Field Name
Description
Name (First, MI, Last)
The First name, Middle name and the last name of the Contact person is displayed here.
Contact name
The Contact name of the person to whom the case is to be distributed is displayed here.
Format type
The Format type refers to the type of report to be generated. Select the Format type from the drop-down list.
When the Format type is E2B, three additional fields sender, receiver and DTD version are displayed in the screen.
If the Format type is 'E2B’ and the Route through agXchange - OST check box is selected, the due date is updated in the agXchange intermediate tables.
Note: If the language for the E2B files is 'Japanese’, a zip folder containing the E2B report and J-item file is stored in SGML format. In this case, the file format selected at the Recipient Company unit is not considered.
If the Format type is 'E2B' or 'Extended E2B' and the Route through agXchange - OST check box is selected, the application generates the CIOMS and the MedWatch FDA3500A (Drug) reports and stores these reports in the CIOMS_BINARY_FILE and FDA_DRG_BINARY_FILE fields of AGX_CONTACT_MESSAGE table respectively.
FDA3500a(Drug) report considers the FDA as authority and E2B language as format language for report generation.
When the Format type is "Reg. Report” and "Other” Report, the default values are empty for Authority, Language and Country. These empty values are saved and displayed when "Reg.Report” and "Other” reports are selected.
When the Format Type is SUE Form A, the Competent Authority Unit lookup field is displayed.
You can have multiple formats for E2B, CIOMS, FDA3500A Drugs or FDA3500A devices based on the Blinded Report field. For example, there can be two CIOMS format for each report type "Blinded” and "Unblinded”.
When you select the Format type as FSCA, then the application does not allow you to edit the fields Authority and Country.
When you select Format type as Australian Device Report for the contact, the Authority field is displayed as ADRAC (Australia) and the Country field is displayed as AUSTRALIA, and the application does not allow you to edit these fields.
Report type
The type of report.
The application displays the report type in the Submission details tab of the Case distribution list.
Submit if previous version is distributed
Copies the contacts that were successfully distributed in the previous version, to the new version.
The application verifies the distributed contacts in the descending order of the case versions. If the immediate previous version does not contain the distributed contacts, then it verifies the preceding versions and copies the distributed contacts to the new version. This process continues until the application finds the version that contains the distributed contacts for copying to the new version.
The contacts are copied only if the case condition in the new version is modified such that the contacts of previous version do not satisfy the modified condition.
Note: For the latest version, the contacts from the previous versions appear in the Distribution list page only when:
this check box is selected.
the Case Significance field value is set to Non-Significant (Reportable to partners) or Significant (Reportable) in the ARISg > Full Data Entry > General tab.
Include Literature document in submission
Indicates that the case literature documents are automatically considered for distribution. When you select the check box, application ignores the distribution of literature documents to the contact.
Note: A literature document once submitted will not be resubmitted to the same contact if the DIST_ATTACHMENTS.FL_SUBMITTED is set as 1 (applicable only for the contacts created in admin).
Export Template name
All the XML templates design available in the library are displayed in the drop-down list. Select the template design to which you want to distribute the AER details in the XML format.
NOTE: You must select template name that contains AER_ID as the only main argument in the query. Based on the AER_ID, the application pass the arguments and get the details of the case as structured in export template.
Email Template
The Email template is used during delivery of documents, notifications, communication/query, and reminders.
Fax Template
The Fax template is used during delivery of fax documents.
Authority
The name of the Authority to whom the case is to be distributed.
This field gets activated only for the following format types:
CIOMS
E2B
Extended E2B
EU Vigilance report (final)
EU Vigilance report (initial)
Other.Reg report
Other report
Note: The Format-level authority selected for CIOMS and E2B must be the same as the Contact-level authority selected for them. This is also applicable when contacts are added manually for CIOMS.
If Authority is not selected for the manually added CIOMS contact, the application considers the 'General' Authority as default for generating the CIOMS report.
Language
The appropriate language for the case.
DTD Version
The DTD version of the case.
Note: This field is available only if 'E2B and Extended E2B’ is selected as the 'Format type’
Sender
The E2B sender of the case.
Note: This field is available only if 'E2B and Extended E2B’ is selected as the 'Format type’
Receiver
The E2B receiver of the case.
Note: This field is available if 'E2B and Extended E2B’ is selected as the 'Format type’.
Country
The name of the country.
This field gets activated only for the following format types:
CIOMS
E2B
Extended E2B
EU Vigilance report (final)
EU Vigilance report (initial)
Other.Reg report
Other report
Preferred Route
Specifies the route for distributing the cases.
The available options are:
Email- To distribute the case through email.
Print- To distribute the case through Printer.
Manual- Select this option if the case is distributed manually. If it satisfies the required condition for distribution, then the contact is appears in the distribution list.
However, the RRM report (Reporting Timelines and Reporting Timelines Line Listing) can be generated even though the 'Preferred Route' is specified as "Manual”.
ESTRI Gateway- To distribute the case through ESTRI Gateway. This option is available for other format types also.
Fax - To distribute the case through Fax. Make sure you select the Route through agXchange-OST check box, when you select the preferred route as Fax.
Route through agXchange-OST
Distributes a case for the specified contact through agXchange application.
If you select the check box when the Preferred Route option is 'ESTRI Gateway’ or 'Email’, the Distribution server updates data in the AGX and E2B database tables, simultaneously.
For contacts added manually, if the Format type is E2B and Extended E2B, the Route through agXchange – OST check box is selected, the due date is updated in the agXchange intermediate tables.
Note: For follow-up Japanese cases, the Reaction term does not appear in the Outbound list page
Data Privacy
This option is available only when the installation parameter Data Privacy is selected.
This is considered for CIOMS, FDA 3500A (Drugs and Devices), MHRA Study, MHRA Spontaneous, BfArM, PPHB, VAERS, Austrian Study, Austrian Spontaneous, French Study, Spanish Study, Spanish Spontaneous, HPB Canadian, MIR, ICSR Old report, and E2B format.
This is also applicable in Cover Letter. The fields of the recipient unit are displayed as PRIVACY for private fields.
The available options are:
Yes: To view the data in the report.
No: The label Privacy is displayed in private fields.
Blinded Report
The Blinded Report has following options -
Yes - To distribute the report in blinded format
No - To distribute the report in unblinded format
Both – To distribute both Blinded and unblinded report formats
Note: This option is applicable to generation of cover letters also.
Note: To activate "Both” option, select SIR Contact from the contact details.
Active
Specifies whether the Contact Address is currently active or not .
Description
Brief description of the case.
Printing Unit
The Company unit that needs to be updated in the informed authority records.
Use the lookup provided to select the company unit.
Informing Unit
The Company unit that needs to be updated in the informed authority records.
Use the lookup provided to select the company unit.
Date of Report
Updates the Date of report with Distribution date. This information is updated in Informed Authority records, which are associated with the distribution list.
If Date of report check box is not selected, then the Date of report field in the Informed Authority records associated with the distribution list is left blank.
Follow-up no
Populates the follow-up number of the AER, which was submitted to the Authority or is to be submitted to the Authority.
System Logic: When system logic is selected, the next number, to the existing follow-up no is taken as the maximum number and + 1 is added to this maximum number. This is followed, if any existing number is present in the record.
If Follow-Up number is not assigned to the existing records (all previous versions), then the Follow-Up number will be 0 for the new record. This is because for the newly created IA record the reporting status is always set as "To be informed’.
Note: When system logic or None is selected; the text field is not accessible for you.
User Logic: This creates the follow-Up number based on the logic specified in the function/procedure.
None: When none option is selected, the follow up number is not generated and is empty.
Cover Letter
Attaches the separate cover letter templates for every contact at the Format and Contact levels.
Use 
to
select the templates from the Cover Letter
Lookup.
When cases are distributed to same or different contacts, the recipients receive the cover letter from the Format level.
In case, the cover letter does not exist, the recipients receive the cover letter from the Contact level.
If the cover letter does not exist at the Format and Contact levels when the cases are distributed, the recipients receive the cover letter from the Distribution server level.
The Distribution server processes a request only when a cover letter is attached.
Note: This field is disabled if the SIR Contact check box is selected.
Access to labelling countries(agXchange-OST)
The agXchange applicaton, fetches the labelling data based on the selection of the countries at the distribution format level in ARISg.
Following default options are available to access the labelling countries.
Available Countries
The list of countries for which the Local Labeling records are displayed based on the labeled records which can be edited or only viewed for the OST contact. The countries are selected based on editable countries or read only countries.
The default option can also be selected for the labeling countries to set the countries to either Editable, read-only or None (None being the default value), and based on this selection, other countries which are not selected in the exceptions as editable/readonly are assigned with the default privileges.
Editable Countries
The countries for which the Local Labeling records can be edited are moved here.
Readonly Countries
The countries for which the Local Labeling records can only be viewed are moved here.
Custom
You can fetch labeling records for Read-only and editable countries.
