Glossary entry

French term or phrase:

Vigilance des essais cliniques

English translation:

(Pharmacovigilance Officer) Clinical Trial Surveillance/Monitoring

Added to glossary by joanna menda
Apr 26, 2019 16:49
5 yrs ago
7 viewers *
French term

Vigilance des essais cliniques

French to English Medical Medical: Pharmaceuticals SAE email
Hi,

This is a doctor's position. Under her name I have the following:
"Pharmacovigilant - Praticien Hospitalier - Vigilance des essais cliniques"

Could it be "clinical trial auditor"?

This is for the US.

Thanks

Joanna

Discussion

Rachel Fell Apr 26, 2019:
I tend to agree with Sue
Sue Davis Apr 26, 2019:
I think this is specifically in connection with pharmacovigilance, not general oversight

Proposed translations

+7
14 hrs
Selected

(Pharmacovigilance Officer) Clinical Trial Surveillance/Monitoring

I think vigilance has to be translated in the context of the pharmacovigilance role

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Note added at 14 hrs (2019-04-27 07:03:27 GMT)
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Sorry missed out Hospitap Practitioner

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Note added at 14 hrs (2019-04-27 07:05:07 GMT)
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As the appointee is a hospital doctor it isn't a full-time job.

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Note added at 14 hrs (2019-04-27 07:06:03 GMT)
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https://gradireland.com/careers-advice/job-descriptions/phar...

Introduction
The pharmacovigilance officer is responsible for the monitoring and reporting of the effectiveness and any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials. They must liaise closely with medical and drug company representatives, patients, doctors and other healthcare professionals to record the effectiveness of drugs and other treatments. The data is meticulously recorded, analysed and processed because the informed opinions of pharmacovigilance officers will help the company maximise product safety and performance and cut down on adverse effects.

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Note added at 14 hrs (2019-04-27 07:09:58 GMT)
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Surveillance is used in an official EMA document
https://www.ema.europa.eu/en/documents/regulatory-procedural...

Recommendation on pharmacovigilance surveillance and
signal detection of veterinary medicinal products

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Note added at 14 hrs (2019-04-27 07:11:04 GMT)
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http://apps.who.int/medicinedocs/en/m/abstract/Js22109en/

Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines
(2015; 21 pages)

Management Sciences for Health (MSH). Standard Operating Procedures. Active Pharmacovigilance Surveillance: Drug Safety Monitoring for New Medicines and Novel Regimens of the National TB Program in the Philippines. Manila, Philippines: MSH; 2015.

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Note added at 14 hrs (2019-04-27 07:27:40 GMT)
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Useful EMA site
https://www.ema.europa.eu/en/human-regulatory/overview/pharm...

Pharmacovigilance: Overview Share


Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.


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Note added at 14 hrs (2019-04-27 07:31:35 GMT)
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http://crisco.unicaen.fr/des/synonymes/vigilance

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Note added at 16 hrs (2019-04-27 09:02:10 GMT)
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ie 'keeping a watch on .......
'https://dictionary.reverso.net/english-synonyms/vigilance

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Note added at 21 hrs (2019-04-27 14:32:32 GMT)
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might be Pharmacovigilance Physician although the text doesn't say that.
Peer comment(s):

agree Rachel Fell
1 hr
Thanks Rachel!
agree Nikki Scott-Despaigne
3 hrs
Thanks Nikki!
agree abe(L)solano : Yes, much better! Don´t now exactly at what level this person was involved.
3 hrs
Thanks!
agree writeaway
4 hrs
Thanks writeaway!
agree Gareth Callagy
1 day 9 hrs
Thanks!
agree Michele Fauble
1 day 11 hrs
Thanks!
agree El Mehdi Hakkou
2 days 1 hr
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thanks Sue!"
+1
7 mins

head/manager of clinical trials

In the sense of monitoring them to make sure they're being carried out correctly.

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Note added at 9 mins (2019-04-26 16:58:29 GMT)
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https://www.topmastersinhealthcare.com/job-profiles/clinical...

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Note added at 10 mins (2019-04-26 16:59:44 GMT)
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"clinical trials manager"
Peer comment(s):

agree abe(L)solano
13 hrs
Thanks, abe.
Something went wrong...
+3
15 mins

Overseeing clincal trials

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5101947/
by KL Hudson - ‎2016 - ‎Cited by 64 - ‎Related articles
As a crucial first step, NIH will require Good Clinical Practice (GCP) training for investigators and NIH staff responsible for conducting or overseeing clinical trials.

https://www.cancer.org/.../clinical-trials/what.../protectio...
... upheld by individuals and groups at the sites conducting research, and also by government agencies charged with overseeing clinical trials.
Peer comment(s):

agree Bashiqa : Fits the bill.
11 mins
Thanks Bashiqa
agree Drmanu49
19 mins
Thanks Drmanu
agree philgoddard : But I think a noun would be more appropriate, so oversight
38 mins
Thanks phil. I find it more natural in this context to use "overseeing", but either would be OK.
Something went wrong...
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