Reports: PMDA Periodic Reports

Every J Periodic Report or Form (not limited to the ones specified below) that fetches data based on the E2B Report, PMDA Paper Form, or Case data submitted to the authority also considers the PMDA E2B(R3) report along with the PMDA E2B(R2) report.

PSR (Form 3, and 4)
ReSD (Form 9, 10, 11, 13 and 14)
Seiyakukyo Clinical and Domestic Study Cases

In Japan, the PMDA accepts CSV format of Non-serious, Unlisted Periodic Report as well as paper format, and many pharma companies have started to submit using CSV forms. The following is the list of the functionality changes as a result of this requirement:

PSR ReSD configuration contains a parameter for generating Non serious, Unlisted PSR in Paper and CSV format.

Configuration Parameter	Validation Rule
Radio button with options Paper Report (FD Report)	When TBD is set to Paper Report in the PSR Configuration screen, Non-serious, Unlisted PSR(Form 7-1 and 7-2) are generated in the Paper Form.When TBD is set to FD Report in the PSR Configuration screen:The Form 7-1 and Form 7-2 check boxes in the PSR Configuration screen are checked and disabled. The Print the report content as Case Listing in the separate paper PSR Configuration parameter is unchecked and disabled. Non-serious, Unlisted PSR (Form 7-1 and 7-2) are generated in CSV format. The Form 7-1 is generated in Paper format along with other PSR/ ReSD forms.

Configuration Parameter

Validation Rule

Radio button with options

Paper Report (FD Report)

When TBD is set to Paper Report in the PSR Configuration screen, Non-serious, Unlisted PSR(Form 7-1 and 7-2) are generated in the Paper Form.When TBD is set to FD Report in the PSR Configuration screen:The Form 7-1 and Form 7-2 check boxes in the PSR Configuration screen are checked and disabled. The Print the report content as Case Listing in the separate paper PSR Configuration parameter is unchecked and disabled. Non-serious, Unlisted PSR (Form 7-1 and 7-2) are generated in CSV format. The Form 7-1 is generated in Paper format along with other PSR/ ReSD forms.

The radio button is set to Paper Report in the existing PSR Configuration for an upgraded database, if Form 7-1 or Form 7-2 is marked.

The Oracle Argus Safety standard Advanced Conditions control (as present in English Periodic Reports) is provided in PSR ReSD Configuration screen for inclusion or exclusion of cases for all forms of PSR and ReSD reports.

UI Element	Validation Rule
Dropdown	The drop-down list displays the default options: None and New in the drop-down list. None is displayed by default. The Advanced Condition names are displayed in the alphabetical order. On specifying an Advanced condition, the system runs the query on the cases retrieved from Product selection and Reporting Time frame.
Advanced Condition Lookup button	The Advanced Condition Lookup dialog box is displayed on clicking this button.
AC	On clicking the AC button, the system displays a message with Yes, No, and Cancel buttons. If you select Yes, the system displays the Advanced Condition Query Set screen. If you select No, the system displays the Advanced Condition screen. If you select Cancel, the system closes the message. If you do not have rights to create or modify AC's, the AC button on the Japanese Periodic Report Configuration screen displays the following message in Japanese: You do not have the rights to create new Advanced Conditions. If there is no AC specified in Japanese Periodic Configuration screen, the Advanced condition (None) is printed. If there is an AC specified in Japanese Periodic Configuration screen, the Advanced condition(<AC Name>) is printed.

UI Element

Validation Rule

Dropdown

The drop-down list displays the default options: None and New in the drop-down list. None is displayed by default. The Advanced Condition names are displayed in the alphabetical order. On specifying an Advanced condition, the system runs the query on the cases retrieved from Product selection and Reporting Time frame.

Advanced Condition Lookup button

The Advanced Condition Lookup dialog box is displayed on clicking this button.

On clicking the AC button, the system displays a message with Yes, No, and Cancel buttons. If you select Yes, the system displays the Advanced Condition Query Set screen. If you select No, the system displays the Advanced Condition screen. If you select Cancel, the system closes the message. If you do not have rights to create or modify AC's, the AC button on the Japanese Periodic Report Configuration screen displays the following message in Japanese:

You do not have the rights to create new Advanced Conditions. If there is no AC specified in Japanese Periodic Configuration screen, the Advanced condition (None) is printed. If there is an AC specified in Japanese Periodic Configuration screen, the Advanced condition(<AC Name>) is printed.

The data population logic of FD report is the same as that of the Paper Report.
The existing profile switch Event counting logic for P.S.R Form 3, 4 and ReSD Form 4, 5 is renamed as Event counting logic for P.S.R Form 3, 4 and ReSD Form 10, 11.
The configuration parameters for PSR Form 3, PSR Form4, ReSD Form 10, and ReSD Form 11 are editable even for the second time frame or above, similar to a fresh report (initial time frame).
A new option under the profile switch Event Counting Logic for PSR Form 3, PSR Form 4, ReSD Form 10, and ReSDForm 11 is added to allow the users to configure the count each event field from a case with the timeframe where the case was last reported along with the count each event field from a case with the timeframe where the case was first reported.
Common profile switch Listedness Assessment Source for PSR and ReSD is deprecated.
A new report-level configuration is added as Listedness Assessed on to configure the assessment parameter for the reaction: Case Assessment and Datasheet.PSR and ReSD reports based on the common profile switch considers the new report-level configuration for the new created reports.For the existing reports prior to upgrade, the option for Listedness Assessed on is set based on the value set in the common profile switch Listedness Assessment Source for PSR and ReSD during upgrade.This report-level parameter is considered for PSR Form 3, PSR Form 4, ReSD Form 10 (for Case listing only), ReSD Form 9, and ReSD tabulation (Listed and Unlisted tabulations).
A new radio button is added in the Report Configurations > Scheduling tab to configure the Inclusion Date of the data:
- For a new report it is set to the Aware Date.
- For the existing reports prior to upgrade or copied reports is set to the Date Submitted.
This option cannot be edited for the second time frame report.
To include the reaction reported to MHLW directly (cases sent from PMDA or MHLW to MAH):
- In the Configuration screen, a new option is added to configure Case Classification using the Classification for cases sent by PMDA list box.
- Filter the cases based on the case classification such that cases are fetched based on the configured classification from the Case Data tables.
- Eliminate the cases already submitted to PMDA in the ESM.
- Consider the cases based on Japan information receipt date.
- Consider the PMDA Reporting criteria applicable for filter logic (Suspected, Serious, excluding un-reportable event).

For more information, see:

Parent topic: Reports