Oct 25, 2003 17:35
21 yrs ago
2 viewers *
Swedish term
Canada
Fast, friendly and flexible.
Native in: English (Variants: Canadian, US) 
Works in: Swedish to English, Danish to English, Norwegian to English, and 1 more.
SAE
Swedish to English
Medical
Medical testing avtal
Företaget övertar prövarens skyldighet att rapportera SAE till Läkemedelsverket.
Proposed translations
(English)
| 5 | serious adverse event |
Anette Herbert
|
Proposed translations
2 hrs
Anette Herbert
Native in Swedish
Medical and health translations
Native in: Swedish
Works in: English to Swedish, Swedish
Related KudoZ points
:
161
Selected
serious adverse event
It is an acronym for a term in clinical trials - serious adverse event, which the testing company has to report to the medical agency.
In your case the company will take over that responsibility.
Allvarlig oönskad händelse eller allvarlig oönskad reaktion see Läkemedelsverket LVFS2003:6
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Note added at 2 hrs 17 mins (2003-10-25 19:53:22 GMT)
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The definition is such:
‘serious adverse event or serious adverse reaction’: any
untoward medical occurrence or effect that at any dose
results in death, is life-threatening, requires hospitalisation
or prolongation of existing hospitalisation, results in
persistent or significant disability or incapacity, or is a
congenital anomaly or birth defect;
see Official Journal of the European Communities 1.5.2001 L 121/34
DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 April 2001
In your case the company will take over that responsibility.
Allvarlig oönskad händelse eller allvarlig oönskad reaktion see Läkemedelsverket LVFS2003:6
--------------------------------------------------
Note added at 2 hrs 17 mins (2003-10-25 19:53:22 GMT)
--------------------------------------------------
The definition is such:
‘serious adverse event or serious adverse reaction’: any
untoward medical occurrence or effect that at any dose
results in death, is life-threatening, requires hospitalisation
or prolongation of existing hospitalisation, results in
persistent or significant disability or incapacity, or is a
congenital anomaly or birth defect;
see Official Journal of the European Communities 1.5.2001 L 121/34
DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 4 April 2001
4 KudoZ points awarded for this answer.
Comment: "Tack så mycket!"
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