By now, you’ve probably read about the new European Union Clinical Trials Regulation that will be replacing Directive 2001/20/EC. I wrote about its implications for translators here, and looked at the new terminology it brings here. The good news for translators is that it’s already officially translated from English into the other 23 working languages of the European Union. All you need to do is align your source and target language versions and you’ll be equipped with a validated translation of the CT Regulation.

The instructions below are for the Clinical Trials Regulation, but you can align any EU legislation by searching for it on the EUR-Lex homepage and following one of the methods described below.

Alignment

The multilingual versions of the Clinical Trials Regulation are available in HTML and PDF format. The link gives you access to a multilingual display with two or three languages, side by side. Choose your languages from the two-letter codes: bg, cs, da, de, el, en, es, et, fi, fr, ga, hr, hu, it, lt, lv, mt, nl, pl, pt, ro, sk, sl, sv.

Method 1: Excel + SDL Trados Studio

1. Go to the EUR-Lex website, open the side-by-side display for two languages and select and copy all the text. You’ll see that the format is parallel, segmented text.
2. Paste it into an empty Excel spreadsheet. Delete the last few rows that just contain a list of articles. Save the Excel file in .xlsx format.
3. Process the file in Studio 2015: Enable the Bilingual Excel file type, define the source and target columns and confirm existing translations. For more detailed instructions, see Nora Diaz’s blog post on the new bilingual Excel file type.

If you have an earlier version of SDL Trados Studio, check out the instructions in a blog post I wrote on the Declaration of Helsinki to use the comma delimited text file type instead.

4. Save the SDLXLIFF file and import it into a translation memory.

Method 2: LF Aligner

While the above method is simple, this one is even easier, despite the longer instructions.

Use the open source LF Aligner, by Andras Farkas, to automatically download and align any EU legislation and save it in TMX format.

1. Download LF Aligner and run the .exe file.
2. Select EU legislation by CELEX number.

3. Browse to the folder where you want to save the alignment.
4. Select your language pair.
5. Enter CELEX number 32014R0536.
6. Select paragraph level segmenting. LF Aligner skips the file segmentation step and uses the presegmented versions of the HTML files instead. (Note that in most other alignment projects, sentence segmentation is probably better.)
7. Select no review (because the alignment needs no editing) or use the graphical editor (to delete the last few rows that just contain a list of articles).
8. Generate the TMX file.
9. Change the Note option to Off (I recommend adding a field later when you import the TMX in Studio).
10. Import the TMX file into a translation memory.

What are CELEX numbers?

CELEX numbers are unique references to official EU records. They are categorised by sector, year, document type and reference number. The CELEX number for EU Regulation 536/2014 is 32014R0536, which is broken down as follows:

• Sector: 3 (legislation)
• Year: 2014
• Document type: R (regulation)
• Reference number: 0536 (a zero is added to make a four-digit number)

Need the ES-EN alignment?

Skip all the above steps and download the Spanish-English version of EU Regulation 536/2014 from this DropBox link. The TMX can be imported into an ES-EN or EN-ES translation memory.