5 Software Requirements

The Adverse Event: InForm and Argus Safety integration requires:

• Oracle® Health Sciences InForm Release 4.6 (SP2 and above), 5.5, or 6.0

  Note:

  Trials must be designed with Central Designer 1.4 or above.

• Oracle® Argus Safety Release 6.0.7 (including Argus J), 7.0.1, 7.0.2, or 7.0.3 (including Argus J).

• Oracle® Application Integration Architecture (AIA) Foundation Pack Release 11.1.1.6, and Service-Oriented Architecture (SOA) Suite with patches 14137846 and 14630316

  Roll-up Patch (RUP) 17423167

• InForm Publisher 1.0.3

• InForm Adapter 1.3.6.1 and above (Optional)

  InForm Adapter's safety web service is used to update case status information on the InForm Safety Event form. If it is not available, case information such as, status, case ID, and rejection reason (only for rejected cases) will not be updated.

• Central Designer 1.4 or above with plug-in installed