Table of Contents
- Title and Copyright Information
- Preface
-
1
What's New
- Technology Stack
- Oracle Argus Compatibility Matrix
-
Enhancements to Oracle Argus Safety
- South Korea MFDS E2B (R3) Export
- Support for EC Manufacturer Incident Report (MIR)
- CDER E2B(R2) Combination Products
- CDER E2B(R2) Similar Device Combination Products
- CBER eVAERS changes
- CDRH eMDR changes
-
Other enhancements to Oracle Argus Safety
- Nullification report to mask the reporter and patient data in E2B(R3) (Enhancement 30729108)
- Draft Report button updates (Enhancement 26335541)
- Removed common profile switch - Perform E2B Check on Case Save
- Updated EMA R3 Profile conformance rule to apply reporter country EU (Enhancement 29820228)
- Updated ACK.B.r.5 Date of ICSR message creation (Enhancement 29999426)
- Health Canada Device Reporting Form changes
- Updated auto expectedness assessment
- Oracle Argus Service configuration changes
- Removed password configuration for Oracle Argus Safety Service users
- Removed E2B PDP job, Bulk Transmit E2B and Bulk Transmit Fax processes
- SMTP configuration changes
- Documentation updates
- Reference documents
- Enhancements to Oracle Argus Mart
- Merged Patches
- Download Oracle Argus 8.2.2
- Install Oracle Argus 8.2.2
- Upgrade Oracle Argus Database