This system is for the reporting of Serious Adverse Events (SAEs).
You are required to submit a SAE report within 24 hours of first knowledge of an SAE.
If you have any difficulty using this system or wish to receive advice prior to submitting a SAE report please contact email@example.com for help.
Please gather relevant information to hand before starting the data entry process. You can save your partially completed SAE report and come back to it later if you wish. A report is not complete until it has been submitted. Prior to this the report can be changed and the changes do not leave an audit trail.
You can use the information tabs to obtain further information and clarification of what is being asked for, during the data entry process.
After completion the report will need to be signed off as complete by the PI, otherwise it is not considered to be a valid report.
Partial data entry is possible but you will be required to provide outstanding information and supply it in a follow up report.
Please make sure that you have checked your protocol as for some trials some types of SAE are considered to be non-reportable and are not required to be notified to the Pharmacovigilance department.
Click here to access the system.