed by the Board and will be: 3.1.1 at least two non-executive directors of the Trust; 3.1.2 the Chief People Officer; and 3.1.3 the Chief Financial Officer. 3.2 The Board will appoint the chair of the Committee from among its non-executive director members (the Committee Chair). In the absence of the Committee Chair and/or an appointed deputy, the remaining members present will elect one of the non-executive members present to chair the meeting. 3.3 Only members of the Committee have the right to attend and vote at Committee meetings. However, the following will be invited to attend meetings of the Committee on a regular basis: 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 the Charity Director the Head of Charitable Giving; the Head of Charitable Operations; the Head of Charity Communications; and Charity Finance Manager Page 2 of 7 3.4 Other individuals may be invited to attend for all or part of any meeting, as and when appropriate and necessary, particularly when the Committee is considering areas of risk or operation that are the responsibility of a particular executive director or manager. 4. Attendance and Quorum 4.1 Members should aim to attend every meeting and should attend a minimum of 75% of meetings held in each financial year. Where a member is unable to attend a meeting they should notify the Committee Chair or secretary in advance. 4.2 The quorum for a meeting will be three members, including two non-executive directors. A duly convened meeting of the Committee at which a quorum is present will be competent to exercise all or any of the authorities, powers and discretions vested in or exercisable by the Committee. 4.3 When an executive director or manager is unable to attend a meeting they should appoint a deputy to attend on their behalf. 5. Frequency of Meetings 5.1 The Committee will meet at least four times each year and otherwise as required. 6. Conduct and Administration of Meetings 6.1 Meetings of the Committee will be convened by the secretary of the Committee at the request of the Committee Chair or any of its members. 6.2 The agenda of items to be discussed at the meeting will be agreed by the Committee Chair with support from the Charity Director. The agenda and supporting papers will be distributed to each member of the Committee and the regular attendees no later than five working days before the date of the meeting. Distribution of any papers after this deadline will require the agreement of the Committee Chair. 6.3 The secretary of the Committee will minute the proceedings of all meetings of the Committee, including recording the names of those present and in attendance and any declarations of interest. 6.4 Draft minutes of Committee meetings and a separate record of the actions to be taken forward will be circulated promptly to all members of the Committee. Once approved by the Committee, minutes will be circulated to all other members of the Board unless it would be inappropriate to do so in the opinion of the Committee Chair. 7. Duties and Responsibilities The Committee will carry out the duties below for the Trust. 7.1 Governance 7.1.1 Ensure that the charitable funds held by the Trust are managed in a manner consistent with its charitable purpose relating to the National Health Service, the requirements of the relevant regulatory and statutory frameworks and the guidance set out by the Charity Commission. 7.1.2 When in this role act solely in the best interests of the Charity and in a manner consistent with the Charity Commission’s requirements and expectations of charity trustees. 7.1.3 Determine the format of the information required to effectively manage the charitable funds. 7.1.4 Receive all necessary information from the Charity Director. Page 3 of 7 7.2 Strategy 7.2.1 Oversee the Charity’s strategy, governance (in accordance with the Charity Governance Code as it applies to the Charity and the Committee), major plans and key risks on behalf of the Trustee. 7.2.2 Review and approve annually objectives, a medium-term strategy and an annual operating plan (including a budget). 7.3 Fundraising 7.3.1 Review and approve annually the overall fundraising strategy of the Charity. 7.3.2 Establish, prioritise, and approve major fundraising projects and expenditure (between £75,001 - £1,000,000), each of which should be supported by an appropriate business case; projects and expenditure over £1,000,000 will require approval from the Board. 7.3.3 Safeguard donated money. 7.3.4 Ensure legacies are realised in a timely and complete manner. 7.4 Utilisation of Funds 7.4.1 Approve charitable fund bids in accordance with the relevant procedures including the Trust’s standing financial instructions and/or any applicable grants policy or criteria. 7.4.2 Endeavour to make an adequate return on prudent investments. 7.4.3 Establish and agree any changes to the Charity’s investment policy and ensure that investment is in accordance with this policy. 7.4.4 Appoint independent advisors on investment policy as the Committee sees fit. 7.4.5 Review the appointment of investment advisors every three years and recommend any changes to the Board. 7.4.6 Monitor the performance of investments and seek clarification from the investment advisors on any relevant issues. 7.4.7 Regularly review the performance of current investments in terms of income and capital appreciation. 7.5 Reporting 7.5.1 Review and approve the Charity’s annual accounts and trustee’s report in accordance with the Charity Commission’s Charities Statement of Recommended Practice. 7.5.2 Fully account to the Charity Commission and the public, including specific reporting requirements agreed with any donors. 7.5.3 Receive regular reports from any sub-committees the Committee has established. 8. Accountability and Reporting 8.1 The Committee Chair will report to the Board following each meeting, drawing the Board’s attention to any matters of significance or where actions or improvements are needed. 8.2 Appendix A sets out the sub-committees that report to and support the Committee in fulfilling its duties and responsibilities. Page 4 of 7 9. Review of Terms of Reference and Performance and Effectiveness 9.1 At least once a year the Committee will review its collective performance and its terms of reference. Any proposed changes to the terms of reference will be recommended to the Board for approval. 10. References 10.1National Health Service Act 2006 10.2Charities Act 2011 10.3Charities (Accounts and Reports) Regulations 2008 10.4Declaration of Trust dated 10 November 1995 (as amended) 10.5Standing Financial Instructions Page 5 of 7 Appendix A Audit and Risk Committee Board of Directors Charitable Funds Committee Finance and Investment Committee Charity Operational Management Group People and Organisational Development Committee Quality Committee Remuneration and Appointment Committee Page 6 of 7 Charitable Funds Committee Terms of Reference Version: 6 Document Monitoring Information Approval Committee: Board of Directors Date of Approval: 25 May 2023 Responsible Committee: Charitable Funds Committee Monitoring (Section 9) for Completion and Presentation to Approval Committee: Target audience: Key words: Main areas affected: Summary of most recent changes if applicable: Consultation: Number of pages: Type of document: Does this document replace or revise an existing document? Should this document be made available on the public website? Is this document to be published in any other format? May 2023 Board of Directors, Charitable Funds Committee, Staff Charitable, Charity, Funds, Committee, Board, Terms of Reference, Hospital Charity Trust-wide Membership and attendees, sub-committee structure and minor clarification and consistency changes Chief People Officer 7 Committee Terms of Reference Yes Yes No Page 7 of 7
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2023-Trust-documents/Charitable-Funds-Committee-ToR-May-2023.pdf

Charitable Funds Committee ToR April 2022

Description: Charitable Funds Committee Terms of Reference Date Issued: Review Date: Document Type: 28 April 2022 April 2023 Committee Terms of Reference Version: 5 Contents Paragraph 1 2 3 4 5 6 7 8 9 10 Role and Purpose Constitution Membership Attendance and Quorum Frequency of Meetings Conduct and Administration of Meetings Duties and Responsibilities Accountability and Reporting Review of Terms of Reference and Performance and Effectiveness References Appendices Appendix A Committee and Reporting Structure Page 2 2 2 3 3 3 3 4 5 5 Page 6 Document Status This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. Page 1 of 7 1. Role and Purpose 1.1 The Charitable Funds Committee (the Committee) is responsible for exercising the functions of University Hospital Southampton NHS Foundation Trust (UHS or the Trust), as sole corporate trustee of Southampton Hospital Charity (registered charity number 1051543) (the Charity), including overseeing the management and monitoring of charitable funds on behalf of the Trust. 1.2 The Committee provides the board of directors of the Trust (the Board) with a means of assurance regarding the administration of the Charity in accordance with applicable legislation. 1.3 The duties and responsibilities of the Committee are more fully described in paragraph 7 below. 2. Constitution 2.1 The Committee has been established by the Board. The Committee has no executive powers other than those set out in these terms of reference. It is supported in its work by other committees established by the Board and other committees and groups as shown in Appendix A. 2.2 The Committee is authorised by the Board to investigate any activity within its terms of reference. It is authorised to seek any information it requires from any member of staff and all members of staff are directed to cooperate with any request made by the Committee. 2.3 In carrying out its role the Committee is authorised to seek reports and assurance from executive directors and managers and will maintain effective relationships with the chairs of other Board committees to understand their processes of assurance and links with the work of the Committee. 2.4 The Committee is authorised to obtain external legal or other independent professional advice if it considers this necessary, taking into consideration any issues of confidentiality and the Trust’s standing financial instructions. 3. Membership 3.1 The members of the Committee will be appointed by the Board and will be: 3.1.1 at least two non-executive directors of the Trust; 3.1.2 the Chief People Officer; and 3.1.3 the Chief Financial Officer. 3.2 The Board will appoint the chair of the Committee from among its non-executive director members (the Committee Chair). In the absence of the Committee Chair and/or an appointed deputy, the remaining members present will elect one of the non-executive members present to chair the meeting. 3.3 Only members of the Committee have the right to attend and vote at Committee meetings. However, the following will be invited to attend meetings of the Committee on a regular basis: 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 the Charity Director four fundholders, as agreed by the Executive Directors; the Assistant Director of Finance; the Head of Charitable Giving; the Head of Charitable Operations; the Head of Charity Communications; and Page 2 of 7 3.3.7 the Charity Funds Manager. 3.4 Other individuals may be invited to attend for all or part of any meeting, as and when appropriate and necessary, particularly when the Committee is considering areas of risk or operation that are the responsibility of a particular executive director or manager. 4. Attendance and Quorum 4.1 Members should aim to attend every meeting and should attend a minimum of 75% of meetings held in each financial year. Where a member is unable to attend a meeting they should notify the Committee Chair or secretary in advance. 4.2 The quorum for a meeting will be three members, including two non-executive directors. A duly convened meeting of the Committee at which a quorum is present will be competent to exercise all or any of the authorities, powers and discretions vested in or exercisable by the Committee. 4.3 When an executive director or manager is unable to attend a meeting they should appoint a deputy to attend on their behalf. 5. Frequency of Meetings 5.1 The Committee will meet at least four times each year and otherwise as required. 6. Conduct and Administration of Meetings 6.1 Meetings of the Committee will be convened by the secretary of the Committee at the request of the Committee Chair or any of its members. 6.2 The agenda of items to be discussed at the meeting will be agreed by the Committee Chair with support from the Charity Director. The agenda and supporting papers will be distributed to each member of the Committee and the regular attendees no later than five working days before the date of the meeting. Distribution of any papers after this deadline will require the agreement of the Committee Chair. 6.3 The secretary of the Committee will minute the proceedings of all meetings of the Committee, including recording the names of those present and in attendance and any declarations of interest. 6.4 Draft minutes of Committee meetings and a separate record of the actions to be taken forward will be circulated promptly to all members of the Committee. Once approved by the Committee, minutes will be circulated to all other members of the Board unless it would be inappropriate to do so in the opinion of the Committee Chair. 7. Duties and Responsibilities The Committee will carry out the duties below for the Trust. 7.1 Governance 7.1.1 Ensure that the charitable funds held by the Trust are managed in a manner consistent with its charitable purpose relating to the National Health Service, the requirements of the relevant regulatory and statutory frameworks and the guidance set out by the Charity Commission. 7.1.2 When in this role act solely in the best interests of the Charity and in a manner consistent with the Charity Commission’s requirements and expectations of charity trustees. 7.1.3 Determine the format of the information required to effectively manage the charitable funds. Page 3 of 7 7.1.4 Receive all necessary information from the Charity Director. 7.2 Strategy 7.2.1 Oversee the Charity’s strategy, governance (in accordance with the Charity Governance Code as it applies to the Charity and the Committee), major plans and key risks on behalf of the Trustee. 7.2.2 Review and approve annually objectives, a medium-term strategy and an annual operating plan (including a budget). 7.3 Fundraising 7.3.1 Review and approve annually the overall fundraising strategy of the Charity. 7.3.2 Establish, prioritise and approve major fundraising projects and expenditure (between £50,001 - £100,000), each of which should be supported by an appropriate business case; projects and expenditure over £100,000 will require approval from the Board. 7.3.3 Safeguard donated money. 7.3.4 Ensure legacies are realised in a timely and complete manner. 7.4 Utilisation of Funds 7.4.1 Approve charitable fund bids in accordance with the relevant procedures including the Trust’s standing financial instructions and/or any applicable grants policy or criteria. 7.4.2 Endeavour to make an adequate return on prudent investments. 7.4.3 Establish and agree any changes to the Charity’s investment policy and ensure that investment is in accordance with this policy. 7.4.4 Appoint independent advisors on investment policy as the Committee sees fit. 7.4.5 Review the appointment of investment advisors every three years and recommend any changes to the Board. 7.4.6 Monitor the performance of investments and seek clarification from the investment advisors on any relevant issues. 7.4.7 Regularly review the performance of current investments in terms of income and capital appreciation. 7.5 Reporting 7.5.1 Review and approve the Charity’s annual accounts and trustee’s report in accordance with the Charity Commission’s Charities Statement of Recommended Practice. 7.5.2 Fully account to the Charity Commission and the public, including specific reporting requirements agreed with any donors. 7.5.3 Receive regular reports from any sub-committees the Committee has established. 8. Accountability and Reporting 8.1 The Committee Chair will report to the Board following each meeting, drawing the Board’s attention to any matters of significance or where actions or improvements are needed. 8.2 Appendix A sets out the sub-committees that report to and support the Committee in fulfilling its duties and responsibilities. Page 4 of 7 9. Review of Terms of Reference and Performance and Effectiveness 9.1 At least once a year the Committee will review its collective performance and its terms of reference. Any proposed changes to the terms of reference will be recommended to the Board for approval. 10. References 10.1National Health Service Act 2006 10.2Charities Act 2011 10.3Charities (Accounts and Reports) Regulations 2008 10.4Declaration of Trust dated 10 November 1995 (as amended) 10.5Standing Financial Instructions Page 5 of 7 Appendix A Audit and Risk Committee Board of Directors Charitable Funds Committee Finance and Investment Committee People and Organisational Development Committee Arts Committee Quality Committee Remuneration and Appointment Committee Charity Operational Management Group Page 6 of 7 Charitable Funds Committee Terms of Reference Version: 5 Document Monitoring Information Approval Committee: Board of Directors Date of Approval: 28 April 2022 Responsible Committee: Charitable Funds Committee Monitoring (Section 9) for Completion and Presentation to Approval Committee: Target audience: Key words: Main areas affected: Summary of most recent changes if applicable: Consultation: Number of pages: Type of document: Does this document replace or revise an existing document? Should this document be made available on the public website? Is this document to be published in any other format? April 2023 Board of Directors, Charitable Funds Committee, Staff Charitable, Charity, Funds, Committee, Board, Terms of Reference, Hospital Charity Trust-wide Membership and attendees, sub-committee structure and minor clarification and consistency changes Chief People Officer 7 Committee Terms of Reference Yes Yes No Page 7 of 7
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2022-Trust-documents/Charitable-Funds-Committee-ToR-April-2022.pdf

Standing Financial Instructions

Description: These Standing Financial Instructions (SFIs) are issued for the regulation of the conduct of Trust members and officers in relation to all financial matters with which they are concerned.
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Finance/StandingFinancialInstructions.pdf

Communicating risk: words or numbers?

Description: Is it better to communicate risks to patients with words or statistics?
Url: /HealthProfessionals/Clinical-law-updates/Communicating-risk-words-or-numbers.aspx

Handling concerns and complaints policy

Description: Handling Complaints Policy, Version 13.0 Trust reference PET003 Version number 13.0 Description Policy to explain how University Hospital Southampton implements the framework for the NHS Complaints (England) Regulations 2009. It clarifies what people should expect when then complain, in accordance with Parliamentary and Health Service Ombudsman’s complaint standards. Level and type of document Target audience Trust-wide corporate policy – controlled document. Staff, patients, relatives, and carers. Author(s) (names and job titles) Policy sponsor Shona Small, Complaints Manager Jenny Milner, Associate Director of Patient Experience This is a controlled document. Whilst this document may be printed, the electronic version posted on Staffnet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from Staffnet. All documents must remain watermarked as ‘draft’ until they have been approved by the Expert Group. 1 Date Version control Author(s) Version Approval created committee 6.9.2024 Shona Small 6.9.2024 Experience of care committee Date of approval 10/7/24 Date next review due 10/7/27 Key changes made to document To bring in line with Ombudsman’s new complaint standard terminology. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 1 2 Index 1 Version control ............................................................................................................... 1 2 Index.............................................................................................................................. 2 3 Introduction .................................................................................................................... 2 4 Quick References .......................................................................................................... 3 5 Scope and purpose ........................................................................................................ 3 6 Definitions ...................................................................................................................... 4 7 Details of policy.............................................................................................................. 5 8 Roles and responsibilities ............................................................................................ 15 9 Communication and training plans ............................................................................... 15 11 Document review...................................................................................................... 16 12 Process for monitoring compliance ........................................................................... 16 13 Appendices .............................................................................................................. 17 • Appendix A ................................................................................................................. 17 • Appendix B................................................................................................................. 18 • Appendix C................................................................................................................. 18 • Appendix D................................................................................................................. 21 • Appendix E ................................................................................................................. 22 • Appendix F ................................................................................................................. 23 • Appendix G................................................................................................................. 24 • Appendix H................................................................................................................. 31 • Appendix I .................................................................................................................. 33 • Appendix J ................................................................................................................. 34 • Appendix K - Audit tool to monitor policy compliance ............................................. 35 • Appendix L ................................................................................................................. 36 14 References ............................................................................................................... 36 3 Introduction The purpose of this policy is to explain how University Hospital Southampton NHS Foundation Trust (UHS) implements the statutory legal framework for the local authority, social services and National Health Service Complaints (England) Regulations 2009, and how the Trust meets the requirements of the NHS Constitution. The policy makes clear what people should expect when they complain (NHS Constitution) and supports a culture of openness, honesty and transparency (duty of candour). Trust practice is informed by the Parliamentary and Health Services Ombudsman (PHSO) Complaint Standards and Principles of Remedy, including the Scale of Injustice. The policy deals with the handling of concerns and complaints (regarding Trust services, buildings or the environment) received from patients, patient’s relatives, carers, visitors and other service users. In most circumstances the quickest and most effective way of resolving a concern or complaint is to deal with the issues when they arise or as soon as possible after this (early resolution). PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 2 In circumstances where early resolution is not possible, this policy describes the processes in place to ensure that complaints are handled efficiently and investigated thoroughly. Patient and Family Relations (P&FR) are responsible for the overall management of complaints. P&FR combines the patient advice and liaison service (PALS) and the complaint handling functions, to provide a flexible approach to resolving complaints. The policy promotes the use of people’s experience of care to improve quality. By listening to people about their experience of healthcare, the Trust can resolve mistakes faster, learn new ways to improve the quality and safety of services, and prevent the same problem from happening again in the future. The reporting and monitoring of trends, themes and lessons learnt is undertaken through divisional governance structures, quality committee and the quality governance steering group and is used to ensure compliance with commissioner, regulatory and good practice requirements. The Trust is committed to providing safe, effective and high-quality services. However, it is recognised that things can occasionally go wrong. When complaints are raised, the Trust has a responsibility to acknowledge the complaint, put things right as quickly as possible, prevent reoccurrence and identify service improvements. Written information regarding how the Trust deals with complaints will be made available in all departments, the main reception, patient support services, the Trust website and through the local Integrated Care Bureau (ICB), The Advocacy People and other patient forums. 4 Quick References None 5 Scope and purpose The purpose of the policy is to: • Outline the Trust policy on handling complaints • Describe the procedure followed to respond to complaints • Confirm the roles and responsibility associated with this process • Provide staff with guidance on how to respond to a complaint • Describe how this policy links to the National Complaint Handling Framework o Promotes a learning and improvement culture o Positively seeks feedback o Is thorough and fair o Gives a fair and accountable decision The aim is to explain how UHS implements the statutory legal framework for the local authority social services and NHS Complaints (England) Regulations 2009, meets the requirements of the NHS Constitution and duty of candour, and ensures compliance with commissioners, regulatory and good practice requirements. The aims and outcomes of this policy promote early, local and prompt resolution involving the complainant in deciding how their complaints are handled. Likewise, good complaint handling and continuous learning is endorsed throughout the policy, promoting improvements in the quality and safety of services at UHS and facilitating positive patient experiences. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 3 Aims • To listen, to acknowledge mistakes, explain what went wrong and to consider prompt, appropriate and proportionate remedy to put things right. • To provide a consistent approach to the timely and efficient handling of complaints and establish an agreed plan with the complainant with an emphasis on early resolution, sharing learning and improving our services. • To ensure organisational openness and an approach that is conciliatory and fair to people both using and delivering services. • To respect the individual’s right to confidentiality and treat all users of this policy with respect and courtesy. Outcomes • The policy and procedure will, as far as is reasonably practical, be easy to understand, accessible, publicised in ways that will reach all service users and include information about support and advocacy services, if relevant. • All staff will receive an appropriate level of training to enable them to respond positively to complaints, and endeavour to resolve issues quickly. • The Trust will ensure that service users and carers can raise a complaint without their care, treatment or relationship with staff being compromised. • Investigations will be thorough, fair, responsive and appropriate to the seriousness of the complaint. They will also be conducted within the timescales agreed with the complainant. • The format of the response to the complaint will be agreed with the complainant. This may be verbal, by phone or at a meeting, or written, by email or letter. • The Trust will strive to resolve all complaints locally, while reminding people of their right to take the matter to the Parliamentary and Health Service Ombudsman if they are not satisfied. • Within divisions and care groups, local leadership and accountability will facilitate early resolution and ensure complaints are responded to promptly and used to initiate actions and opportunities for service and staff improvement. • Divisional governance structures will be used to ensure organisational learning from complaints and the sharing of best practice. 6 Definitions Please see Appendix A for flow chart. For the purpose of this policy, the following definition will apply: Term Everyday Conversations Early Resolution Definition Defined as every-day issues that with help can be resolved there and then (within 24 hours), without the person becoming dissatisfied and wanting to make a complaint. Defined as a more straightforward complaint that can be resolved fairly quickly (within 10 days), e.g., appointment issues, staff attitude, services not provided to expected standards. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 4 Closer Look Defined as an expression of dissatisfaction, or a perceived grievance or injustice, that needs a closer look. Timescale for resolution is agreed with the complainant. 7 Details of policy 7.0 Details of complaints process – refer to Appendix B for process overview. 7.1 Making a complaint Service users and the public who contact P&FR to make a complaint will receive appropriate assistance from the Trust to enable them to understand the procedure and, if required, will be signposted to complaint advocacy. 7.1.1 How to make a complaint – Stage 1 Information on how to raise a concern or make a complaint can be found on both our internal and external webpages. Complaints may be made about any matter reasonably connected with the exercise of the functions of the Trust, both clinical and non-clinical. They can be made verbally, in person or via telephone, or in writing either in a letter or electronically. A complaint may be raised with any member of Trust staff, P&FR (PALS or complaints team) or the chief executive. Alternatively, the complainant may choose to address their complaint to their local commissioner, NHS England, a member of parliament or another third party, such a health advocate. 7.1.2 Who may make a complaint – Stage 1 Complaints may be made by a patient, their representative, or any persons who are affected by or likely to be affected by the action, omission or decision of the Trust. This includes family, carers, advocates, care home/nursing homes, MPs, Integrated Care Bureau (ICB) and NHS England. When complaints are made by persons other than the complainant, the need for consent will be assessed. In the above circumstances where the Trust does not intend to consider a complaint, the complainant will be notified of the reasons for this decision in writing. Complainants will be made aware of independent complaints advocacy for help and support to make a complaint. Other specialist advocacy agencies covering areas such as mental health, learning disabilities, elderly or disadvantaged groups, and independent mental capacity advocacy (IMCA) are also available for general support. Details are available from PALS and the complaints team. 7.1.3 Consent if the complainant is not the patient – Stage 1 In cases where a patient’s representative makes a complaint, consent will be obtained from the patient, or person legally responsible for the patient, for permission to access their health records for the purpose of the investigation, where required, and to release the details of the investigation to the representative. If the patient is unable to act for themselves, the nominated first contact, or an individual who holds Power of Attorney (POA) for Health and Welfare can make a complaint on the patient’s behalf and will be able to provide consent for this to be investigated and the details released PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 5 to them. If the complainant is not the patient’s nominated first contact or does not hold POA, we will inform the complainant that the nominated first contact, or POA holder needs to confirm they are happy for the outcome of the investigation to be shared with another party. If the patient has died, the Trust will respect any known wishes that had been expressed by the patient. This includes sharing the outcome of an investigation with parties who are not the nominated first contact or POA holder, but in these circumstances, we will contact the nominated first contact, or POA holder to ensure they are happy for the details to be shared. In circumstances where a complaint is made by a third party when the patient has not authorised the complainant to act on their behalf, this does not preclude the Trust from undertaking a full and thorough investigation into the concerns raised. Specifically, if the complaint raises concerns about patient safety or the conduct of staff, the relevant Trust policies will be evoked. Without consent, a response to the third party will be limited and the reasons for this explained to the complainant. 7.1.4 Complaints relating to Private Patient Services For complaints relating to private patient services at UHS, the patient should refer to the private patient policy, which includes the private patient complaint’s procedure for patients wishing to raise a concern regarding their private treatment at the Trust. 7.1.5 Complaints excluded from the scope of this policy The Trust is not required to consider the complaint in the following circumstances. However, the Trust will consider each case individually and, as soon as reasonably practicable, notify the complainant in writing of its decision and the reason for the decision. a) A complaint made by a responsible body (local authority, NHS body, primary care provider or independent provider who provides care under arrangements made with an NHS body). b) A complaint by an employee of a local authority or NHS body about any matter relating to that employment. c) A complaint which has been investigated previously or either has been or is currently being investigated by the Parliamentary and Health Service Ombudsman. d) A complaint arising out of the alleged failure to comply with a request for information under the Data Protection Act 2018, or a request for information under the Freedom of Information Act 2000. Please refer to the UHS information governance policy. e) Complaints about private treatment provided in the Trust. However, any complaint made about the Trust’s staff or facilities relating to care in their private bed will be investigated under this policy. f) Lost property claims, which are investigated and handled directly by the care group manager. However, any claim for lost property made as part of a complaint will be dealt with under this policy. g) Complaints concerning incidents or events which occurred over 12 months from the date the complaint is submitted. These are seen as out of time in the NHS complaints process – see 3.2.8. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 6 7.2 Specific considerations when dealing with complaints 7.2.1 Complaints involving a vulnerable adult or child protection Where it is known that the complaint involves a vulnerable adult or child, the executive lead for child protection or vulnerable adults will be informed. The name nurse for safeguarding children or adults (as appropriate) will be consulted and contribute to the decision as to the most appropriate route of investigation agreed. This may not be the complaints procedure. The named nurse will support with advice on additional notifications and communication with the complainant. 7.2.2 Complaints that include a Patient Safety Incident Investigation (PSII) If the content of the complaint is only about the ‘event’, the patient safety team (PST) will lead and co-ordinate the PSIRF investigation, explain duty of candour and respond to the complainant. If there are matters that need to be investigated outside of PSIRF, agreement will be made between the PST and the complaints team about which elements of the investigation will not be covered by PSIRF and will need to be investigated through the complaints process. In these circumstances, the PST will notify P&FR of appropriate timescales for completion and release of their investigation. P&FR will then agree the timescale for the final complaint response with the complainant and will usually continue to be the main point of contact for the complainant. This is dependent on the nature of the incident and sometimes different arrangements are agreed at the patient safety case review meeting. If there is a need for a dual approach to the investigation, this will be explained to the complainant. Usually, a written response to the whole complaint (i.e., including both investigations) will be offered, explaining the extended period of time required for the Trust to respond. Where a written response is required, this will be produced by the P&FR with support from the PST. Where the investigation has uncovered significant failings in care and treatment, oversight of this process will be provided by the head of P&FR working in partnership with legal services, head of patient safety and Trust medical lead for complaints as appropriate. The complainant will also be offered the opportunity to meet with Trust staff to discuss the findings of the PSII and provide opportunity for Trust staff to respond to any outstanding queries. Alternatively, the complainant may choose to receive the outcome of the two investigations in separate written responses. 7.2.3 Complaints that are relating to Overseas Visitors If a patient considers that they have been charged incorrectly, they should raise this with the Overseas Visitor Manager (OVM) in the first instance to discuss on what basis they have been found to be chargeable and whether the provision of further documentary evidence is required. Where there continues to be a disagreement about how the Charging Regulations have been applied to a particular patient, the patient may want to seek the services of PALS. Where a patient is unhappy with the healthcare they have received, they or someone on their behalf and with their consent, can use the NHS complaints procedure as set out in this policy. The OVMs will ensure that the chargeable patients are aware of the complaint’s procedure. Complaints regarding charging will be fairly heard by an impartial person who is independent of the overseas visitors charging operation within the Trust. 7.2.4 Clinical negligence, personal injury or another claim. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 7 If the complainant indicates a clear intention to bring legal proceedings for clinical negligence, personal injury or other claim, the use of the complaint’s procedure is not necessarily precluded. The complaints team will discuss the nature of the complaint with the litigation and insurance services department or Trust solicitor, if required), to determine whether the progression of the complaint might prejudice subsequent legal or judicial action. If there is no legal reason why the complaint should not be investigated, the complaints team will continue to investigate the complaint in accordance with Trust policy. In cases where there are legal reasons why a complaint should not be dealt with under this policy, the complaint investigation will cease. The complainant will be advised of this fact and requested to ask their legal representative to contact the claims department. The complaints team can continue to investigate any issues raised within the complaint that are not part of the claim. 7.2.5 Disciplinary or professional investigation or investigation of a criminal offence Cases regarding professional conduct where a complaint is found to be justified may require an internal disciplinary investigation to be undertaken. Such an investigation may result in the involvement of one of the professional regulatory bodies and/or police/counter fraud team depending on the nature of the allegations. Appropriate action will be taken in accordance with the Trust disciplinary procedure. In such circumstances, the complainant will be informed that a disciplinary investigation will be undertaken but that they have no right to be informed of the outcome of the investigation. Any other issues raised in the complaint which do not form part of the disciplinary or criminal investigation may continue to be dealt with under the complaints policy. 7.2.6 Coroner’s inquest In complaints involving a death that is referred to the coroner, the PST will lead and co-ordinate the investigation. This ensures clear lines of communication and investigation for clinicians and families. The complaints team will advise the family that their concerns will be investigated by the PST in preparation for the inquest hearing and that HM coroner’s office (HMCO) will endeavour to include all concerns raised. Any separate issues can be investigated by the complaints team under the NHS complaint regulations. 7.2.7 Allegations of fraud or corruption Any complaint concerning possible allegations of fraud and corruption is passed immediately to the NHS counter fraud service for action. 7.2.8 Media interest In cases where a complainant has contacted, or expresses their intention to contact, the media, the head of communications will be informed and will take appropriate action regarding Trust communication and media management. 7.2.9 Time limit for making a complaint Normally a complaint should be made within 12 months of the date on which the matter occurred, or 12 months of the date on which the matter came to the notice of the complainant. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 8 Where a complaint is made after this time, the complaint may be investigated if the complainant had good reasons for not making the complaint within the above time limits and where, given the time lapse, it is still possible to investigate the complaint effectively and efficiently. In circumstances when a complaint is not being investigated on this basis, the complainant will be informed of the reason for that decision and advised that they may still ask the Parliamentary and Health Service Ombudsman to consider their complaint. 7.2.10 Handling of joint complaints between organisations In cases where a complaint involves more than one NHS provider, commissioner, local authority or third-party independent provider, and the complainant so wishes, the Trust will work with the other relevant organisations in seeking resolution. There is a jointly agreed protocol for the ‘Handling of NHS Inter-organisational Complaints in Hampshire and the Isle of Wight’, (Appendix C). This provides a framework for the handling of joint complaints between organisations, clarifies roles and responsibilities of organisations, enhances inter-organisation co-operation and reduces confusion for service users. The lead organisation will provide a single response on behalf of all organisations involved, ensuring that the complainant receives a seamless, effective service. The procedure for dealing with multi-agency complaints involving third party independent providers can be found at Appendix D. 7.3.11 Complaints received from nursing and care homes on behalf of their residents See Appendix E 7.3.12 Harassment and vexatious/intractable complainants Harassment Violence, racial, sexual or verbal harassment towards staff will not be tolerated; neither will language that is of a personal, abusive or threatening nature, either written or verbal. If staff should encounter this behaviour, they should seek support from their line manager and complete an adverse event form (AER). Where appropriate, the complainant will be informed in writing that their behaviour is unacceptable. Please see the UHS eliminating bullying and harassment policy. Abuse will be reported to the police. In the event that the complainant has harassed or threatened staff dealing with their complaint, all personal contact with the complainant will be discontinued. The complaint thereafter can only be pursued through written communication. Vexatious or intractable complainants In a minority of cases, people pursue their complaints in a way that can either impede the investigation of their complaint or can have a significant resource issue for the Trust and cause undue stress for staff. Unfortunately, despite patience and sympathy there are times when there is nothing further that can reasonably be done to assist them to rectify a real or perceived problem. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 9 Judgement and discretion must be used when considering potential persistent, habitual or vexatious complainants. The criteria and procedure can be found at Appendix F and authorisation of vexatious status will be made by the head of P&FR. 7.3 Responding to complaints of patients, their relatives or carers 7.3.1 Local resolution Early resolution is the first line of investigation and response to a complaint and is undertaken within the Trust. Local resolution enables the Trust to provide the quickest opportunity for a full and thorough investigation and respond with the emphasis on a positive outcome rather than the process. The local resolution response will: • Acknowledge failures. • Apologise. • Quickly put things right when they have gone wrong. • Use the opportunity to improve services. Complaints are often raised directly to the staff involved. This is often frontline staff in wards, clinics or reception. All Trust staff, as a means of improving service provision, will welcome the complainant’s concerns or complaint positively. In most circumstances, the quickest and most effective way of resolving a complaint is to deal with the issues when they arise or as soon as possible after this (early local resolution). Upon raising a complaint, the complainant will be listened to, treated courteously and have their confidentiality assured. Discussions should include seeking an understanding of how they would like their complaint managed and what outcomes they are seeking. Every opportunity should be taken to resolve complaints at the outset and deescalate the complaint. If the staff member approached is unable to deal with the issue, they will refer the matter to a more senior member of staff on duty at the time, such as ward sister, matron, head of department or site manager. A complainant may simply require an apology, explanation, clarification of a misunderstanding or remedial action to be taken and therefore should not be automatically referred to P&FR, unless this is the complainant’s wish. 7.3.2 Early resolution All complaints are first assessed by our PALS team. If possible, they will agree with the complainant to investigate to achieve early resolution, in a sooner timescale. The PALS team will investigate via the NHS complaints process and provide a written response. 7.3.3 Taking a closer look If it is not possible to achieve early resolution, the complaint is passed to the complaints team to take a closer look. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 10 • 7.3.3 Complaint assessment and acknowledgement On receipt of a complaint in the PALS or complaints team the first responsibility is to ensure that the patient’s immediate health needs are being met; ideally this will occur within 24 hours. In cases where a complaint that is being investigated under the NHS Complaint Regulations is received verbally, a transcript of the concerns should be made and sent to the complainant for agreement before the start of the investigation. The nature, complexity and seriousness of the complaint are assessed and graded using the complaint assessment tool (Appendix G). Any immediate actions are undertaken which may include, but are not restricted to, contact with Trust directors or divisional leads, PST, claims, communications, child protection, vulnerable adults, infection prevention and human resources. An assessment will also be made as to the requirement for consent to be sought before any investigation can proceed. Complaints are acknowledged within three working days, and this includes details of advocacy services and ‘Raising a concern or complaint’ (previously ‘Have your say’) leaflet detailing the Trust’s complaint process. Complaints received via email out of hours will receive an automated acknowledgement of receipt of email. The complaint handler will establish a relationship, offer an apology or empathy, clarify issues for investigation and seek to understand what resolution looks like for the complainant. They will also discuss and agree the management of the complaint, including any opportunity for early resolution, the timescales and the method of response. 7.3.4 Complaint investigation planning The nature and grade of the complaint will influence the level of investigation and the level of notification or cascade throughout the organisation. This is based on the complexity and severity score of the complaint (minimum, minor, moderate, major or severe) and the primary focus or professional group who are the subject of the complaint (medical, nursing, allied professionals, managerial or administrative). Higher graded complaints require prompt action, more robust investigations and may require the involvement of investigation contributors: • external to the division but internal to the organisation • external to the organisation The complaint handler will assess the complaint and plan the scope and approach to the investigation. This includes identifying the key staff required to contribute to the investigation (complaint investigation contributors). Where the contributors are adversely commented upon in the complaint, care is taken to ensure they are informed of the complaint by the complaint lead or line manager to ensure they receive support throughout the process. The complaint lead (CL) can add an additional level of scrutiny and modify or validate the complaint investigation plan prior to the start of the investigation, usually within three days. Staff directly involved in the complaint will not be allocated the role of complaint lead. 7.3.5 Complaint investigation Complaints will be thoroughly investigated in a manner appropriate to resolving the issues speedily and efficiently within the agreed timeframe. The complaint handler remains responsible for keeping the complainant up to date with the progress of the investigation and negotiates any necessary extensions to the agreed timeframe. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 11 For all complaints assessed as ‘severe’, if appropriate, and where possible a scoping meeting will be held by the PST to identify any immediate actions and to support investigation planning. This meeting may be virtual or face-to-face, involving the complaint lead, complaint handler and care group clinical lead or matron. The complaint lead will oversee the quality and timeliness of the investigation and validate the conclusions, outcome and actions agreed for inclusion in the complaint response. On completion of the investigation the complaint handler will review the complaint investigation to ensure that it has been thorough and addresses all the issues raised by the complainant. The complaint lead will support the complaint handler to scrutinise the findings, draw conclusions, agree the complaint outcome and consider whether there is evidence of service failure or maladministration. The compliant lead will also ensure that a robust action plan is formulated to cover all upheld elements of the complaint. 7.3.6 Complaint Response When responding to a complaint staff will give a clear, balanced account of what happened based on the established facts. Staff will be open and honest when things have gone wrong and where improvements can be made. All complaints will receive a fair and honest response. The complainant may prefer to receive this via letter, email, at a meeting or as a telephone call. The latter will usually be followed up in writing or via email. The response will address all issues raised, provide a full explanation, an apology as appropriate, any decisions regarding remedy and any actions that have or are planned to be undertaken to put the matter right. Details will also be given of what actions should be taken should the complainant believe the response has not adequately answered the issues raised. Where possible, the response will be in a format suitable for the complainant, such as large font or translation into another language. The complaint handler is responsible for producing a draft response for validation by the complaint lead once all contributors have had the opportunity to comment. The written response may take the form of a complaint response letter or a letter of apology, together with a separate investigation report or recorded audio disc. A final internal quality assurance check is undertaken before sending the response letter to the CEO or delegated deputy for signing and sending out by registered mail or secure email. A main complaint category is identified with the complainant, and this is used to determine the status of the complaint on closure by the complaint handler. Where the main category is found to be upheld, the complaint is recorded as upheld. If the main category is not upheld but some or all of the remaining categories are upheld, the complaint is closed as partially upheld. 7.3.7 Remedy If a complaint is upheld or partially upheld, the Trust will decide whether the maladministration or service failure has caused an injustice (Health Service Ombudsman’s Principles of Remedy). The Trust should, as far as is possible, put the individual back into the position they would have been in if the maladministration or service failure had not occurred. If that is not possible, the Trust should compensate appropriately. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 12 The Trust will consider suitable and proportionate financial and non-financial remedies for the complainant and, where appropriate, for others who have suffered the same injustice. An appropriate remedy may be an apology, an explanation or remedial action. Financial compensation will not be appropriate in every case but should be considered. Appropriate and proportionate financial remedy will be considered by the CGM (budget holder for the service complained about) and complaint handler in the first instance. If an agreement cannot be reached, the head of P&FR will review, make comparisons to similar cases and reach agreement for any financial remedy with the director of nursing and, where appropriate, the key internal stakeholders involved. This provides consistency in evaluating the amount of financial remedy that is fair, reasonable and proportionate to the injustice suffered. On agreement with the CGM, any financial remedy is then offered to the complainant explaining the amount, why this has been offered and who to contact to accept the offer. The governance framework includes monitoring of the decision-making processes and recording payments of financial remedy offered to complainants. This will be reported quarterly to the patient experience and engagement steering group. This policy does not relate to medico-legal claims for compensation which will be dealt with through the legal services department in conjunction with the NHSLA. 7.3.8 Re-investigation of a complaint – Stage 2 In cases where the complainant is not satisfied with the Trust response, the complaint will be re-opened, also called Stage 2. This may be because the complainant considers the initial investigation to be inadequate, incomplete or unsatisfactory, or the complainant believes that their issues have not been addressed, fully understood or new questions have been raised. The complaint will be reassessed and the issues that remain unresolved for the complainant will need to be clarified and a new complaint investigation plan agreed. The same investigative procedure will be followed. However, the Trust can decline a Stage 2 investigation if the team feel that there is nothing more to investigate, add or clarify, and believe that the Stage 1 investigation is complete. Independent advice or a second opinion may be considered on the element of the complaint that has been re-opened for investigation. Meeting with the complainant is encouraged to aid resolution of the complaint. In some circumstances, and in agreement with all parties, conciliation or mediation could also be considered. If early resolution has been completely exhausted and the complainant still remains dissatisfied, the complainant is informed of their right to go to the PHSO. 7.3.9 Stage 3: Parliamentary and Health Service Ombudsman (PHSO) & The Independent Sector Adjudication Service (ISCAS) PHSO: In cases where the Trust has been unable to resolve a complaint to the complainant’s satisfaction, the complainant has the right to refer their complaint to the PHSO for independent review. The PHSO is independent of the NHS and is appointed by the government and will undertake an independent investigation into complaints where it is considered that the Trust has not acted properly, fairly or has provided a poor service. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 13 The Trust will fully comply with all PHSO requests for information. As appropriate, divisional management teams and directors will be notified by P&FR of any complaint that is being investigated by the PHSO, or any recommendations made by them. The PHSO can be contacted at: www.ombudsman.org.uk Parliamentary and Health Service Ombudsman Millbank Tower 30 Millbank Westminster London SE1P 4QP Telephone: 0345 015 4033 ISCAS: Is a scheme that provides independent adjudication on complaints about independent healthcare providers. ISCAS CEDR, 3rd Floor 100 St Paul’s Churchyard London EC4M 8BU www.iscas.cedr.com Telephone: 0207 7536 6091 7.4 Confidentiality and record keeping 7.4.1 Confidentiality and ensuring patients, their relatives and carers are not treated differently as a result of raising a concern or complaint Information about complaints and all the people involved is strictly confidential, in accordance with Caldicott principles. Information is only disclosed to those with a demonstrable need to know or a legal right to access those records under the Data Protection Act 2018. All data will be processed in accordance with Trust policy. Complaints will not be filed on health records but maintained in a separate case file subject to the need to record any information that is strictly relevant to their health record. Complaints must not affect the patient’s/complainant’s treatment and the complainant must not be discriminated against. Any identified discrimination will be reported to HR and managed as per Trust policies. 7.4.2 Record keeping A complete documentary record will be maintained for each complaint on the Ulysses database. This will include all written or verbal contacts with the complainant, staff involved in the investigative process and all actions taken in investigating the complaint. The complaint file is a confidential record. It will be stored securely and should be easily retrieved and understood in the event of further enquiry. In accordance with the UHS records management policy 2010, complaint files are kept and disposed of confidentially. Complaint files are retained for eight years. 7.5 Support for complainant and staff See Appendix H describing roles and responsibility of staff who can provide support. 7.3.6 Process by which the organisation aims to improve as a result of concerns and complaints being raised PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 14 Every complaint received should be regarded as an opportunity to learn and improve services. 7.6.1 Development of action plans P&FR will request a completed action report (Appendix I) from the complaint investigation contributors involved in all complaints that are upheld or partially upheld. In some cases, the actions required may already be completed and documented within the complaint response. In this situation the complaint lead should inform P&FR that a separate plan is not required, and this should be recorded on the complaints database. The complaint lead or divisional governance team is responsible for validating the action plan identified within the report. The divisional director of operations (DDO), or delegated person, is responsible for ensuring the action plans arising from concerns and complaints are completed within the agreed timescales and processes are in place for the action plan to be reviewed and monitored by the local governance groups. The DDO, or delegated, is supported by the divisional governance manager (DGM). 7.6.2 P&FR - support of learning The P&FR team will support divisional complaint information hubs, allowing real time information to be accessed by divisions and care groups as to number of complaints for each clinical area and identified key themes. Each division will have an identified lead within P&FR to support development of their individual approaches to learning and they will attend divisional and care group governance with the division. See Action Plan (Appendix I). 7.6.3 Complainant feedback The P&FR will ensure every complaint response is sent out with a patient satisfaction survey and the results are monitored, reported annually to QGSG and used to consider quality improvements. 8 Roles and responsibilities Roles and responsibilities See Appendix H describing roles and responsibilities of staff involved in resolving complaints. 9 Communication and training plans Communication plan This policy will be displayed on the Trust website and Staffnet and sent to divisional management teams to ensure dissemination throughout each division to all staff groups. An introduction to complaints is provided within the staff induction programme and further training is available via the Trust VLE portal in electronic format. Bespoke face-to-face training will be provided by the P&FR team on request to all staff groups. Monitoring of this policy by P&FR team will be used to identify areas where further training may be required. 10 Equality impact assessment (for all policies only) See Appendix L and J Equality and diversity are at the heart of our Trust values. Throughout the development of the policy, we give regard to the need to eliminate discrimination, harassment and victimisation, PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 15 to advance equality or opportunity, and to foster good relations between people who share a relevant protected characteristic (as cited in under the Equality Act 2010) and those who do not share it. As part of its development this Complaints policy and its impact on equality has been analysed and approved as being appropriate. The Policy & Guidance Team hold all equality impact assessments centrally. These are available upon request from Policy&Guidance@uhs.nhs.uk 11 Document review All Trust policies will be subject to a specific minimum review period of one year; we do not expect policies to be reviewed more frequently than annually unless changes in legislation occur or new evidence becomes available. The maximum review period for policies is every three years. The author of the policy will decide an appropriate frequency of review between these boundaries. Where a policy becomes subject to a partial review due to legislative or national guidance, but the majority of the content remains unchanged, the whole document will still need to be taken through the agreed process as described in this policy with highlighted changes. This Complaints policy will be reviewed in three years’ time in 2027. This policy will be reviewed every three years or earlier if any amendments to the NHS complaints regulations are made, or if any aspect of the policy is found to be inadequate. 12 Process for monitoring compliance The purpose of monitoring is to provide assurance that the agreed approach is being followed. This ensures that we get things right for patients, use resources well and protect our reputation. Our monitoring will therefore be proportionate, achievable and deal with specifics that can be assessed or measured. Key aspects of this policy will be monitored: Element to be monitored Lead (name/job title) Tool Frequency Reporting arrangements Compliance to NHS Complaints (England) Regulation 2009 and Parliamentary and Health Service Ombudsman’s Complaints Standards. Shona Small Measure against policies Every three years Reporting to Jenny Milner Where monitoring identifies deficiencies actions plans will be developed to address them. PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 16 13 Appendices • Appendix A Managing complaints Processing complaints in the PALS and complaints team. Complaint received into PALS & complaints team. The role of patient support officers (PSOs) and the complaint coordinator is to listen, understand concerns and risk assess situation. PSOs and/or administrator to register issue on Ulysses, consider whether consent is required, categorise concern and discuss with complainant how they would like the matter resolved. Low level to medium level of seriousness and can be resolved in 24 hours or up to 10 days Categorise as a COMPLAINT (Early Resolution) Managed by PALS manager and Patient Support Officers (PSO). • Identify actions needed. Provide feedback to care group if issues are for feedback only • Escalate any concerns to B6/B7/Matron/Consultant • Signpost to other teams/bodies where relevant, such as The Advocacy People • Investigate • Find resolution • Respond to complainant at the earliest opportunity and within 10 working days • Identify learning and share with care group Resolved – Yes • Record outcome and close case Resolved – No • Review whether complaint needs to be passed to the complaints team to take a closer look. Medium to high level of seriousness and requires investigation via the NHS complaints process. Categorise as a COMPLAINT (Taking a Closer Look) Managed by complaints team • Further risk assessment such as PST or safeguarding • Investigate in accordance with the complaints policy • Respond within agreed timescale with a Trust letter or hold complaint resolution meeting to share outcome of investigation • Identify learning and share with care group and divisional governance Resolved – Yes • Record outcome and close case on Ulysses. Resolved – No • Re-open case on Ulysses • Discuss and agree further actions or investigation plan with complainant • Respond within agreed timescale with a Trust letter or share outcome with complainant at resolution meeting Resolved – Yes • Record outcome and close case on Ulysses Resolved – No • Direct complainant to the Parliamentary and Health Service Ombudsman (PHSO) or litigation PET003 Handling Complaints Policy version 13. Issued 10.7.24 Page 17 • Appendix B Making a Complaint process There are different ways to make a complaint. It is usually easier to resolve concerns close to the time they occur by talking to the staff who are looking after you. This may be the ward manager, or matron for the department. They can discuss the things you are not happy with and will try to resolve them for you. If your concerns have not been resolved by talking to the department, you can contact the Patient Advice and Liaison Service (PALS). Their contact details are: Telephone: 023
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