Version History. Contents. Organisation R&D Management Arrangements

Transcription

1 v1c NIHR Guideline B01 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Approved by Updated by RDOCS /09/ /09/ CHS BOARD A Cook RDOCS 002 Contents Organisation R&D Management Arrangements Organisation Study Capabilities Organisation Services Organisation R&D Interests Organisation R&D Planning and Investments Organisation R&D Standard Operating Procedures Register Planned and Actual Studies Register Other Information Organisation R&D Management Arrangements Information on key contacts Organisation Details Name of Organisation R&D Lead / Director (with responsibility for reporting on R&D to the Organisation Board) R&D Office details: Name: Address: Contact Number: Contact Other relevant information: Croydon Health Services NHS Trust Dr Y L Chang Aline Cook Croydon Research Office, 1st Floor Woodcroft Wing, 530 London Road, Croydon, Surrey. CR7 7YE aline.cook@croydonhealth.nhs.uk Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Role: Name: Contact Number: Contact Contact 2: Role: Name: Contact Number: Contact Contact 3: Role: Name: Contact Number: Contact R&D Director Dr Y L Chang john.chang@croydonhealth.nhs.uk Medical Director/Caldicott Guardian Mr Stephen Ebbs (From ) steve.ebbs@croydonhealth.nhs.uk Information Governance Manager Gregory Ugbiyobo ext 5671 gregory.ugbiyobo@croydonhealth.nhs.uk Page 1 of 11

2 Add further contacts by selecting and then copying the five Excel rows (ie whole rows) above for Contact, role, name, number and . Then select the blank row under the table and 'insert copied cells'. (Please do not select and copy individual cells or groups of cells as this does not preserve formatting.) Page 2 of 11

3 Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) Whole Time Equivalent R&D Manager 1 R&D Support Officers 1 Research Co-Ordinator 1.5 Research Nurses 1.6 Comments indicate if shared/joint/week days in office etc Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.) Reporting Structures R&D committee. R&D Director on Risk Management Committee and Clinical Governance committee, and reports to the Trust Board Information on Research Networks supporting/working with the Organisation. Information on how the Organisation works with the Comprehensive Local Research Network (CLRN), Primary Care Research Network (PCRN), Topic Specific Clinical Research Networks (TCRN). Research Networks Research Network (name/location) Role/relationship of the Research Network eg host Organisation South West London Cancer Research Network Trust hosts studies South East Stroke Network Trust hosts studies Medicines and Children Research Network Trust hosts studies Urogynaecology Trust hosts studies and own account work London South CLRN Portfolio studies and RM&G issues Information on collaborations and partnerships for research activity (e.g. Biomedical Research Centre/Unit, Other NHS Organisations, Higher Education Institutes, Industry) Current Collaborations / Partnerships Organisation Name CLRN London South Epsom & St Helier/Kingston Details of Collaboration / Partnership (eg Informal collaboration Contact Name Ann Marie Murgatagh Yvonne Reilly Page 3 of 11 address Contact Number

4 Academic Health Science Network - South London Joint Clinical Trials Office, Kings Partnership St Georges Homerton Hospital Royal Marsden Hosptial Formal partner Industry Studies Hosting studies Hosting studies Hosting studies- Cancer John Goulston Ali Sellors/Elizabeth O'Sullivan Nigel Kinner - E-Prime Paul Heath - PUNS Kate Costello - PIPs Dr Robert Huddart/Professor John Yarnold Dr Soonie Patel Page 4 of 11

5 Organisation Study Capabilities Information on the types of studies that can be supported by the Organisation to the relevant regulatory standards Types of Studies Organisation has capabilities in (please tick applicable) CTIMPs (indicate Phases) Clinical Trial of a Medical Device Other Clinical Studies Human Tissue: Tissue Samples Studies Study Administering Questionnaires Qualitative Study As Sponsoring Organisation x x x x As Participating Organisation As Participant Identification Centre Own Account work OTHER Which licences does the organisation hold which may be relevant to research? Organisation Licences Licence Name Example: Human Tissue Authority Licence Licence Details Licence Start Date (if applicable) Human Tissue Authority Licence Biochemistry Licence Radiation Licence Pharmacy Licence Licence No: th June 2010 Licence End Date (if applicable) Remains in force until revoked PCT ONLY: Information on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices Page 5 of 11

6 Organisation Services Information on key clinical services contacts and facilities/equipment which may be used in studies for supporting R&D governance decisions across the organisation. Clinical Service Departments Service Department Specialist facilities that may be provided (eg number/type of scanners) Contact Name within Contact Service Department Contact number Pathology Lead Pathology Dr Anne Tarn Radiology Clinical Lead Dr Satkurunathan ext Maheshwaran nhs.uk 4122 Pharmacy Chief Pharmacist Louise Coughlan ext 4145 Therapies SALT Physiotherapy Details of any internal agreement templates and other comments Information on key management contacts for supporting R&D governance decisions across the organisation. Management Support e.g. Finance, Legal Services, Archiving Department Specialist services that may be provided Contact Name within Contact Service Department Contact number Archiving Aline Cook Contracts Aline Cook Data management support Aline Cook Finance Teddy Mulenga ext 4407 Information Technology Tony Varney Legal Diane-Kareen Charles HR Michael Burden Statistical support Univeristy of Surrey Details of any internal agreement templates and other comments Page 6 of 11

7 Organisation R&D Interests Information on the areas of research interest to the Organisation Organisation R&D Areas of Interest Area of Interest Breast Details Cancer Contact Name Mr Stephen Ebbs Miss Caroline Pogson Contact Contact Number Colorectal Cancer Colorectal surgery Mr Muti Abulafi Mr Ian Swift Cardiology Dr Lin Soo Dermatology Dr Eleanor Mallon ext 5793 Elderly Care Stroke Dr Enas Lawrence Dr Karen Kee Dr Selina Lim Gastroenterology Dr Mike Mendall Dr Sanjay Gupta Haematology Haematology Haematology Haematology HIV Dr Hilary Lumley Dr Jenny Maitland Dr Nnenna Osuji Dr Corinna Pollard Dr Ian Cormack Dr Ali Elgalib ext ext 5007 Obstectrics/Gyanecology Gynaecology oncology, Colposcopy and Mr Abi Oladipo Vulva diseases Paediatrics Neonatalogy Diabetes Dr John Chang Dr Susanna Hart Sickle Cell Disease Neonatology Dr Grant Marais Oncology Dr Soonie Patel Respiratory Medicine Dr Tuck-Kay Loke Rhematology Dr Sarah Levy Urogynaecology Diagnostic gynaecology, Urogynaecology Mr Abdul Sultan including pelvic floor dysfunction, urinary and anal incontinence and prolapse Continence, prolapse and perineal trauma Miss Ranee Thakar Surgery - Cancer Surgery - Cancer Vascular Surgery Mr Gary Das Mr Krish Ramasubbu Miss Stella Vig gary.das@croydonhealth.nhs.uk krish.ramasubbu@croydonhealth.nhs.uk stella.vig@croydonhealth.nhs.uk Information on Local / National Specialty group membership within the Organisation which has been shared with the CLRN Specialty Group Membership (Local and National) National / Local Specialty Group Specialty Area (if only specific areas within Contact Name Contact Contact Number Example: Injuries and Accidents Example: Burns Diagnostic gynaecology, Urogynaecology Mr Abdu Sultan abul.sultan@mayday.nhs.uk Lead for Urogynacology Urogynaecology including pelvic floor dysfunction, urinary and anal incontinence and prolapse Page 7 of 11

8 Lead for Breast Breast Breast cancer surgery Mr Steve Ebbs Lead for Colorectal Colorectal Colorectal surgery and cancer Mr Muti Abulafi Lead for Urology Mr Gary Das Lead for Neonatology SW London Neonatal Network Dr John Chang Organisation R&D Planning and Investments Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) Facilities Training Recruitment Staff Resources Description of Planned Investment Value of Investment Office 20k GCP On-Line Training 1.5k Posters and adverts for annual R&D Afternoon to diseminate information to rest of Trust 2k Full time Research Nurse/Facilitator to help facilitate portfolio studies 46k Funding 0.5 wte post for research nurse from SWLCRN to help facilitate portfolio studies 23k Supporting Pharmacy posts to facilitate research 33k 12/12 PDP/Education 4k 12/12 Equipment 2k 6/12 Support clinicians 10k 6/12 Indicative dates Page 8 of 11

9 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP NO 1 SOP Title Preparation, Approval, Review and Issue of Standard Operating Procedures SOP Details To describe the procedure for preparing, approving and distrubution of SOPs. To describe the procedure for revision and conduct of regular review of SOPs. Valid from Valid to SOP NO 2 Definition & Delegation of Responsibilities To assist in the definition and delgation of study responsibilties within the Study team. SOP NO 3 The Process of Obtaining Informed Consent for a Research Study To describe the procedure for obtaining written informed consent form a study subject. SOP NO 4 Study File & Filing To describe the procedure for the filing of study documentation. SOP NO 5 Case Report Form (CRF) Competion To describe the procedure for completing, signing and correcting case report forms. SOP NO 6 SOP NO 7 Ethics & R&D Submissions & Apprioval Adverse Event & Serious Adverse Event Reporting To describe the procedure required by a host research site for completing and submitting the documentation required to obtain Site Specific Approval & R&D approval. To describe the procedure for identifying, recording and reporting safety data such as adverse events and serious adverse events. SOP NO 8 Audit & Inspection To give a guideline for the prepatory activities for an audit or inspection, SOP NO 9 Archiving & Destroying Documents To describe the procedure for archiving study documnents at the end of a clinical trial. SOP NO 10 Performing & Documenting Training for Research Staff To ensure new research staff are properly trained and able to produce evidence of such training. SOP NO 11 Monitorig Visit To describe the preparation and procedure to following during and followig monitoring visits. SOP NO 12 Study Close Down To describe the procedure for study close down, detaiing the process and essential documentation required. SOP NO 13 Initiation Visit To describe the preparation and procedure to follow prior, during and following initiation visits. SOP NO 14 Handling & Processing of Clinical Trial Samples To describe the procedures required to ensure accurate handling, processing and dispatch of human blood, urine, and tissue samples as required for a clinical trial SOP NO 15 Safe Collection of Clinical Trial Samples To describe the procedure for the safe collection, handling and dispatch of human tissue samples. SOP NO 16 Reporting of Serious Breaches To describe the standard procedures to be followed for managing serious breaches of protocols/gcp in clinical drials or studies conducted by Croydon Univeristy Hospital. SOP NO 17 Preparation & Approval of Clinical Trial Amendments To provide guidance on the implementation of amendments and urgent safety measures. Page 9 of 11

10 Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports CUH manages Research Passports using the NIHR Human Resources Good Practice Resource Pack. HR have delegated authority to the R&D department to issue Honarary Contracts or Letters of Access as necessary. Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes Escalation Process R&D Director reports directly to the Medical Director and Trust Governance committee. Page 10 of 11

11 Planned and Actual Studies Register The Organisation should maintain or have access to a current list of planned and actual studies which its staff lead or collaborate in. Comments The Trust uses CSP and Excel spreadsheet to manage active and planned research and uses this information for R&D annual returns. Other Information For example, where can information be found about the publications and other outcomes of research which key staff led or collaborated in? Other Information (relevant to the capability of the Organisation) Knowledge Service Department holds a list of publications irrespective of whether the publications are directly related to hosted NIHR portolio studies. Page 11 of 11