11 If yes, please confirm that HPRA Yes approval will be obtained prior to study No commencement. N/A 12 Will an independent Trial Steering Yes Committee (TSC) be established? No N/A 13 Will the trial or investigation be Yes registered in a publicly available, free No to access, searchable clinical trial or N/A investigation registry? 14 Will the requisite insurance cover be Yes sought for the clinical trial or No investigation and evidence of cover N/A submitted to SFI prior to trial initiation? 15 Does this clinical trial or investigation Yes involve activities outside of the No Republic of Ireland or partnerships N/A with international Collaborators? Human cells/Tissues 16 Does your research involve human Yes cells or tissues? No N/A 17 Does your application include an Yes element of biobanking? No N/A Personal Data 18 Does your research involve personal Yes data collection and/or processing? No N/A 19 If any potentially commercially Yes exploitable results may be based upon No tissues or samples derived from N/A human participants, will appropriate informed consent for such use be sought?
11 If yes, please confirm that HPRA approval will be obtained prior to study commencement. Yes No N/A 12 Will an independent Trial Steering Committee (TSC) be established? Yes No N/A 13 Will the trial or investigation be registered in a publicly available, free to access, searchable clinical trial or investigation registry? Yes No N/A 14 Will the requisite insurance cover be sought for the clinical trial or investigation and evidence of cover submitted to SFI prior to trial initiation? Yes No N/A 15 Does this clinical trial or investigation involve activities outside of the Republic of Ireland or partnerships with international Collaborators? Yes No N/A Human cells/Tissues 16 Does your research involve human cells or tissues? Yes No N/A 17 Does your application include an element of biobanking? Yes No N/A Personal Data 18 Does your research involve personal data collection and/or processing? Yes No N/A 19 If any potentially commercially exploitable results may be based upon tissues or samples derived from human participants, will appropriate informed consent for such use be sought? Yes No N/A