9 Local Lock Functionality

Argus Safety supports a concept of global lock that indicates the readiness of case data for global reporting, and a concept of local data locks that indicates the readiness of case data for local reporting having fulfilled the local data entry and assessment needs.

9.1 Enabling Local Data Entry

The application allows local users to open a case for entering local data without globally unlocking the case and at the same time maintain the integrity of the "global" case data.

In order to achieve this:

The fields in the application are categorized into global and local fields. The local fields have been identified as local to one or more countries. The local fields for only Japan are supported in this release.
All Argus J users are considered as Japan Local user in this release and as having access to edit the Japan local fields.

9.1.1 Local Fields

A field is identified as a Local field to one or more countries based on a new attribute in the CMN_FIELDS table. The local fields for only Japan are supported in this release.

Customers can configure any field in the Case Form > General, Patient, Products, Events tabs, and in the Analysis > PMDA tab as a Local field for Japan through back-end updates to the CMN_FIELDS table.

The Enterprise copy configuration action will copy these updates as per existing functionality.

If a customer configures a field that could update global value as a local field, it is expected that the customers maintain the integrity of the global data by business SOPs or custom software processes.

All the fields in a case that is not a Local PRPT case are simply treated as global fields.

All Argus J users are considered as having access to edit the Japan local fields.

All Japanese text fields, including J User-Defined fields are considered as Local fields for Japan.

i. All Japanese text fields are the fields that currently has separate _J columns.

ii. All fields from PMDA tab, PMDA Device Information section.

Argus Safety allows selection of secondary LLT (stored in LLT_J or LLT_CODE_J field) or Synonym (SYN_CODE_J) encoding using MedDRA J browser that does not change the base MedDRA hierarchy of English.

The Event Assessment > Listedness field in the tab for for the licenses of the local country corresponding to the local user is considered as local field. However, this field is available for editing for the user only when the local user has listedness privilege for that local country assigned to them via the User Group > Listedness Determination - Countries access and the datasheet associated with that local country license is configured with "Global / No Local Assessment Required" checkbox as unchecked.

The Events tab > Infection and Event Exclusion checkbox are also considered as local field for Japan.

Any field where an update to a global field can occur is NOT considered as Local field.

All numeric fields, date fields, drop-down fields which share same data value for English and Japan sides are not considered as Local fields.

However, there are exceptions to this rule where some fields that contain global values are available for update to local users and in such a scenario, it is expected that the global value should be protected by customer's business SOPs.

Case classification is such a field that can cause update to global value and it is available as a Local field in the application out-of-the-box.

Study section under General tab requires special handling by the application during local editing. Study Name, Study Description, Protocol Number, Clinical Compound Number and Center Name are local fields.

When the study is a configured study, all these fields are disabled for local editing except Center Name (J). Center Name (J) is available as an editable local field.

Product Information section in Products tab requires special handling by the application during local editing. J Drug Code type and the corresponding J Drug Code/OTC Drug Code/Temporary Code (i.e., DRUG_CODE_TYPE_J, DRUG_CODE_J,), J Generic Name and J Product Name fields are local fields.

Any field that is already editable after case lock will remain editable even after local lock.

An auto-narrative generation performed during Japan Local data entry (after global lock) only updates the J field value and does not update the English or any other language field value.

9.2 References for Details on Local Case Data Lock Functionality

This section lists the different sections where the functionality for Local Case Data Lock has been documented in the Argus Safety suite of documentation.

Refer to the following table for the list of features and the corresponding Guides where they have been documented:

Local Lock Feature	Overview	Documented in
Local Locking and Local Unlocking - Configuration	Introduction of new switches: Allow Local Locking - to allow a local user to be set up with the privilege to locally lock or unlock a case Enable Local Unlocking - to provide a system level control permitting local users to locally unlock a case and make any corrections to the previously entered local data.	Oracle Argus Safety Administrator's Guide > 2 Access Management > Configuring Users Oracle Argus Safety Administrator's Guide > 4 System Configuration > Configuring System Management - Common Profile Switches Oracle Argus Safety User's Guide > Global User Management
Changes to the Case Locking Mechanism in Argus Safety - Case Form Changes	Introduction of action icon - Local Lock - to allow a user to locally lock or unlock a case	Oracle Argus Safety User's Guide > 1 Getting Started > Quick Launch Toolbar
Changes to the Case Locking Mechanism in Argus Safety - Changes to global locking, One Step Global and Local Lock	Allow Global locking and triggering of global and local reports, and allow one step global and local locking	Oracle Argus Safety User's Guide > Locking a Case
Changes to the Case Locking Mechanism in Argus Safety - Changes to Global Unlocking - Configuration	Introduction of new switches: Allow Forced unlock (Global and Local) - to allow users to be set up with the privilege to forcibly unlock a case that been globally and/or locally locked but pending report generation Allow Global Unlock on Pending Local Lock - to allow users to be set up with the privilege to forcibly unlock a case that is still pending a local lock	Oracle Argus Safety Administrator's Guide > 2 Access Management > Configuring Users Oracle Argus Safety Administrator's Guide > 2 System Configuration > Configuring System Management - Common Profile Switches Oracle Argus Safety User's Guide > Global User Management
Changes to the Case Locking mechanism in Argus Safety - Changes to global unlocking - Case Form changes	Control globally unlocking a case based on local/global reports pending generation and /or cases pending local lock	Oracle Argus Safety User's Guide > Unlocking a Case
Case Form changes - Local Reports Configuration - Local Reporting Rule and Local Reports	Configuring Local Reporting Rules and Local Reports	Oracle Argus Safety Japanese Administrator's Guide > 3 System Configuration > Configuring Local Reports - Local Reporting Rule and Local Reports
Triggering Local Reports - Changes to Report Scheduling and Generation Algorithm - Auto Scheduling	Changes to report auto-scheduling for scheduling local reports	Oracle Argus Safety User's Guide > Report Scheduling - Auto-Scheduling
Triggering Local Reports - Changes to Report Scheduling Algorithm - Manual Scheduling	Changes to report manual scheduling for scheduling local reports	Oracle Argus Safety User's Guide > Report Scheduling - Manual Scheduling
Triggering Local Reports - Changes to Report Generation Algorithm	Changes to report generation for generating local reports	Oracle Argus Safety User's Guide > Triggering Local Reports - Report Generation Algorithm
Changes to Expedited Reports and Periodic Reports on DLP	Changes to DLP while generating local expedited and periodic reports	Oracle Argus Safety Japanese User's Guide > Reports

9.3 Report Scheduling - Auto-Scheduling

The changes described below are applicable only when local reports are configured in the application (that is, when there is data in the Local Reports Configuration table).

On the Global lock of a case by a user, the application triggers the qualifying reporting rules including the Japan reporting rules and schedule the relevant global and local reports. There are modifications to the Report Generation functionality however, and is explained under section Changes to Report Generation.

On the Local Lock of a case by a user, the Local Reporting Rules for Japan are triggered again as follows, depending on the value in the configuration switch "Case Form Configuration | Auto Regulatory Scheduling":

If the value is set to Always: The Local Japan reporting rules are triggered on case save during the follow-up cycles of case processing when any of the local fields caused the "Significant" data change. If any of the other fields caused the "Significant" data change, then all the reporting rules are triggered as with the existing algorithm. Also, for the initial case cycle, only local reporting rules are triggered on Local lock.
If the value is set to Significant: The Local Japan reporting rules are triggered on Local Lock but respecting the existing algorithm to check that Significant Follow-up was added during the prior global lock cycle during the follow-up cycles. For the initial case cycle, as with the existing algorithm, they trigger on Local lock.
If the value is set to any value other than None, including Manual: A new checkbox called Schedule Local Reports Only will be added under the Total Number of Rows section in the Regulatory Reports tab of the Case Form. This checkbox is visible only when the configuration switch "Case Form Configuration > Auto Regulatory Scheduling is not set to None. After the rules are successfully triggered, the application unchecks the checkbox. If the checkbox is unchecked, the application triggers all the qualifying reporting rules keeping the current functionality.

Note:

As a result of triggering of local reporting rules again, the Local reports that were already scheduled during Global Lock may result in being overwritten or being removed.

Force Distribution: If force distribute is checked for a reporting rule, the application triggers that reporting rule as per the existing functionality. However, the generation and force distribution of the Local Reports have the following modifications:

a. When a Local reporting rule marked for "Force Distribute" has a local report that has become due, the report is scheduled, generated and force distributed by performing the global and local lock on the case using the existing AG Service Force Reporting process.

i. When a Local report that was already scheduled outside of the force distribution process from a local reporting rule marked for "Force Distribute" has become due, the application does not force generate this report keeping it consistent with the existing functionality.

b. For the above scenario, AG Service uses the one step global/local lock comment "Case Globally and Locally locked for JP." (refer section Routing Comments Log and Case Print) followed by the configured comments under Argus Console ' Reporting ' Expedited screen' Forced Distribution comments.

i. Case Globally and Locally locked for JP. << Forced Distribution comments>>

c. After the report generation is complete, the case gets unlocked globally. AG Service uses the one step global/local unlock comment "Case Globally and Locally unlocked for JP." (refer section Routing Comments Log and Case Print) followed by the configured comments under Argus Console ' Reporting ' Expedited screen' Forced Distribution comments.

i. Case Globally and Locally unlocked for JP. << Forced Distribution comments>>

9.4 Report Scheduling - Manual Scheduling

The changes described below are applicable only when there are local reports configured in the application (i.e., there is data in the Local Reports Configuration table).

On Manual Scheduling of a report by a user, the application identifies if the report is a Local Japan report by matching the Country of the License#, Destination and Report Form chosen by the user in the "Schedule New Report" manual report scheduling dialog box with the "Local Reports Configuration".

If DLP is not enabled for Expedited Report Generation:

a. On the Global lock of a case by a user, the application generates the global reports but does not generate any Local Japan reports.

b. The Local Japan reports shall be generated on subsequent local lock for Japan.

If DLP is enabled for Expedited Report Generation, refer to the chapter in Oracle Argus Safety Japanese User's Guide > 4 Reports.

For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan report by matching only the Destination and Report Form chosen by the user.

For a Study-based WHO Drug Report, the application identifies if the report is a Local Japan report by ignoring the country, matching only the Destination and Report Form chosen by the user and if the Truly Local Case switch returns value > 0.

Note that if AUTO_FOLLOWUP_MANUAL switch is ON, the existing functionality of scheduling a follow-up report for a manual report is retained as is and if the manual report was a local report, the follow-up is treated as a local report.

9.5 Outlier Processing

In scenarios where the suspect product with local license has been removed on a follow-up, the case will remain a Local PRPT Case until the corresponding nullification/downgrade local reports have been generated.

If a customer wants to change Local Reports configuration data after being in production with this release, it is recommended that customers ensure that cases/reports under processing be completed before changing configuration data to avoid unpredictable results. So note that if a customer changes the Local Reports configuration data mid-way where the reports are mid-way processing (e.g., scheduled), the reports will be determined as local/global based on what type it was at the time when the report was scheduled and will be completed processing that way irrespective of current configuration even if inconsistent with the configuration. Also note that presence of local reports will determine that the case is local case.

It is also recommended that customers ensure that cases/reports under processing be completed before up taking the Local Locking feature and (thereby) installing the local lock configuration data (refer to Upgrade Changes - Enabling Local Locking in Argus Safety). So note that if the case was mid-way processing (e.g., case was open in data entry workflow) when customer up took the Local Locking feature, a subsequent case save will determine if the case is local or global.

9.6 Upgrade Changes - Enabling Local Locking in Argus Safety

In order to activate the Local Locking feature in Argus Safety, the installer provides the users with an option to install the underlying metadata that enables the local lock feature in the application. A customer, who may not prefer to turn on the local locking feature due to existing business processes that already handle the local processing needs for a company, could choose not to install the metadata and thus not uptake the local lock feature in the application.

A separate database script is provided so that the user can run to turn on the Local lock feature after an upgrade or fresh install. On executing this script, it prompts the user to choose to turn on the local locking feature and uptake the Local Locking seed data.

The application assumes the default value of 1, parses the user input and installs the Local Locking seed data for each of the enterprise specified in the comma separated list.

Local Reports Configuration Seed Data

A new table is seeded to identify Local Reports for Japan:

Country - The seed data is the country id for Japan (from codelist Countries) for this release.

Reporting Destination - The script prompts the customer to provide the default value of reporting destination for PMDA.

- The seed data is the following Japan reports for this release:.

Prompt - "Please enter Agency Name for the PMDA reporting destination as configured in the "Reporting Destination" codelist. This name will be used to identify Local Reports for all enterprises".

Report Form - The seed data is the following Japan reports:

Local Users Seed Data

The upgrade installer script prompts the user to choose if all the Argus J users will be updated to have local locking privileges.

Local Fields Seed Data

Note that the CMN_FIELDS are always seeded as part of install/upgrade factory data to identify the Local Fields for Japan and will be present irrespective of if the customer chooses local locking feature or not.

In case of Multi-tenancy, the customer input value is used to set the seed values across all enterprises.

This seeding of Local users data is audit logged with the system user.

After install/upgrade, if customer has turned on the local locking, the icons in the applicable screens start reflecting the local/global lock status of the case.

9.7 Triggering Local Reports - Report Generation Algorithm

The changes described below are applicable only when there are local reports configured in the application (i.e. there is data in the Local Reports Configuration table).

The Report Generation functionality does not generate any Japan Local reports, including the reports that were scheduled by the local reporting rules that were marked as Active Moiety or Super Rules, until a local lock occurs. The global reports are generated on global lock.

In Case Form > Regulatory Reports tab, the Final hyper link for a local report is NOT available for a case that is not yet locally locked (similar to the existing functionality for global report on a global unlocked case).

In Case Form > Regulatory Reports tab, the Regenerate Report menu for a local report is NOT available for a case that is not yet locally locked (similar to the existing functionality for global report on a global unlocked case).

The Final checkbox in Case Actions > Case Open > Batch Print dialog box will remain disabled and grayed out when any of the case selected is locally unlocked as it does today when a case is globally unlocked.

If report generation is invoked from the Batch Report Generation AG Service, the AG Service skips the case that is not yet locally locked similar to the existing global unlocked cases.

Note that Worklist > Bulk ICSR Transmit > Re-Transmit and Re-Transmit Multiple Reports put a failed report back in generation to be picked up for processing by Batch Report Generation AG Service. The above point will apply in this scenario.

If report generation is invoked from other AG Services listed below, the AG Service today ignores the global locked status and generates reports. This has been corrected so that the AG Service skips the case that is not yet globally locked when generating global reports similar to the existing Batch Report Generation AG Service. Similarly, the AG Services listed below skip the locally unlocked cases while generating local reports: