MHRA Application form for - Sheffield Clinical Research



Research DepartmentResearch GovernanceTrial Master File* / Investigator Site File**delete as appropriateThis guidance applies to all research registered within STH Trust, regardless of design or location. The Trial Master File/ Investigator Site File should contain the essential documents, which individually and collectively permit evaluation of the conduct of a research trial. The contents of the file serve to demonstrate the compliance of the investigator and the research team with the standards of Good Clinical Practice (GCP) and to the requirements of the Research Governance Framework.The CI will keep a Trial Master File. The local PI will keep an Investigator Site File. In the case of a single centre study there will often be a single file for both CI and PI, in this case this file will be a Trial Master File.The documents contained in the file are those that will be audited as part of the research governance process to confirm the validity of the trial conduct.Those sections which do not apply to an Investigator Site File (where this file is not also acting as a Trial Master File) are greyed out in the ISF column. Some sections and sub-sections may not apply to all projects. If you are unsure about whether a particular element applies to your project, please seek advice from the Research Department. Master File* / Investigator Site File*STH ref:NIHR CSP ref:REC ref:MHRA ref:CTA No:EudraCT No:Study title:Chief Investigator:Principal Investigator:Sponsor:Funder:Emergency contacts:NameTelephone inc extensionEmail Chief InvestigatorPrincipal InvestigatorSub InvestigatorResearch NursePharmacyOut of HoursResearch Department coordinatorOther (eg extermal)TMF*ISF*1 Core Study Documents (current REC approved)1.1Protocol 1.2Participant Information Sheet(s)1.3Informed Consent Form(s)1.4Information for GPs or consultants1.5Letters of invitation to participants1.6Questionnaires1.7Participant Card / Diary1.8Adverts for recruitment1.9Interview Schedule1.10Other REC approved documents2 Independent Scientific Review2.1Report / Evidence of independent scientific review3 Ethics3.1The Ethics Committee Approval letter3.2Amendment Approvals/sponsor confirmation non-substantial amendment3.3Amendment notification forms3.4Application forms (original REC form)3.5NIGB Documents3.6Annual Progress Reports3.7Annual Safety Reports 3.8All correspondence with the committee(s)4 Regulatory Documents4.1MHRA Notice of no objection4.2MHRA Amendment approval4.3MHRA Application form for CTA (original and any amended forms)4.4Investigator Brochure / SmPC / IMP Dossier / CE-marked device instructions for use4.5Annual Safety Reports/ DSUR4.6Gene Therapy Advisory Committee documents5 Research Governance Documents5.1Project registration form/Confirmation email5.2SSI Form 5.3Research Department Authorisation Letter5.4Research Department Amendments Letters / non-notifiable confirmation email 5.5Insurance Certificate / Indemnity arrangements6 Financial Management6.1Signed site agreement (and side letter where applicable)Other signed financial agreements, service agreements, technical agreements and collaboration agreements6.2Industry Costing template6.3STH Finance form6.4Funding application forms6.5Confirmation of funding7 Investigator, facilities and Research Team7.1CI CV7.2Local Principal Investigator CV 7.3Co-investigators CVs and training record, including GCP training7.4Signature Log of all members of the research team7.5List of tasks and responsibilities delegated to co-investigators7.6Honorary Contracts/Letters of Access8 Participant Information8.1Original signed consent forms8.2Participant enrolment log8.3Participant tracking log8.4Sample tracking log(for stored or shipped samples)8.5Record of tapes and transcripts of interviews and focus groups8.6SAE reports 8.7SAE log8.8SUSAR reports9 Project Management9.1Terms of reference and minutes or other records of Steering Group and/or Data Monitoring Group meetings9.2Monitoring arrangements9.3Standard Operating Procedures for trial specific tests/interviews/focus groups and the processing of study material/data9.4Laboratory Accreditation certificate9.5Normal laboratory values9.6Blank copy of case report form/data collection sheet/interview schedule.9.7Blank copy of SAE report form/ pregnancy report form10 Pharmacy (file note for location if separate pharmacy file held)10.1Pharmacy Arrangements (dispensing guide)10.2Randomisation schedule/Treatment allocation procedures10.3Code Break procedures/SOP10.4Prescribing arrangements/ template prescription10.5Dispensing log10.6Drug Accountability (including drug shipment, patient compliance records and drug destruction records)10.7Sample drug labels10.8IMP storage arrangements (including temperature log)11 Monitoring and Auditing11.1Records of internal monitoring11.2Completed monitoring reports 11.3Monitoring log11.4Protocol non-compliance reports and log12 Study Closure12.1Recruitment summary12.2Archiving arrangements12.3Dissemination: plans for/record of12.4End of study declaration to REC and MHRA12.5Final Report to REC and MHRA13 Correspondence13.1All trial related correspondence other than as listed elsewhere14 Research Governance Compliance14.1Declaration of Helsinki14.2ICH Good Clinical Practice (GCP) booklet15 Superseded Documents15.1Copy of all superseded study documents approved by site R&D Office for use (including documents not approved due to being non-notifiable amendments)15.2Copy of all superseded study documents submitted to REC and/or Regulatory Authority. ................
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