Table 1 Functionality specification for an efficient eSAE system

• Automated numbering of a new AE/SAE report

• Prepopulating duplicated fields in an SAE form from those in an AE form, or fields from other forms (e.g. treatment allocation, randomisation date from the randomisation form)

• Ability to flag initiation of a SAE report

• Ability to indicate SAE is ready for review and email to be sent to sponsor representative when SAE is ready to be reviewed

• Ability to update an SAE report

• Ability to flag any updates made by a site to an SAE report and email to be sent to sponsor representative to inform of update that needs to be reviewed

• Clear highlighting of any changes made to a report

• Ability for users of different types to interact/view/edit with the form according to role (CI, site, sponsor)

• Ability to see the history of all changes made