At different stages of case processing, such as, data entry, assessment and reporting, the application allows you to enter a comprehensive description up to twenty thousand characters manually or by using the standard template.
In this chapter, you learn to enter the case description and also translate the description in multiple languages.
The application verifies all the Narratives/E2B field description fields for invalid characters. If the description consists of special characters, then the application considers them as invalid characters and displays the Validation messages along with the field names where the special characters are present.
• If the PMDA/MHLW invalid characters present in the Narratives/E2B field description, then validation message “one or more invalid characters for PMDA submissions are found” is displayed.
• If the FDA invalid characters present in Narratives/E2B field description, then validation message “one or more invalid characters for FDA submissions are found” is displayed.
Entering the Case Description Manually
On the Full Data Entry page, click the Narratives tab and again click any of the sub-tabs.
Select a language from the standard menu bar.
Enter
your description in the relevant columns.
Additionally, you can view the description
on the portable screen by clicking the respective language
flag available on the Narratives
tab.
In the Remarks window consists
of Remarks1, Remarks2,
Remarks3, and Remarks4
tabs, where you can enter description for J.13.1/J2.19,
J.13.2/J2.20, J.13.3/J2.21,
and J.13.4/J2.22, respectively.
You
can move the fixed language specific Post-it Remarks
window to a desired location.
While performing data entry, the character
length displayed at lower -right corner notifies you on the
remaining
characters in a narrative field.
Press F3
to open in an Exploded View. This helps you
to enter the data in No Distraction Mode. After you have entered the
data, click OK. The entered data remains same in Normal and Exploded
views.
Click
Save.
When a new version is created for an international case, the Pharmacovigilance
comments will be available, when the parameter Clear
medical eval. in next int. version? available in Admin>>Installation
Parameters>>General>>General is set to Yes.
Capturing the Case Description Using a Standard Template
Place your cursor in the sub-tab text area.
Click
the Edit menu and select Statement.
The Statement Lookup window
appears.
Enter
the search criteria.
For example, select English from the Language drop-down list.
Click
Search.
The results display in the Statement title and Statement text sections.
Choose
a statement title from the list and click Select.
The narrative text appears in the text area of the sub-tab you selected.
Displaying AER Number Automatically in the Narrative Text Area
The application captures the bookmark<<AER no>> from the Statement text area of the Statement Lookup window and replaces the bookmark with the current case number in the Event description text area.
You must first enter your description in different languages and save.
Open the description in any language, For example: English.
Click
any of the flags on the right-hand side of the page.
For example: The Japanese Flag.
The application displays the comments that you entered while setting
the language as Japanese, in a Post-It Notes widget.
Note: The Multi Language Support functionality is available for all sub tabs of the Narratives screen.
Using the CLT+F5 hot key or Validate Chars in the Records menu in the Full Data Entry screen, you have the option to validate the descriptions entered in any of the Narrative/E2B field for special characters.
To remove the special characters from the Narrative/E2B field description, perform the following steps:
On the Records
menu, click Validate Chars.
Or
Press CTRL+F5.
The Validate Text dialog box
appears where the special characters existing in the description are
highlighted.
Delete the invalid characters and click OK to save the description.
The valid description for PMDA/FDA submission displays in the respective field.