RESEARCH AND INNOVATION (R&I) Research Capacity and Capability Assessment Guidance

Transcription

1 RESEARCH AND INNOVATION (R&I) Research Capacity and Capability Assessment Guidance Title: Prepared for: Author: Purpose of document: Research Capacity, Capability and Delivery Guidance Research & Innovation Carol Sleigh, Research & Innovation Manager To give guidance to researchers and CSUs on undertaking accurate and comprehensive capacity and capability (also known as feasibility) review of potential research studies to support effective research delivery/performance.

2 1.0 Background The NIHR has implemented a number of performance management metrics with the aim of increasing the speed of study set up and ensuring the delivery of quality research in the UK. All research active NHS trusts are required to report performance, initiation and delivery (PID) data to the Department of Health (DH) quarterly on studies that involve; Clinical trials of investigational medicinal products (CTIMPs) Trials subject to EAG (Expert Advisory Group on Clinical Trials or CHM (Commission on Human Medicines) assessment Gene therapy medicinal products Clinical investigations or other studies of medical devices PID data specifically includes information on; Initiation recruitment of the first patients within 70 days of submission of a valid research application (currently SSI) regardless of how quickly R&D departments approve studies. For example if an R&D department approve a study within 5 days, the study team will then have 65 days to recruit their first patient. Delivery recruitment of agreed local recruitment targets within the study recruitment period i.e. 10 patients in 12 months If studies do not meet initiation and delivery targets, detailed information i.e. the number of patients; approached, declining to take part in study (and themes of why), consented, failed pre randomisation investigations etc. need to be reported to DH. 2.0 Why undertake capacity and capability review? As well as potential financial implications of not achieving NIHR performance management targets it is essential that research grants are awarded to studies that are feasible in practice, recruit their target numbers of participants and that resources are not wasted. Only studies that recruit their target patient numbers can deliver scientifically significant knowledge. Undertaking robust capacity and capability review allows us to identify which studies can be delivered in the Trust when considering patient population, ability to meet trial timelines, local resources and impact on service support departments as well as the experience and previous performance of potential Principal Investigators. Whilst undertaking capacity and capability assessment does not guarantee success, conducting thorough local assessments can help to identify studies likely to achieve performance management metrics within LTHT s patient pathways and resources.

3 3.0 CSU review process Before a study can proceed at LTHT the principal investigator (PI) must complete a comprehensive capacity and capability (feasibility) assessment. PI to complete the Capacity and Capability Assessment Form in discussion with specialty team (Appendix 2) PI to send information of the impact of the study to all service support departments that will be involved PI to discuss Capacity and Capability Assessment Form at the CSU Research Group (See Appendix 1 for template Terms of Reference) or with the CSU Clinical Director (CD) and Research Lead Include feedback from key service support departments in discussions When CSU approval is obtained (via CSU Research Group or discussion with the CSU CD and Research Lead) the Capacity and Capability Assessment Form and CSU approval letter (see Appendix 3 for template letter) to R&I Liaise with R&I to coordinate set up of study at LTHT (key service support department, finance and contract review and sign off)

4 Appendix 1 THE LEEDS TEACHING HOSPITALS NHS TRUST Terms of Reference Clinical Service/Support Unit (CSU) Research Interest Group 1. PURPOSE The Clinical Service/Support Unit (CSU) Research Group has been established to assess capacity and capability (feasibility) of new studies potentially to be carried out in the CSU. The Group s purpose is to ensure that a comprehensive and robust system is in place for capacity and capability assessment of potential research studies within the CSU and that studies are delivering to recruitment time and target. The Principal Investigator and Research Nurse should attend to present their studies. 2. MEMBERSHIP The Research Group should consist of; Clinical Lead/CSU R&I Lead Chair Finance/Business Manager Research and non-research Consultants Study specific Principal Investigator Research Nurse A quorum shall be 2 members including Chair or deputy Chair. 4. FREQUENCY Depending on the research activity within the CSU, the group may meet monthly or meetings may be called when new research studies are being considered. Meetings should take place at least quarterly to feed into R&I performance initiation and delivery reporting schedule. 5. REPORTING It is the Principal Investigator s responsibility to submit the Capacity and Capability Assessment Form, protocol and any responses from service support departments and attend the group to present their study. The minutes of the CSU Research Group will be recorded and archived with the protocol and capacity and capability assessment form. Actions will be tracked using an action tracking tool, or all outstanding actions brought forward with the next meeting agenda. The group will provide assurance to the Trust R&I Department that all aspects of capacity and capability of studies have been considered at CSU level.

5 6. DUTIES The key duties of the CSU Research Group are to: Provide leadership for capacity and capability research protocols within the specialty/csu ensuring robust structures and processes are established to assess feasibility for each potential study the CSU will support reviewing the protocol, resource implications, patient pathway and the development of a recruitment strategy prior to submission for Trust approval, Govern the quality of research services and ensuring that services are safe within the CSU Promote a culture of research activity to improve quality of care and patient experience. Report quarterly to R&I on performance, initiation and delivery information (first patient in 70 days and recruitment to time and target and reasons why targets have not been achieve if relevant) Report to CSU Clinical Governance Forum quarterly, with a list of studies (in set up, open to recruitment, closed in follow up) and performance, initiation and delivery information, and reasons why targets have not been achieve if relevant) On the basis of the information reviewed, the Group will identify any actions to be taken locally, and disseminate to other specialty forums, or escalate to the CSU Clinical Governance Forum as appropriate. 7. APPROVED Approved by: Date: (Insert date approved) 8. REVIEW DATE

6 Appendix 2 Capacity and Capability Assessment Form Before a research study can proceed at Leeds Teaching Hospitals NHS Trust (LTHT) the Principal Investigator (PI)/Research team is required to complete capacity and capability (feasibility) assessment of the potential new study, which includes; 1. PI/Research team completes the capacity and capability assessment form; 2. PI presents capacity and capability assessment for CSU review to either the CSU Research Group/CSU Clinical Director/CSU Research Lead; 3. PI/Research team contacts all departments that the study will impact on so they can provide written assurance that they can support the study before submission to R&I; 4. PI submits completed capacity and capability assessment form indicating CSU approval to R&I ( address to be inserted), prior to proceeding with study set up. *CSU approval of studies should only be given once the capacity and capability assessment has been completed. For more information about study capacity and capability see Research Capacity and Capability Guidance (link/url to be inserted) Completed by (insert name) Role in study address Telephone number PI RN/DM Study Overview Full name of study NIHR adopted Y/N (give reference number) Reference numbers R&I EUDRACT?? Synopsis: provide a brief 1-2 paragraph lay summary overview of the project, (including study aim, treatment/investigation/follow up plan and who will be working on the study) Does the study fit PID reporting criteria (See Further Information) Y/N Disease group/target population Chief Investigator Sponsor Institution Non-commercial/Commercial (if commercial, add company name) Give details of study funding/free drugs/equipment

7 Does the study involve a medical device? Is it being used off label? For CTIMP studies, is there an exit strategy in place for the end of the study? (See Further Information) Conduct and Recruitment What is the Sponsors overall target recruitment? Is this a multi-centre study? What is the total local recruitment target? Is study recruitment competitive? What are the recruitment timelines for this study? (start and end date if know) Are there any barriers that will effect recruitment (nationally and locally) and how will these be addressed? e.g. tight timelines for study investigations Give details of how patients will be identified, screened and approached Would any of the eligibility criteria make patients difficult to recruit? How many eligible patients do you see annually? When did you last see a patient that could have been approached for this study? When would you reasonably expect to see another patient who would meet the inclusion criteria for this study? Where will the study/follow up take place? What is the length and intensity of follow up? Have all specialty colleagues agreed to recruit patients to the study? Can the protocol be readily integrated with routine care? Give details of any logistical issues that cause concern e.g. patient pathways, work that might need to take place outside of normal working hours/weekends, activities taking place across hospital sites Service Support Departments Give summary of impact on radiology and any special reporting requirements Give summary of impact on pharmacy

8 and any special reporting requirements Give summary of impact on Pathology (Blood Sciences/Specialist laboratory Medicine, Microbiology/Virology, Cellular Pathology, genetics) and any special reporting require Give summary of impact on outpatients department Give summary of impact on any other department e.g. outpatients/wards What responses have you received from service support departments? Performance and support Give details of achievement of first patient recruitment and recruitment to time and target for all studies with same PI over the last year Does the PI have research time allocated in their job plan? Have Co-investigators and Research Nurses been identified to undertake the study including non-research staff and any additional staff being recruited? Please list Current research activity in department Give the number of other studies that are open to recruitment in this disease site Give the number of studies that are in active follow up? (give details of patient numbers and activity involved) Competing research studies Are there any studies competing for this patient group or resources? If so, explain why you want to open this study and identify your recruitment plan to enable you to achieve targets for the completing studies. Capacity and resources Are there likely to be any issues around research team support? e.g. limited staff availability, long term sickness, maternity leave, recruitment over summer or Christmas period If there is a delay in study set up please re assess prior to study set up Does the site have all the facilities

9 and equipment required to accommodate the study? E.g. freezers Give any information you have available re potential savings to the Trust in the future e.g. on-going treatment that may not be needed if the study treatment is successful Please give details of any other issues that might impact on capacity and capability (feasibility) e.g. planned changes to LTHT patient pathways for this patient group during the recruitment period Where will (paper and electronic) records be stored during the lifetime of the study? Where will (paper and electronic) records be archived once study has ended? Has funding for this been agreed? Training Does everyone have up to date GCP training Please give details of any specialist expertise or training required for the study that might impact on site capacity and capability (feasibility) including timely access to training Completed by (role) Name Date Further Information 1. PID reportable studies; Clinical trials of interventional medicinal products (CTIMPs) Trials subject to EAG (Expert Advisory Group on Clinical Trials or CHM (Commission on Human Medicines) assessment Gene therapy medicinal products Clinical investigations or other studies of medical devices 2. CTMP exit strategy An agreement prior to R&I approval and commencement of patient recruitment, of whether successful treatment will be funded after the research study has ended.

10 Appendix 3 CSU Address Enquiries to: Direct Line: Fax: Ref: Date: Study Title: To whom it may concern, I am writing to confirm that the above study has been reviewed and has received xx CSU approval. Yours sincerely Name Title Name of CSU