Forms in several languages

The languages of the study, translating a form, licensed questionnaires, and how the patient chooses a language in ePRO.

One study can run in several languages: a patient in Israel answers in Hebrew, a patient in Kazakhstan in Kazakh, and the data is the same for all. Forms in several languages translate only the texts: questions, hints, units, answer options, the form's name and the messages of checks. The codes of fields and answers do not change, so exports, checks and statistics do not depend on the language the patient answered in.

The study's languages

In the eCRF builder press Languages. Choose the language the forms are written in and tick the translations the study offers to patients and sites (up to eight). Hebrew and Arabic are shown right to left. The table on the page shows each form and how many of its texts are translated into each language: green is translated in full, yellow in part. The patient's forms come first.

Translating a form

Press the cell of a form and a language, or Translations on the form's page. The source text is on the left and the box for the translation on the right; an empty box keeps the text untranslated. If a question is later reworded in the builder, its old translation is marked source changed and does not count until someone checks it and saves it again. Preview shows the form in the chosen language with the same checks. The visit names are translated on their own page: the patient sees them next to the questionnaire.

Licensed questionnaires

EQ-5D, SF-36 and other licensed scales may be used only in the owner's official translation, under the licence. When a form has a scale passport, its translation page says so and does not save a translation until it says where it comes from (for example, the owner's official Hebrew version and the date of the licence). While the texts of a scale are locked, its translations are locked too: to add the official translation, unlock the texts with a reason, save the translation and lock them again.

What the patient sees

When the study has translations, a choice of language appears at the top of every patient page, each language in its own name (עברית, Қазақша). The site can choose the language in the patient card too, in the questionnaires block. A questionnaire is shown in the patient's language only when it is translated in full; otherwise it is shown in the source language, never half and half. The answers are stored with the same codes, warnings for the doctor open queries in the study's language, and the language the patient answered in is kept with the time and the device and shown on the form.

Buttons and messages of the patient's pages

The portal itself speaks Russian and English: in these languages the buttons and messages of the patient's pages are already translated. For another language (Hebrew, Arabic, Kazakh) the languages page has a row Buttons and messages of the patient's pages: the study's translator translates the PIN sign-in, the list of questionnaires, the questionnaire's buttons and the usual messages. Places like %(num)d and %(d)s stay as they are: the portal puts a number or a date there. An untranslated text shows in the portal's language.

Versions and the audit trail

A form's translation is part of the eCRF. Before the first release it shows in data entry at once; after it, it waits in the draft and reaches patients with the next version, and comparing versions shows which texts changed in which language. Every saved translation, change of the study's languages and patient's choice of language goes to the audit trail with the old and the new text. The buttons of the patient's pages are not part of the eCRF version: a change takes effect at once and goes to the audit trail as well.