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Glossary entry

español term or phrase:

baja (del investigador principal y del centro)

inglés translation:

termination

Added to glossary by Hinanit Glazer
Aug 9, 2012 21:43
11 yrs ago
12 viewers *
español term

baja (del investigador principal y del centro)

español al inglés Medicina Medicina: Farmacia clinical trial
This is part of an official document related to a clinical trial.

I cannot seem to find the right term... withdrawal, discharge... isn't there a better word?

"vuestra administración emite la aprobación de la baja del centro del Dr. xxx"
"copia de la aprobación de baja al investigador principal Dr. xxx"

Thanks!
Proposed translations (inglés)
3 termination
4 +1 withdrawal
4 deregistration
3 wihtdrawal
3 Discontinue participation

Proposed translations

11 horas
español term (edited): baja
Selected

termination

IMO this does refer to the trial site/investigator (but not to the principal investigator, who will only receive a copy of the approval document). In this case, the investigator may either terminate participation or be terminated by the principal investigator or sponsor (e.g. for misconduct, non-compliance, etc). Unless it is clear from the context, you might need a term which covers both options.


"The sponsor must notify FDA when a clinical investigator’s participation is terminated for noncompliance. Sponsors who are reluctant to report misconduct may terminate an investigator for “administrative” reasons and are not required to report."
http://oig.hhs.gov/oei/reports/oei-05-99-00350.pdf

Reference:

http://ctmagnifier.org/ctmconf/2011/P21%20-%20Audrey%20Shum.pdf

Note from asker:
This is very helpful! Thanks so much. This definitely sound like the right term, withdrawal and discharge just didn't seem right...
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thanks again!"
+1
12 minutos

withdrawal

The investigator and/or the center withdrew from the study.
Note from asker:
Thanks!
Peer comment(s):
neutral Joseph Tein : When your answer is identical to an answer that someone else provided before yours, the thing to do is to post an Agree with the first answerer because a duplicate answer doesn't add anything new for the benefit of the asker.
19 minutos
(1) I didn't know about her answer when I prepared and submitted mine. It took me longer because I was looking through the wrong references to try to back up my statement (which I already knew). (2) She yielded her priority by adding new material.
neutral liz askew : my answer was given at 8 minutes, so "yielded her priority" doesn't enter into it:)
10 horas
agree Mariano Osvaldo Maddaleno
2 días 19 minutos
Something went wrong...
8 minutos

wihtdrawal

(NWORTH 3.09) Approvals
www.bangor.ac.uk/imscar/nworth/.../3.09trialclosurevs4_000....
File Format: PDF/Adobe Acrobat - Quick View
25 Jan 2012 – for example if the care organisation withdraws research governance approval, or the Principal Investigator withdraws from the study, or the ...

--------------------------------------------------
Note added at 8 mins (2012-08-09 21:51:40 GMT)
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oops

withdrawal

--------------------------------------------------
Note added at 14 mins (2012-08-09 21:58:02 GMT)
--------------------------------------------------

PATIENT WITHDRAWAL FORM
www.ahcdc.ca/.../BBPSP 8.6 - STUDY WITHDRAW...
File Format: PDF/Adobe Acrobat
TS-21/04/2004. Study Withdrawal. Page 1 of 1. PATIENT WITHDRAWAL FORM. Please Print. Keep original in clinic file. Please send copy to BBPSP Attn: T. Soll ...

--------------------------------------------------
Note added at 15 mins (2012-08-09 21:59:10 GMT)
--------------------------------------------------

so withdrawal approval may come from the study physcian

I don't think they mean withdrawal of the physician here:)
Note from asker:
Thank you!
Something went wrong...
17 minutos

Discontinue participation

The center discontinued their participation in a clinical study
Note from asker:
Thank you!
Something went wrong...
1 día 20 horas

deregistration

In this context, alta and baja is when a site or PI is registered or deregistered in a clinical trial. It's all about the paperwork, not discontinuation or withdrawal due to clinical reasons.

I know it sounds awkward, but I've been advised to use it by clients.
See the recent discussion here:
http://www.proz.com/kudoz/spanish_to_english/medical:_pharma...

And the Concise Oxford definition of deregister:
deregister
· v. remove from a register.
– DERIVATIVES deregistration n.
Something went wrong...
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