Previous Topic

Next Topic

Book Contents

When might an InForm site user include multiple adverse events when sending data to Argus?

You can design the study so that InForm site users include all the adverse event information on a single Adverse Event form and each form opens an Argus Safety Case.

You can also allow InForm site users to group multiple related adverse events entered into multiple Adverse Event forms to be reported together in a single Argus case.

Note:Be mindful that all adverse event data included in a Safety Case form will not be sent to Argus until the Safety Case form is filled out by the site.

Including multiple adverse events for a single Argus Safety case is useful when a subject has experienced several adverse events that are related to each other and you need to submit them together as one safety case to Argus. Multiple versions of the Adverse Event form are also allowable if you are not including a Safety Case form. For example, there might be one Adverse Event form for typical adverse and serious events and a different version of the Adverse Event form for pregnancies. Also, if needed, you can include all the different adverse events in a single dynamic grid.

Send Feedback