PSUR Report Selection

The Periodic Safety Update Report (PSUR) is a periodic report developed in accordance with the International Conference of Harmonization (ICH) E2C guidelines.

The purpose of the PSUR is to harmonize the safety evaluation processes of the ICH regions and to provide a standard template and content for reporting safety information.

PSUR can be generated for a batch of AERs specified within a date range, for a particular product that is marketed under a particular trade name, etc. These specifications can be defined in the Selection tab of the PSUR Report Selection page.

Sections in a PSUR Report

For each of the above-mentioned reports, you can set certain parameters called as the Run time parameters based on the requirements of each report.

General parameters like the Dictionary Type to be used, ART term type to be used and Disease Dictionary type to be used can also be set from this page.

You can generate PSUR by specifying the run-time parameters in the PSUR Report Selection page. The tabs of the PSUR Report Selection page have been described in detail in the subsequent topics.

Note: The parameters set during run time, i.e., the parameters you set in the following sections has precedence over the parameters set through the System Administration module.

PSUR Report Selection Page

To generate the PSUR report, select Reports à PSUR menu option in ARISg to invoke the PSUR Selection Criteria page.

This page has four main tabs, which in turn has secondary tabs. They have been listed below:

The PSUR Selection page has the following buttons. The functionality of these, have been described below:

General/ Selection Tab of PSUR

On invoking the PSUR Selection page, the General tab is activated with its Selection tab invoked.

Field Name	Description
Date Range From-To	Specify the date range for which the report is to be generated. The Date entered in From field is considered for calculating the Interval Summary Tabulation.
Development International Birth Date (DIBD)	Enter the start date of the annual period on which the clinical trials of the product is initiated. The Date entered in this field is considered for calculating the Cumulative Summary Tabulation for clinical trials. The Cumulative Summary Tabulation is comprehensive information about the adverse events (AEs) reported in the PSUR during the clinical trials phase.
International Birth Date (IBD)	Enter the date on which the authorized and approved for marketing the product. If the IBD Date is not available, then the Date for this field is considered from CPD for calculating Cumulative Summary Tabulation.
Date Type	Select the date type from the drop-down list. The following options are available: Received date -date of receipt of AER Date closed - date of closure of AER Date closed for - date closed for follow-up AERs and Received date for initial AERs Approved date -date of approval of AER. Note: Date type is enabled only if the parameter 'Include cases without informed authority information’ is checked in the Report Parameters Page with PSUR tab invoked. (This page is explained in the Administrator Guide.
For Alert/Non Alert Date	Select the alert/non alert date from the drop-down list. The following options are available Received date - date of receipt of AER Date closed - date of closure of AER Date closed for - date closed for follow-up AERs and Received date for initial AERs Decision date - the decision date Informed date - the Informed date Note: Informed date is not applicable to the Non Alert date field. Approved date - date of approval of AER. Alert/Non-alert date types both are enabled only if the parameter Include cases without informed authority information is unchecked in the PSUR Report Parameter. (This page is explained in the Administrator Guide).
Other info
Authority	Select appropriate approval authority from the drop-down list. Note: If there is no association made between the Authority and the Product, ARISg considers ALL of the suspect products.
Labeling Country	Select the country for which the labeling of the drug is to be checked. Note: When labeling is set to 'AER’, the labeling record must have product, reaction, country and status of the label for inclusion in the PSU report. When Labeling is set to CDD level and there is no labeling record available for the country at CDD level, the AE is considered as unlabeled. When you select ''Labeling Country” as "International”, the application prints "Listed or Unlisted” instead of "Labeled or Unlabeled”.
Report Language	Select the language in which the report is to be printed.
Listedness from	Specify whether the Listedness should be considered from the case or from the Company Product Dictionary with the help of the drop-down list.
Initial/Followup
Initial and Follow up cases	Select the option for printing Initial and Follow up cases from the drop-down list. The following categories are available: Together - Select this option to print Initial and Follow up cases together. Separate - Select this option to print Initial and Follow up cases separately. Select on this option to enable the Print option, which is explained below: Print Option: Specify the print option from the drop-down list: Initial - Select this option to print only the Initial cases. Follow up - Select this option to print only the Follow up cases. Both - Select this option to print Initial and Follow up cases separately. Note: Cases are considered as Initial or Follow-up depending on the follow-up number of the informed authority records that match the Authority specified in the selection page. Note: Both ICHLL and summary tabulations display the case as Initial if the authority in the case does not match the authority entered in the selection criteria. Note: If the report parameter 'Include cases without informed authority information’ is selected and Authority is not selected in the selection criteria screen, then the case is always considered as Initial.
Ignore not relevant flag	There are instances as Study department prints all the records in the regulatory reports whereas Post Marketing department wants to print only some of the records on the selection of the ”Not relevant flag”. If yes value is entered in the parameter then the records marked as not relevant are also considered for report generation.
Include solicited cases	The application considers printing of AERs with solicited source. The solicited case will be a part of "Non-interventional post-marketing study and reports from other solicited". Select the checkbox to consider solicited source in the PSUR. This option is unchecked by default. Note: Solicited cases will be marked with the legend ”%” in the ICHLL and the same appears as the indicator in the footer if this option is selected.
Select product by one of the following:
WHO DD	Enter the WHO DD for the product to be included in the report. Note: In the corresponding field, the de-code is automatically displayed based on the WHO DD
Trade Name	Enter the Trade name of the product(s) to be included within the report. It is possible to include wildcards in the report selection criteria. Alternatively, you can select the Trade name with the help of the look up button.
Trade Name Type	Select the trade name type from the drop-down list. Note: When you select the PPD code option, the system generates the PSUR report for a specific trade name along with its PPD code as a product’s PPD code does not change with the change in its trade name.
Internal Drug Code	Enter the internal drug code of the product using the lookup provided.
Approval Number	Select the approval number of the product with the help of the look up button.
Approval Country	Select the approval country of the product from the drop-down list.
Approval Type	Select the type of approval of the product from the drop-down list.
Therapy info
Route of admin.	Specify the Route of Administration of the drug by selecting it from the drop-down list.
Form of admin	Specify the form of Administration of the drug by selecting it from the drop-down list.
Study info
Protocol no.	Study number of a case. To enter the Protocol number: Click the lookup, Protocol Reference Selection lookup appears. Enter the search fields in the lookup and click OK to view the results. You can select multiple protocol numbers and project numbers from the list. In the Report, the application prints all the cases associated with the protocol number and project number you select. In the Select column, select the check boxes corresponding to Protocol numbers which want you to include when printing the associated cases in the Report. By default the option is Null. For more information on Lookups, refer to the Data Entry Features guide.
Project no.	Enter the Project number.
Medical confirmation info
Medical Confirmation	Select the appropriate option from the drop-down list. The following options are available: Confirmed - Select this to include all medically confirmed cases Unconfirmed - Select this to include all medically unconfirmed cases. Both - Select this to include both medically confirmed as well as unconfirmed cases.
Consider null values	Check this box to consider null values in medical confirmation also to be included in the report.
Case reports
Case reports	Select the required option to print regulatory reports along with PSUR report: FDA3500a - Select this option to generate FDA3500a reports for all serious or non-serious and listed or unlisted cases. CIOMS - Select this option to generate CIOMS reports for all serious or non-serious and listed or unlisted cases. VAERS - Select this option to generate VAERS reports for all serious or non-serious and listed or unlisted cases. None - Select this option to suppress printing of any of the regulatory reports. Note: If ”Privacy Type” for Regulatory report is set as ”Normal”, and then report is considered as public.
Country for CIOMS	When you select the CIOMS option in the Case reports section, the Country for CIOMS drop-down gets enabled. This option is recommend setting in the PSUR Report Selection window instead of setting the parameter in the User Preference.

Blinding Support tab of PSUR

Field Name	Description
Report Type	Select one of the following options: Blinded: To print blinded report(default). Unblinded: To print unblinded report.
Select Unblinded report type to display the following options.
Choose the following options to either print the blinded info or to prevent the unblinded case getting printed in the unblinded report.
Note: The options ”Print blinded info” and ”Do not include case” are applicable only for unprivileged user.
Print blinded info.	Select this option to print blinded information in unblinded report. This option is selected by default. AER Number contains the ”#”symbol, when you print the blinded product information in the unblinded report. Note: Footer of the unblinded report prints ”#: Blinded product information printed”.
Do not include case.	When you do not have privileges for a case and if you select the checkbox, the application restricts you from printing the unblinded cases in the report. The application prints an empty report, when you do not select any data. Select the checkbox, to print Blinded records and Normal records in the report.
Blinded Case. Prevent blinded cases	Select ”Prevent blinded cases” checkbox to restrict the printing of blinded cases in unblinded reports. Do not select ”Prevent blinded cases” check box to print blinded and normal records of the case in unblinded reports. This option is applicable for privileged and unprivileged users. AER Number contains the ”~”symbol, when you print blinded product information in the unblinded report. Note: Footer of unblinded report prints "~: Blinded case”.

Layout Tab of PSUR

Specify the runtime parameters pertaining to the layout of the PSUR report in the Layout tab of the PSUR Report Selection page.

Field Name	Description
Missing date	The missing date string is printed if the date is missing for a particular date field.
Missing Text	The missing text string, which is to be printed if the data is missing for a text field.
Imprecise date	The text string, which is to be printed if the date is imprecise.
Date separator	The string, which is to be printed to separate the date fields.
Print selection	Select the check box to specify if the selection criterion is to be printed on the report.
Print ICHLL	It is possible to print the line listing and summary tabulations separately. Select this check box to determine if the Line Listing is to be printed with the summary tabulation. By default, this checkbox is not selected.
Print summary tabulation	Select the check box to print the Summary Tabulation Report along with the line listing report. By default, the Print summary tabulation (ST) checkbox is not selected.
Print exception list	Specify whether the Exception List is to be printed or not. Note: The Exception list contains cases for which one or more reactions are not coded or does not have a labeling record. Note: The reason for exclusion is also mentioned in the list. The selection criteria are printed on the first page of the report.
Cumulative ST for clinical trials	Select the checkbox to calculate and print the cumulative and interval summary tabulation information in the following separate columns under the heading Cumulative summary tabulations of serious adverse events from clinical trials in the PSUR Report: Summary Tabulation - Prints information about Event, Study Drug, Blinded drug, Comparator drug, Placebo, and Unknown. NOTE: The Cumulative ST for clinical trials is calculated based on the Development International Birth Date (DIBD) entered in the General > Selection tab in PSUR Selection criteria page. If the DIBD Date is not entered, then: the DIBD Date for calculation is considered from CPD for the selected product. If the DIBD Date is not available in CPD, then: the "From" date is considered for calculation. By default, this checkbox is selected.
Cumulative and interval ST for PMS	Select the checkbox to calculate and print the cumulative and interval summary tabulation information in the following separate columns under the heading Numbers of Adverse Drug Reactions by Term from Post-Marketing Sources in the PSUR Report: Cumulative Summary Tabulation - Prints all the serious and non-serious adverse reactions from the International Birth Date( IBD) to the Data lock point (To date of the report). Interval Summary Tabulation - Prints the list of all the serious and non-serious adverse reactions from the Interval period (FROM and TO Dates of the report). NOTE: The Cumulative and Interval ST is calculated based on the International Birth Date (IBD) entered in the General > Selection tab in PSUR Selection criteria page. If the IBD Date is not entered, then: • the Date for calculation is considered from CPD for the selected product. If the IBD Date is not available in CPD, then: • the "From" date is considered for calculation. By default, this checkbox is selected.
NOTE: When you select either or both Cumulative ST for clinical trials and Cumulative and interval ST for PMS for printing Summary Tabulation in the PSUR Report, ensure to set the Consider ICH/Summary tab indexes independently parameter as Yes in ADMIN > Parameters > Report Parameters > Periodic > PSUR.
Print report generation date and time	Select an option to indicate if the time and date when the report is generated must be printed in the report or not.
Date format	Specify the date format to be printed in the report. The format can be: dd-mm-yyyy mm-dd-yyyy dd-mon-yyyy
Report title	The information entered in this field is printed as the report title under the following sections in the PSUR Report : Selection Criteria Line Listing Summary Tabulation Exception List You are allowed to enter a maximum of 55 characters. NOTE: When you do not enter any text in the Report title field, by default, the title "PERIODIC SAFETY UPDATE REPORT" is printed as the report title in the PSUR Report. By default, this field is blank.

ICHLL/Print Tab of PSUR

Specify the runtime parameters that are to be taken into account in generating the ICHLL report. The ICHLL tab has four secondary tabs namely:

On selecting the ICHLL tab in the PSUR Report Selection page, the Print tab is invoked by default. In the Print tab, specify the contents that are to be printed in the ICHLL report.

Field Name	Description
Reported AER no.	Select the appropriate option from the drop-down list to specify the Reported AER No. A Reported AER Number can either be Local AER No or an AER Number at Initial Units.
Follow-up no. with AER no.	Check this option if the follow-up number of the AER is to be printed with the AER number.
Sources	Select the appropriate option from the drop-down list: All Sources - To print all the sources including the primary source of the AER in alphabetical order Primary Source - to print only the primary source of the AER Note: AERs with primary source as 'Health Authority’ are considered in PSUR under the section 'Regulatory bodies’.
Print child data	Check this option to specify if the information related to the child is to be printed in the report. Note: The child data is printed only when a case selected for printing involves a congenital anomaly.
Type of onset date	Specify if the AE Onset Date or the Latency date is to be printed on the report by selecting the appropriate option from the drop-down list. Note: If the parameter is set to AE Onset date and the same is missing in the AER, by default the Latency date is printed.
Include dose no.	Check this option to specify if the number of doses administered is to be printed on the report
Drug name type	Specify the drug name type that is to be printed on the report by selecting the appropriate option from the drop-down list.
Formulation in drug name	Check this option to specify whether the formulation needs to be printed with the drug name.
Co-manifestation reactions	Select an option from the drop-down list to indicate if the co-manifestation reactions must be printed in the PSUR or not. The co-manifestation reactions prefixed with '-' are printed in the PSUR, if the option selected for: Print Co-Manifestation AE is 'No' and that for the Co-manifestation Reactions is 'Yes' Print Co-Manifestation AE and Co-manifestation Reactions is 'Yes' The co-manifestation reactions are not printed in the PSUR, if the option selected for: Print Co-Manifestation AE is 'Yes' and that for the Co-manifestation Reactions is 'No' Print Co-Manifestation AE and Co-manifestation Reactions is 'No', The outcome of all co-manifestation reactions is printed in the PSUR if the option selected for Print reaction info is 'All Reactions' and Print Co-Manifestation Reaction is 'Yes'. The outcome data of all co-manifestation reactions is printed in the PSUR, based on priority if the option selected for Print reaction info is 'Single Reaction' and Print Co-manifestation reaction is 'Yes'. The outcome data of co-manifestation reactions is not printed in the PSUR, if the option selected for Print reaction info is 'Single Reaction' /'All Reactions' and Print Co-manifestation reaction is 'No'. The onset date for co-manifestation reactions is printed in the PSUR, if the option selected for: Print Co-Manifestation AE is 'No' and that for the Co-manifestation Reactions is 'Yes' Print Co-Manifestation AE and Co-manifestation Reactions is 'Yes', The onset date for co-manifestation reactions is not printed in the PSUR, if the option selected for: Print Co-Manifestation AE is 'Yes' and that for the Co-manifestation Reactions is 'No' Print Co-Manifestation AE and Co-manifestation Reactions is 'No',
Print indexes without data	Check this option to specify whether the indexes that do not contain any data are to be printed on the report. By default this option is checked. Note: If this parameter is unchecked and no case is selected, then the report prints a blank page with the literal ”No data selected”.
Print page no.	Check this option to specify if page numbers are to be printed on the report.
Starting page no.	Enter the start value for numbering the pages of the report. Note: You can enter this field only if the parameter in the field Print Page No. is set to Yes.
Include dose with	Select the appropriate check boxes from the following options: Unit dose Frequency Strength Formulation Route
Group	Specify if the following options are to be grouped together or separate in the report by selecting the appropriate option from the drop-down list: Indication Body system Sources (i.e. Spontaneous, Literature, Study) Seriousness (Serious, non-serious AERs) Labeling Note: When the seriousness information is not available, default values are not considered for the PSUR, as a result the AER does not get considered for PSUR generation.
Suspect drug with	Specify whether the ingredients or full WHO DD decode is printed with the suspect drug by selecting the appropriate option from the drop-down list.
Concomitant drug with	Specify whether the ingredients or full WHO DD decode is printed with the concomitant drug by selecting the appropriate option from the drop-down list.

Header/ Footer Tab of ICHLL

You can define the page headers, page footers and report footers for the ICHLL Report in this tab of the PSUR Report Selection page.

Field Name	Description
Page title string	Specify the page heading for the report. The text entered here is printed at the top of every page of the ICHLL report. The text is centrally aligned.
Page footer string	Specify the page footer for the report. The text entered here is printed at the bottom of every page of the ICHLL report. This string is centrally aligned.
Report footer string	Specify the report footer. The string entered here is printed only on the last page of the ICHLL report.

Comments/Narratives Tab of ICHLL

Field Name	Description
Print the following
Comments	The comments column contains product and event information. Select the appropriate check boxes from the following options to be printed in the ICHLL: Serious info Labeling info Causality info De/Rechallenge The selected product and event information appears in the Comments column.
Narratives	Select the appropriate check boxes from the following options to be printed in the ICHLL: Study Info Authority ID Literature data Suspect drugs Interacting drugs Co-Meds Pharmacovig. Comments Company remarks Disease data Indication for use The additional information like Pharmacovig. Comments, Company remarks, Interacting drugs etc. and narratives like Study info, Authority ID, Literature data, Indication for use etc. appears under Additional Information/Narratives heading.
Summary option	Select the appropriate option from the drop-down list. Summary desc. AER description Do not Print

Indexes Tab of ICHLL

Parameters for printing AERs and AER information can be set in this tab. Selecting the Indexes tab of ICHLL will display the PSUR Report Selection page.

Field Name

Description

Spontaneous/ Literature/Study/ Authority/ Other source cases

You can choose the combination of the following categories of Spontaneous, Literature, Study, Authority and Other cases in the report by marking the appropriate check boxes:

Serious, Listed
Serious, Unlisted
Non Serious, Listed
Non-Serious, Unlisted

Print Sub-Tab of the Summary Tabulation Tab

Specify the runtime parameters that are to be taken into account in generating the Summary Tabulation report. The Summary Tabulation has three secondary tabs namely:

Select the Summary Tabulation tab of the PSUR Report Selection page to invoke the Print sub tab.

Field Name	Description
Print tabulation even if no data is available	Select the check box to print the tabulation even if there is no data available for Summary Tabulation.
Print page no	Select the check box to print the page numbers in the tabulation report.
Starting page no	Specify the Starting page number for the tabulation report.
Group all reactions regardless of source	Specify if all reactions are to be grouped together or separate regardless of the source by selecting the appropriate radio button.
Group all serious/non-serious reactions	Specify if all the serious/non-serious reactions are to be grouped together or separate by selecting the appropriate radio button.
Group on Indication	Specify if the cases are to be grouped on indication by marking the check box.
Sort order for reactions under a body system	The listings or the Tabulations under SOC are grouped by Internationally Agreed Order. Define the sort order for reactions in a body system either alphabetically or by frequency of the reactions by selecting the appropriate option from the drop-down list.
Consider other sources under PMS	Select this checkbox to consider the reaction of a case associated with 'other' sources for printing in the Numbers of Adverse Drug Reactions by Term from Post-Marketing Sources under Spontaneous column in PSUR Report. By default, this checkbox is not selected.
Consider observational case under Non-Interventional Study	Select this checkbox to consider the reaction of a cases associated with Observational Study for printing in Cumulative and interval summary tabulations from post marketing data sources under the Non-interventional study column. By default, this checkbox is not selected. NOTE: When this checkbox is selected, the reactions of cases with the source as Clinical Study is not considered for printing under the "Cumulative Summary tabulation of SAE from Clinical Trials".

Header/Footer Tab of the Summary Tabulation

Field Name	Description
Title String for Summary Tabulation sub-report	Enter the string that is to be displayed as the title of the Summary Tabulation sub-report.
Footer string for Summary Tabulation sub-report	Enter the string that is to be displayed in the footer of the Summary Tabulation sub-report.
Report footer string at the end of the Summary Tabulation sub-report	Enter the string that is to be displayed in the footer at the end of the Summary Tabulation sub report.

Indexes Sub -Tab of the Summary Tabulation

Field Name

Description

Spontaneous/Literature/Study/Authority/ Other Source Reactions

You can choose the combination of the following categories of Spontaneous, Literature, Study and Authority reactions in the report by marking the appropriate check boxes:

Serious, Listed
Serious, Unlisted
Non Serious, Listed
Non Serious, Unlisted

Dictionary Tab of PSUR

Initially, this tab reflects the settings made in the Dictionary tab of PSUR in the System Administrator’s module. You can alter the values of these parameters to suit your requirements.

Field Name	Description
Dictionary type	Select the type of Dictionary from the drop-down list.
Reported Term/ Included Term/LLT/ Preferred Term/ Code from dictionary	Select the check boxes to select the appropriate ART Term type. The options are: Reported Term Included Term/LLT Preferred Term Code from dictionary
Disease Dictionary type	Select the appropriate disease dictionary type from the drop-down list. However, the runtime parameters set in the PSUR Report Selection page supersede the Report specific parameter settings in the System Administration Module. When the installation parameter 'Use unapproved AER concept’ is set to Yes, then the regulatory line listing reports will always use the latest approved version of the AER. The following reports use this concept: CIOMS-II FDA periodic report PSUR Note: If the installation parameter 'Use Approved AER’s in line listing’ is set to 'Use Approval status of AER’ then the case which does not have a approved version will not be included in the reports. Regulatory reports will not print the logically deleted records.