Adverse event reporting and harms {22}
ADVERSE EVENTS, EVENTS, ADVERSE EVENT
Participants will be asked to record signs and symptoms associated with known ADRs in the diary for review by the field worker during the post-dosing safety visit occurring 1 month post dose.The participant will be asked to provide information on any other events, physician visits or hospitalizations, and treatment taken during day 0 through day 6 during the post dosing safety visit.Participants will be asked about any AEs occurring after the 6th day and up to the next dosing day. As the IP will no longer be present in the participant’s system at detectable levels, these events will be deemed unrelated to the IP. These events will be recorded on adverse event logs, which form part of the source data and will not be included in the data analysis. These unrelated events will be reported to IRBs and DSMB in 6 monthly line listings unless local regulations specify otherwise.Participants shall be encouraged to contact the Investigator by telephone to report severe events in case the investigator deems an ad hoc visit by the participant to the site or local clinic is required.The investigator and/or sub-investigator with assistance from delegated study staff will visit local hospitals in the district to review in- and out-patient records to ensure all adverse events for trial participants are captured. The investigator or appropriately qualified sub-investigator shall determine the severity and causality for all events.All AEs and SAEs occurring from the time a volunteer consents to participate in the study until 4 weeks after he or she has completed or discontinued the IP must be recorded in the Patient’s electronic records and trial database. BOHEMIA will use MedDRA coding and CIOMS forms to ensure standardization of terminology across the trial.Importantly, SAEs will have to be reported, either by email or by Fax, by the site PI/Co-PI or sub-investigator to IntuVigilance Limited within 24 h of awareness of an SAE.