e) For studies requiring IT based activities, are there Yes No provisions in place to allow access? E.g. for eCRF completion and IWRS. f) What are the arrangements for archiving after the Study is a CTIMP/Device/combined CTIMP & device and end of the study period? will be archived in an off-site archiving facility- (Iron (It is good practice to archive all studies in a long term secure Mountain) storage facility. However, this is only mandatory for CTIMPs, studies of medical devices and combined CTIMP/device Study is not a CTIMP/Device/combined CTIMP & device studies. For all other studies, if suitable facilities exist but will be archived in an off-site archiving facility- (Iron (lockable, fireproof filing cabinet in secure room) then study Mountain) (encouraged for all studies where possible, files can be archived within the research division). where funding allows ) Study is not a CTIMP/Device/combined CTIMP & device therefore off-site archiving is not mandatory , study can be archived within suitable facility within the research division 5. REGULATORY ASPECTS: a) Is MHRA approval required? MHRA CTIMP MHRA Device No b) Is this a clinical involving gene Yes, GTAC required No therapy? c) Are there specific requirements i.e. working with children or incapacitated adults? (What extra measures are in place to undertake with this?). d) Does the study involve ionising IRMER radiation or radioactive substances Yes No (IRMER/ARSAC)? Yes No For has contact been made with the Medical Physics Dept? Yes No
e) For studies requiring IT based activities, are there provisions in place to allow access? E.g. for eCRF completion and IWRS. Yes No f) What are the arrangements for archiving after the end of the study period? (It is good practice to archive all studies in a long term secure storage facility. However, this is only mandatory for CTIMPs, studies of medical devices and combined CTIMP/device studies. For all other studies, if suitable facilities exist (lockable, fireproof filing cabinet in secure room) then study files can be archived within the research division). Study is a CTIMP/Device/combined CTIMP & device and will be archived in an off-site archiving facility- (Iron Mountain) Study is not a CTIMP/Device/combined CTIMP & device but will be archived in an off-site archiving facility- (Iron Mountain) (encouraged for all studies where possible, where funding allows ) Study is not a CTIMP/Device/combined CTIMP & device therefore off-site archiving is not mandatory , study can be archived within suitable facility within the research division 5. REGULATORY ASPECTS: a) Is MHRA approval required? MHRA CTIMP MHRA Device No b) Is this a clinical involving gene therapy? Yes, GTAC required No c) Are there specific requirements i.e. working with children or incapacitated adults? (What extra measures are in place to undertake with this?). d) Does the study involve ionising radiation or radioactive substances (IRMER/ARSAC)? IRMER Yes No Yes No For has contact been made with the Medical Physics Dept? Yes No
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