5 Code List Configuration

Information about configuring the following code list items is included in this chapter.

• Autosignals

• Batch Reports

• Letters

• Justification

• Electronic Transmission Recipient

• Literary Citation

• Reporting Destination

• Routes of Administration

• Study Center

• Other Code List Items

Configuring Code Lists

Code List items appear at several locations in the Case Form. It is essential to configure relevant Code List items in order to ensure that case entry in Argus Safety is done according to your company's policies. Before configuring Code List items, the Administrator should consult the company's policies and the terminology used by the company.

To ensure that the Administrator does not have to enter excessive amounts of data during Code List configuration, Argus Safety is shipped with factory data for many of the Code List items.

Tip:

The following Code List Items have been described to familiarize you with the Code List configuration.

• For the complete set of Code Lists refer to the Argus Console->Code List section.

• The default help text associated with each code list item is displayed at the bottom of the left panel.

Code List Item	Description
Autosignals	This screen helps in capturing Auto Signal information. Users can define the criteria that triggers Autosignal within Argus
Batch Reports	This screen helps in capturing Batch Reports information.
Letters	The screen helps in configuring the system to create and schedule letters automatically, according to pre-defined business rules.
Justification	This screen helps in capturing justification information.
Electronic Transmission Recipient	This screen helps in capturing electronic transmission recipient information.
Literary Citation	This screen helps in capturing information about Literary Citations.
Reporting Destination	This screen helps in capturing Reporting Destination information.
Routes of Administration	This screen helps in capturing Route of Administration information.
Study Center	This screen helps in capturing Study Center information.

Configuring Autosignals

This screen enables you to capture the Auto Signal information.Using this screen, you can define the criteria that triggers Autosignal within Argus.

Example: If an event is reported within x number of days, an email is sent to the defined individual or workgroup. The system checks for patterns each time new data is entered, and sends e-mails to the appropriate individuals or departments on finding a matching pattern.

Select Code Lists --> Argus to view the Code List Maintenance screen.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Field Descriptions

The following table describes the fields associated with this section.

Field/Control Name	Description
Name	Enables the user to enter the name of the Autosignal. This is a required field.
Number of Occurrences	Enables the user to enter the number of occurrences of the autosignal.
Occurrences of	Enables the user to enter the user to select or create an advanced condition for the autosignal through Select icon.
Number of days	Displays the number of days for the autosignal.
As cases are entered	Enables the user to perform autosignal as cases are entered.
Every N Days	Enables the user to enter the number of days, when autosignal should be executed.
Email	Enables the user to enter the email address of Argus users to whom the email about autosignal occurrence should be sent.

To configure Autosignals

1. Click on the Autosignals folder in the left panel. The associated autosignal data appears in the Total Number of Rows section in the right panel.

   
   

2. Click on the Name (or row), to view the details associated with the selected autosignal. The details appear in the Modify Autosignal section.

   You can use the Autosignals Filter to make your search specific to an autosignal. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value.

6. Click Filter to apply the selected criteria.

   This displays the search results under Total Number of Rows.

   Tip: You can alternatively click Add New to create a new auto signal. Click Copy to make an editable copy of an existing autosignal. Click Delete to delete a selected auto signal.:

7. Enter the name of the autosignal in the Name field.

8. Enter the number of occurrences of the autosignal in the Number of Occurrences field.

9. Select or create an Advanced Condition, if any from the button in the Occurrences of field.

   Tip:

   Click here for details on Advanced Conditions

10. Enter the number of days for the autosignal under the Number of days field.

11. Select the As cases are Entered checkbox to perform autosignal as cases are entered.

12. Enter the number of days when the autosignal should perform under the Every N Days field.

13. Enter the e-mail address that receives email about autosignal occurrence in the Email field.

14. Click Save to save the changes made to this screen.

Configuring Batch Reports

This screen enables you to configure Batch Reports information.

• Scheduled reports can be automatically generated and stored in the database by Argus Safety Service. This screen displays a list of all the existing Batch Reports.

• By default the Batch reports shown are report regeneration. The Argus user can see the list of scheduled reports for memorized reports, using the Memorized Reports option.

• Select Code Lists --> Argus to view the Code List page.

• Click on the Batch Reports folder in the left panel.

The associated report data appears in the Total Number of Rows section in the right panel.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Field Descriptions

The following table describes the fields associated with this section.

Field/Control Name	Description
Title Name	This is the unique name for the batch report name.
Report	Enables the user to select a report that has to be scheduled. Report Regeneration Memorized report
Product	Enables the user to select a product for which the report is generated.
Frequency: Every Hrs.	Enables the user to enter the number of days after which the report is to be generated. The value has to be --> 0.
Next Run Date	Enables the user to enter the next date from which the report has to be scheduled.
Advanced Condition	Enables the user to select the Advance Condition that satisfies the criteria which will trigger the Signal. You can either select an existing criteria or create a new one.
Report Type	Enables the user to select the type of the report.
Group	Enables the user to select the group to which the report must be assigned.

To configure Batch Reports

1. Click on the Report Title (or row), to view the details associated with that report. The details appear in the Modify Batch Report section.

   You can use the Batch Reports Filter to make your search specific to a batch report. The filtering criterion is essential as it helps you to search for specific items.

2. Select the appropriate Field as the filtering criteria from the drop-down list.

3. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

4. Enter the search criteria in Value

5. Click Filter to apply the selected criteria.

6. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new report.

   • Use Copy to make an editable copy of an existing report.

   • Use Delete to delete an existing report.

7. Enter the Title Name for the batch report.

8. Select the Report Type from the drop-down list.

9. Select the Group to which the report must be assigned.

10. Select the report to be scheduled as Memorized Reports or Reports Regeneration.

11. Select the Frequency of generating the report after the specified number of days have elapsed.

12. Select the Product for which the report is to generated, from the drop-down list box.

13. Select the Report from the drop-down list.

14. Enter the Next Run Date. This is the next date from which the report has to be scheduled.

15. Select the Advanced Condition associated with the report configuration.

16. Click Select to launch the Advanced Conditions browser.

    Tip:

    Click here for details about Advanced Conditions

17. Click Save to save the changes made to this section.

Configuring Letters

Argus Safety enables you to customize letter templates in order to correspond with reporters or health officials and keep them updated with case activity. Access to the Letter Configuration dialog can be granted to any user or user-group, as found appropriate by the Administrator.

• To automatically generate a letter, the system reads a template that specifies the information that must appear in the letter.

• The template is a file in Rich Text Format (".rtf" format) that contains the letter text and some field identifiers (also called placeholders). The system substitutes information specific to the current case for the placeholders in the template. Thus, a letter containing case-specific information is automatically generated.

• The administrator can set up the system to create and schedule letters automatically, according to pre-defined business rules. This section discusses the creation, modification, and deletion of letter templates.

Select Code Lists--> Argus to view the Code List page.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured.

The details of this code list item appear in the right panel.

Field Descriptions

The following table describes the fields associated with this section.

Field/Control Name	Description
Name	Enables the user to specify the name of the letter as it will appear in the Letters menu.
Name (J)	Enables the user to specify the Japanese name of the letter as it will appear in the Letters menu.
Edit Template	Enables the user to open the letter in MS-Word (template) for editing.
Regulatory Cover Letter	Enables the user to indicate whether this letter template should appear in the Regulatory Rules dialog Cover letter drop-down list box.
Schedule - Letter	Enables the user to enter the number of days (from the receipt date) when the letter will be due.
Schedule - Action	The Action field enables the Administrator to specify the number of days (from the current date) after which the Action Item for following up on this letter will be due.
Sites	Argus Console provides the ability to configure letters to user sites. Enables users to select single or multiple sites for that letter. The system will only allow users to see letters that are configured to their site.
Action Items	The action items list is a drop-down list of action item codes from the Action Type List Maintenance.
Return Email Address	Enables the user to enter a default email address where the mails will be sent. This address is displayed by default in the Activities tab of the Case Form.
Advanced Condition	Enables the user to configure Advanced Conditions. If the case matches with the Advanced Condition, the configured letter is scheduled for the case.

To configure letters

1. Click on the Letter Configuration folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.

2. Click on the Name (or row), to view the details associated with that letter. The details appear in the Modify Letter Configuration section.

3. You may use the Letter Configuration Filter to make your search specific to a letter. The filtering criterion is essential as it helps you to search for specific items.

4. Select the appropriate Field as the filtering criteria from the drop-down list.

5. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

6. Enter the search criteria in Value.

7. Click Filter to apply the selected criteria.

8. This displays the search results under Total Number of Rows.

   Tip: You can alternatively click Add New to create a new letter.:

   • Use Copy to make an editable copy of an existing letter.

   • Use Delete to delete an existing letter.

9. Click Select to specify the path of the letter template to be used.

   Tip:

   Click Edit Template to save the existent template on to your local drive of the system.

   You can edit this template and repeat the step listed above, to ensure that the updated template is used for letters.

10. Enter the name of the letter, as it will appear, in the Letters Menu section in Enter a new item.

11. Click Add or Delete to configure letter to the user Sites.

12. Select the Action Item from the drop-down list box. The action items list is a drop-down list of action item codes, from the Action Type List Maintenance.

13. Configure the Advanced Condition for the case.

14. Enter the Schedule (days)-Letter. This is the number of days from the receipt date when the letter is due.

15. Enter the Schedule (days)-Action. This is the number of days from the current date, after which the Action Item for the follow up on this letter will be due.

16. Enable the Regulatory Cover Letter option to indicate whether this letter template should appear in the Regulatory Rules dialog.

17. Enter the default e-mail address in Return Email Address.

18. Click Save to save the changes made for this section.

Configuring Justifications

This screen enables you to capture justification information.

Argus Safety users can enter the reasons for overriding system determinations using the Justifications dialog. The Justification items appear on the Action Justification dialog on the screen.

Select Code Lists--> Argus to view the Code List page.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured.

The details of this code list item appear in the right panel.

Field Descriptions

The following table describes the fields associated with this section.

Field/Control Name	Description
Type	Enables the user to configure the type.
Value	Enables the user to configure the value.

To configure justification

1. Click on the Justifications folder in the left panel. The associated report data appears in the Total Number of Rows section in the right panel.

2. Click on the Type (or row), to view the details associated with that justification. The details appear in the Modify Justification section.

3. You may use the Justifications Filter to make your search specific to a justification. The filtering criterion is essential as it helps you to search for specific items.

4. Select the appropriate Field as the filtering criteria from the drop-down list.

5. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

6. Enter the search criteria in Value.

7. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new justification.

   • Use Copy to make an editable copy of an existing justification.

   • Use Delete to delete an existing justification.

8. Select the Type from the drop-down list.

9. Enter the Value for the justification.

10. Click Save to save the changes made for this section.

Configuring Electronic Transmission

This screen enables you to configure electronic transmission recipient information.

• Details of electronic transmission recipient such as name, title, address etc. are submitted here.

• Select Code Lists--> Argus to view the Code List page.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Field Descriptions

The following table lists and describes the fields associated with this section.

Field/Control Name	Description
Name	Enables the user to enter the name of Electronic Transmission Recipient.
Title	Enables the user to enter the title of Electronic Transmission Recipient.
Address	Enables the user to enter the address of Electronic Transmission Recipient.
City	Enables the user to enter the city of Electronic Transmission Recipient.
State/Province	Enables the user to enter the state/province of Electronic Transmission Recipient.
Country	Enables the user to select the country of the user.
Postal Code	Enables the user to enter the postal code of Electronic Transmission Recipient.
Phone	Enables the user to enter the phone number of Electronic Transmission Recipient.
Fax	Enables the user to enter the fax of Electronic Transmission Recipient.
Email	Enables the user to enter the email of Electronic Transmission Recipient.
Preferred Method	Enables the user to select the preferred method of transmission from the drop-down list. This can be by fax or by email.

To configure the electronic transmission recipient

1. Click on the Electronic Transmission Recipient folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.

2. Click on the Name Title (or row), to view the details associated with that electronic transmission. The details appear in the Modify Electronic Transmission Recipient section.

3. You may use the Electronic Transmission Recipient Filter to make your search specific to an electronic transmission recipient. The filtering criterion is essential as it helps you to search for specific items

4. Select the appropriate Field as the filtering criteria from the drop-down list.

5. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

6. Enter the search criteria in Value.

7. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new electronic transmission recipient.

   • Use Copy to make an editable copy of an existing electronic transmission recipient.

   • Use Delete to delete an existing electronic transmission recipient.

8. Enter the Name of the electronic transmission recipient.

9. Enter the Title of the electronic transmission recipient.

10. Enter the Address of the electronic transmission recipient.

11. Enter the City of the electronic transmission recipient.

12. Enter the State/Province of the electronic transmission recipient.

13. Select the Country of the electronic transmission recipient, from the drop-down list.

14. Enter the Postal Code of the electronic transmission recipient.

15. Enter the Phone of the electronic transmission recipient.

16. Enter the Fax of the electronic transmission recipient.

17. Enter the Email of the electronic transmission recipient.

18. Select the Preferred Method of communication (by fax or email) for the electronic transmission recipient.

19. Click Save to save the changes made to this section.

Configuring Literary Citations

This screen enables you to configure information about Literary Citations.

• The information configured in this form is displayed in the Literature Info section of the Case Form.

• Select Code Lists --> Argus to view the Code List Maintenance screen.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Field Descriptions

The following table lists and describes the fields associated with this section.

Field/Control Name	Description
Journal	Displays the name of the journal where the citation appears. This is a required field.
Author	Displays the name of the author.
Title	Displays the title of the citation.
Volume	Displays the volume number of the journal where the citation appears.
Year	Displays the publication year of the journal where the citation appears.
Pages	Displays the number of pages in the journal where the citation appears.

To configure literary citations

1. Click on the Literary Citations folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.

2. Click Journal/Author (or row) to view the details associated with the literary citation. The details appear in the Modify Literature section.

3. You may use the Literary Citation Filter to make your search specific to a citation. The filtering criterion is essential as it helps you to search for specific items.

4. Select the appropriate Field as the filtering criteria from the drop-down list.

5. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

6. Enter the search criteria in Value.

7. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new citation.

   • Click Copy to make an editable copy of an existing citation.

   • Click Delete to delete a selected citation.

   • Click Print to print the selected information as a PDF.

8. Enter the name of the journal in the Journal field.

9. Enter the name of the author of the citation in the Author field.

10. Enter the title of the citation in the Title field.

11. Enter the Volume Number in the Volume field.

12. Enter the year in the Year field.

13. Enter the number of pages in the Pages field.

14. Click Save to save the changes made.

Configuring Message Type

This screen enables you to configure information about message type.

• The message type specified in this section enables you to specify auto-submission of reports.

• Select Code Lists --> Argus to view the Code List Maintenance screen.

  
  

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Field Descriptions

The following table lists and describes the fields associated with this section.

Field/Control Name	Description
Message Type	Displays the message type for a report.
English ICSR	Displays if the message type belongs to English ICSR.
Expedited/Periodic	Displays if the message type is expedited or periodic. Note: By default, ICHICSR is considered as Expedited, while the other message types are considered as Periodic.
Description	Displays a description about the message type.
Auto Submit	Displays if the report has been auto submitted.
Japan ICSR	Displays if the report belongs to Japan ICSR.
Display	Displays if the report needs to be displayed or hidden.

To configure message type

1. Click on the Message Type folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.

2. Click Message Type (or row) to view the details associated with the message type. The details appear in the Modify Message Type section.

3. You may use the Message Type Filter to make your search specific to a message type. The filtering criterion is essential as it helps you to search for specific items.

4. Select the appropriate Field as the filtering criteria from the drop-down list.

5. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

6. Enter the search criteria in Value.

7. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new message type.

   • Click Copy to make an editable copy of an existing message type.

   • Click Delete to delete a selected message type.

   • Click Print to print the selected information as a PDF.

8. Enter the type of message in the Message Type field.

9. Enter the description for the message type in the Description field.

10. Select the English ICSR or Japan ICSR radio button, as applicable.

11. Click the Expedited checkbox if the message type is for an expedited report.

12. Click the Mark as Auto Submit checkbox if you wish to mark for auto submission.

13. Click the Display checkbox if you wish to display the message type.

14. Click Save to save the changes made.

Configuring Reporting Destination

Regulatory reports are submitted to the Reporting Destination. Local company contact information is also provided on this screen.

The system enables the user to configure the XML Source Classification and the PDF Source Classifications used for classifications defined while the Source E2B File / PDF for Initial Intake or E2B Differences report shall be classified.

Be aware of the following

• During upgrade the system automatically populates the Selection source classification as "E2B Differences Report" from existing classifications and the XML Source Classifications shall be empty

• The system tracks updates made in the Audit Log

• The system prints the additional fields on the Printout as shown in the following illustration.

When a case is accepted as an initial or follow-up case, the system attaches the source XML and the Initial Selection PDF to the case on the Additional Info tab with the as follows.

Initial/Follow-up Source XML

Attachment Classification: As specified in the Reporting Destination for XML Source Classification.

Date: System Date when the user accepted the case for XML.

Description: Acceptance Notes the user entered for XML.

When you click the Source ICSR, the system you can view the ICSR opening the ICSR Viewer (E2B Viewer) as configured for the ICSR Viewer. The following is an illustration of the icon that identifies the XML Attachment.

Initial Selection PDF

Attachment Classification: As specified in the Reporting Destination for Selection Source Classification

Date: The system date the user accepted the Case for XML

Description: Acceptance Notes the user entered r for XML

Follow-up Source XML

On clicking the Source ICSR PDF or the E2B Difference Report, the system enables the user to view the Initial Selection PDF or the E2B Difference Report in a different IE dialog.

Be aware of the following:

• Once the Case is accepted as an Initial or a Follow-up ICSR, the system shall prefix the Business Level Acknowledgement Notes with the Case Number in the following format:

  • Notes Imported Case #: XXXXX followed by the current Notes which are sent in the Business Level Acknowledgement

• If the ICSR is received via the Physical Gateway (Configured at the reporting destination level) the system shall send out a low level ACK in the following format to indicate that the file was received by the Interchange Services at Argus.

• The system permits you to define Auto Accept to accept the following E2B files:

  • All (default -- This option enables importing of Initial and Follow-up reports only

  • Initial -- The system only accepts initial E2B reports automatically.

  • Follow-Up -- The system automatically accepts only Follow-up E2B reports.

  • This field is enabled only when the user checks Auto Accept ICSR's.

• For the Auto Accepted ICSR's, the system shall not attach the Source PDF within the case since the Source XML is attached as is with the case.

Name	Description
M.1 ICHICSRMESSAGEHEADER	Type: Entity Source Format: None E2B Element Format: None Notes: This is an entity name that shall appear as first line of each E2B acknowledgment.
M.1.1 MESSAGETYPE	Type: Data element Source Format: None E2B Element Format: Alphanumeric (16) Notes: The message type shall contain the value ARGUSINTERACK
M.1.2 MESSAGEFORMATVERSION	Type: Data element Source Format: Character(5) E2B Element Format: Alphanumeric (3) Notes: The message format version is the DTD version of the acknowledgment and shall contain the value 1.1"
M.1.3 MESSAGEFORMATRELEASE	Type: Data element Source Format: Character(5) E2B Element Format: Alphanumeric (3) Notes: The message format release is the release version of the acknowledgment DTD and shall contain the value 1.0"
M.1.4 MESSAGENUMBER	Type: Data element Source: Sequence from the table where the acknowledgment information stored that way this value will be always unique Source Format: Number E2B Element Format: Alphanumeric (100) Notes: The message number is a unique identifier for the acknowledgment message assigned by the sender of the acknowledgment. Each acknowledgment shall have a unique message number automatically created by ESM.
M.1.5 MESSAGESENDERIDENTIFIER	Type: Data element Source: Element M.1.6 of the ICH ICSR message header, i.e. receiver of the ICSR reports. Source Format: Alphanumeric (60) E2B Element Format: Alphanumeric (60) Notes: This field identifies the sender of the E2B acknowledgment. In other words, this field contains the receiver of the E2B message (ICSR report) i.e. value from M.1.6 of the E2B Message.
M.1.6 MESSAGERECEIVERIDENTIFIER	Type: Data element Source: Element M.1.5 of the ICH ICSR message header, i.e. sender of the ICSR reports. Source Format: Alphanumeric (60) E2B Element Format: Alphanumeric (60) Notes: This field identifies the receiver of the E2B acknowledgment. In other words, this field contains the sender of the E2B message (ICSR report) i.e. value from M.1.5 of the E2B Message.
M.1.7a MESSAGEDATEFORMAT	Type: Data element Source: Hard code to 204" Source Format: None E2B Element Format: Number (3) Notes: The value is hardcoded to 204" and 204 means format CCYYMMDDHHMMSS. Where C = Century, Y = Year, M= Month, D= Day, H= Hour and S= Second.
M.1.7b MESSAGEDATE	Type: Data element Source: sysdate (Database date) Source Format: Date E2B Element Format: Number (14) Notes: This data element shall contain the system date (database date in GMT) on the day the acknowledgment was initiated.
A.1 MESSAGEACKNOWLEDGMENT	Type: Entity Source Format: None E2B Element Format: None Notes: This is an entity name that shall appear as first line of each E2B acknowledgment.
A.1.1 ICSRMESSAGENUMB	Type: Data element Source: Element M.1.4 of the ICH ICSR message header, i.e. message tracking number of the ICSR message. Source Format: Alpha Numeric (100) E2B Element Format: Alpha Numeric (100) Notes: This field identifies the unique tracking number assign to a specific ICH ICSR message file. The sender of the E2B message assigns this number. Transmit: When system generates the acknowledgment for the received E2B message. The system shall assign the value to this element from M.1.4 of the received E2B message. Receive: This element shall be used to find the E2B message in the system.
A.1.2 LOCALMESSAGENUMB	Type: Data element Source Format: None E2B Element Format: Alpha Numeric (100) Notes: This field identifies the unique number assign to a specific ICH ICSR message file by the receiving organization of the ICH ICSR message. Example if Pharma company transmitting an E2B message to regulatory authority. The regulatory authority shall assign a unique message number to E2B message. This number shall be used for this element in building the acknowledgment.
A.1.3 ICSRMESSAGESENDERIDENTIFIER	Type: Data element Source: Element M.1.5 of the ICH ICSR message header, i.e. sender of the ICH ICSR message. Source Format: Alpha Numeric (60) E2B Element Format: Alpha Numeric (60) Notes: This field identifies the sender of the ICH ICSR message file.
A.1.4 ICSRMESSAGERECEIVERIDENTIFIER	Type: Data element Source: Element M.1.6 of the ICHICSR message header, i.e. receiver of the ICH ICSR message. Source Format: None E2B Element Format: Alpha Numeric (60) Notes: This field identifies the receiver of the ICH ICSR message file.
A.1.5a ICSRMESSAGEDATEFORMAT	Type: Data element Source: Hard code to 204" Source Format: None E2B Element Format: Number (3) Notes: The value is hardcoded to 204" and 204 means format CCYYMMDDHHMMSS. Where C = Century, Y = Year, M= Month, D= Day, H= Hour and S= Second.
A.1.5b ICSRMESSAGEDATE	Type: Data element Source: sysdate (Database date) Element M.1.7b message date of the E2B message was initiated Source Format: Date E2B Element Format: Number (14) Notes: This data element shall contain the system date (database date) on the day the E2B message was initiated. The value can be assign from M.1.7b message date of the E2B message was initiated.
A.1.6 TRANSMISSIONACKNOWLEDGMENTCODE	Type: Data element Source Format: Number E2B Element Format: Number (2) Notes: This data element shall used to inform the sender about the status of each report. The value of this element can be 01,02,03. If all reports successfully loaded without any error then value of this element is 01. If some reports are loaded and some has the errors then the value of this element is 02. If none report is loaded due to the SGML parsing error, then the value of this element shall be 03.
A.1.7 PARSINGERRORMESSAGE	Type: Data element Source Format: None E2B Element Format: Alphanumeric (250) Notes: If the above element A.1.6 (transmission acknowledgment code) has value 03 then only this element shall contains the value. The value of this element is the description of SGML parsing This file shall be placed in the Physical Out folders as configured for the reporting destination within the E2B Mapping configuration. For EDI received files, the system shall continue to let the EDI Gateway send the Low level ACK as current functionality. The Low Level ACK received in the Physical In folder for the destination shall not be processed by the Interchange Service but shall enter any errors in the Log file as the file will always be rejected by the ESM Service.

To configure reporting destination

1. Select Code Lists --> Argus to view the Code List Maintenance screen.

   Tip:

   The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

2. Select Reporting Destination. The screen appears as shown.

   
   

Agency Information

The Agency Information tab is displayed by default, on selecting Reporting Destination.

Field Descriptions

The fields under the Agency Information tab are described in the following table:

Field/Control Name	Description
Agency Name	Displays the name of the agency. This is a required field.
Agency Type	Enables the user to select the agency type.
Department	Enables the user to enter the name of the department.
Email Address	Enables the user to enter the email address of the agency.
Preferred Method	Enables the user to select the preferred method of agency information.
Registration #	Enables the user to enter the registration number.
FAX	Enables the user to enter the FAX Number.
FAX Cover	Enables the user to enter the FAX Cover.
Contact Type	Manufacturer - Enables the user to select manufacturer as the type of contact Importer - Enables the user to select importer as the type of contact Distributor - Enables the user to select distributor as the type of contact
Offline Recipient	Enables the user to configure the regulatory agency as an offline agency.
Title	Enables the user to enter the title of the regulatory contact.
First Name	Enables the user to enter the first name of the regulatory contact.
Middle	Enables the user to enter the middle name of the regulatory contact.
Last	Enables the user to enter the last name of the regulatory contact.
Address	Enables the user to enter the address of the regulatory contact.
Phone	Enables the user to enter the phone number of the regulatory contact.
Ext	Enables the user to enter the extension number of the regulatory contact.
Country Code	Enables the user to enter the country code of the regulatory contact.
FAX	Enables the user to enter the fax number of the regulatory contact.
Ext	Enables the user to enter the extension number of the regulatory contact.
Country Code	Enables the user to enter the country code of the regulatory contact.
City	Enables the user to enter the city of the regulatory contact.
State/Province	Enables the user to enter the state/province of the regulatory contact.
Country	Enables the user to enter the country of the regulatory contact.
Postal Code	Enables the user to enter the postal code of the regulatory contact.
Report per Email	Enables the user to enter the number of reports to be received in each email.
Attachments	Enables the user to select the format of attachments.
Email Text Body	Select - Enables the user to select a .txt or .rtf file to be uploaded. Note: The file should be in .txt, or .rtf format. After the uploaded file is saved, the Edit button displays a clip button, denoting an attachment. Edit - Enables the user to open the uploaded file / text in a word document from the server and edit the text inside it. If no file was uploaded earlier, a blank document is opened. Note: You can save the edited document on the local machine and click Select to save the file.
Report for Marketed	Enables the user to select whether reports are to be marketed always or only for the Spontaneous cases or no Investigational.
Allow WHO Drug reporting	Enables the user to schedule a report for WHO Drug Reporting.
Report for Investigational	Enables the user to select if the reports are to be investigational always or only for clinical case or no marketed license.
Adjust Expedited Report Due Dates for Holidays and Weekends	Enables the user to check to enable the Reporting rule due date adjustment. By default, this is unchecked.
Before	Enables the user to adjust the due date so it falls before a holiday or weekend. This is enabled only when the "Adjust Expedited Report Due Dates for Holidays and Weekends" checkbox is checked.
After	Enables the user to adjust the due date so it falls after a holiday or weekend. This is enabled only when the "Adjust Expedited Report Due Dates for Holidays and Weekends" checkbox is checked.

Be aware of the following:

• When the "Adjust Expedited Report Due Dates for Holidays and Weekends" checkbox is checked the first time, the "Before" option is the default.

• The system matches the Country of the Reporting Destination with the country in the holiday calendar to identify the holidays to be adjusted for the reporting destination.

• When the user selects "Before," and the reporting agency's report scheduled date falls on a holiday (configured by the codelist) or weekend (set by the system), the system schedules the report before the due date.

• When the user selects "After," and the reporting agency's report scheduled date falls on a holiday (configured by the codelist) or weekend (set by the system), the system schedules the report after the due date.

• If the "Adjust Expedited Report Due Dates for Holidays and Weekends" checkbox is checked in Reporting Destination and no holiday is set for the country in the Holiday Calendar Codelist, then the due date of the reports will stll be adjusted based on weekends.

• If the "Adjust Due Dates to be set on Friday if falling on Weekends" profile switch is checked, then the system marks the checkbox as checked the selects the "Before" option for all reporting destinations.

To configure agency information

1. Select the Agency Name (or row) of the reporting destination displayed under Total Number of Rows that needs to be modified. The Modify section displays the information about the selected code list.

2. You may use the Reporting Destination Filter to make your search specific to an agency. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value

6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   Tip: You can alternatively click Add New to create a new agency information.

   • Click Copy to make an editable copy of an existing agency information.

   • Click Delete to delete the selected agency information.

   • Click Print to print the selected information as a PDF.

7. Enter the name of the agency in the Agency Name field.

8. Select the type of agency in the Agency Type field.

9. Enter the department in the Department field.

10. Enter the email address in the Email field.

11. Select the preferred method from the Preferred Method drop-down list. The options available are Fax or Email.

12. Enter the registration number in the Registration # field.

13. Enter the Fax Number in the FAX field.

14. Enter the Fax Cover in the FAX Cover field.

15. Select the preferred contact type by clicking the checkboxes available under Contact Type.

    The options available are Manufacturer, Importer and Distributor.

16. Select the Offline Recipient checkbox to configure the regulatory agency as an offline agency.

17. Select the Title of the regulatory contact. The options available are Mr., Miss and Mrs.

18. Enter the first name of the regulatory contact under the First Name field.

19. Enter the middle name of the regulatory contact under the Middle field.

20. Enter the last name of the regulatory contact under the Last field.

21. Enter the postal contact address of the regulatory contact under the Address field.

22. Enter the phone number of the regulatory contact under the Phone field.

23. Enter the extension number of the regulatory contact under the Ext field.

24. Enter the country code to be dialed in calling up the regulatory contact under the Country Code field.

25. Enter the fax number of the regulatory contact under the FAX field.

26. Enter the fax extension number of the regulatory contact under the Ext field.

27. Enter the country code required in faxing up the regulatory contact under the Country Code field.

28. Enter the name of the city where the regulatory contact lives in the City field.

29. Enter the name of the state/province where the regulatory contact lives in the State/Province field.

30. Enter the name of the country where the regulatory contact lives in the Country field.

31. Enter the postal code of the place where the regulatory contact lives in the Postal Code field.

32. Enter the number of reports that need to be sent in every email to the regulatory contact in the Report per Email field.

33. Select the format of the attachments being sent with the emails through the Attachments drop-down list.

    The formats available to be sent as attachments are PDF or RTF formats.

34. Click Text or RTF to save and view a letter attachment in text or RTF format.

    This enables the user to select the email body in Text or RTF format.

35. Select how the report is to be marketed from the Report to be marketed drop-down list.

36. The options in this list are Always or Spontaneous or No Investigational.

37. Select the Allow WHO Drug Reporting checkbox to schedule the report for WHO Drug Reporting.

38. Select the type of reports as Investigational always or Only for clinical case or No marketed license from the Report for Investigational drop-down list.

39. Click Save to save the changes made.

Local Company Contact

This section lists the Field Descriptions and configuration steps for the Local Company Contact tab.

Field Descriptions

The fields the following table lists and describes the fields on the Local Company Contact tab.

Field/Control Name	Description
Company Name	Displays the name of the company. This is a required field
Sender Type	Enables the user to select the sender type
Department	Enables the user to enter the name of the department
Email Address	Enables the user to enter the email address of the agency
Lab Code	Enables the user to enter the lab code
Event Term on Expedited Reports	Enables the user to select the event term on expedited reports.
Title	Enables the user to enter the title of the local company contact
First Name	Enables the user to enter the first name of the contact
Middle	Enables the user to enter the middle name of the contact
Last	Enables the user to enter the last name of the contact
Address	Enables the user to enter the address of the contact
Phone	Enables the user to enter the phone number of the contact
Ext	Enables the user to enter the extension number of the contact
Country Code	Enables the user to enter the country code of the contact
FAX	Enables the user to enter the fax number of the contact
Ext	Enables the user to enter the fax extension number of the contact
Country Code	Enables the user to enter the fax country code of the contact
City	Enables the user to enter the city of the contact
State/Province	Enables the user to enter the state/province of the contact
Country	Enables the user to enter the country of the contact
Postal Code	Enables the user to enter the postal code of the contact

To configure the local company contact

1. Select the Agency Name (or row) of the reporting destination displayed under Total Number of Rows that needs to be modified. The Modify section is populated with information about the selected code list.

2. You can use the Reporting Destination Filter to make your search specific to a company. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value

6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new company contact.

   • Click Copy to make an editable copy of an existing company contact.

   • Click Delete to delete a selected company contact.

   • Click Print to print the selected information as a PDF.

7. Enter the name of the company in the Company Name field.

8. Select the type of sender in the Sender Type drop-down list.

9. Enter the name of the department under the Department field.

10. Enter the email address of the agency under the Email Address field.

11. Enter the lab code of the agency under the Lab Code field.

12. Select the type of event term on preferred reports from the Event Term on Preferred Reports drop-down list. The options available under this list are Preferred and Lower Level.

13. Select the Title of the regulatory contact. The options available are Mr., Miss and Mrs.

14. Enter the first name of the regulatory contact under the First Name field.

15. Enter the middle name of the regulatory contact under the Middle field.

16. Enter the last name of the regulatory contact under the Last field.

17. Enter the postal contact address of the regulatory contact under the Address field.

18. Enter the phone number of the regulatory contact under the Phone field.

19. Enter the extension number of the regulatory contact under the Ext field.

20. Enter the country code to be dialed in calling up the regulatory contact under the Country Code field.

21. Enter the fax number of the regulatory contact under the FAX field.

22. Enter the fax extension number of the regulatory contact under the Ext field.

23. Enter the country code required in faxing up the regulatory contact under the Country Code field.

24. Enter the name of the city where the regulatory contact lives in the City field.

25. Enter the name of the state/province where the regulatory contact lives in the State/Province field.

26. Enter the name of the country where the regulatory contact lives in the Country field.

27. Enter the postal code of the place where the regulatory contact lives in the Postal Code field.

28. Click Save to save the changes made.

Configuring EDI

This section lists the field descriptions and configuration steps for the EDI tab.

Field Descriptions

The following table lists and describes the fields on the EDI tab.

Field/Control Name	Description
SGML/XML	Enables the user to select whether to send the report in SGML of XML format.
Mark as Auto Submit	Enables the user to mark the report for auto submission.
Imported Cases are assigned to	Enables the user to select the country, where the imported cases need to be assigned. Note: This list comprises the configured Argus sites. The default value is the site of the importing user.
Initial Workflow State	Enables the user to configure the initial workflow state of the case. Note: This list comprises Argus workflow states, with the default value being blank. If you select blank as the workflow state, it is treated as a new case being booked-in.
Agency Identifier	Enables the user to enter the routing ID configured in Cyclone for the sender community.
Identification Code	Enables the user to enter the agency Duns code, a unique identification code that identifies the trading partner.
Code Qualifier	Enables the user to enter the code qualifier here. The code qualifier is used to interpret the identification code.
Message Profile	Enables the user to select a message profile.
ACK Profile	Enables the user to select the acknowledgement profile.
Identification Code	Enables the user to enter the company Duns code, a unique identification code that identifies the trading partner.
Company Identifier	Enables the user to enter the company identifier
Code Qualifier	Enables the user to enter the code qualifier here. The code qualifier is used to interpret the identification code.
File Name	Enables the user to enter the file name
SGML Declaration File	Enables the user to enter the SGML Declaration File.
Maximum # of reports to include in the msg	Enables the user to enter the maximum number of reports that will be transmitted in one message.
Method	Enables the user to select a method here. This field contains E2B ESTRI Gateway and E2b Media values.
EDI Header	Enables the user to generate the EDI Header
XML Version	Enables the user to enter the XML Version.
URL of Message DTD	Enables the user to enter the path where the message DTD resides on the internet or enter full path if it is located on the disk.
Encoding	Enables the user to select the character set encoding used in XML
URL of ACK DTD	Enables the user to enter the path where the ACK DTD resides on the internet or enter the full path if it is located on the disk.
Auto Accept ICSR's	Click this checkbox to auto accept ICSR's. This checkbox is visible only when case numbering is set to Automatic.
Transmit E2B Attachments	Click this checkbox to transmit E2B attachments.

To configure EDI

1. Select the Agency Name (or row) of the reporting destination displayed under Total Number of Rows that needs to be modified. The Modify section is populated with information about the selected code list.

2. You may use the Reporting Destination Filter to make your search specific to an EDI. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value

6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new EDI.

   • Click Copy to make an editable copy of an existing EDI.

   • Click Delete to delete a selected EDI.

   • Click Print to print the selected information as a PDF.

7. Select the format in which the report is to be sent by selecting the SGML and XML radio buttons.

8. Click the Mark as Auto Submit checkbox if you wish to mark the report for auto-submission.

9. Select the country where the imported cases need to be assigned.

10. Select the initial workflow state of the case.

11. Enter the routing ID configured in Cyclone for the sender community under the Agency Identifier field.

12. Enter the Agency Duns code under the Identification Code field.

13. Enter the Code Qualifier under the Code Qualifier field.

14. Select the message profile from the Message Profile drop-down list.

15. Select the acknowledgement profile from the ACK Profile drop-down list.

16. Enter the Agency Duns Code in the Identification Code field.

17. Enter the Company Identifier in the Company Identifier field.

18. Enter the Code Qualifier in the Code Qualifier field.

19. Enter the name of the file in the File Name field.

20. Select the SGML file in the SGML Declaration File drop-down list.

21. Enter the maximum number of reports that need to be included in the message under the Maximum # of reports to include in the msg field.

22. Select the method from the Method drop-down list. This list contains options like E2B - Gateway, Physical Media and XML Transmission.

23. Click the EDI Header checkbox to generate an EDI Header.

24. Enter the version of XML in which it is coded in the XML Version field.

25. Enter the path where the message DTD resides on the internet or enter full path if it is located on the disk under the URL of Message DTD field.

26. Select the character set encoding used in XML in the Encoding drop-down list.

27. Enter the path where the ACK DTD resides on the internet or enter the full path if it is located on the disk in the URL of ACK DTD.

28. Click Auto Accept ICSR's to auto accept ICSR's.

29. Click Transmit E2B Attachments to transmit E2B attachments.

30. Click Save to save the changes made.

SMTP

This section lists the Field Descriptions and configuration steps for the SMTP tab.

Field Descriptions

The following tables lists and describes the fields on the SMTP tab.

Field/Control Name	Description
From	Enables the user to enter the email address of the sender.
CC	Enables the user to enter the email addresses to send email as CC.
BCC	Enables the user to enter the email addresses to send email as BCC.
Delivery Receipt	Enables the user to check this box to receive a delivery receipt.
Read Receipt	Enables the user to check this box to receive a read receipt.

To configure SMTP

1. Select the Agency Name (or row) of the reporting destination displayed under Total Number of Rows that needs to be modified. The Modify section is populated with information about the selected code list.

2. You may use the Reporting Destination Filter to make your search specific to an SMTP. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value

6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new SMTP.

   • Click Copy to make an editable copy of an existing SMTP.

   • Click Delete to delete a selected SMTP.

   • Click Print to print the selected information as a PDF.

7. Enter the email address of the sender under the From field.

8. Enter the email addresses to send email as CC under the To field.

9. Enter the email addresses to send email as BCC under the BCC field.

10. Click the Delivery Receipt checkbox to receive a delivery receipt.

11. Click the Read Receipt checkbox to receive a read receipt.

12. Click Save to save the changes made.

13. Click Save to save the changes made.

Configuring Routes of Administration

This screen enables you to configure the Route of Administration information. This describes the route of drug administered to the patient. This data is reflected in Expedited and Periodic regulatory reports.

• The values entered here and marked under Display appear in the in the Route of Administration list on the Products tab.

• Select Code Lists --> Argus to view the Code List Maintenance screen.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Click on the Routes of Administration folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.

Field Descriptions

The following table describes the fields associated with this section.

Field/Control Name	Description
Administration Route	Displays the administration route information. This is a required field.
Short Name	Displays the short name of the administrator route.
Description	Displays a description of the administrator route.
E2B Code	Displays the E2B Code of the administrator route.
Display	Enables the user to display the record in the Administrator Route in the Products screen.

To configure routes of administration

1. Click the Administration Route (or row) to view the details associated with the administration route. The details appear in the Modify Administration Route section.

2. You may use the Routes of Administration Filter to make your search specific to a route. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value

6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   Tip: You can alternatively click Add New to create a new route.

   • Click Copy to make an editable copy of an existing route.

   • Click Delete to delete a selected route.

   • Click Print to print the selected information as a PDF.

7. Enter information about the administrator route in the Enter Administrator Route field.

8. Enter a short name about the administrator route in the Short Name field.

9. Enter the E2B Code of the administrator route in the E2B field.

10. Select the Display checkbox to display the record in the Administrator Route in the Products screen.

11. Enter the description about the administrator route in the Enter Description field.

12. Click Save to save the changes made.

Configuring Study Center

This screen enables you to configure the Study Center information. This screen is used to enter information regarding each Study Center. The Study Centers defined in this dialog appear on a drop-down list in the Clinical Studies Information dialog under the Centers tab in List Maintenance. You can create a Study Center with the same Center ID but with a different name and address. When you select the studies in the Study Look and Center Lookup in the Console, the system concatenates the Center Name (Center ID) in the look-up dialog.

• Investigators for each Center can also be added via this dialog.

• Select Code Lists --> Argus to view the Code List Maintenance screen.

• Click on the Study Center folder in the left panel. The associated data appears in the Total Number of Rows section in the right panel.

Tip:

The code list items are displayed in the left-panel. Click on the required Code List folder to be configured. The details of this code list item appear in the right panel.

Field Descriptions

The following table lists and describes the fields associated with this section.

Field/Control Name	Description
Center ID	Enables the user to enter the Center ID.
Name	Enables the user to enter the name of the center.
Address	Enables the user to enter the address of the center.
Copy from Reporters	Enables the user to copy the information from Reporters.
#	Displays the row count of the number of investigators.
Investigator	Enables the user to enter the name of the investigator.
Phone	Enables the user to enter the phone number of the investigator.
Fax	Enables the user to enter the fax number of the investigator.
Notes	Enables the user to enter comments or remarks.

To configure study center

1. Click the Center ID (or row) to view the details associated with the administration route. The details appear in the Modify Study Center section.

2. You may use the Study Center Filter to make your search specific to a center. The filtering criterion is essential as it helps you to search for specific items.

3. Select the appropriate Field as the filtering criteria from the drop-down list.

4. Once you have selected the Field, you can specify whether your search should contain or start with specific alphabets.

5. Enter the search criteria in Value

6. Click Filter to apply the selected criteria. This displays the search results under Total Number of Rows.

   Tip:

   You can alternatively click Add New to create a new center.

   • Click Copy to make an editable copy of an existing center.

   • Click Delete to delete a selected center.

   • Click Print to print the selected information as a PDF.

7. Enter the ID of the center in the Center ID field.

8. Enter the name of the center in the Name field.

9. Enter the address of the center in the Address field.

10. Select the Copy from Reporters checkbox to copy the information from Reporters.

11. Enter the name of the investigator in the Investigators field.

    Tip:

    Tip: Click Add to add a new investigator. Click Delete to delete a selected investigator record.

12. Enter the phone number of the investigator in the Phone field.

13. Enter the fax number of the investigator in the Fax field.

14. Enter comments, if any, under the Notes field.

15. Click Save.

Other Code List Items

The following table lists and describes additional code list items that you should be aware of.

Code List Item	Description
Accidental Exposure	Enables you to capture Accidental Exposure information. Accidental Exposure is in the Dosage regimen section of the Products tab as a drop-down.
Action Taken	Enables you to capture Action Taken information. Action Taken information is required when capturing information about steps taken when an adverse drug event occurs. The values you enter in this field are read-only and appear in the Dosage Regimen section on the Action Take drop-down on the Case Form Product tab.
Action Type	Enables you to capture Action Type information that describes the action type required for the case. Values entered in this field are read-only and appear in the Code/Description list of the Activities tab. Select Code List Maintenance-->Code List-Argus and click Action Type in the browser tree.
Age Group	Enables you to capture Age Group information. An Age Group is the range of lower and upper age limits. Patients are categorized in different age groups. This data appears in Expedited and Periodic regulatory reports. The values you enter in this field appear on the Patient Information Screen, Age Group drop-down list.
Age Unit	Enables you to capture Age Unit information. An Age Unit expresses time in periods such as year, month, day, hours, and so forth. This data appears in the Expedited and Periodic regulatory reports and in the Age Unit drop-down list on the Patient Information screen. This code list item accepts decimal numbers and integers. however, it only accepts a single digit after the decimal point.
Always Serious Term List	Enables you to capture information about conditions that are always serious. You select the term from the MedDRA dialog box and the system transfers it to the Always Serious Term list. Be aware of the following: If any case has any of the terms in the Always SErious Term List," the system marks the case level serious "Yes" when it saves the case. The MedDRA recoding tool updates the terms when the MedDRA dictionary is upgraded. The system prints out the Always Serious Term List code list.
Anatomical Location	Enables you to capture information about the location where vaccination are given. This data appears in the expedited and periodic regulatory reports. The values you enter in these fields appear on the Anatomical Location drop-down list on the Vaccine screen.
Attachment Classifications	Enables you to capture attachment classification used to describe attachment types. The values you enter in these fields appear in the Attachment Classification section on the Additional Information screen.
Attachment Keywords	Enables you to capture information about the attachment keywords used to define an attachment type. The values appear in the Attachment Keywords section on the Additional Information screen.
Birth Type	Enables you to capture birth type information when capturing pregnancy information. This data appears in multiple regulatory reports and appear in the Birth Type drop-down list on the Pregnancy information screen.
Case Classifications	Enables you to capture Case Classification to help categorizee cases. This information does not impact any report or screen but is used during case searches to narrow the results set. These values appear on the Classification list, General information screen.
Causality Category	Enables you to capture information about the causality type. This data appears in expedited and periodic regulatory reports and on the Event Causality drop-down list in the Eve Assessment section on the Event screen.
Clinical Reference Type	Enables you to capture information about the clinical reference type. The Clinical Reference Type appears as a drop-down list in the Study configuration
Condition Type	Enables you to capture information about the condition of the patient. Categories for condition types are Medical history relevant to AE, historical condition, and current condition. This data appears in expedited and periodic regulatory reports and in the Condition Type drop-down list on the Other Relevant History screen.
Contact Type	Enables you to capture information about the type of contact (e.g., Follow-up, Investigator). The values appear in the Contact Type drop-down list in the Contact Log section of the Activity Tab.
Countries	Enables you to capture information about the country where the adverse event occurred. If you enter A2, A3, or the numeric country code, the system automatically populates the Country field with the name of the country. Obtain the country name and country codes from the ISO 3166 country code specification. You may receive the following error messages: "A duplicate country name already exists! " -- The country name you entered already exists in the system. "A duplicate A2 code already exists!" -- The A2 code you entered already exists in the system. "A duplicate A3 code already exists!" -- The A3 code you entered already exists in the system. "A duplicate country number exists!" -- The country number you entered already exists in the system. "Please enter a valid code (A2)." -- The two-character code is not specified. "Please enter a valid code (A3)." -- The three-character code is not specified.
Date Ranges	Enables you to capture date range information as follows: Description -- Enables you to enter a description of the date range. Duration -- When selected, enables you to specific a specific length of time as opposed to a range of dates. Must be used in conjunction with Amount and Units. When you select "Duration," the system disables the "Range" radio button. Amount -- The numeric value that specifies the length of the time period when combined with a value selected from the Units drop-down list (e.g., days, weeks, months, years, etc.) Units -- The unit of the duration (e.g., days, months, years, etc. Range -- Enables you to select a specific range of dates. Must be used in conjunction with the Start and End fields. When you select "Range," the system disables the "Duration" radio button. Start -- The beginning date of the date range. End -- The ending date of the date range.
Delivery Types	Enables you to capture information about the type of delivery that occurred during pregnancy. This data appears in expedited and periodic regulatory reports and on the Delivery Types drop-down list on the Pregnancy Information screen.
Device Preliminary Comments	Enables you to capture comments about medical devices. Device Preliminary Comments appear on the Product screen when the user selects the Device option.
Device Subcomponents	Enables you to capture information about subcomponents that are part of a medical device. This information appears on the Product screen when the user selects the Device option.
Causality Source	Enables you to capture Causality Source information. It appears on the Case Form Event Assessment tab.The E2B report uses this information to determine the drug assessment method.
Device Type	Enables you to capture information about patient device types. This data appears in expedited and periodic regulatory reports.
Dosage Frequency	Enables you to capture information about how often medication is given (e.g., daily, bid, weekly, etc.) This information appears on the frequency drop-down list on the Products screen. Frequency -- how often the dose is given Number of doses per day -- The number of doses administered each day. Number of separate dosage -- Enables the use to define the dosage verbatim. Number of units in the interval -- Enables the user to define the dosage verbatim. Definition of Interval -- The length of time between doses (i.e., year, month, day week (default), hour, minute).
Dosage Unit	Enables you to capture dosage units information. This information is required when capturing the quantity of drug on sale and also appears in expedited and periodic reports. Unit Name -- The name of the dosage unit. E2B Code -- The E2B code associated with the Dosage Unit. Dosage Unit -- When checked, indicates that the current item is the dosage unit. Lab Test Unit -- When checked, indicates that this is a lab test unit. Display -- When checked, indicates that the Unit Name displays in the application.
Ethnicity	Enables you to capture information about the ethnic groups patients belong to. This information appears in periodic regulatory reports and on the Ethnicity drop-down list on the Patient Information screen.
Evaluation Reason	Enables you to capture information about the reason the product is being evaluation. This information appears in the Evaluation Reason list on the case form Product tab.
Event Frequency	Enables you capture information about the frequency of the event. It includes categories such as intermittent, continuous, and single episode. The values entered in this field appear in the Event Frequency drop-down list on the Event Information screen.
Event Intensity	Enables you to capture information about the intensity of the adverse event and includes categories such as mild, moderate, and severe. The values you enter on this screen appear on the Event Intensity drop-down list on the Event Information screen
Event Outcome	Enables you to capture event outcome information such as Fatal, Abortion due to AE/Infection, and Recovered. This data appears in expedited and periodic regulatory reports and on the Event Outcome drop-down list on the Event Information screen.
Fetal Outcome	Enables you to capture information about fetal outcome and includes information such as abnormal development or perinatal complications. This data appears in expedited and periodic regulatory reports and values entered here appear on the Fetal Outcomes drop-down list on the Pregnancy Information screen.
Formulation	Enables you to capture information about the formulations (cream, drop, capsule, etc.) available for a product. The values you enter appear on the Formulation drop-down list on the Product screen.
Gender	Enables you to capture gender information. This information appears in expedited and periodic regulatory reports.
Holiday Calendar Code List	Enables you to create and store holiday information in the code list. . When defining this code list item, you enter the holiday name, date, a description of the holidy, and the country in which the holiday occurs.
Ingredients	Enables you to capture information about the ingredients in the product. This includes the ingredient and the concentration and units of ingredients used to make the product. This information appears in expedited and periodic regulatory reports.
Institution	Enables the user to store the names and IDs of institutions used in other code lists. Access this code list item by selecting Institutions from the left pane in the Code List Maintenance window. When you click "Add New," the system permits you to new information about institutions as follows: Institution -- Enables the user to enter the name of the Institution. Institution ID -- Enables the user to enter the value that identifies the Institution. Display -- Enables you to enter an E2B code. Institution (J) -- Enables the user to enter the Japanese equivalent of the English name.
Intermediary	Enables you to capture information about intermediaries such as sales rep, licensee, regulatory authority or local affiliate. The values you enter appear on the Intermediary drop-down list on the Reporters screen.
Justifications	Enables you to capture justification information. You can enter reasons for overriding system determinations in the Justifications dialog box. The values you enter appear in the Action Justification dialog.
Lab Assessment Terms	Enables you to capture the lab result assessment terms that define the terms that describe the patient's results on various lab tests (e.g., elevated and depressed, etc.). This data is reflected in expedited and periodic regulatory reports. The values you enter appear on the Lab Result Assessment Terms drop-down list on the Laboratory Data screen.
Lab Test Group	Enables you to create and store a lab test group in the code list.
Lab Test Type	Enables you to capture the lab test type. This defines test type and its normal, high, and low values and can be coded as defined in the MedDRA dictionary. The values you enter appear on the Lab Test drop-down on the Patient screen.
Literary Citations	Enables you to literary citations information.
Local Evaluation Comment Type	Enables you to capture the category of a local comment such as French, German, English, etc. The values you enter appear in the Analysis, Local Comment type.
Manufacturer	Enables you to capture information about the product manufacturer. Manufacturer is required while capturing, adding, or modifying information on manufacturer sites. This data appears in expedited and periodic regulatory reports and on the Manufacturer drop-down list on the Product Configuration screen.
Medical Status	Enables you to capture medical information about patient status. This data appears in both the expedited and periodic regulatory reports. The values you enter here appear on the Medical Status drop-down list,
Message Type	Enables you to enter information about each E2B message type. The system uses the defined message types when it creates an E2B file.
Nature of Event	Enables you to capture information about the type of adverse event that occurred.
Occupations	Enables you to capture information about patient and reporter occupations such as physician, regulatory agent, and journalist. This data appears in both expedited and periodic regulatory reports. The values you enter are marked as ICH Occupation appear in the Reporter's Occupation drop-down list on the General Screen.
Package Units	Enables you to capture information about product packaging. The package units defines the number of units in a package.
Product Group	Enables you to capture information about a specific Product Group. Users can use the Product group field to categorize Product Families based on therapeutic area. The values you enter here appear in the drop-down list associated with the Project Group field of the Product Family.
Project ID	Enables you to capture project ID information used to group similar studies under a single project. The values you enter in this field appear on the Project ID field drop-down on the Study Configuration.
Reference Types	Enables you to capture reference type information and defines a list a reference types such as Parent-Child Link, Patient ID, etc. The values you enter appear in the Type drop-down in the References section on the Additional Info tab.
Report Media	Enables you to capture Report Media information. The values you enter appear on a drop-down field in the Reporter Information section.
Report Types	Enables you to capture information about report types. The report type describes the type of report and the abbreviation associated with the specific type. This data appears in expedited and periodic regulatory reports. The values you enter here appear on the Report Type drop-down list on the General Screen.
Reporter Information	Enables the user to add Institutions to the Reporter Information. Be aware of the following: The Institution field has a drop-down list of items from the Institution Code List. Reporter Information cannot belong to duplicate institutions.
Reporter Type	Enables you to capture information about the person reporting the adverse event and includes categories such as lawyer, nurse, doctor, etc. The values you enter here appear on the Reporter Type drop-down list on the Product screen.
Reporting Destination Type	Enables you to capture information about the reporting destination. The values you enter here appear on the Reporting Destination configuration.
Routes of Administration	Enables you to capture information about how a drug is administered to a patient such as shot, by mouth, etc.
Study Center	Enables you to capture information about the study centers. Values entered here appear on a drop-down in the Clinical Studies Information dialog and on the Centers tab in List Maintenances. You can also add investigators for each center. You can create a study center with the same center ID but with a different name and address.

Formulation Factory Data

The following table provides information about the Formulation Factory Data.

Formulation ID	Formulation	Formulation Name	Formulation Symbol
38	Aerosol (Spray and Inhalation)	Aerosols	AER
13	Alternative Form
23	Cachet (including wafer)	Cachet	CTS
2	Capsule	Capsules	CAP
24	Chewable Tablet	Chewing Tablets	CTB
25	Drop	Drops	DRO
32	Dusting Powder	Dusting Powders	DPO
39	Ear Drops	Ear Drops	EDR
8	Effervescent Tablet
47	Enema	Enemas	ENM
21	Enteric Table	Enteric-coated dosage forms	ENT
49	External Use
12	Extra Formulation	External Preparations of Uncertain Dosage Form	EXT
40	Eye Drops	Eye Drops	EED
41	Eye Ointment	Eye Ointments	EOI
20	Grain	Granules	GRA
18	Granule	Fine Granules	FGR
46	Implantation	Inserting Preparations	IMP
43	Inhalation Gas	Gas Inhalant	INS
6	Infusion	Infusing Preparations	INF
9	Inhaler	Inhalants	INH
5	Injection	Injections	INJ
48	Jelly	Jellies	JEL
11	Liquid	External Liquids	LIQ
33	Lotion (except lotion for eye)	Lotions	LOT
28	Lozenge (troche and candy too)	Lozenges	LOZ
45	Mouthwash	Throat Washings	MWH
17	N/A
42	Nasal Drops/Spray	Nose Drops	NDF
34	Ointment/Cream	Ointments/Creams	OIT
31	Oral Drug Unspecified Form	Oral Preparations of Uncertain Dosage Form	POR
4	Patch
26	Pill (except tablets)	Pills	PIL
19	Powder (except DPO)	Powders	POW
35	Shampoo	Shampoos	SHP
22	Slow Release Capsules	Slow-release Capsules	SRC
30	Slo Release Granule	Slow-release Granules	SRG
29	Slow Release Tablet	Slow-release Tablets	SRT
27	Solution (except Syrup)	Solutions for Oral Use	SOL
44	Spin Cap	Spin Cap	SPC
36	Spray (except Inhalation)	Sprays	SPR
3	Suppository	Rectal Suppositories	SUP
7	Syrup	Syrups	SYR
1	Tablet	Tablets	TAB
37	Tape (including Poultice)	Tapes	TAP
16	Unknown	Uncertain	XXX

Literary Citations Code List Item

When configuring the Literary Citations code list item, be aware of the following:

• You can save a literary citation. If a literary citation with the same name is already in the system, the system presents an error message. Otherwise it simply saves the Literary Citation information.

• The main English screen has a J Data Entry button. This button is available only to J users.

• When you click J Data Entry, the system prompts you to enter the data in required fields in the English screen before opening the Japanese Translation window. The system opens a dialog box where you can enter Japanese equivalent text for the corresponding field.

• If you click J Data Entry and a literary citation exists, the system does the following:

  • Prompts the user to save the data on the English screen before opening the J screen with the following message: "Do you want to save the changes before opening the Japanese screen?"

  • If the user chooses to save the data, the system saves the data and the changes are reflected on the J screen,

  • If the user chooses not to save the data, the changes made on the English screen are not reflected on the J screen.

• If you click J Data Entry for a new literary citation, the system does the following:

  • Prompts the user to save the data on the English screen before opening with the following message: "Data must be saved before opening the Japanese screen. Do you want to save?"

  • If the user chooses to save the data, the system saves the data and the changes reflected on the J screen.

  • If the user choose not to save the data, the J screen does not open.

• When using the copy function, be aware of the following:

  • When you copy data, the system does not copy the equivalent Japanese data.

  • When you copy the data, the system prefixes the data with the words "Copy of" in the English UI but not in the Japanese UI.

  • If the English Journal name is not unique, and the user clicks Save or J Data Entry, the system displays the following message: "A duplicate Journal already exists!" to force the user to change the name.

Additional Information about the Manufacturer Code List Item

When configuring the Manufacturer Code List item, be aware of the following:

• The screen contains the following note: "Note: Clicking the SAVE button will reflect the changes made on this English screen to the Japanese pop-up."

• The main English screen has a J Data Entry button available only to J users.

• When you click J Data Entry, the system prompts you to enter the data in required fields in the English screen before opening the Japanese Translation window. The system opens a dialog box where you can enter Japanese equivalent text for the corresponding field.

• If you click JData Entry for an existing manufacturer the system does the following:

  • Prompts the user to save the data on the English screen before opening with the following message: "Do you want to save changes before opening the Japanese screen? "

  • If the user chooses to save the data, the system saves the data and the changes reflected on the J screen.

  • If the user choose not to save the data, the J screen does not open.

• If you click J Data Entry for a new manufacturer, the system does the following:

  • Presents the user with the following message: "Data must be saved before opening the Japanese screen. Do you want to save?"

  • If the user chooses the save the data, the system saves the data and the changes are reflected on the J screen.

  • If the user chooses not to save the data, the system will not open the J screen.

• When using the copy function, be aware of the following:

  • When you copy data, the system does not copy the equivalent Japanese data.

  • When you copy the data, the system prefixes the data with the words "Copy of" in the English UI but not in the Japanese UI.

  • If the English Journal name is not unique, and the user clicks Save or J Data Entry, the system displays the following message: "A duplicate Journal already exists!" to force the user to change the name.

  • If the Japanese name is not unique, the system presents the user with the following message: "A duplicate name already exists!" This forces the user to change the duplicate name in the J data entry field.

Additional Information about the Reporter Information Code List Item

This code list item enables you to capture reporter information. When configuring the Reporter Information Code List item, be aware of the following:

• The screen contains the following note: "Note: Clicking the SAVE button will reflect the changes made on this English screen to the Japanese pop-up."

• The main English screen has a J Data Entry button available only to J users.

• When you click J Data Entry, the system prompts you to enter the data in required fields in the English screen before opening the Japanese Translation window. The system opens a dialog box where you can enter Japanese equivalent text for the corresponding field.

• You must enter required data before opening the Japanese pop-up. If you fail to do so, the system presents the following message: "Enter data in all the mandatory fields!"

• If you click JData Entry for an existing reporter the system does the following:

  • Prompts the user to save the data on the English screen before opening with the following message: "Do you want to save changes before opening the Japanese screen? "

  • If the user chooses to save the data, the system saves the data and the changes reflected on the J screen.

  • If the user choose not to save the data, the J screen does not open.

• If you click J Data Entry for a new reporter, the system does the following:

  • Presents the user with the following message: "Data must be saved before opening the Japanese screen. Do you want to save?"

  • If the user chooses the save the data, the system saves the data and the changes are reflected on the J screen.

  • If the user chooses not to save the data, the system will not open the J screen.

• When using the copy function, be aware of the following:

  • When you copy data, the system does not copy the equivalent Japanese data.

  • When you copy the data, the system prefixes the data with the words "Copy of" in the English UI but not in the Japanese UI.

  • If the English Journal name is not unique, and the user clicks Save or J Data Entry, the system displays the following message: "A duplicate Journal already exists!" to force the user to change the name.

  • If the Japanese name is not unique, the system presents the user with the following message: "A duplicate name already exists!" This forces the user to change the duplicate name in the J data entry field.

Additional Information about the Reporting Destination Code List Item

Regulatory Reports are submitted to a reporting destination. The code list element enables you to capture information about the reporting destination. A number of fields on the screen are unique to Argus J.

The following table lists and describes these fields.

Field Name	Description
Agency Name (J)	Enables the user to enter the name of the agency in Japanese.
Company Name (J)	Enables the user to enter the name of the company in Japanese.
Message Profile 2	Enables the user to select a message profile to accommodate ESM-J reporting.
Use Japanese Aware Date for Reporting	Enables the user to specify whether the Japanese Aware Date is used for reporting. If checked, all automatic calculation of scheduled due dates for scheduled report to the selected authority are based on the japanese Aware date rather than the standard aware date.
Allow Multiple Reports for Marketed Drugs	When checked, the reporting rule schedules a report for each suspected marketed drug for the case.
Allow Multiple Reports for Investigational Drugs	When checked, the reporting rule schedules a report for each suspected investigation drug for the case.
Method	Enables the user to select a transmission method as follows: E2B--EDI Gateway E2B-Physical Media E2B-XML Transmission E2B-Binary Transmission

Study Development Phase Code List Element

This code list element enables you to capture development phase information. Values you specify appear on the drop-down list and in te Studies LM section and for E2B.

The following tables lists and describes the available fields.

Field Name	Description
Development Phase	Enables the use to enter the Japanese equivalent of the development phase information. Development Phase can be one of the following: Phase I Phase II Phase III Biological equivalence study Clinical pharmacology study Preparation NDA submission NDA submitted Other
Display	Enables the user to select whether to display the item or not.
E2B Code	Enables the user to enter the E2B code.
Development Phase J	The user can enter the Japanese equivalent of the develop phase information in Japanese. Phase I Phase II Phase III Biological equivalence study Clinical pharmacology study Preparation NDA submission NDA submitted Other

Event Occurred as Consequence of Code List Element

This code list item enables the capture of information about the circumstances that triggered the adverse event. Both the Event Occurred as Consequence of and the Term field are required.