Create division of responsibilities document

1. 1 Decide where to submit application, Submit for sponsorship to sponsorship issued Is it research? See link for Guidance. Who is the most appropriate sponsor? See link for Guidance. 2 • Chief Investigator or point of contact completes the sponsorship application form here and submits it with a copy of the protocol, chief investigator’s CV and evidence of peer review, if that has already taken place, to researchapprovals@uhbristol.nhs.uk. Submit sponsorship application 3 Research Projects Assistant (RPA) picks up projects from the Research Approvals inbox. A check that the study is not on e-dge already is done, a reference number is allocated and added to the spreadsheet and details of the study are put onto e-dge. The R&I file is made up, and the RPA emails the CI and/or point of contact the study reference number. Register project with R&I Check study not already on e-dge Add reference number to spreadsheet Put details of study on e-dge Make up paper/ e-file Email PI / point of contact study reference number • The study is allocated to a Research Management Facilitator (RMF). RMF checks the application pack and contacts Researcher if anything is missing. 4 Allocate study to RMF Check application pack • RMF begins the Research Support Services risk assessment process. Checks around the following are done: Application quality, suitability for UH Bristol sponsorship, complexity/organisational responsibility, IMP, consent, study type, data and tissue, research team, recruitment and retention, finance, resource, ‘other’ relating to study, regulatory and contractual requirements. 5 Start RSS risk assessment Ensure standard wording incorporated, with all required documents Discuss with researcher: New application OR Revisions/ additional information Has feasibility with support departments and trial unit been discussed? 6 • RMF liaises with the CI/point of contact, addressing risks identified and requesting revisions, additional information or a new application. What are the funding arrangements? • RMF requests reviews from experts, if required. This includes scientific review if not already done, input from clinical leads, service managers and from finance. 7 Liaise with expert reviewers if required Incorporate comments from scientific review if required • RMF updates RSS risk assessment following feedback from experts. 8 • RMF prepares to issue sponsorship. This includes updating e-dge, creating the sponsorship letter and producing the division of responsibilities document for signature by the CI. [RMF refers to R&I office manual for details of process]. Update RSS risk assessment 9 Prepare to issue sponsorship Create sponsorship letter Update e-dge Create division of responsibilities document Researcher activity • RMF emails sponsorship documents to the CI. R&I activity Email sponsorship documents to CI 10 • CI/point of contact prepares for submission to R&I for NHS permission (R&D approval), setting up contracts and other setup activities. R&I sub-processes Liaise with R&I about contracting and NHS permission when ready 11