KudoZ home » Spanish to English » Medical (general)

El adjunto de seguridad

English translation: enclosed safety summary/report

Advertisement

Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs
(or are passionate about them). Participation is free and the site has a strict confidentiality policy.
GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:El adjunto de seguridad
English translation:enclosed safety summary/report
Entered by: Adam Burman
Options:
- Contribute to this entry
- Include in personal glossary

18:44 Oct 22, 2006
Spanish to English translations [PRO]
Medical - Medical (general) / Research report for new drug
Spanish term or phrase: El adjunto de seguridad
El adjunto de seguridad incluye los listados de efectos adversos graves clasificados como relacionados con el fármaco o no, por paciente, en los estudios sobre MDD y VMS.

Safety attachment?

TIA
Adam Burman
United Kingdom
Local time: 22:12
enclosed safety summary
Explanation:
See:


http://64.233.183.104/search?q=cache:FN4495sbzlEJ:www.geneng...

NDA Submission
When clinical testing has been completed and analyzed, final manufacturing processes and procedures are in place, and the company has ready other required information, it must submit a New Drug Application (NDA) to the FDA. No action can be taken to market any therapeutic drug product in the U.S. until the FDA has approved an NDA.
The data in the NDA must establish that the drug is safe for use under the proposed labeling conditions and is effective for its proposed use(s). Substantial evidence is defined by statute and FDA regulation to mean evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and experience, to evaluate the effectiveness of the drug involved.
The NDA must contain data-obtained outlines from the clinical trials of the drug, as well as a description and analysis of the drug’s pharmacokinetics. It must also include a description and analysis of any other data relevant to the safety and effectiveness of the drug product obtained from any source, foreign or domestic.
The NDA also includes an integrated summary of all available information about the safety of the drug product, including potential adverse effects and clinically significant potential adverse reactions with other related drugs.




http://64.233.183.104/search?q=cache:9vGJ7T1DLLIJ:en.wikiped...


Selected response from:

liz askew
United Kingdom
Local time: 22:12
Grading comment
Thanks Liz :-)
4 KudoZ points were awarded for this answer

Advertisement


Summary of answers provided
5patient information leaflet
Carol Gullidge
3 +2Safety exhibit / schedule / section
Maria
4safety reportxxxLia Fail
4enclosed safety summaryliz askew
3Safety attachment leaflet
Javier Perez
3the security attachment/annex
Laura Iglesias


Discussion entries: 2





  

Answers


4 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
the security attachment/annex


Explanation:
an idea

Laura Iglesias
Spain
Local time: 23:12
Works in field
Native speaker of: Native in SpanishSpanish, Native in GalicianGalician
PRO pts in category: 16
1 corroborated select project
in this pair and field What is ProZ.com Project History(SM)?
Login to enter a peer comment (or grade)

4 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
Safety exhibit / schedule / section


Explanation:
creo que cualquiera de ellas serviría.

Maria
Local time: 16:12
Works in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 35

Peer comments on this answer (and responses from the answerer)
agree  Jorge Blanco: I would use section.
1 hr

agree  silviantonia: Tanto exhibit como schedule incluyen el significado de adjunto.
8 hrs
Login to enter a peer comment (or grade)

18 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
Safety attachment leaflet


Explanation:
Una idea

Javier Perez
Uruguay
Local time: 18:12
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 27
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 5/5
patient information leaflet


Explanation:
in UK

I'm staring at one right now, and that's what it says at the top

Carol Gullidge
United Kingdom
Local time: 22:12
Native speaker of: Native in EnglishEnglish
PRO pts in category: 57

Peer comments on this answer (and responses from the answerer)
neutral  xxxLia Fail: A patient info leaflet informs patients in 'patient' language about a trial they are participating in. This is a report on adverse affects aimed at health authorities/ the scientific community.
22 hrs
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
safety report


Explanation:
Even if this is an attached document, it still has to be called a "safety something".

Given the content described, "Safety report" seems a logical translation, as that, in effect is what happenes, these adverse effects are 'reported' to a health authority.


Online Ethics Center: Ethical and Policy Issues in Research ...
(1) Unanticipated adverse device effects. An investigator shall submit to the ... Followup information to a safety report shall be submitted as soon as the ...onlineethics.org/reseth/nbac/happendixh.html - 21k - Cached - Similar pages
A systematic review of the safety profile of levetiracetam: a new ...
Methods: The integrated summary of safety report submitted for regulatory review ... Higher incidences of adverse effects, particularly behavioral effects, ...cat.inist.fr/?aModele=afficheN&cpsidt=14132112 - Similar pages
G Therapy - safety report
*Volunteers/Researchers*, G-therapy : Safety Report ... of few months to couple of years and has proved to be very safe, with almost no adverse effects. ...www.g-therapy.org/safety.htm - 16k - Cached - Similar pages
FEHB Patient Safety Information for the Bluecare Network of MI
Pharmacy Quality/Safety Report: Prevention of Adverse Effects in Elderly Patients. During 2003, Blue Care Network moved into its third year of quarterly ...www.opm.gov/insure/04/safety/g7.asp - 19k - Cached - Similar pages
Drug report barred by FDA / Scientist links antidepressants to ...
... Arava, which had generated numerous reports of adverse effects, ... who had prepared a 37-page safety report, were present at the hearing but were not ...www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/02/01/MNG... - 31k - Cached - Similar pages


xxxLia Fail
Spain
Local time: 23:12
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 100
Login to enter a peer comment (or grade)

21 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
enclosed safety summary


Explanation:
See:


http://64.233.183.104/search?q=cache:FN4495sbzlEJ:www.geneng...

NDA Submission
When clinical testing has been completed and analyzed, final manufacturing processes and procedures are in place, and the company has ready other required information, it must submit a New Drug Application (NDA) to the FDA. No action can be taken to market any therapeutic drug product in the U.S. until the FDA has approved an NDA.
The data in the NDA must establish that the drug is safe for use under the proposed labeling conditions and is effective for its proposed use(s). Substantial evidence is defined by statute and FDA regulation to mean evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and experience, to evaluate the effectiveness of the drug involved.
The NDA must contain data-obtained outlines from the clinical trials of the drug, as well as a description and analysis of the drug’s pharmacokinetics. It must also include a description and analysis of any other data relevant to the safety and effectiveness of the drug product obtained from any source, foreign or domestic.
The NDA also includes an integrated summary of all available information about the safety of the drug product, including potential adverse effects and clinically significant potential adverse reactions with other related drugs.




http://64.233.183.104/search?q=cache:9vGJ7T1DLLIJ:en.wikiped...




liz askew
United Kingdom
Local time: 22:12
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 3841
Grading comment
Thanks Liz :-)
Login to enter a peer comment (or grade)




Return to KudoZ list


KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.



See also:



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