Harms 22 Plans for collecting, assessing, Reporting of adverse event is the reporting, and managing solicited object of the study. Experimental and spontaneously reported intervention to the “introduction App” adverse events and other is not a risk for patients included in unintended effects of trial VigipSEP, so a safety monitoring interventions or trial conduct board is not necessary. Auditing 23 Frequency and procedures for Sponsor CHU de Caen applies a auditing trial conduct, if any, and random auditing of their trials on whether the process will be these low risk studies. independent from investigators and the sponsor Ethics and dissemination 24 Plans for seeking research ethics Approved by CPP ethics committee/institutional review approval board (REC/IRB) approval Protocol 25 Plans for communicating Done important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators) Consent 26a Who will obtain informed consent Done or assent or assent from potential trial participants or authorised surrogates, and how (see Item 32) 26b Additional consent provisions for NA collection and use of participant data and biological specimens in ancillary studies, if applicable 27 How personal information about Done (CNIL) potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial 28 Financial and other competing Done of interests for principal investigators interests for the overall trial and each study site
Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct Reporting of adverse event is the object of the study. Experimental intervention “introduction to the App” is not a risk for patients included in VigipSEP, so a safety monitoring board is not necessary. Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor Sponsor CHU de Caen applies a random auditing of their trials on these low risk studies. Ethics and dissemination ethics approval 24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval Approved by CPP Protocol 25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators) Done Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32) Done 26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable NA 27 How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial Done (CNIL) of interests 28 Financial and other competing interests for principal investigators for the overall trial and each study site Done
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