5 Code List Configuration

Field Descriptions

The following table describes the fields associated with this section.

Use the following procedure 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 autosignal.

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.

Field Descriptions

The following table describes the fields associated with this section.

Use the following procedure 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 icon to launch the Advanced Conditions browser.

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

Field Descriptions

The following table describes the fields associated with this section.

Use the following procedure 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.

Field Descriptions

The following table describes the fields associated with this section.

Use the following procedure 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 justification reason in Justification.

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.

Field Descriptions

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

Use the following procedure 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 RecipientFilter 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.

Terms tab

The following table describes the fields associated with Event Groups > Terms tab.

Use the following procedure to configure Terms:

1. Click Event Groups on the left pane of the Code List.

   You can use the Event Group Filter on the right pane, to make your search specific to an event group. 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 event group.

   • Use Copy to make an editable copy of an existing event group.

   • Use Delete to delete an existing event group.

7. Enter the name of the event group under Event Group Name.

8. If it is also required for a Japanese user, enter the Japanese name of the event group under Event Group Name (J).

9. Check the Display checkbox to display the Event Group in Business Configuration > Products and Licenses > Product Family > Datasheet.

10. Click Export (or Import) to export (or import, respectively) a file in a valid file format from (or into) your local system. Valid file formats require that the file be in .xls, .xlsx, or .csv formats.

    Important: The format of the data in the csv, xls or xlsx file must be as follows:

    It must have only a single column of data. An import file can have ~ 16 K Terms.

    The first/header row must have text as "PT" or "HLT" or "HLGT" or "SOC" in upper or lower case.

    All the rows below the header row must contain corresponding terms (text) such as PT text or HLT text or HLGT text or SOC text.

11. Click Save to save the changes made to this tab.

Event Groups tab

Click the Event Groups tab to configure event groups.

The following screen is displayed:

The following table describes the fields associated with Event Groups > Event Groups tab.

SMQ tab

Click the SMQ tab to configure SMQ terms.

The following screen is displayed:

The following table describes the fields associated with Event Groups > SMQ tab.

On clicking the Add button, the MedDRA Browser is displayed, as shown below:

Export:

The Export button is enabled in two scenarios - when MedDRA is opened from:i) Argus Console > Business Configuration > Products and Licenses > Product Family > Datasheetor, from:ii) Argus Console > Code Lists > Argus > Event GroupMedDRA terms are selected at any level of the MedDRA hierarchy.On clicking this button, a dialog is displayed, that allows you to select the file type - .csv / .xls / .xlsx file.On specifying the file type, the selected PT terms are then exported in the Export file. in the <PT terms> format.

Import:

This button is enabled in two scenarios - when MedDRA is opened from:i) Argus Console > Business Configuration > Products and Licenses > Product Family > Datasheetor, from:ii) Argus Console > Code Lists > Argus > Event GroupMedDRA terms are selected at any level of the MedDRA hierarchy.On clicking this button, a dialog is displayed, that allows you to browse and upload a .csv / .xls / .xlsx file from the desired location on your local machine.The format of the data in the selected file should be as follows:It should have only one column of dataThe first header/row must display 'PT' or 'HLT' or 'HLGT' or 'SOC'.All the rows under the header row should contain corresponding terms such as PT text, or HLT text, or HLGT text, or SOC text.The MedDRA terms in the file should be matched against the MedDRA terms table at the level specified in the header row. Duplicate terms within the import file should be ignored.If the user enters a search criteria at any levels of the MedDRA hierarchy and continues to search for terms, the results obtained from the Import will be lost. The user may need to import terms again, using the Import button.

Save:

The Save button is enabled only on selection of the PT term(s).

Field Descriptions

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

Use the following procedure 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 digital object identifier in the Digital Object Identifier field.

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

15. Click Save to save the changes made.

Field Descriptions

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

Use the following procedure 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.

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:

Use the following procedure 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. Multiple e-mail addresses must be separated by a comma (,), and not by a semi-colon (;). If you separate the email addresses by a semi-colon, the transmission service will fail.

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 1 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.

Use the following procedure 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.

Use the following procedure to configure reporting destination:

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

2. Select Reporting Destination on the left pane of the Code List screen. The screen appears as shown below.

   
   

Field Descriptions

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

Use the following procedure 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. 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.

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

22. 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.

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

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

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

26. 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.

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

28. 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".

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

30. Click Transmit E2B Attachments to transmit E2B attachments.

31. Click Save to save the changes made.

Use the following procedure 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 below.

   
   

Configuring the Base Directory Path

A new database only (not shown in the UI) global level common profile switch BASE_DIR_PATH_FOR_GATEWAY_FOLDERS is available for providing the base path for all incoming, outgoing and E2B attachments folders.

Users can configure the base directory path of a machine or network shared path through this swtich. This path is suffixed with values provided in new configurations and all incoming, outgoing and E2B attachment folders are created under base directory only. This profile switch is mandatory for the Oracle cloud customers whereas it is optional for the on-premise customers. With this optional set up, on-premise customers can retain their existing folder structure when upgrading from older version of Argus Safety. Cloud customers would need to reconfigure their gateway folders based on the new architecture. When the BASE_DIR_PATH_FOR_GATEWAY_FOLDERS is set, make sure to create the base directory path along with the enterprise name.

For example,

If BASE_DIR_PATH_FOR_GATEWAY_FOLDERS is set to C:\BASE_DIR for the enterprise ENT_DEFAULT, then the folder C:\BASE_DIR\ENT_DEFAULT is created. IF the Incoming Folder is set to AGECNCY\Incoming, Outgoing Folder to AGECNCY\Outgoing and ISCR Outgoing Attachment Folder to AGECNCY\OutAttachment, the actual incoming folder path would be C:\BASE_DIR\ENT_DEFAULT\AGECNCY\Incoming. The same standard applies for the outgoing and attachment folder too.

If the BASE_DIR_PATH_FOR_GATEWAY_FOLDERS is not set, the Incoming, Outgoing and Attachment folders could have the complete directory path.

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.

Use the following procedure 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. Multiple e-mail addresses must be separated by a comma (,), and not by a semi-colon (;). If you separate the email addresses by a semi-colon, the transmission service will fail.

9. Enter the email addresses to send email as BCC under the BCC field. Multiple e-mail addresses must be separated by a comma (,), and not by a semi-colon (;). If you separate the email addresses by a semi-colon, the transmission service will fail.

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.

Field Descriptions

The following table describes the fields associated with this section.

Use the following procedure 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:

   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 administration route in the Enter Administration Route field.

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

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

10. Select the Display checkbox to display the record in the Add field in the Products screen.

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

12. Click Save to save the changes made.

Field Descriptions

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

Use the following procedure 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.

Field Descriptions

The following table describes the fields associated with this section.

Use the following procedure to configure study center.

1. Click the Holiday Name (or row) to view the details associated with that Holiday Calendar. The details appear in the Modify Holiday Calendar section.

2. You may use the Holiday Calendar Filter to make your search specific to a Holiday Calendar record. 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 Holiday Calendar record.

   • Click Copy to make an editable copy of an existing Holiday Calendar record.

   • Click Delete to delete an existing Holiday Calendar record.

7. Enter the Holiday Name for the Holiday Calendar.

8. Enter the Date for the record.

9. Enter the Country (or countries) with which the holiday must be associated.

10. Enter the Description for the Holiday Calendar record.

11. Click Save.

Formulation Factory Data

The following table provides information about the Formulation Factory Data: