Suspected unexpected serious adverse reactions (SUSARs)
ADVERSE REACTIONS, EVENT
All SAEs assigned by the site PI or medical delegate as suspected to be related to the trial treatment and which are unexpected will be classified as suspected, unexpected, serious adverse reactions (SUSAR) and will be subject to expedited reporting to each participating Regulatory Authority, Ethics Committees and the sponsor within seven working days of being reported to the LSHTM CTU Global Health Trials Group.In the case of a SUSAR, the site staff will:Contact the LSHTM CTU Global Health Trials Group immediately by phone or email to inform them of the event and obtain guidance on the reporting procedure if neededSubmit an AE report, completed with all available information (signed and dated) within 24 h, together with relevant treatment forms and anonymised copies of all relevant clinical investigationsSubmit any additional information promptly upon requestEmergency contact details for advice on reporting SAEs and SUSARs can be found in the Investigator Study File. AE reporting forms will be submitted either via the trial database (see Investigator Study File for full details) or email to imwoman.data@lshtm.ac.uk. AEs that the site PI or the LSHTM CTU Global Health Trials Group consider related to the trial medication will be followed either until resolution or the event is considered stable.The LSHTM CTU Global Health Trials Group or sponsor representative will report all SUSARs to the relevant regulatory authorities, Research Ethics Committees (REC), and other parties as applicable. For fatal and life-threatening SUSARS, this will be done no later than seven calendar days after the LSHTM CTU Global Health Trials Group is first made aware of the reaction. Any additional relevant information will be reported within eight calendar days of the initial report. All other SUSARs will be reported within 15 calendar days. Treatment codes will be unblinded for specific participants if required. Site PIs will be informed of all SUSARs for all studies sponsored by LSHTM that use tranexamic acid, whether the event occurred in the I’M WOMAN trial. All other AEs will be reported as requested by the relevant authorities.