Pages in topic:   [1 2] >
Clinical trial translation
Thread poster: nikoniko4649
nikoniko4649  Identity Verified

Japanese to English
Oct 18, 2013

Hello Prozians

I have been trying to search the forums in Proz about clinical trial translations, but could not find any which could answer my questions...Not sure if I have overlooked any....

I have always kept away from even looking at translations of clinical trial, but recently, one of my friends posted some information about some app for clinical trials...and that made me to read a little further about it....It was quite interesting to read about this concept, so I started thinking from the perspective of translation...

Though my specialization is in the field of IT for the language pair JPN to EN, I wanted to ask if any of you can share your insights on how to go about doing translation in this field. Is it only possible for those in the field of medicine or can anyone who is willing to learn from the scratch pick it up ?

I have not as such seen how a report or translated document would be, and maybe I have to search about it, but I don't know where and how to start..If it is possible, I would like to learn and its not that I will jump into accepting translations right away !!! I am going to take time (maybe years) and see if its really possible for me, but again as I said, I would really be grateful if any of you can share some links or information for beginners like me...As such I have about 10 years of experience in translation, so adapting the style of translation for this genre and a lots of reading is what I expect to do if feasible...

Hoping to hear from experienced people soon !

Thanks...


Direct link Reply with quote
 

Andriy Yasharov  Identity Verified
Ukraine
Local time: 13:28
Member (2008)
English to Russian
+ ...
Time and effort Oct 18, 2013

It does take time to learn how to deal with translation of clinical trial documents. Even with a University degree in biology and several years' experience in medical translation, as it is in my case, it took me at least two years to feel comfortable when translating clinical study protocols and investigator's brochures.
If I were you, I'd start with learning anything that is related to clinical trials, focusing on the principles of GCP, GMP, study design, phases of a study, methods of comparison, etc. All this information, including webinars, videos and other media is widely available on the Internet.


Direct link Reply with quote
 

Helios_Dang  Identity Verified
Vietnam
Local time: 17:28
English to Vietnamese
+ ...
Understanding about Clinical Trials Oct 18, 2013

You can come here: https://tghn.org/elearning/ and learn about Clinical Trials. Very basic, understandable and totally free. It does not require a lot of time to read as well.

Direct link Reply with quote
 

Emma Goldsmith  Identity Verified
Spain
Local time: 12:28
Member (2010)
Spanish to English
Skills required for translating clinical trials Oct 18, 2013

Clinical trial translations require two skills:
1. Knowledge of trial-related terminology, procedures, protocols, etc. In other words, all the regulatory side of a trial.
2. Medical knowledge.

For the first skill, you can read the EU Clinical Trials Directive:
http://new.eur-lex.europa.eu/legal-content/EN/TXT/?qid=1382089814916&uri=CELEX:32001L0020
Unfortunately it's not in Japanese - only EU languages.

You can buy the UK Good clinical Practice Guide:
http://www.tsoshop.co.uk/bookstore.asp?FO=1160007&DI=635071&trackid=000039
It's all about clinical trials in the UK. If you like, you can read my review of it here:
http://signsandsymptomsoftranslation.com/2012/10/03/gcp/

You can read about on-going clinical trials here:
https://www.clinicaltrialsregister.eu/
and here:
http://clinicaltrials.gov/

You can read up on terminology here:
http://clinicaltrials.gov/ct2/about-studies/glossary
and on pharma company websites, such as:
http://www.novctrd.com/ctrdWebApp/patients/at_glossary.jsp

The second skill is harder. Medical knowledge can only be gained through years of study, either through formal training or self-learning.

Good luck!


Direct link Reply with quote
 
nikoniko4649  Identity Verified

Japanese to English
TOPIC STARTER
There's so much more than meets the eye !! Oct 18, 2013

Wow....thanks a lot for those detailed responses - Andrey, Hang & Emma !!
I truly appreciate that !!

The one thing that I expected to hear was this is going to take years of effort (which I am actually quite willing to put in), but the one which I didn't expect was such precise directions on how I could begin ! At least now I know where to start, unlike yesterday when I was fumbling for details..!

I am going to search more about what Andrey said ( quote : "anything that is related to clinical trials, focusing on the principles of GCP, GMP, study design, phases of a study, methods of comparison, etc") as well as those links which Hang & Emma have sent....That's quite a good way to start off with....

Please keep this thread running for beginners like me who want to choose this particular genre.

The other thing I would like to know is what are the kinds of documents that one gets for clinical trials? For example, in case of IT field, I know the various documents requiring different styles of translation, say specifications, manuals etc. (to quote a few), and am quite aware of that. In this case, what are most common types of documents dealt with regularly? Is it called clinical report? I am quite keen on getting into this after a few years during which I want to learn, and in this case, I will have to depend on pure self-learning along with virtual support from fellow translators. Also since I deal with the Japanese to English pair, will there be a major difference in which translation is handled?


Direct link Reply with quote
 

Andriy Yasharov  Identity Verified
Ukraine
Local time: 13:28
Member (2008)
English to Russian
+ ...
Documents Oct 18, 2013

what are the kinds of documents that one gets for clinical trials?

The documents that I regularly translate are patient information sheets, informed consent forms, clinical study protocols, certificates of analysis, clinical trial agreements, investigator's brochures, patient questionnaires, just to name a few. These are the most common types of documents of clinical trials.


Direct link Reply with quote
 

Fiona Grace Peterson  Identity Verified
Italy
Local time: 12:28
Member
Italian to English
JAT Oct 18, 2013

Since you are in Japan, you may find the JAT website of interest. Lots of articles in English too

http://jat.org/articles/show/how-to-become-established-as-a-medical-translator


Direct link Reply with quote
 

Marjolein Snippe  Identity Verified
Netherlands
Local time: 12:28
Member (2012)
English to Dutch
+ ...
open online courses Oct 18, 2013

I do think it may take a while if you come from a different background, but if you are really interested there is a lot to be found.

I recently attended a free online course about trial design.
I found it rather basic, but perhaps that is because I have a background in the subject; I did find it gives you a few tips as to where you can go for more information.
Have a look at coursera:
https://www.coursera.org/course/clintrials
https://www.coursera.org/course/vacctrials

(I'm sure other online courses are available too, if you search for them.)


Direct link Reply with quote
 
xxxClaudia Gill  Identity Verified
Belgium
Local time: 12:28
English to French
+ ...
Coursera is great. Oct 18, 2013

Marjolein is right when advising Coursera.

As you are a complete beginner in this field, maybe it would be a good idea to attend this course :
https://www.coursera.org/course/clinicalterminology


Direct link Reply with quote
 
nikoniko4649  Identity Verified

Japanese to English
TOPIC STARTER
Thanks Andrey Oct 18, 2013

Andrey Yasharov wrote:

what are the kinds of documents that one gets for clinical trials?

The documents that I regularly translate are patient information sheets, informed consent forms, clinical study protocols, certificates of analysis, clinical trial agreements, investigator's brochures, patient questionnaires, just to name a few. These are the most common types of documents of clinical trials.


Thanks Andrey....this is exactly what I was looking for...Based on this input, I will try to search for relevant links and samples!


Direct link Reply with quote
 
nikoniko4649  Identity Verified

Japanese to English
TOPIC STARTER
Thanks Fiona Marjolein & Claudia... Oct 18, 2013

That is really very helpful !

Claudia Gillard wrote:

Marjolein is right when advising Coursera.

As you are a complete beginner in this field, maybe it would be a good idea to attend this course :
https://www.coursera.org/course/clinicalterminology



As soon as I saw this link, I immediately subscribed to ../course/clintrials & ..../course/.clinicalterminology ! The latter is next month and the former is in Feb 2014...! Looks like a very systematic explanation....and saw that these are video presentations..I am now looking forward to attending those sessions !

I am so glad I posted here for guidance and I have got more than I even imagined

Oh btw, the coursera link hints at U.S. and one other Prozian mentioned U.K.
What are the similarities/differences? Maybe those working in the respective countries can give some idea about it ?

And, I'm still waiting for response from someone in my language pair....Now I am trying to hunt for glossaries in clinical trials from JPN to EN...if anyone has a good link, please do share them !
I'm very sure that this thread will provide wealth of information to those looking at this opportunity.

[Edited at 2013-10-18 14:26 GMT]


Direct link Reply with quote
 
QHE
United States
Local time: 06:28
English to Chinese
+ ...
Regulations in different countries Oct 18, 2013

nikoniko4649 wrote:
That is really very helpful !

Oh btw, the coursera link hints at U.S. and one other Prozian mentioned U.K.
What are the similarities/differences? Maybe those working in the respective countries can give some idea about it ?


Hope the following links would shed some light for the subject.


Clinical Trial Requirements U.S. vs. EU Similarities and Differences
http://www.slideshare.net/RETIRE/clinical-trial-requirements-us-vs-eu-similarities-and-differences


Clinical Trials in the Developing World
http://www.debatingmatters.com/documents/DM_TopicGuidesClinicalTrials.pdf

http://www.gsk.com/content/dam/gsk/globals/documents/pdf/GSK-on-clinical-trials-in-the-developing-world.pdf


Conducting Clinical Trials in Asia
http://www.slideshare.net/medpace/conducting-clinical-trials-in-asia-global-engagemay2012


Direct link Reply with quote
 
philgoddard
United States
Member (2009)
German to English
+ ...
Not disagreeing with previous posters, but... Oct 18, 2013

... I've done large numbers of patient information sheets, consent forms and ethics committee correspondence, despite having limited medical knowledge.

There are a few bits of terminology you need to know, like "principal investigator", "double blind", "randomization" and "adverse event", but most of them are common sense and can be looked up online.

You might make a few mistakes at first (I did), but you soon learn. Get your first couple of translations checked by someone who knows about clinical trials, and go for it!


Direct link Reply with quote
 

Emma Goldsmith  Identity Verified
Spain
Local time: 12:28
Member (2010)
Spanish to English
Good point Oct 18, 2013

philgoddard wrote:

patient information sheets, consent forms and ethics committee correspondence, despite having limited medical knowledge.



Fair enough, Phil, you've named the three types of documents that are quite low key (from a medical point of view). In fact, the first two should actually avoid medical jargon, as you know.

I wouldn't like an investigator's brochure or a clinical trial protocol to fall into inexpert hands though...


Direct link Reply with quote
 

jyuan_us  Identity Verified
United States
Local time: 06:28
Member (2005)
English to Chinese
+ ...
You can translate clinical trial documents Oct 19, 2013

Actually any one could. However, someone without a formal medical education would not be able to judge what is right and what is wrong. A concept can easily be translated to the opposite of their intended meaning but the translator themselves might not realize it. That could cost lives.

If I were a client, I would not use anyone without a medical background.

[Edited at 2013-10-19 07:34 GMT]


Direct link Reply with quote
 
Pages in topic:   [1 2] >


To report site rules violations or get help, contact a site moderator:


You can also contact site staff by submitting a support request »

Clinical trial translation

Advanced search







TM-Town
Manage your TMs and Terms ... and boost your translation business

Are you ready for something fresh in the industry? TM-Town is a unique new site for you -- the freelance translator -- to store, manage and share translation memories (TMs) and glossaries...and potentially meet new clients on the basis of your prior work.

More info »
Across v6.3
Translation Toolkit and Sales Potential under One Roof

Apart from features that enable you to translate more efficiently, the new Across Translator Edition v6.3 comprises your crossMarket membership. The new online network for Across users assists you in exploring new sales potential and generating revenue.

More info »



Forums
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search