Recode MedDRA
The MedDRA Recoding tool displays the following options for each case with the existing data elements after the case number in the XLS export or tab delimited file:
- Current Workflow State
- Current Workflow Group
These options are available for the end user logs.
The SOC/HLGT/HLT/PT/LLT and Synonym columns in the MedDRA schema and the MedDRA table have been expanded to 250 characters to conform to the ICH guidelines.
| Oracle Argus Safety Database Table | Location in the application |
|---|---|
|
CASE_PAT_HIST |
Oracle Argus Safety > Case Form > Patient Tab > Parent Section > Other Relevant History |
|
CASE_EVENT |
Oracle Argus Safety > Case Form > Events Tab > Event Information |
|
CASE_PROD_INDICATIONS |
Oracle Argus Safety > Case Form > Products > Products Indication |
|
CASE_ASSESS |
Oracle Argus Safety > Case Form > Events Tab > Event Assessment > Event PT (Description)/LLT |
|
CASE_DEATH_DETAILS |
Oracle Argus Safety > Case Form > Events Tab > Seriousness Criteria > Death Details > Cause of Death & Autopsy Details |
|
CASE_LAB_DATA |
Oracle Argus Safety > Case Form > Patient Tab > Lab Data |
|
LM_ALWAYS_SERIOUS_TERM |
Argus Console > Code Lists > Always Serious Term List |
|
LM_LABELED_TERM |
Argus Console > Business Configuration > Products and Licenses > Datasheet |
|
LM_PRODUCT |
Argus Console > Business Configuration > Products and Licenses > Primary Indication |
|
LM_LAB_TEST_TYPES |
Argus Console > Code Lists > Lab Test Type |
For more information, see: