a copy of the signed form/a signed form

English translation: State explicitly "signed ORIGINAL"

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15:41 Apr 19, 2018
English to English translations [PRO]
Medical - Medical: Pharmaceuticals / Informed Consent Forms
English term or phrase: a copy of the signed form/a signed form
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.
Tuncay Kurt
Turkey
English translation:State explicitly "signed ORIGINAL"
Explanation:
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
Selected response from:

Lian Pang
Poland
Local time: 14:25
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +3State explicitly "signed ORIGINAL"
Lian Pang


Discussion entries: 4





  

Answers


10 mins   confidence: Answerer confidence 5/5 peer agreement (net): +3
State explicitly "signed ORIGINAL"


Explanation:
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)

--------------------------------------------------
Note added at 12 mins (2018-04-19 15:53:42 GMT)
--------------------------------------------------

This is just a general comment. I am not specialized in ICF documents

Lian Pang
Poland
Local time: 14:25
Meets criteria
Works in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 4
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
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
  -> 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...

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

agree  Ashutosh Mitra
11 hrs
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