Glossary entry (derived from question below)
French term or phrase:
Enveloppe codes
English translation:
unblinding enveloppes (see refs)
Added to glossary by
:::::::::: (X)
Mar 4, 2009 04:40
15 yrs ago
4 viewers *
French term
NAATI Accredited (M.A in Translation)
Native in: French 
Works in: English to French, Spanish to French, French to English, and 1 more.
Enveloppe codes
French to English
Medical
Medical: Pharmaceuticals
[Il s'agit de documents a fournir lors d'un essai clinique]
...instructions éventuelles quant à l’ouverture des codes (en cas d’étude en aveugle)...
Quelqu'un peut-il m'aider?
...instructions éventuelles quant à l’ouverture des codes (en cas d’étude en aveugle)...
Quelqu'un peut-il m'aider?
Proposed translations
(English)
| 5 +3 | unblinding enveloppes (see refs) |
:::::::::: (X)
|
| 3 | envelope containing/the/ codes |
liz askew
|
| 3 | code-break envelopes |
Marga Shaw
|
Change log
Mar 4, 2009 07:15: SJLD changed "Language pair" from "English to French" to "French to English"
Mar 5, 2009 06:31: :::::::::: (X) Created KOG entry
Proposed translations
+3
3 hrs
Selected
unblinding enveloppes (see refs)
Unblinding Clinical Trials Directory - Information from the ... - [ Traduire cette page ]Unblinding. Usually, treatment codes in a blinded trial should be broken by the sponsor ... 4200JMON.htm. This important review examines the effects of ...
ecancer-prostatecancermastasticizedtolymphnode.co.cc/unblinding-clinical-trials/ - Il y a 20 heures - Pages similaires
Scientific Misconduct Blog: Micro Statistics Tutorial 05 ... - [ Traduire cette page ]9 Feb 2008 ... In other words "could Schering Plough have cheated by trying to work out the outcome of ENHANCE before the "opening" the unblinding codes". ...
scientific-misconduct.blogspot.com/2008/02/micro-statistics-tutorial-05-functional.html - 32k - En cache - Pages similaires
[PDF] Standard Operating Procedures - [ Traduire cette page ]Format de fichier: PDF/Adobe Acrobat - Version HTML
Central Registry – The location that holds the allocation codes for each person participating in a trial in the form of unblinding envelopes
ecancer-prostatecancermastasticizedtolymphnode.co.cc/unblinding-clinical-trials/ - Il y a 20 heures - Pages similaires
Scientific Misconduct Blog: Micro Statistics Tutorial 05 ... - [ Traduire cette page ]9 Feb 2008 ... In other words "could Schering Plough have cheated by trying to work out the outcome of ENHANCE before the "opening" the unblinding codes". ...
scientific-misconduct.blogspot.com/2008/02/micro-statistics-tutorial-05-functional.html - 32k - En cache - Pages similaires
[PDF] Standard Operating Procedures - [ Traduire cette page ]Format de fichier: PDF/Adobe Acrobat - Version HTML
Central Registry – The location that holds the allocation codes for each person participating in a trial in the form of unblinding envelopes
Peer comment(s):
| agree |
SJLD
: probably - although context rather thin
3 mins
|
|
MERCI :)
|
|
| agree |
cjohnstone
: could do I think, quite well
6 mins
|
| agree |
FBrisson
1 hr
|
4 KudoZ points awarded for this answer.
Comment: "Thanks a lot!"
4 hrs
envelope containing/the/ codes
http://www.google.co.uk/search?q=envelopes containing the co...
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Note added at 4 hrs (2009-03-04 09:00:15 GMT)
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Microsoft PowerPoint - cours EClin.05.2006.ppt
- [ Translate this page ]
ESSAI CLINIQUE: toute étude réalisée chez l’être humain, visant à vérifier, ..... randomisation avec / sans enveloppes (code). • NON PROGRAMMABLE ...
www.gsasa.ch/formation/assistantes/fichiers/caph0506/ams_ec... - Similar pages
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Note added at 4 hrs (2009-03-04 09:01:27 GMT)
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Hi
New contribution:
Code envelope
Randomisation and Blinding
Note in the medical chart of the subject the randomisation code/study subject number. ... code envelope:. The date of unblinding, the reason for unblinding ...
content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ProduktNr=229514&ArtikelNr=74691 - Similar pages
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Note added at 4 hrs (2009-03-04 09:03:40 GMT)
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#
"Blinding: Codes and Code Breaking". In: Good Clinical Practice
as a trial that blinds the patient (single blind). Double blind trials are those ... All staff must know where any code envelopes are stored. Code envelopes ...
doi.wiley.com/10.1002/0470842520.ch20 - Similar pages
#
Comparison of descriptions of allocation concealment in trial ...
Code envelopes. In 42 of the 55 double blind studies, a security system for .... In most trial publications, allocation concealment is unclear or inadequate ...
bmj.bmjjournals.com/cgi/content/full/330/7499/1049 - Similar pages
by J Pildal - 2005 - Cited by 37 - Related articles
--------------------------------------------------
Note added at 4 hrs (2009-03-04 09:00:15 GMT)
--------------------------------------------------
Microsoft PowerPoint - cours EClin.05.2006.ppt
- [ Translate this page ]
ESSAI CLINIQUE: toute étude réalisée chez l’être humain, visant à vérifier, ..... randomisation avec / sans enveloppes (code). • NON PROGRAMMABLE ...
www.gsasa.ch/formation/assistantes/fichiers/caph0506/ams_ec... - Similar pages
--------------------------------------------------
Note added at 4 hrs (2009-03-04 09:01:27 GMT)
--------------------------------------------------
Hi
New contribution:
Code envelope
Randomisation and Blinding
Note in the medical chart of the subject the randomisation code/study subject number. ... code envelope:. The date of unblinding, the reason for unblinding ...
content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowPDF&ProduktNr=229514&ArtikelNr=74691 - Similar pages
--------------------------------------------------
Note added at 4 hrs (2009-03-04 09:03:40 GMT)
--------------------------------------------------
#
"Blinding: Codes and Code Breaking". In: Good Clinical Practice
as a trial that blinds the patient (single blind). Double blind trials are those ... All staff must know where any code envelopes are stored. Code envelopes ...
doi.wiley.com/10.1002/0470842520.ch20 - Similar pages
#
Comparison of descriptions of allocation concealment in trial ...
Code envelopes. In 42 of the 55 double blind studies, a security system for .... In most trial publications, allocation concealment is unclear or inadequate ...
bmj.bmjjournals.com/cgi/content/full/330/7499/1049 - Similar pages
by J Pildal - 2005 - Cited by 37 - Related articles
11 hrs
Marga Shaw
United Kingdom
United Kingdom
Specializes in field
United Kingdom
Language matters
Native in: German (Variants: Austrian, Germany, Swiss)
Works in: English to German, German to English
Related KudoZ points
:
4
code-break envelopes
Code-break envelopes
At randomisation stage the patients participating in a clinical trial are for example sequentially randomised to either treatment with the study drug or placebo. For example in a double-blind trial neither patient nor investigator know which type of treatment the patient receives. In order to be able identify the treatment received by the patient, there is an envelope which contains a code. The envelope is sealed and is stored in the study centre for emergencies, in which case the code may be broken.
For example:
Randomisation procedures and unblinding
The randomisation procedures as specified in the clinical trial protocol should be followed at all times.
The code breaks should only be revealed if:
- Treatment of an adverse event is dependant upon knowledge of the drug administered
- The study must be terminated for safety reasons
- A third party requires the information (e.g. coroner)
The patient’s welfare must always take priority over any other consideration in determining when a code break should be revealed. Except in the case of an emergency, the code break should only be revealed with the agreement of the sponsor company.
If the code break envelope has been opened; it should be re-sealed dated and signed by the opener. The reason for revealing the code must be written on the envelope and a note made in the site file. Any accidental or non-accidental opening of a code break envelope must be reported to the sponsor company.
All code break envelopes must be returned unopened (unless they have been opened for any of the above reasons) to the sponsor the end of the study.
www.elybridge.co.uk/SOPS_Mgmt.htm
At randomisation stage the patients participating in a clinical trial are for example sequentially randomised to either treatment with the study drug or placebo. For example in a double-blind trial neither patient nor investigator know which type of treatment the patient receives. In order to be able identify the treatment received by the patient, there is an envelope which contains a code. The envelope is sealed and is stored in the study centre for emergencies, in which case the code may be broken.
For example:
Randomisation procedures and unblinding
The randomisation procedures as specified in the clinical trial protocol should be followed at all times.
The code breaks should only be revealed if:
- Treatment of an adverse event is dependant upon knowledge of the drug administered
- The study must be terminated for safety reasons
- A third party requires the information (e.g. coroner)
The patient’s welfare must always take priority over any other consideration in determining when a code break should be revealed. Except in the case of an emergency, the code break should only be revealed with the agreement of the sponsor company.
If the code break envelope has been opened; it should be re-sealed dated and signed by the opener. The reason for revealing the code must be written on the envelope and a note made in the site file. Any accidental or non-accidental opening of a code break envelope must be reported to the sponsor company.
All code break envelopes must be returned unopened (unless they have been opened for any of the above reasons) to the sponsor the end of the study.
www.elybridge.co.uk/SOPS_Mgmt.htm
Discussion