Apr 19, 2018 15:41
6 yrs ago
11 viewers *
English term
Türkiye
MEDICAL & PHARMACEUTICAL TRANSLATION
Native in: Turkish (Variant: Standard-İstanbul ) 
Works in: English to Turkish, Turkish to English
a copy of the signed form/a signed form
English
Medical
Medical: Pharmaceuticals
Informed Consent Forms
Hello All,
I have a somewhat tricky issue here and would like to get your opinion/feedback on this. As you know, subjects/patients must sign an ICF document to enter any clinical trial. While obtaining the consent from subjects usually they sign/date two original forms and one of them is given to subject and the other one is kep in study file by the investigator.
Recently, I have a negative feedback from one of my clients and their Editor indicated an issue about the translation of this sentence: "You will be given a signed form to keep."
Instead of translating it exactly I have chosen to use a somewhat different translation which reads as "You will be given a copy of the signed form to keep" and the Editor' comment is: Translation states that “a copy of the signed form” will be given to the patient. This can trigger comments from EC/RA. Patient will be given a signed original.
There are two original ICF documents (ie, there are two copies prepared and both of them are original documents) and subjects signs each of them. One copy is given to the subject. I do not think an investigator "copies" the original document. Does this term "copy" states that it is not original (in my opinion, NOT). In English (in legal terms or as a general rule in ICF documents), does it make any difference?
Sorry if it is a bit confusing but I do not have any knowledge in such a legal topic beyond being a medical translator who has been working on ICF documents for 12 years.
Please kindly share your thoughts.
I have a somewhat tricky issue here and would like to get your opinion/feedback on this. As you know, subjects/patients must sign an ICF document to enter any clinical trial. While obtaining the consent from subjects usually they sign/date two original forms and one of them is given to subject and the other one is kep in study file by the investigator.
Recently, I have a negative feedback from one of my clients and their Editor indicated an issue about the translation of this sentence: "You will be given a signed form to keep."
Instead of translating it exactly I have chosen to use a somewhat different translation which reads as "You will be given a copy of the signed form to keep" and the Editor' comment is: Translation states that “a copy of the signed form” will be given to the patient. This can trigger comments from EC/RA. Patient will be given a signed original.
There are two original ICF documents (ie, there are two copies prepared and both of them are original documents) and subjects signs each of them. One copy is given to the subject. I do not think an investigator "copies" the original document. Does this term "copy" states that it is not original (in my opinion, NOT). In English (in legal terms or as a general rule in ICF documents), does it make any difference?
Sorry if it is a bit confusing but I do not have any knowledge in such a legal topic beyond being a medical translator who has been working on ICF documents for 12 years.
Please kindly share your thoughts.
Responses
| 5 +3 | State explicitly "signed ORIGINAL" |
Lian Pang
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Responses
+3
10 mins
Selected
State explicitly "signed ORIGINAL"
If I get what you mean correctly, You used the word "copy" as in " set", "you will be given a set of the signed form (original) to keep". Right ?
Well it is indeed tricky. But as far as i am concerned and have encountered, "copy" in most cases means " photocopy", as opposed to the "original". I think it's better to state explicitly to stay on the safe side. (Or at least say "duplicate" if acceptable)
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Note added at 12 mins (2018-04-19 15:53:42 GMT)
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This is just a general comment. I am not specialized in ICF documents
Well it is indeed tricky. But as far as i am concerned and have encountered, "copy" in most cases means " photocopy", as opposed to the "original". I think it's better to state explicitly to stay on the safe side. (Or at least say "duplicate" if acceptable)
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Note added at 12 mins (2018-04-19 15:53:42 GMT)
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This is just a general comment. I am not specialized in ICF documents
Peer comment(s):
| agree |
Tony M
: Yes, this is a very important point, and the ambiguity in EN means you simply can't get away with using 'copy'.
27 mins
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Thank you Tony. I have been filing some paper works to the authorities recently, and sometimes they also use "copy" to mean "additional original", which have caused me unnecessary troubles...
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| agree |
Charles Davis
: There are several possibilities in English, and it's not essential to use the word "original", but the word "copy" will almost certainly be misinterpreted.
1 hr
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| agree |
Ashutosh Mitra
11 hrs
|
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
Discussion
One way round it is to slightly re-phrase, so you say something like "the form will be signed in duplicate by both parties, one copy of which will be given to the patient." Here, the use of 'one' (rather than just 'a') clarifies that it is one of the duplicate signed originals.
Actually, that is the explanation I have provided to the Editor and tried to tell that "one of the original document" or "a copy of the original document" are the same. I have translated this from English to Turkish and already asked some co-workers but wanted to have the input from other translators translating from English or from native English speakers working on such documents.
Either way, I think this question is difficult to answer unless you know both languages. Would it be better to post it in the language pair concerned?
"Copy" can be confusing in English, because it can sometimes mean an original.