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

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

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

• If you choose to have one adverse event per case, you have two form setup options:
  • Include a Safety case form and associate it with that AE.
  • Don't include a Safety Case form (all AE information would be on the AE form).
• If you include multiple adverse events per case:
  • If all adverse events need to be selected by the site, you need a Safety Case form.
  • If some adverse events need to be sent via time frames, you can choose whether to include a Safety Case form.

Note:

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

Including multiple adverse events for a single Oracle 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 Oracle Argus Safety. 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.