Common Profile Switches for Reporting
The following screen is displayed when you navigate to Common Profile > Argus J > Reporting:
The following table explains the fields used in the screen:
| Field Name | Description | Field Options |
|---|---|---|
|
Follow-Up Action Item for Incompletion Report Submission"Due In ____ days" |
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Populated based on Action Type Code list values (not deleted and not hidden) For more information, see Profile Switch for Incomplete Report Submission - Auto Action item. |
|
Follow-up Action Item for Incompletion Report Submission Group Assignment |
This field represents the user group to which the Incompletion Report Submission Action Item is assigned. Default value is blank. |
User Groups from Console For more information, see Profile Switch for Incomplete Report Submission - Auto Action item. |
|
Auto Distribution Submission Comments (J) |
This field allows you to enter the Japanese Submission comments used for Expedited Reports Transmission, which are auto-distributed by the system based on Expedited Reporting Rules or Reporting Destinations. These comments are used in the same way as Auto Submission Comments, but when J user is on the system. |
Field Length: 1000 Audit Log: Yes |
|
Text to display as comment when a downgrade report is scheduled |
The field length is 2000 J. The text appears in the Report Detail > Comment tab. |
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|
Auto Distribution Transmission Comments (J) |
This field allows you to enter the Japanese Transmission comments used for Expedited Reports Transmission, which are auto-distributed by the system based on Expedited Reporting Rules or Reporting Destinations. These comments are used in the same way as Auto Distribution Comments, but when J user is on the system. |
Field Length: 1000 Audit Log: Yes |
|
Event counting logic for PSR Form 3, 4 and ReSD Form 10, 11 |
Option 1 is deprecated. Option 2 - If this option is selected, then the PSR Form 3, 4 and ReSD Form 10, 11 is be updated to count or print all the events from the case only under the timeframe where that case was reported first. Even if a new event (new event_seq_num) from a case has been reported in an E2B or Paper Report to PMDA in the current reporting period, it must be counted or printed under the original timeframe. Option 3 - If this option is selected, then the PSR Form 3, 4 and ReSD Form 10,11 are updated to count or print the events from the latest submitted E2B or Paper Report in the latest timeframe where it was reported across all the timeframes for which the report is executed. |
1. Count each event as reported in that timeframe (Deprecated)) 2. Count each event from a case with the timeframe where the case was reported first. 3. Count each event from a case with the timeframe where the case was reported last. |
|
Listedness Assessment Source for PSR and ReSD (Deprecated) |
The common profile switch “Listedness Assessment Source for PSR and ReSD" is marked as deprecated. Instead a new report level parameter is added “Listedness Assessed on" in PSR/ReSD configuration window. |
Configured Datasheets Case Event Assessment |
|
Offset from GMT used to calculate Japanese date/time fields for Interchange-J (in hours) |
This field represents the offset from GMT that is used to calculate Japanese date/time fields. ESM-JDefault Value: 7 |
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|
Blinded text for PMDA AE Paper reports |
Enables you to enter blinded text for PMDA AE Paper reports. |
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|
Major Developed Countries for Approval Status in J-DSUR |
This field lists the countries to be considered as major developed countries for J-DSURs. |
Text box with 1000 characters limit, without any default value. Users can also configure comma-separated A2 country codes. |
|
Perform Japanese character validation at E2B Check and E2B Report Generation. |
If this is checked, the Japanese language check is performed during E2B Report Generation. Default value is checked. |
This option is in the same section as Additional invalid characters to be checked in Japanese character validation. |
|
Additional invalid characters to be checked in Japanese character validation |
This field allows you to add invalid Japanese characters to be checked in Japanese Language check in the profile switch. |
This option is in the same section as Perform Japanese character validation at E2B Check and E2B Report Generation When the Perform Japanese character validation at E2B Check and E2B Report Generation checkbox is unchecked, this field is disabled. |
|
Characters to be allowed to use in AN (Alphanumeric) E2B items |
In this field, you can enter English characters allowed in Oracle Argus Safety Japan. When this is entered, the English characters E2B check validates if AN fields (Allow Japanese Characters=No) has undefined characters in the Profile Switch. The E2B check displays following error message when invalid character(s) (characters not configured in the Profile switch) are found in the E2B item: Value of element [element tag] has invalid English character(s). Default Value: ABCDEFGHIJKLMNOPQRSTUVWXYZabcdefghijklmnopqrstuvwxyz0123456789.E+- !"#$%'()*+,-.:;=?@[\]^_/{|}~ |
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|
Perform PMDA Event Reportability calculation on each Case Lock |
If this common profile switch is set to "Yes", then when the case is locked from any point in the Oracle Argus Safety application, it triggers fresh calculation of the PMDA Event Reportability data. |
Yes, No (Default). |
|
PMDA E2B Nullification Reason Text for No Valid Event Scenario |
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No For more information, see PMDA Downgrade/nullification Report Scenario when All Events are Non-Reportable |
|
Product details printing format in PSR NUPR - Word format |
When you select Option 1 (Print Trade Name, Formulation, Strength, Drug code as available), the application prints data in the format <Trade Name (J)> (<Formulation (J)>space<Strength> <Unit (J)>) (Drug Code (J)). If the Formulation or Strength fields (or both) do not contain value, then prescribed text is printed to indicate that they are unknown. When you select Option 2 (Print Trade Name unknown when Formulation or Strength not available) the application prints data in the format: <Trade Name (J)> (<Formulation (J)>space<Strength> <Unit (J)>) (Drug Code (J)). If the Formulation or Strength fields (or both) do not contain value, then the application prints only the J Drug Code. |
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For more information, see: