1. INTRODUCTION 2. SCOPE Feasibility assessments will ascertain any operational concerns about a research study which may delay NHS Permission or cause issues with study delivery. By conducting an assessment it ensures that Nottingham University Hospital (NUH) researchers are able to undertake the proposed research study in accordance with the requirements of the study protocol and achieve recruitment to time and target. Applicable to all non-adopted non commercial studies requesting NUH NHS permission where the study originates within NUH, or where NUH is participating site at R&I team s discretion. 3. PROCESS R&I are notified of investigators intent to undertake a research study within NUH or documents are submitted to the R&I applications central e-mail box. Whichever is the earliest notification the allocated governance individual will undertake a feasibility assessment (FA) in conjunction with the research team. When a study is submitted to the R&I department the Research Administrative team will register the project, make up a file and add to DOCUMAS within 3 days. The R&I Operations Manager (or delegated individual) will then assign the study to a relevant member of the team for an initial review and confirmation on whether it is a valid submission. The allocated Research Manager/Research Governance Facilitator will determine which documents are missing by completing a checklist of missing documents (Appendix 1) which will be passed on to the Research Administrative team to send out to the individual who submitted the study within 6 days. Where NUH is requested to act as research sponsor organisation or as a participating site in a study the relevant feasibility assessment will be carried out using the RSS and NUH assessment tools in Appendix 2, a meeting/teleconference will be set up with the research team. The planning tool will quickly highlight any areas of concern. The reviewer can assess whether the Investigator and research team have the experience and capacity to carry out the study and assess the overall feasibility of the study with regards to resources, support department involvement and delivery of recruitment to time and target. The identification of any concerns at this stage means that they can be addressed promptly with the sponsor/ci/local investigator and appropriate plans can be put in place early in the NHS Permission process. Once the feasibility assessment has been conducted the study team will be notified via e-mail (Appendix 3) of the outcome and whether the study is; SOP 49 Feasibility Assessments Non Commercial Studies Page 2
Feasible no further action required- proceed to governance review Potentially feasible areas to be addressed/resolved Not feasible at this time- R&I staff will discuss with the Investigator/Study team and Sponsor NUH R&I will work closely with the Investigator/study team and sponsor to resolve any issues. As soon as the outstanding study documents, as requested on the R&I submission checklist are received the application is considered to be a valid submission and the governance review may be undertaken taking into account the FA. The reviewer advises the PI/designated study contact of any governance queries for their action and documents these issues on the R&I governance review document and research database. The timeline from a valid submission being received to R&I approval time is aimed to be 30 calendar days. Please refer to Appendix 4 for a summary of the process. Once all the governance issues have been resolved the study may proceed to NHS permission. Post permission the study team are requested to report 1st patient recruited and quarterly reports (via e-mail address rdmon@nuh.nhs.uk)so recruitment to time and target can be monitored. SOP REVIEW PERIOD This procedure will be reviewed by the owner on a bi-annual basis, unless new local, national and/or international recommendations force an earlier review. SOP 49 Feasibility Assessments Non Commercial Studies Page 3
Appendix 1 Research & Innovation Application Checklist You must provide ALL documents that apply to your study before R&I will consider this a valid submission. R&I will notify you when your submission is considered to be valid Document Electronic copies (pdf format) of IRAS application including R&D and Site Specific Information (SSI) forms. Printed copy of SSI form with Declaration signed by PI or local collaborator including all authorisations (e-mail) from the support departments, e.g.pharmacy, Pathology Favourable opinion letter (pdf format) listing all approved documents (including amendments if applicable) from recognised REC/University of Nottingham Medical School Ethics Committee when available. Electronic copies of the following documents must have version number and date on each page and on appropriately headed paper: Protocol Participant Information Sheet Consent Form Other study documents (e.g. questionnaire, data collection forms) Electronic or hard copy of CV signed and dated (signed in last year) for each member of the research team Electronic or hard copy of ICH GCP training certificate (undertaken in last 2 years) for each member of the research team Clinical Trials Authorisation (CTA) from the Medicinal and Healthcare Products Regulatory Agency (MHRA) for CTIMPS or notice of no objection for medicinal devices, plus evidence of response to remarks and subsequent acceptance by MHRA. If your study involves imaging, the following documents must be sent by email to MPE@nuh.nhs.uk and authorisations received: - Protocol - R&D & SSI form - Patient information sheet and consent form - Study Image summary sheet Please contact R&I at the earliest opportunity to discuss this. Human Tissue Transfer Agreement (HTTA) to be provided by the Sponsor (this may form part of agreement)- if required Clinical Trial Agreement (ABPI, unsigned) and costings proforma (on standard industry template) Indemnity (in ABPI format) and insurance certificate If pharmacy involvement; Pharmacy manual Drug preparation guidelines Drug storage requirements Comments (please explain why this document is not required) SOP 49 Feasibility Assessments Non Commercial Studies Page 4
Expiry details Label example Handling precautions. Please submit all electronic documents to rdappl@nuh.nhs.uk SOP 49 Feasibility Assessments Non Commercial Studies Page 5
Appendix 2 http://www.nihr.ac.uk/systems/pages/rss_documents.aspx Feasibility Assessment Study title: Principal Investigator: Contact information: Sponsor: Proposed start date: Adopted/non-adopted: Protocol Protocol 1) Is there anything in the protocol which is nonstandard and requires early support department discussions? N.B.: Radiology procedures- find out how many scans required & frequency & the number of patients. If a lot of patients or several scans required within a very narrow timeline, please flag this as an issue to the site to discuss with Radiology as soon as possible Funding 1) Has the project got funding- if no how are costs to be covered? 2) How much 3) Who from 4) Awarded or pending 5) NIHR partner? If NUH sponsoring then fees applicable N.B If project has no funding then cannot go ahead- (suggest applying for pump priming) Resource 1) Who will be working on the study? 2) Is there a back-up co-investigator? 3) Who will be taking consent? 4) Do site staff have sufficient resource? 5) How many studies are currently being run by the department? 6) Are there any competing studies? SOP 49 Feasibility Assessments Non Commercial Studies Page 6
Facilities Site: 1) Patient visits: - Who will do what? - Where will patients be seen (different departments)? - Will patients need to be sedated at any point (e.g. colonoscopies)? 2) Does the site have adequate facilities & equipment to accommodate the study? - Patient/research area - Blood pressure machine - ECG - Freezer - Fridge - Centrifuge - Water bath 3) If not, how will the site access facilities/equipment? Pharmacy: please ensure pharmacy are visited at the SSV by the Sponsor so that any concerns can be raised early 1) Which Pharmacy will be used? 2) Does Pharmacy have adequate storage facilities for the IMP? 3) Do they have the capacity? 4) Is there anything unusual about this drug/drug regime? 5) Will Pharmacy have to source drugs or are these provided by Sponsor? 6) Will these drugs be paid for by the Sponsor? 7) Chemo drugs- infusion devices- PVC infusion bags- which make? (Macopharma model not approved by NUH) SOP 49 Feasibility Assessments Non Commercial Studies Page 7
Other support departments: 1) Which support departments will be required to conduct the study? Recruitment 1) What will the primary recruitment methods be? a) Nurse/doctor approaching patient b) Database c) Posters d) Radio ads/newspaper ads 2) Who will be responsible for identifying patients? If a research nurse, check they are involved in the patient s clinical care- if they are not, they cannot search patient database/notes until consent is signed by the patient 3) Who will be responsible for driving recruitment? 4) What is the patient pathway? 5) Do other departments/people need to be contacted to make them aware of the study (think of the patient pathway)? Who will do this? 6) Is there anything in the protocol design or inclusion/exclusion criteria which may impact recruitment? 7) How many patients are currently seen a) Per month b) Per year 8) What is the anticipated screen failure rate? 9) Length of recruitment 10) Proposed recruitment target N.B Discuss with the site the importance of being recruitment ready. Provided staff are SOP 49 Feasibility Assessments Non Commercial Studies Page 8
involved in the clinical care of the patient the nurse/doctor can take some time prior to R&I approval to identify a list of potential patients, check inclusion/exclusion criteria. As soon as R&I approval has been granted, the patients can then be approached. Need to aim for FSI within 14-28days of R&I approval. Governance 1) Has everyone got an up-to-date CV and GCP training certificate? 2) Who will be completing the SSI form? Do they have an IRAS account? 3) Who will be responsible for submitting information to the support departments identified above? Are they aware of the new process (e-mail authorisations)? 4) Who will submit all the documents to R&I? Aware of the process and requirements? General Site file: 1) Who will be responsible for ensuring site file is kept inspection-ready? 2) Where are files and study related documents stored? 3) Any issues with space identified? Medical Equipment: 1) Will any equipment be required for the purposes of the trial? Discuss the MESU procedure. Comments NUH feasibility assessment version 3.0 22Feb11 SOP 49 Feasibility Assessments Non Commercial Studies Page 9
Appendix 3 Dear Dr XXXX, Study title: R&I reference PI Sponsor Thank you for your time at the recent feasibility meeting/discussion At the meeting we discussed several items and I completed the NUH feasibility assessment for your site. i. Feasible no further action required- proceed to governance review ii. Potentially feasible areas to be addressed/resolved iii. Not feasible at this time All discussions have been documented in your feasibility assessment document and a copy is filed in the R&I department. At the visit I was asked to provide x and y on your behalf. These actions have now been completed. Or, the following actions are outstanding and list. Critical to the successful delivery of research studies at NUH is fast approval times and recruitment to target. NUH s target is to achieve first patient in within 14-28 days of R&D approval/site initiation and we must endeavour to meet our agreed overall recruitment target. For non-nihr-adopted studies, please ensure that when you recruit your first patient, you contact rdmon@nuh.nhs.uk in R&I to alert us of the date. Thereafter, please ensure that you provide recruitment figures quarterly as these figures will now be reported to the Trust Board. If I can be of any further assistance please do not hesitate to contact me. SOP 49 Feasibility Assessments Non Commercial Studies Page 10
Appendix 4 R&I Process Flow Chart- Start to Approval Application comes into R&I via post / rdappl in box. 3 Days ADMIN-; 1) Make up file (inc KPI sheet in hard copy and in elec file) 2) Register on EPS and allocate R&I ref number 3) Add to non adopted tracker in R&I ref number in red & put file on review shelf CD checks non portfolio tracker daily. Allocates newly added studies to GOVN STAFF 3 Days GOVN STAFF- Initial check Generate checklist of missing documents/ confirms valid submission. GOVN STAFF- Arrange feasibility assessment with research team Assessment completed and outcome fed back to team Checklist of missing docs or confirmation of valid submission to ADMIN 2 Days ADMIN- send out missing docs list (standard email 2a) with allocated R&I ref No. or confirmation of valid submission (standard e-mail 2b ) with allocated R&I ref No. Update non adopted tracker comment; If valid submission- turn R&I ref number green If further docs requested turn R&I ref number yellow. VALID SUBMISSION SOP 49 Feasibility Assessments Non Commercial Studies Page 11
GOVN STAFF GOVERNANCE REVIEW; (taking account of feasibility) 1) CTA and budget, costing proforma 2) REC favorable opinion 3) CTA from MHRA (if applicable) 4) Insurance cert 5) Localised docs 6) Signed and dated CVs (& GCP if CTIMP) Once CTA and Budget agreed with sponsor send to Amy. GREEN on contract tracker=ok GOVN STAFF Send outcome of governance review template to PI/study team. Keep PI/study team up to date with any progress or delays. Update non portfolio tracker comments. Ready for NHS permission GOVN STAFF Complete approval checklist- File to ADMIN for approval letter; FILE to Rachael for final checks. DOCUMAS, Archiving, Inclusion in project approved numbers. NHS permission letter not ready to go out Return file back to Reviewer SOP 49 Feasibility Assessments Non Commercial Studies Page 12
Within 30 Days ADMIN produce NHS permissions letter and obtain signature. Update DOCUMAS if letter being issued. R&I process flow chart v3 inc feasibility 24/07/11 CD SOP 49 Feasibility Assessments Non Commercial Studies Page 13