In December 2015, Spain incorporated Clinical Trials Regulation EU No. 536/2014 into Spanish law through Real Decreto 1090/2015. In April 2016, the AEMPS published an ‘unofficial’ English translation of the Royal Decree (RD) on its website. One year on, I’m going to share my alignment of the source and target texts and look at the translation decisions for three official names in the English version. The first is an old friend and the subject of much debate; the second, a variation on a well-known theme; and the third, a new term that is already cropping up in Spanish source texts:

1. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
2. Comité de Ética de la Investigación con medicamentos (CEIm)
3. Registro Español de Estudios Clínicos (REec)

1. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

The English translation,  Spanish Agency of Medicines and Medical Devices, reflects the translation used most often on the AEMPS website, but the exact wording remains arbitrary. After using healthcare products and medical devices interchangeably for ‘Productos Sanitarios’ for several years, the AEMPS now mostly translates its name as Spanish Agency of Medicines and Medical Devices, occasionally opting for medicinal products instead of medicines for ‘Medicamentos’. When I checked the EN home page today, I found:

It would be very helpful to have a validated English translation for the full AEMPS name, and I would suggest Spanish Agency for Medicines and Medical Devices (a version used by the AEMPS itself ten years ago¹). The preposition for is more common than of as a collocate of agency.²

2. Comités de Ética de la Investigación con medicamentos (CEIm)

Ethics committees in Spain have changed names and functions over the years. Back in 1978, they were introduced as Comités de Ensayos Clínicos (CEC), changing in 2004 to Comités Éticos de Investigación Clínica (CEIC) and in 2007 to Comités de Ética de la Investigación (CEI) to cover non-pharmacological research studies.

Royal Decree 1090/2015 requires CEIs to become accredited as Comités de Ética de la Investigación con medicamentos (CEIm).

How should we translate all these bodies into English?

Ethics committees are called Research Ethics Committees (REC) in the UK and Institutional Review Boards or Independent Ethics Committees (IRB/IEC) in the US.

However, the equivalent UK or US term can’t be used as a blanket term to cover CEIC, CEI and CEIm indiscriminately. Sponsors and Contract Research Organizations have preferences for translating these abbreviations and I have been instructed, depending on the client, to translate CEIC as IEC, CREC, REC or keep it as CEIC. In this field, a separate translation memory and termbase for each client is clearly essential.

In the Royal Decree, Comités de Ética de la Investigación con Medicamentos is translated as Ethics Committees for investigation with medicinal products. I think this literal translation is a good solution for the Royal Decree, especially as the Spanish abbreviation CEIm is retained. However, in practice my clients ask me to use RECm or IECm. Both abbreviations are readily understandable for non-Spanish speakers, while retaining the “m” appendage to reflect the new type of ethics committee. Another solution is to simply use the English expansion, without an abbreviation.³

In the unofficial translation, I was intrigued by the choice of initial capitals for Ethics Committees and lowercase for investigation with medicinal products. The decision makes sense semantically, but is hard to justify because of the single lowercase ‘m’ in the abbreviation.

I was also surprised by the choice of investigation rather than research. The word research is invariably used for ethics committees, and in fact the ‘I’ stands for independent, not investigation, in the US abbreviation IEC.

3. Registro Español de Estudios Clínicos (REec)

The new Royal Decree introduces a national register for clinical studies. The term clinical study is quite deliberate here, because the Spanish register will include non-interventional studies as well as clinical trials. (For a discussion of the new distinction between trials and studies, see an earlier blog post I wrote on Regulation EU 536/2014.)

In English, registry and register are often used interchangeably, although, according to the Oxford dictionary, a registry is ‘A place where registers or records are kept’ or ‘An official list or register’ and register is ‘An official list or record of names or items’.

I agree with the unofficial translation Spanish Clinical Studies Registry. Except for the EU Clinical Trials Register, English-speaking institutions show a clear preference for registry:

WHO International Clinical Trials Registry Platform
‘ClinicalTrials.gov is a registry and results database‘
Australian New Zealand Clinical Trials Registry (ANZCTR)

Again, the abbreviation REec has been retained in Spanish throughout the English version of the Royal Decree. Note the deliberate use of two uppercase followed by two lowercase characters.

ES-EN alignment of the Royal Decree and practicalities

I downloaded the ES and EN pdf files, converted them to txt files, and used LF Aligner to align the files and create this tmx. I added a field in my own translation memory to note that this translation is unofficial, and in Studio projects I set up a filter to apply a small penalty to that field. I’ll explain how to do this in more detail in a future post, but hope the tmx is useful in the meantime.

References
¹ Spanish Agency for Medicines and Medical Devices, unofficial EN translation of RD 1344/2007
² Sketch Engine TenTen Corpus, 2013
³ Gallego-Borghini, L. La traducción de géneros jurídico-administrativos en la gestión de ensayos clínicos multinacionales en España: más allá del protocolo. Panace@ 2012; 13 (36): 176-200

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