Managing Electronic Submissions

E2B is the international standard for transmitting electronic safety data in XML format. ARISg application enables you to submit individual case safety reports (ICSRs) in E2B format to Regulatory Authorities.

The E2B Export/ Import facility supported in ARISg, facilitates the electronic exporting and importing, of individual case safety reports (ICSR) between your company and trading partners such as regulatory authorities and business partners.

Exporting E2B Cases

E2B Export is used to export files from ARISg database as SGML or XML files.

Note: To perform E2B export and import operations RP_JSERVICE should be up. In Windows 2003, you should set RP_JSERVICE to Interact with desktop for E2B export option to work. Otherwise it is set to This Account option, which enables report generation.

In the List of Selected AERs page, select Operations --> E2B Export to display E2B Export page.

Field Description of Export panel

Note: If more then one case is selected for E2B export from ARISg->QBE then the application validates the existence of unique message type value in the selected cases. If the message type differs, then the message "Cases with different E2B message type cannot be exported together” is displayed and export operation is not done.

Export page consists of the following tabs:

Sender
Receiver
Options

The Sender tab is displayed by default.

Sending Cases

Select the Sender tab.

Field Description of Sender tab

Receiver

Select the Receiver tab to display the receiver details.

Field Description of Receiver tab

Options

Select the Options tab.

Field Description of Options tab

Enter details in the tabs provided and click the OK button in the Export page. ARISg prompts with the User Authentication page, if the installation parameter "Authentication required for” is set to "Critical operations only” or "Both”:

Enter the password and click the OK button to export the selected AER(s).

It is not possible to export multiple AERs if the language is specified as 'Japanese'. The following message appears:

Multiple selection of AERs is not allowed for Japanese Language

Note: While exporting AERs from QBE, if the SGML files are not found, ARISg displays the message "Unable to zip files”.

Multiple Languages Support for Distribution/E2B export

ARISg now supports multiple languages in the distribution server for E2B files, that is an E2B file can be exported in all languages that ARISg supports for data entry.

When a case is processed through the workflow and the distribution rule is fulfilled at different stages of the workflow, then the same case version is distributed only once to the recipient even if the distribution condition is met more than once. The case is distributed only if the distribution status is to be distributed or to be re-distributed.

Messages Displayed on Export of AER(s)

When the AER(s) are exported in the E2B format,

The log file contains the following information:

AERs Exported without errors - This means the AER(s) had all the mandatory requirements of E2B satisfied.
AERs Exported with errors - This could mean that the AER(s) were missing some details that are mandatory in E2B format. The details that are mandatory could be a field or a record. The errors could also be Parser errors, data mismatch errors etc.
Total number of AERs Exported - This is the total number of AER(s) that were exported.

The explanation of the possible messages in the log file is as detailed below.

Error Message	Error Source
Data is missing for this Tag <" + tag_name + "> which is mandatory as per E2B/M2 ICSR DTD";	The message is flagged when the user tries to export a field, when the mandatory fields are not entered as per E2B/M2 ICSR DTD.
<TagName> too large for ARISg database. Truncated to this many characters.	The message is flagged when the user tries to export a field, whose length is greater than that Specified by E2B/M2 ICSR.
<TagName> too large for ARISg database. Will be truncated to this many characters. This AER is not exported. ";	The message is flagged when the user tries to export a field, whose length is greater than that Specified by E2B/M2 ICSR & the case will not exported.
The field FieldName() is not exported as its size exceeds E2B/M2 tag size.	The message is flagged when the user tries to export a field, whose size exceeds E2B/M2 Tag Size.
The field FieldName Invalid data as per E2B/M2 specifications. The field FieldName Data is missing	The message is flagged when the user tries to export a field when the field name is invalid or field name data is missing as per E2B/M2.
The field FieldName is too large for E2B/M2 tag <TagName >, Truncated.	The message is flagged when the user tries to export a field, whose size exceeds E2B/M2 Tag Size.
Precision of data in FieldName is reduced for exporting.	The message is flagged when the user tries to export a field name, which is reduced for exporting.
This Date format in FieldName is not supported by E2B/M2.	The message is flagged when the user tries to export a field, when the date format is not supported by E2B/M2.
The code for this field FieldName is not supported by E2B/M2.	The message is flagged when the user tries to export a field name which is not supported by E2B/M2
Since there is no patient record which is mandatory as per E2B/M2 ICSR DTD the data related to Parent, Reaction, Test, Drug and Summary information are not exported	The message is flagged when the user tries to export a field, when there is no patient record.

Importing E2B Files

E2B Import is used to import data from files exported in the E2B format into the ARISg database.

Select CASE à Import from the menu bar to display the Import page.

Select the option E2B to display the E2B Import screen.

Field Description of E2B Import

Click the Analyze button for analyzing potential problems before importing to ARISg database.
The application compares the sent file with the standard format and the displays the errors.

Messages Displayed on Import of AER(s)

When the AER(s) are imported in the E2B format,

The log file contains the following information:

AERs imported successfully - This means the AER(s) had all the mandatory requirements of E2B satisfied.
AERs imported with errors - This could mean that the AER(s) were missing some details that are mandatory in E2B format. The details that are mandatory could be a field or a record. The errors could also be Parser errors, data mismatch errors etc.
AERs, which are not imported - This is the total number of AER(s) that were imported.

Explanation of possible messages in the log file is as detailed below.

Error Message	Error Cause
Tag <tag_name > which is not valid as per E2B/M2 ICSR DTD	The message is flagged when the user tries to Import a file, which is not a valid field for E2B/M2 ICSR DTD.
Invalid ParentTagName <parent_tag_name> occurs, for the tag <tag_name> instead of ParentTagName <parent_element_name > as per E2B/M2 ICSR DTD	The message is flagged when the user tries to Import a file, when the parent tag name occurs instead tag name E2B/M2 ICSR DTD.
Tag <tag_name> not found in DTD, which is not valid as per E2B/M2 ICSR DTD	The message is flagged when the user tries to Import a file when the tag name is not a valid as per E2B/M2 ICSR DTD.
Incomplete Tag <tag_name>. End of this tag not found	The message is flagged when the user tries to export a file when the tag name is incomplete.
Invalid Tag <tag_name> occurs after the tag <prev_tag_name> which doesn't have any successing child as per E2B/M2 ICSR DTD	The message is flagged when the user tries to Import a file when the tag name doesn’t count Succeeding child tags.
<tag_name> should have <prev_element_name> as previous tag and not <prev_tag_name>	The message is flagged when the user tries to Import a file when the tag name doesn’t count previous tag name.
Data is missing for this Tag <tag_name> which is mandatory as per E2B/M2 ICSR DTD	The message is flagged when the user tries to import a file when the mandatory data is missing.
Tag <tag_name> occurs no_of_occurence times. But it should occur ZeroOrOnce as per E2B/M2 ICSR DTD. Except the last occurrence all others are not considered.	The message is flagged when the user tries to Import a file when the tag name occurs more than once.
Tag occurs no_of_occurrence. But it should occur only once as per E2B/M2 ICSR DTD	The message is flagged when the user tries to Import a file with multiple occurrence of a tag when it is supposed to occur only once in the file.
Tag name: Invalid data (Check the length of the data and it's contents). Tag name: Data is missing.	The message is flagged when the user tries to Import a file when the data is invalid and if data is missing.
Root Tag safety report was expected, AER cannot be imported.	The message is flagged when the user tries to Import a file when the Root tag is missing.
Tag name: Invalid tag.	The message is flagged when the user tries to import a file when the tag name is invalid.
This Safety report will not be imported. Since authority is not specified, Authority related information is not imported.	The message is flagged when the user tries to import a file when the authority data is missing.
Tag name is not imported as its size exceeds ARISg field size. Tag name will not be imported as its size exceeds ARISg field size.	The message is flagged when the user tries to import a file when the size exceeds the field.
Tag name: Invalid data as per ARISg database specifications. Tag name: Data is missing	The message is flagged when the user tries to import a file when the data is invalid
Tag name too large for ARISg database. Truncated to number characters. Tag name too large for ARISg database. Will be truncated to number characters.	The message is flagged when the user tries to import a file when the tag is too large.
Since company in tag<drugauthorizationholder> is not found in company unit Look up of ARISg, it is not imported. Since company in tag<drugauthorizationholder> is not found in company unit Look up of ARISg, it will not be imported.	The message is flagged when the user tries to import a file when the tag drug authorization is missing.
Since term in tag<reactionterm> is not found in MedDRA dictionary, it is not imported. Since term in tag<reactionterm> is not found in MedDRA dictionary, it is not imported.	The message is flagged when the user tries to import a file when the reaction term is missing.
Since company in tag<duplicatesource> is not found in company unit Look up of ARISg, it is not imported.	The message is flagged when the user tries to import a file when then duplicate source is missing.
Saving time Error - Earlier Unapproved Version is existing in database.	The message is flagged when the user tries to import a file when the unapproved version exists in database.
Saving time Error - Case already exists in the database and Ignore if AER Exists option selected.	The message is flagged when the user tries to import a file when the case exists in the database.
Saving time Error - Unapproved version of same case is existing in database.	The message is flagged when the user tries to import a file when the unapproved version case exists in database.
Saving time Error - Greater International Version exists in Database.	The message is flagged when the user tries to import a file when the greater intl. version exists in database.

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Field Name	Description
E2B Version	Indicates the Document Type Definition used for building the SGML/XML file. The options available: DTD version 2.0 DTD version 2.1 Note: You can set the default value of E2B version in the General tab of Installation Parameters.
Authority	Authority to whom the case is "Informed/To be informed”.
Country	Select the country from the drop down list.
Language	The language used for the text fields. Note: If the language is not specified in the E2B Export page, then the application considers the default language as "English”.

Field Name	Description
Name-Last/First/MI	Displays the Last name, First name and Middle initial of the person who is sending the case details in E2B format. Note: Use the lookup provided to select the Sender’s name. This is a mandatory field. On selecting the Sender’s name, all the other details are displayed in the respective fields and are not editable.
Title	The title of the person who is sending the case details in E2B format.
Unit code	The unit code of the E2B Sender and the corresponding decode.
Sender id	ID of the sender.
Sender Type	Displays the sender type. Includes the following sender types: Authority Company Contact Distributor Partner Others
Organization	The organization name to which the sender belongs.
Department	The department of the sender.
Address	The address of the sender.
City	The name of the sender's city.
State	The name of the state of the sender.
Zip	The zip code of the city to which the sender belongs
Country	Name of the Country to which the sender belongs.
Phone no. /Extension no. /Country code	The phone number details of the sender.
Fax no. /Extension no. / Country code	The fax details of the sender.
Email ID	The Email ID of the sender.

Field Name	Description
Name-Last/First/MI	Displays the Last name, First name and Middle initial of the person who is receiving the case details in E2B format. Note: Use the lookup provided to select the Receiver’s name. This is a mandatory field. On selecting the Receiver’s name, all the other details are populated in the respective fields and are not editable.
Title	Displays the title of the person who is receiving the case details in E2B format.
Unit code	Displays the unit code of the E2B Receiver and the corresponding decode.
Receiver ID	Displays the ID of the receiver. This is a mandatory field.
Receiver Type	Displays the receiver type. Includes the following: Pharmaceutical company Regulatory authority Health professional Regional pharmacovigilance center WHO center for drug monitoring Other
Organization	Displays the organization name to which the receiver belongs.
Department	Displays the name of the department.
Address	Displays the address of the receiver.
City	Displays the name of the city of the receiver.
State	Displays the name of the state of the receiver.
Zip	Displays the zip code of the receiver.
Country	Displays the country of the receiver.
Phone no. /Extension no. /Country code	Displays the phone number details of the receiver.
Fax no. /Extension no. / Country code	Displays the fax details of the receiver.
Email ID	Displays the Email ID of the receiver.

Field Name	Description
File name	The name of the file to import in E2B format. Use the browse button provided to select the file. You can import files of the following types: SGML (File extension: .sgm, .sgml, and .gml) XML (File extension: .xml)
Import AER as	AER imported in E2B format either as approved or unapproved AER. If the Installation parameter "Use Unapproved AER Concept" is set to "NO", i.e., "Case Approval Concept"parameter is not used, then the option "Import AER as" is disabled. Then all the cases are imported as "Approved". If the Installation parameter "Use Unapproved AER Concept" is set to "YES" i.e. Case Approval concept is in use, then the option "Import AER as" is enabled and AER can either be imported as "Approved" or "Unapproved" depending on the option selected.
Set AER Owner unit	Indicating AER owner unit (company unit that created the AER). Same as user: Select this option to select the AER owner Unit as the User. This is by default. Specify: Select the appropriate AER owner unit from the lookup button.
E2B Version	Indicates the Document Type Definition used for building the SGML/XML file. The options available: DTD version 2.0 DTD version 2.1 Note: The default value of E2B version can be set in the General Parameter Tab of Installation Parameters.
Authority	Appropriate authority to which the case is 'Informed/To be informed’. If the authority is not specified, then the company unit entered in the "Set AER Owner unit" field is considered. If the company unit is not specified, the company unit of the User, currently logged into ARISg is considered.
Language	By default, the E2B files can be imported for Japanese language.