ࡱ>  0tbjbj Dz|  8Pv+:*******$-b0*9*0+^**r )T * kjFa)*F+0v+o)0WP0 *0 ***Pv+0 :  Investigator Site File for Sheffield Hallam University Sponsored 㽶Ƶ The projects Principal Investigator is responsible for establishing the Site File before the project commences and for keeping its contents up-to-date over the projects lifetime. A Site File is intended to keep all study documents in one place and is designed to: Provide a comprehensive record of all documents that are relevant to the project Demonstrate a projects compliance with the research governance standards prescribed in the Department of Healths 㽶Ƶ Governance Framework Be a management tool for researchers Facilitate project audits Site Files should be kept in a secure but accessible location. Basic information:Principal Investigator: Project Title: IRAS Project ID: Project Start Date: Project End Date:   Expected content: Tick to copy and paste: P 1 Documents (create and store in Site File before the project s start):YN/ACross-reference / commentAuditProtocol and Participant Information1.1Study protocol (final approved version)1.2Participant information sheet (final approved version)1.3Participant consent form (final approved version)1.4Other protocol/participant documentationSponsorship and Approval1.5Evidence of scientific review (SHU/Converis/SHUREC confirmation of application approved)1.6Insurance certificates1.7NHS REC approval letter and related correspondence1.8HRA approval letter and related correspondence1.9IRAS form (final approved version)1.10Statement of activities (final approved version)1.11Schedule of events (final approved version)Other1.12Signed agreements/contracts between involved parties1.13Project financial agreements/documents1.14Honorary research contracts/access letters (research passports)1.15Other relevant documentation 2 Documents (create and store in Site File during the projects lifetime):YN/ACross-reference / commentAuditProtocol and Participant Information2.1Any revisions/amendments to study protocol2.2Any revisions/amendments to participant information sheet2.3Any revisions/amendments to participant consent formProject Management2.4Any ethics amendments approved by NHS REC2.5Monitoring progress reports2.6Completed adverse event report form (should an adverse event have occurred) and evidence of notification to sponsor and site(s)2.7Key correspondence - records of significant decisions in the projects lifetime e.g. emails, letters, minutes, reports2.8Original signed participant consent forms 2.9Interim project finance reports/budget statements2.10Other relevant documentation 3 Documents (create and store in Site File after completion or termination of the project):YN/ACross-reference / commentAudit3.1Final project report, final monitoring progress report3.2Plans for dissemination of research findings3.3Final project finance reports/budget statements3.4Other relevant documentation Sponsor audit conducted by: KLM     ( . 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