Development_Safety_Update_Report

Select Reports > Peridoic > DSUR option in ARISg to display the DSUR Selection Criteria page.

Field Name	Description
Date Range From-To	The date range for which the report is generated. Application considers the date format mentioned in the user preferences.
Development International Birth Date (DIBD)	Date of first approval (or authorisation) for conducting an interventional clinical trial in any country. The application considers this date for calculating ’From date’ for Summary tabulation. If this date is not entered, then the application considers the DIBD from CPD for the selected product. If DIBD is greater than the ’From date’ entered in selection criteria, then ’From date’ is considered for calculating the counts in cumulative summary tabulation.
When informed Authority is not considered	Indicates the selection of the parameter Include cases without informed authority information in the Admin application.
Date type	The type of date considered for date range. Date type is available only when the parameter Include cases without informed authority information is not selected. Select the date type from the drop-down list. The following options are available: Received date Date closed Date closed for Approved date
When informed Authority is considered	Indicates the selection of the parameter Include cases without informed authority information in the Admin application
Alert date type	Indicates the type of report for Authority. Select the 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 Approved date - the date on which the case was approved.
Alert/Non Alert Date type	Select the 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 date on which the case is informed to the authority Approved date - the date of approval of AER. Alert/Non-alert date types are enabled only if the parameter Include cases without informed authority information is not selected.
Other Info.
Authority	The approval authority of the report. Select appropriate approval authority from the drop-down list. By default the option is Null.
Report Language	The language in which the report is printed. By default the option is Null
Labeling Country	Indicates the country for which the labeling of the drug is selected. If nothing is selected, then by default the application considers labeling country as International. By default the option is Null.
Listedness from	Indicates if the labelling is considered from the case or from the Company Product Dictionary. The available options are: AER (Default option) CPD
Include solicited cases	Indicates the inclusion of solicited cases in the report. Select the checkbox to consider solicited source in the DSUR. This option is not selected by default.
Select any one of the following. Select either Product or Study.
Product
Preferred Product Description	Indicates the product description from the CPD lookup. By default the option is Null.
Use PPD Code	Select the check box to generate the DSUR report for a specific trade name along with its PPD code. Note:The product’s PPD code is constant and does not change when its trade name changes.
Include associated products in the LL	When the search criteria is based on Product (PPD) and/or Study Protocol, selecting this checkbox prints only those cases in the Line Listing (LL) where the products or comparator product associated with the respective case has Assess Relationship set to Yes. • If the search is based on Product (PPD), the application considers all those Cases where the products or comparator product associated with the respective case has Assess Relationship set to Yes. • If the search is based on Study Protocol, the application search for those cases matching the protocol selection criteria and considers only those cases for printing in the LL report where the products or comparator product associated with the respective case has Assess Relationship set to Yes. The cases that are mapped to Source (A.1.4) as “Observational Study” (Standard code 28 in codelist) are excluded and printed under exception section in the DSUR Report, even in the scenario where the Study Protocol criteria are provided. NOTE: The validation message appears in the following scenarios on clicking Generate in the DSUR screen: • Product or Study should be entered – This message appears when the “Include associated products in the LL” parameter is not selected, and the Study Protocol parameters (Project no./Protocol no./EudraCT no.) and Preferred Product Description is blank. • Product should be entered - This message appears when the “Include associated products in the LL” parameter is selected, and the Study Protocol parameters (Project no./Protocol no./EudraCT no.) and Preferred Product Description is blank. • Either Product or Study should be entered - This message appears when the “Include associated products in the LL” parameter is selected, and any one of the Study Protocol parameters (Project no./Protocol no./EudraCT no.) is not selected and Preferred Product Description is blank.
Study info
EudraCT No.	A unique identification number of a clinical trail in the European Union. Indicates the EudraCT No. of the study case for which DSUR is generated. By default the option is Null.
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. Select one of the record and click Select to enter the Protocol number. By default the option is Null. For more information on Lookups, refer Data Entry Features guide.
Project no.	Enter the Project number. By default the option is Null.
When you select multiple Protocol numbers in the Protocol Lookup screen, all the protocol numbers and project numbers you have selected are displayed in the Protocol No. and Project No. fields with a separator (\|\|) between each of the protocol numbers and project numbers. For example: If you select Prot1, Prot2 and Prot3 in the lookup, then these protocol numbers and project numbers are displayed as shown in the following figure:
Group By- Check the options to group the cases in Line listing and Summary Tabulation sections of DSUR. The grouping of cases is in following order: Protocol number Initial/ Follow-up Indication SOC Labeling
Protocol number	Select this option to group the cases by Protocol number in Line listing and Summary Tabulation sections of DSUR.
Initial/Follow-up	Indicates the printing of Initial and Follow-up cases.
Print option	Indicates the grouping of Line listing and Summary Tabulation. This option is available only when Initial/ Follow-up grouping is selected. By default Both is selected.
SOC	SOC is a group of adverse reaction Preferred terms pertaining to the same system-organ. Select the checkbox to group the Line listing cases. The group by SOC is applicable only for line-listing cases.
Others	Select either labeling or indication to group the case. The case gets listed under UNKNOWN, if there is no data available for the group by option set. For example, if group by indication is selected and if indication is not available for a case, then the case gets listed under UNKNOWN.

Field Name	Description
Data Privacy
Data	Indicates the printing of personal information in the report. Select one of the following options: Private: When you select private, you find the label ”r;Privacy” printed in the reports, irrespective of the user privileges.(Default option) Public: You will be able to view the data printed in the reports. This is applicable for only those who have access to view private data. For Unprivileged users, a label ”privacy” is printed to indicate private fields in the report.
Report Type	Select one of the following options: Blinded: To print blinded report (Default option). Unblinded: To print unblinded report.
Select Unblinded report type to display the following options.
Choose the following options to either print the blinded information or to prevent the blinded case getting printed in the unblinded report. 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. Footer of the unblinded report prints ”#: Blinded product information printed”. This footer is printed when the runtime parameter ’If no access to unblinded data’ is set to ’Print blinded info’,
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. Footer of unblinded report prints "~: Blinded case”. This footer is printed when the runtime parameter ’r;If no access to unblinded data’ is set to ’r;Print blinded info’,

Field Name	Description
Text literals
Text which will appear on the report for:
Missing date	Indicates the printing of text for a missing date field. Enter the text, the application prints the entered text in the missing date fields of the report. The application prints the default value from the parameter settings AdminàParametersàReportParametersàDevelopment Safety Update Report
Missing Text	Indicates the printing of text for a missing text field. Enter the text, the application prints the entered text in the missing text fields of the report. The application prints the default value from the parameter settings AdminàParametersàReportParametersàDevelopment Safety Update Report
Imprecise date	Printing the text string for an imprecise date. Enter the text, the application prints the entered text in the imprecise date fields of the report. The application prints the default value from the parameter settings AdminàParametersàReportParametersàDevelopment Safety Update Report
Date separator	Indicates the printing of the character to separate day, month, and year of the date in the report. Enter the character, the application prints the entered text as the seperator in the date field to seperate day, month, and year. The application prints the default value from the parameter settings AdminàParametersàReportParametersàDevelopment Safety Update Report
Date format	The date format to print in the report. Select the format from the drop down. The available formats are: dd-mm-yyyy mm-dd-yyyy dd-mon-yyyy YYYYMMDD The application prints the default value from the parameter settings AdminàParametersàReportParametersàDevelopment Safety Update Report
Print section
Print selection criteria	Indicates the printing of selection criteria on the report. Select the checkbox to print the selection criteria in the report. By default the check box is selected.
Print line listing report for clinical trial	Indicates the printing of Line Listing on the report. Select the checkbox to print line listing cases in the report. By default the check box is selected.
Print list of death cases.	Indicates the printing of death cases in the report. Select the checkbox to print the death cases in the report. By default the check box is selected.
Print summary tabulation	Indicates the printing of summary tabulation in the report. Select the check box to print the Summary Tabulation in the report. By default the check box is selected.
Print AESI List	Indicates the printing of AESI (AE's of special interest) in the report. Select the check box to print the list of AE's of special interest in the report. By default the check box is selected.
Print list of subject drop outs	Indicates the printing of Tabulations and listings of information on withdrawal of cases in the report. Select the check box to print the list of withdrawal of cases in the report. By default the check box is selected.
Print exception list	Indicates the printing of Exception List in the report. Select the check box to print the Exception list in the report. By default the check box is selected.

Field Name

Description

Reported AER no.

Indicates the printing AER no. in the report.

Select the following options:

Local AER no.: Prints the local AER no in the Line Listing section.
AER no. at initial unit: AER number from AER at units screen is considered. If AER number is not available in AER at units screen, then local AER number is printed.

By default Local AER no. gets selected.

Product name type

Indicates the printing of product description in the report.

Select the following options:

Product description: Prints the product description from Product screen.
Active ingredient: Prints the generic name in the report.

By default Product description gets selected.

Suspect drug with

Indicates the printing of Ingredients in the report.

Select the following options:

Ingr.: Prints ingredients depending on the settings of the installation parameter Print ingredients From.

When the installation parameter Print ingredients from is set to AER, then substance name from ingredients tab gets printed.

When the installation parameter Print ingredients from is set to Dictionar’, ingredients gets printed from DRL dictionary.

Full WHO DD decode: Prints WHO DD decode in the report.
None: Prints nothing in the report.

By default None gets selected.

AER with

Indicates the printing of AER number with follow-up number or with version number.

Select the following options:

Follow-up Number : Prints the follow-up number of the AER. The follow-up number is considered from the Informed Authority information and the highest follow-up number is considered.
Format of printing
<AER number> (<follow-up number>)
If there is no Informed Authority record and if the report parameter 'Include case without informed authority information’ is set to 'Yes’, then the follow-up number is not printed.
If the report parameter 'Include case without informed authority information’ is set to 'No’ and there is an Informed Authority record but no follow up number is specified, then a default value of 0 (zero) is printed. If the follow-up number is specified, then the follow-up number is printed.
Version Number: Prints the version number of the AER. Only International version is considered.

Format of printing

<AER number> (<version number>)

None: Prints only the AER number.

Format of printing

<AER number

By default None gets selected.

Include serious co-manifestation drug reactions

Indicates the printing of Serious co-manifestation reactions in the report.

Yes: Pints the Serious co-manifestation reactions in the report.

Format of printing

-< co manifestation>

Default value is Yes.

Print Child data

Indicates the printing of age and sex of the child in the report.

Yes: The applications prints the age and sex of the child when the you satisfy the following conditions:

Congenital anomaly is set to Yes in Full Data EntryàPatientàPregnancy screen

and

Pregnancy outcome is set to congenital malformation

By default the option is not selected.

Print MedDRA version no.

Indicates the printing of MedDRA version for coding the reported terms.

For study cases the application prints the Protocol MedDRA version.

When the product is a drug the application prints the MedDRA version from the installation parameter settings in the Admin application.

When you select Print MedDRA version no. check box MedDRA version is printed in the footer of line listing section of the report.

By default the option is selected.

Print Formulation

Indicates the printing of formulation along with the drug name in the report.

By default the option is selected.

Print Page no and Starting page no

Select the options to print the page numbers on the report and mention the starting page number for numbering the pages of the report in the print page no section.

If you do not mention the starting number, then the application considers the default value as 1.
You can enter this field only if the parameter in the field 'Print Page No.’ is selected..

Parameter Name	Possible Values
Page title string	Enter the title for Summary Tabulation section which gets printed on Top-center of each page.
Page footer string	Enter the page footer string for Summary Tabulation section which gets printed at the bottom-center of each page.
Report footer string	Enter the report footer string for Summary Tabulation section which gets printed at bottom-center of the end of the report.

Field Name	Description
Print the following
Serious info	Indicates the event level serious characteristics like death, life threatening, hospitalization, hospitalization prolonged, disability or permanent damage, congenital anomaly, required intervention (devices) and other Serious (Important medical events). Select the option to print the selected event level seriousness characteristics in the comments column of Line listing report. If the application does not contain these characteristics at the reaction level, then AER level characteristics get printed. By default the checkbox is selected.
Labeling info	Indicates the printing of labeling information for each reaction in the report. If the reaction is labeled, then ’Labeled’ gets printed, if unlabeled, then ’Unlabeled’ gets printed. If labeling info is not available for a reaction, then nothing gets printed. By default the checkbox is selected.
Causality info	Indicates the printing of E2B causality information in the comments column. Select this option to print the Causality information. The application prints the causality information from Reporter/Company/Headquarters depending on the report parameter in Admin->Parameters->Report Parameters->Development Safety Update->Data->Causality as per By default the checkbox is selected. Format of printing Source Result <Source text> <Result text>
De/Rechallenge	Indicates the printing of information on withdrawal and Re-introduction of the same drug in the comments column of the report. By default the checkbox is selected. Format of printing Dechallenge: <Dechallenge > Rechallenge: <Rechallenge >
Cause of AE	Indicates the printing of the Cause of AE in the comments column of the report. Select this option to print the comments from Reporter or company. The application prints the comments depending on the settings of the report parameter in Admin->Parameters->Report Parameters->Development Safety Update Report->Data ->Cause of AE By default the checkbox is selected. Format of printing Protocol Relatedness Company: < Cause of AE (As per Company)> Reporter : < Cause of AE (As per Reporter)>
Indication for use	Indicates the printing of indication information in the comments column of the report. Select this option to print the disease term in the report. The application prints the disease term depending on the settings of the report parameter in Admin->Parameters->Report Parameters->Development Safety Updae Report->Data->Disease term By default the checkbox is selected. Format of printing Indication(s) for use < Indication term/PT term >
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 Cause of AE Indication for use The selected product and event information appears in the Comments column.
Narratives	Select the appropriate check boxes from Narratives to print in the ICHLL: 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

Field	Description
Summary tabulation for Serious adverse event Serious adverse reaction	Select either of the options
Summary tabulation even if no data is available	Select this option to print the tabulation even when no data is available.
Print page No.	Select this option to print the page number for each page of summary tabulation in the report.
Starting page No.	Mention the starting page number for numbering the pages of the report.
Sort order for reactions under SOC	Select the order to sort all reactions under a body system on the basis of indications, from the drop-down list. The Listings or the Tabulations under SOC are grouped by Internationally Agreed Order. Possible values: Alphabetical by reaction (Default) By frequency

Development Safety Update Report Selection