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BRC Assistant Project Manager_ Study Manager PS_15 11 2023

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EMPLOYMENT CRITERIA / PERSON SPECIFICATION The purpose of this specification is to identify the attributes required by applicants to perform the duties in the job descriptio
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/Media/Southampton-Clinical-Research/Downloads/BRC-Assistant-Project-Manager-Study-Manager-PS-15-11-2023.pdf

UHSNFT Ultrasound Referral guidelines for GPs V6- new neck referral included

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UNIVERSITY HOPSITAL SOUTHAMPTON GUIDELINES FOR GP ULTRASOUND REFERRALS IN ADULTS Introduction Ultrasound is often used as a first line investigation as the test is available, non-invasive and does not involve ionising radiation. Many primary care clinicians express considerable uncertainty as to where it can be used most effectively. These guidelines are designed to help GPs in that challenging decision making process, reducing GP workload and reducing demand for scans where ultrasound is unlikely to be helpful, creating capacity for those who really need it. At the same time, we ask for careful consideration before marking a case as “urgent”. This prolongs waiting times for everyone, and delays some patients being referred for an appropriate test as they wait for an ultrasound, which may not be indicated. We recognise that there may be specific clinical situations not within the scope of these guidelines when an ultrasound is helpful, and if there are any clinical queries we would be happy to answer these. Please contact uhs.pacssupport@nhs.net and leave your query with your preferred contact details and the relevant radiology consultant, registrar or sonographer will get back to you. These new guidelines have been developed by the local consultant radiologists and the lead clinician for gynaecology ultrasound to help general practitioners use ultrasound most effectively to the benefit of all their patients. Advice has been pulled together from the Royal College of Radiologists, Royal College of General Practitioners and relevant local and national guidelines with input from local specialists. UHS Guidelines for Ultrasound Referral in Adults 1 ABDOMINAL ULTRASOUND Indications • Clinically suspected cholelithiasis • Right upper quadrant pain- ?liver abscess or subphrenic collection • Investigation of jaundice • Persistently abnormal LFTs (not slightly elevated GGT) • Ascites • Evaluation of pulsatile abdominal mass/abdominal bruit NOTES 1. The value of ultrasound is in answering specific clinical questions and confirming/refuting a provisional diagnosis. 2. It is not of value as a “screening test” for vague abdominal symptoms, to rule out malignancy or for abdominal bloating. If ovarian pathology is suspected then a pelvic ultrasound is advised. 3. In the absence of clinical abnormality or a specific indication it is unlikely to be helpful in investigating left upper quadrant pain or pelvic pain in males. 4. It is not the investigation of choice for imaging the GI tract or excluding GI pathology. It will not reliably detect GI tumours. 5. As with clinical examination there are limits in what ultrasound can detect in obese patients. 6. Most abdominal masses, ?cancer, will probably require CT with the exception of documenting malignancy in palliative cases and should therefore be referred to outpatients. 7. Acute abdomens will generally require CT rather than ultrasound with the exception of ?benign biliary pathology or ?gynaecological cause (especially in young patients) and will therefore require surgical assessment. UHS Guidelines for Ultrasound Referral in Adults 2 ADULT GYNAECOLOGY/PELVIC ULTRASOUND This document is not advice on the follow-up protocols of established pathology e.g. ovarian cysts. - Urgent scenarios e.g. early pregnancy and acute gynaecology – acutely ill patients should have a pregnancy test and referral to Early Pregnancy Unit/Gynaecology Assessment Unit (EPU/GAU) where they may have an urgent scan (depends on the clinical scenario – some same day, some a few days later). In no particular order: INDICATIONS Pelvic pain Post-Menopausal Bleeding (PMB) Menorrhagia Pelvic mass Vague pelvic symptoms – to exclude ovarian cancer Intermenstrual bleeding (IMB), Postcoital bleeding (PCB) Urinary symptoms Lost coil Subfertility History of swollen lower limbs (could be unilateral or bilateral) NOT INDICATED Vulval conditions Vaginal cysts Polycystic Ovaries PCO NOTES on indications Gynaecology ultrasound - a pelvic scan - should be performed Transvaginally (TV) in all cases except where the patient is virgo intact, if the patient doesn’t consent or if she is unable to consent. In those cases, the patient will undergo a transabdominal pelvic scan. In some cases, a transabdominal pelvic scan may be indicated in addition to the TV Scan e.g. for fibroids. Pelvic pain - endometriosis can now be diagnosed on ultrasound in specialist centres (e.g. PAH). The average diagnostic delay between symptoms and diagnosis of endometriosis is currently 8 years. The clinical suspicion is raised when the pain is exclusively related to menses, and if there are cyclical bowel symptoms especially so. PMB – please note whether the patient is on HRT (very low risk of malignancy) and if so, which type (cyclical or continuous combined). Also mention if she is on Tamoxifen (higher risk for endometrial cancer) in which case she still needs a scan, but also an endometrial biopsy is required (hence referral to the PMB clinic will be required for such patients). UHS Guidelines for Ultrasound Referral in Adults 3 ALL patients with PMB need a speculum examination (to exclude e.g. cervical cancer) as well as an ultrasound, if both are normal then referral to PMB clinic can be avoided (SIGN guidelines). Menorrhagia NICE suggests scan not necessary prior to fitting Mirena. Conditions such as fibroids, adenomyosis, will lead to lower success rates with Mirena/ablation. Pelvic mass – if there is a pelvic mass palpable with a suspicion of malignancy, an urgent pelvic ultrasound is indicated, unless it is obviously a fibroid, in which case a routine scan is more suitable. Vague pelvic symptoms – to exclude ovarian cancer - NICE guidelines – in this context bloating means permanent abdominal distension, not intermittent ‘windy’ abdomen. A CA125 is not required prior to the ultrasound (this is not a good diagnostic test for malignancy and is often falsely raised in premenopausal women). IMB/PCB – it is important to exclude an intrauterine cause e.g. endometrial polyp. Many cervical cancers are also visible on ultrasound. Such patients also need a speculum examination (and sometimes Chlamydia swabs). Coils – a scan can determine the location of the coil (this is not an urgent request) and sometimes whether a uterine perforation has occurred. Subfertility – in an asymptomatic patient, a routine pelvic scan is useful after 1 year of regular intercourse with no pregnancy. History of swollen lower limbs (could be unilateral or bilateral) – scan can exclude a pelvic mass causing vascular flow obstruction NOTES on not indicated Vulval conditions – clinical examination is superior Vaginal cysts - ultrasound is only required occasionally in a specialist setting Polycystic Ovaries – this is rarely useful – for the diagnosis of PCOS (Polycystic Ovarian Syndrome, 2/3 criteria are required – irregular menstruation, evidence of high testosterone levels, and ultrasound evidence of polycystic ovaries (PCO). (See Rotterdam Criteria). Most patients referred for ‘?PCO’ already have irregular periods and hirsutism, so ultrasound doesn’t really add much. We can perform a scan for this indication, especially if you indicate how it would affect management. Some specialist endocrine clinics and IVF units do require a scan as it can be clinically useful. Ovaries which look polycystic on ultrasound (PCO) do not cause pain and such patients are not infertile. UHS Guidelines for Ultrasound Referral in Adults 4 RENAL ULTRASOUND Indications • Chronic loin pain – MSK causes excluded • First UTI in male (require flow and residual volume assessment also) • Recurrent/persistent UTI in female • Deteriorating renal function to exclude obstruction (again ideally flow and residual volume assessment in males) • Chronic kidney disease (CKD) stage 4 or 5 (eGFR <30) once only, not in case of changing renal function, unless symptoms of obstruction • CKD 1,2 &3 with urine albumin/ creatinine ratio <30mg/mmol, only if there is a history of urological disease or a family history of polycystic renal disease. • Screening for adult polycystic renal disease (note that cysts may not appear until patients are in their 20s) • Unexplained renal failure with blood +/- protein in the urine Not Indicated • Acute renal colic – requires CT KUB [link to CTKUB pathway] • Haematuria – patients require fast track referral to haematuria clinic as per local guidelines (which will inevitably involve ultrasound as part of assessment and therefore creates duplicate requesting). Ultrasound could be considered in unexplained, non-visible haematuria in patients under 60 but this should not delay appropriate referral. • Further investigation of suspected absent/ectopic kidney – renogram preferred • CKD 1,2 &3 – see exceptions above • First line screen for renovascular hypertension – these patients should be referred for specialist assessment (MRI is a more sensitive test) UHS Guidelines for Ultrasound Referral in Adults 5 BLADDER Indications • Measurement of post voiding residual in suspected outlet obstruction • Neurogenic bladder • Urinary incontinence UHS Guidelines for Ultrasound Referral in Adults 6 SCROTUM Indications • Intra-testicular lump or uncertainty about whether a lump is intra or extra-testicular • Impalpable testis • Hydrocele of recent origin Not indicated • Definite extra-testicular lump with normal testis • Subcutaneous lumps/pinhead sized nodules – these are common and are not testicular cancers • Short-term testicular/epididymal pain and normal examination • Suspected torsion – requires immediate referral UHS Guidelines for Ultrasound Referral in Adults 7 INGUINAL HERNIAS Not indicated • An inguinal hernia is a palpable lump and is therefore generally detectible clinically • Groin pain in the absence of a lump is not an indication for US If lymphadenopathy or other lumps are suspected, this should be followed up clinically and specialist referral considered if persistent • A specialist hernia surgeon may require ultrasound in challenging cases. UHS Guidelines for Ultrasound Referral in Adults 8 CAROTID DOPPLERS Not indicated Ultrasound imaging of carotid arteries forms part of a specialist clinical assessment and is not offered as a direct access test UHS Guidelines for Ultrasound Referral in Adults 9 PERIPHERAL ARTERIAL STUDIES AND VENOUS MAPPING Not indicated These studies form part of a specialist clinical assessment and are not offered as a direct access test UHS Guidelines for Ultrasound Referral in Adults 10 Neck Ultrasound Ultrasound may be useful as a first line investigation for palpable neck lumps. However, many requests are received where ultrasound is unlikely to be helpful, delaying some patients being referred for a more appropriate investigation and subsequently prolonging waiting times for everyone. At UHS, neck ultrasound is performed by trained sonographers or consultant radiologists. To ensure the patient is booked onto the most suitable list, and avoid requiring a repeat visit, the radiology team heavily relies upon the history given. Please try to include the following information on referral for ultrasound: - Relevant clinical history including potential risk factors if malignancy is a concern. (red flags signs should be urgently referred for clinical assessment under 2WW). - Exact location of the lump. - Estimated size of the neck lump and consistency (soft vs hard). - Whether definite palpable lump or possible lump. - Whether single or multiple lumps - Clinical differential diagnosis These guidelines have been carefully considered and updated following discussion with the relevant ENT, OMFS and Endocrine teams to aid the general practitioner in the decisionmaking process for neck ultrasound referral. INDICATION LYMPH NODES THYROID COMMENT GP REFERRAL JUSTIFIED? RECOMMENDATION IF NOT Small, mobile, likely benign lymph nodes do not require ultrasound assessment. These must be assessed clinically (not virtually or via telephone consultations) and can be monitored clinically NO. Please perform clinical follow up in the first instance Palpable lymph nodes with clinical concern regarding underlying malignancy/red flag signs require urgent 2WW specialist referral. NO. Please refer to ONE STOP NECK LUMP CLINIC at UHS. UHS Guidelines for Ultrasound Referral in Adults 11 Thyroid swelling Diffuse, gradually increasing thyroid swelling most likely represents a benign multinodular goiter but a small proportion may have underlying malignancy- If not investigated previously, an US is indicated. YES, if not previously investigated. Hyperthyroidism Hypothyroidism Hyperparathyroidism and hypercalcaemia SALIVARY GLANDS SKIN LESIONS Routine imaging of known benign nodules or NO. stable multinodular goitres is NOT recommended. New thyroid swelling +/- palpable enlarged lymph or rapid increase in size of known thyroid nodules. NO. Please refer to ONE STOP NECK LUMP CLINIC at UHS. If any Red flag signs (hard swelling, palpable nodes, family history, childhood radiation exposure, voice change) refer urgently to under 2WW. NO. Please refer to ONE STOP NECK LUMP CLINIC at UHS. Ultrasound is not indicated unless there is a palpable thyroid nodule- please see above. Ultrasound is not indicated unless there is a palpable thyroid nodule- please see above. In the absence of a palpable thyroid nodule, NO. Please refer to Endocrinology. In the absence of a thyroid nodule, NO. Ultrasound is only indicated in biochemically proven primary hyperparathyroidism as part of a localisation procedure through a specialist. NO. Please refer to a parathyroid specialist. Mealtime salivary gland swelling suggestive of obstruction. YES. For significant, recurrent obstructive episodes, specialist referral may be more appropriate in the first instance. Persistent/palpable salivary gland swelling may represent a primary salivary gland neoplasm and requires specialist assessment. NO. Please refer to ONE STOP NECK LUMP CLINIC at UHS. Ultrasound is non-specific in its evaluation of skin lesions and therefore not indicated. NO. Please refer to dermatology. UHS Guidelines for Ultrasound Referral in Adults 12 Small subcutaneous lipomas can be assessed clinically and monitored by the patient to ensure stability. NO. Please monitor clinically Lipomas greater than 5cm or known lipomas which have increased in size or have concerning features require specialist referral with a view to dedicated imaging and possible excision. NO. Requires specialist referral DIFFUSE SWELLING NECK PAIN Diffuse soft tissue swelling particularly within NO. the supraclavicular fossae is common. In the absence of a palpable mass, ultrasound is not indicated. Ultrasound is not indicated for neck pain in the absence of a palpable mass- this is likely musculoskeletal in nature. NO. Please consider referral to community MSK service. TMJ Ultrasound is not indicated. PAIN/DYSFUNCTION NO. Please consider specialist referral to Oral & Maxillofacial surgery. BONY LUMPS Ultrasound is not indicated for bony hard NO. lumps or bone defects on the skull, forehead or cervical spine (eg transverse or spinous processes) UHS Guidelines for Ultrasound Referral in Adults 13 ADULT MUSCULOSKELETAL ULTRASOUND SHOULDER NICE guidelines for suspected intrinsic shoulder disorders recommend that the Oxford University Hospitals protocol is followed: http://www.ouh.nhs.uk [Oxford Shoulder Clinic, 2010] For the initial management of shoulder pain without red flags NICE recommends: analgesia, advice about occupational and daily activities, and consideration of physiotherapy referral +/- review in 2 weeks if pain is persistent (sooner if worsening). Common shoulder problems are self-limiting but the rehabilitation period may be 6 months or longer. • Please note that the primary use of ultrasound is for investigation of rotator cuff tear for which there is a high sensitivity and inter- observer correlation. • Diagnoses of ‘impingement’, adhesive capsulitis or degenerative change are not excluded by ultrasound and the diagnosis is usually arrived at clinically or on plain film. • One of the objectives of the shoulder imaging guidelines is to offer an efficient ultrasound service for those patients with a rotator cuff tear who are most likely to benefit from surgical treatment and to refer those patients either in whom a rotator cuff tear is unlikely, or who may benefit from a surgical opinion as to their suitability for surgery direct to secondary care. ELBOW Not indicated • Acute clinical distal biceps rupture should be referred urgently for orthopaedic opinion as there is a 3 week window of opportunity for repair. Ultrasound may be performed at specialist request to assess degree of retraction. • Lateral epicondylitis is readily elicited clinically and does not require ultrasound confirmation. FOOT AND ANKLE Indicated • Heel pain non-responsive to conservative measures may be assessed by ultrasound to exclude/confirm plantar fasciitis, peroneal or tibialis tendon damage and impingement syndromes. Not indicated • Morton’s neuroma/Forefoot symptoms - Ultrasound is not felt to contribute significantly to the diagnosis of forefoot pain in the non-specialist setting. Either a referral to podiatry, intermediate or secondary care should be considered. UHS Guidelines for Ultrasound Referral in Adults 14 Notes • Diagnosis of the patient presenting with metatarsalgia often presents a challenge. • Differential diagnosis includes: metatarsal stress phenomena, MTP joint problems, abnormal biomechanics, tendon pathology, Morton’s neuroma and other pathology. • Ultrasound correlates poorly and may lead to overdiagnosis. ACHILLES TENDON Not indicated Acute tears of the Achilles tendon require urgent orthopaedic assessment and ultrasound is usually performed immediately at their request. Chronic Achilles tendinosis is a clinical diagnosis. The tendon is easily palpable and ultrasound adds little to the diagnosis. KNEE Indicated • The primary use for ultrasound of the knee is for assessing disorders of the extensor apparatus. Quadriceps and patellar tendinopathy/tears are well demonstrated • Popliteal fossa lesions Bakers’ Cyst – not indicated. This commonly reflects fluid secondary to internal knee pathology. Routine MR from local service provider would be preferable as this will assess the Cyst and provide more information regarding the underlying state of the knee (GIRFT). Popliteal aneurysm – indicated – vascular US referral. DVT – indicated but should be assessed as part of the whole limb by referral for US Doppler. Soft tissue lesions – indicated. Not indicated • Ultrasound does not detect intra-articular pathology such as ligament injuries, meniscal tears and degenerative change. HIPS Not indicated routinely • Ultrasound should not be used routinely in the investigation of lateral hip/ greater trochanteric pain. • Ultrasound is of limited value in the assessment of hip disease and is only used to confirm the presence of an effusion in a painful, potentially infected or inflamed hip. • Lateral (greater trochanteric) pain is a common clinical syndrome where patients, with a strong female predominance, present with pain and tenderness over the greater trochanter. UHS Guidelines for Ultrasound Referral in Adults 15 The diagnosis is primarily clinical, and there is poor correlation ultrasound findings (which suffer from high inter-observer variability) and the clinical symptoms. • A normal ultrasound does not exclude a diagnosis of gluteal pain syndrome. An ultrasound therefore does not add to management in the vast majority of cases. SYNOVITIS • Ultrasound screening for synovitis is not performed by main ultrasound and referral to the rheumatology clinic is needed UHS Guidelines for Ultrasound Referral in Adults 16 -Breast lumps and axillary lumps with a history of previous breast cancer should be referred directly to the breast service at Princess Anne Hospital as urgent 2WW. References: 1. NHS Dorset Clinical Commissioning Group Dorset Guidelines for GP Ultrasound Referral in Adults. 2016 2. Map of Medicine. 3. Royal College of Radiologists iRefer 4. NICE guidelines UHS Guidelines for Ultrasound Referral in Adults 17
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/Media/UHS-website-2019/Docs/Services/Radiology/UHSNFT-Ultrasound-Referral-guidelines-for-GPs-V6-new-neck-referral-included.pdf

Registering New Studies into the CRF

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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
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Fragility fractures - patient information

Description
This factsheet explains what fragility fractures are and what you can do to avoid them.
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/Media/UHS-website-2019/Patientinformation/Muscles,jointsandbones/Fragility-fractures-2559-PIL.pdf

UHS Green Plan 2025-2028

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Green Plan 2025 - 2028 Approved November 2025 Contents 1 Executive Summary 2 Introduction and Context 3 Organisational Vision 4 Review of Progress 2022-2025 5 Key Areas of Focu
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/Media/UHS-website-2019/Docs/About-the-Trust/Sustainability-and-Green-Plan/UHS-Green-Plan-2025-2028.pdf

Tarlatamab (EAMS)

Description
Chemotherapy Protocol LUNG CANCER – SMALL CELL (SCLC) Tarlatamab (EAMS) Regimen • SCLC – Tarlatamab (EAMS) Indication • Tarlatamab is i
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-small-cellSCLC/Tarlatamab-EAMS-Ver-1.0.pdf

Papers Trust Board - 25 July 2024

Description
Agenda Trust Board – Open Session Date 25/07/2024 Time 9:00 - 13:00 Location Anaesthetic Seminar Room (CE95/99), E Level, Centre Block,
Url
/Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2024-Trust-documents/Papers-Trust-Board-25-July-2024.pdf

Papers Trust Board - 30 January 2020

Description
Date Time Location Chair Apologies Agenda Trust Board – Open Session 30/01/2020 9:00 - 11:45 Conference Room,
Url
/Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2020/Papers-Trust-Board-30-January-2020.pdf

Papers Trust Board 28 March 2019

Description
Agenda Group Name: Date of Meeting: Venue: Time: Apologies to: Trust Board – Open Session 28 March 2019 Conference Room, Heartbeat Educati
Url
/Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2019/Papers-Trust-Board-28-March-2019.pdf

Enhanced recovery after elective caesarean section - patient information

Description
This leaflet contains information about the recovery process after having a planned (elective) caesarean section.
Url
/Media/UHS-website-2019/Patientinformation/Pregnancyandbirth/Enhanced-recovery-after-elective-caesarean-section-1130-PIL.pdf
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