How locales are applied in the InForm user interface

Administration

The administration pages in the InForm user interface are all based on the default product locale that is defined during the installation (or by using pfadmin commands). The only exception is the Reset Password page, which uses the user's product locale.

For the following items, you can use the administration pages to create item names in any locale:

• Site names.
• Country names.
• Rights groups names.
• Custom group names.

  Standard group names are provided in English.

Login

Uses the locale that matches the user's browser setting, if available. Otherwise, the page uses the default Product Locale.

Screening Log

Uses the user's Product Locale.

CRFs

Day, month, and year ordering is controlled through configuration settings at the study, site, and user levels. The user's Product Locale controls whether months appear as abbreviations or numbers.

Subject (users) listings

Operational status values such as subject status (Enrolled, Randomized, and so on), form status (Verified, Locked, and so on) and query status (Open, Answered, and so on) display based on the user's Product Locale.

• Visit names display based on user's Study Locale.
• All labels other than the visit names display based on the user's Product Locale.

Time and Events Schedule page

Presents visit and CRF names in the user's Study Locale. Other text is in the user's Product Locale.

Source Verification

Displays study elements such as visit and CRF names in the user's Study Locale. This applies to the saved filter dialog box as well.

The user's Product Locale is used for all other displayed elements.

Reg Docs and Visit Reports

For other monitor functions, the Reg Doc and Visit Report forms must be translated to each of the study locales, and they appear in the user's Study Locale.

Query Listing

Uses the user's Study Locale for displaying study elements. All other page elements are rendered using the user's Product Locale.

• Query actions in the drop-down list on the Query Listings Action View page display based on the user's Product Locale.
• The language of the default query reason drop-down list on the Query Listings Action View page displays based on the user's Product Locale.

Queries

• Users can enter manual query text in any language, regardless of locale settings.
• Product labels are based on the user's Product Locale.
• CRF elements on the Queries page display in the language of the associated CRF instance.
• Query actions in a drop-down list display in the user's Product Locale.

  Note: The audit trail may contain a mix of languages describing the query action (Open, Answer, Close) as well as the query text itself.

Data Value(s)

• The reason for change drop-down list defaults to the user's Product Locale.
• Other product labels display based on user's Product Locale.
• CRF elements display in the language of the associated CRF instance.

Audit Trail

Data in the Audit Trail page is in the language that was captured at the time of an event. Following a subject transfer, codelist labels (such as Male/Female) are translated to the language of a receiving site.

• CRF elements in the Audit Trail page display in the language of the associated CRF instance.
• Labels on the Audit Trail page display based on the user's Product Locale.

  The audit trail in the InForm application and CRF Submit application may contain a mix of languages for event labels.

  In addition, audit trails include dates and times based on the local time of the site user and might be associated with the CRF locale.

Online Help

There are two types of online Help:

• InForm system help is available in any of the supported product locales and displays in the user's Product Locale.
• CRF Help (if implemented) displays based on the user's Study Locale.

Comment history

• The Comment page and Itemset Row Comment page display the standard Incomplete Reasons based on the user's Product Locale.
• Labels are based on user's Product Locale.
• CRF elements on the Comment page and Itemset Row Comment page display in the language of the associated CRF instance.
• When presented in CRFs, Incomplete Reasons appear in the user's Product Locale for the user that is viewing the page. This means that different users viewing the CRF may see Incomplete Reasons in different languages.

Subject record transfers

When subjects move between sites that have different study locales, the already started CRFs display in the locale of the destination site. The InForm application does not allow subject transfers to sites that are on earlier study versions or which do not have translations for any started CRFs in the study locale of the destination site.

• The archival copy of the CRFs for the source site is stored in the Study Locale for that site, with exceptions around audit trail entries that may be in other languages.
• Reasons for change/transfer display in the default Product Locale used in the Subject Record Transfer administrative page.
• Text data in the audit trail entries in both the archival copy of CRFs and the live CRFs are stored in the language entered and appear in that language.

  The archival copy is created at the time of the subject transfer using the Study Locale of the source site. This includes codelists (such as race and gender). CRFs viewed at the destination site after the subject transfer are rendered in the locale of the destination site.

Affidavit

The InForm application allows for signature affidavit text to be translated to any Study Locale and displayed to the signer in the language specific to a CRF's Study Locale. The signature print preview functionality is configurable by study.

Note: Translating the signature affidavit must be done by editing the MedML, not through the Central Designer application. For more information, see the Utilities Guide.

The InForm application supports a paper-based signature process. You have the option to print a copy of the CRF in order to manually sign the CRF or CRB.

Data Viewer

Uses the same multilingual support as the main InForm application.

• All user interactions such as commands, menus, and dialog boxes appear in the user’s Product Locale.

  You set the user's Product Locale on the User details page—Details tab. For more information, see User details page.

• All study metadata such as form names, visit names, and code labels appear in the Review Schema Locale. For information on how to change the Review Schema Locale, see the Installation Guide.

Documents

The Documents button displays:

• A set of document tabs according to the available study locales.
• Study-specific documentation appears with the user's Study Locale. The Central Designer application allows users to create study documentation in each study locale.