When reporting dates use dd/mmm/yy Submit SAE reports to: _______________________________________ Participant details Participant initials: Initial report Date of this report: Male Female Follow-up report Date of or age at time of event Weight at time of event (if known): Date PI notified of _______kg Investigator details Investigator name: _______________________________________ Phone #:_________________________________ Study Site Address: ____________________________________________________________________________________________________ ____________________________________________________________________________________________________________________ Investigational product(s) Name (indicate if Batch Dose & Start Stop Indication for use Causality unblended or not) number frequency date/time date/time assessment (or ongoing) * Causality: 1=Definite, 2=Probable, 3=Possible, 4=Unlikely, 5=Unknown Concomitant medicines/treatments at time of event, i.e. not to treat event (or attach copy of relevant case record form)
When reporting dates use dd/mmm/yy Submit SAE reports to: _______________________________________ Participant details Participant initials: Male Female Initial report Follow-up report Date of this report: Date of or age at time of event Weight at time of event (if known): _______kg Date PI notified of Investigator details Investigator name: _______________________________________ Phone #:_________________________________ Study Site Address: ____________________________________________________________________________________________________ ____________________________________________________________________________________________________________________ Investigational product(s) Name (indicate if unblended or not) Batch number Dose & frequency Start date/time Stop date/time (or ongoing) Indication for use Causality assessment * Causality: 1=Definite, 2=Probable, 3=Possible, 4=Unlikely, 5=Unknown Concomitant medicines/treatments at time of event, i.e. not to treat event (or attach copy of relevant case record form)
Serious_Adverse_Events_Form_template.docx