Presentation on theme: "Create division of responsibilities document Submit sponsorship application Register project with R&I Add reference number to spreadsheet Allocate study."— Presentation transcript:
Create division of responsibilities document Submit sponsorship application Register project with R&I Add reference number to spreadsheet Allocate study to RMF Start RSS risk assessment Discuss with researcher: New application OR Revisions/ additional information Liaise with expert reviewers if required Update RSS risk assessment Prepare to issue sponsorship sponsorship documents to CI Put details of study on e-dge Make up paper/ e-file PI / point of contact study reference number Check study not already on e-dge Check application pack Update e-dge Create sponsorship letter Researcher activity R&I activity R&I sub-processes Liaise with R&I about contracting and NHS permission when ready Submit for sponsorship to sponsorship issued Incorporate comments from scientific review if required Ensure standard wording incorporated, with all required documents Has feasibility with support departments and trial unit been discussed? 5 What are the funding arrangements? 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 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 s the CI and/or point of contact the 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. 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.Research Support Services risk assessment Application qualityIMPconsentdatatissueresearch teamfinance regulatorycontractual RMF liaises with the CI/point of contact, addressing risks identified and requesting revisions, additional information or a new application. RMF requests reviews from experts, if required. This includes scientific review if not already done, input from clinical leads, service managers and from finance.scientific reviewservice RMF updates RSS risk assessment following feedback from experts. 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]. RMF s sponsorship documents to the CI. CI/point of contact prepares for submission to R&I for NHS permission (R&D approval), setting up contracts and other setup activities. 1 Decide where to submit application, Is it research? See link for Guidance. Who is the most appropriate sponsor? See link for Guidance.See link for GuidanceSee link for Guidance.