Glossary entry (derived from question below)
Italian term or phrase:
scioglimento della riserva
English translation:
lifting of restrictions
Added to glossary by
liz askew
Jul 2, 2022 16:49
1 yr ago
29 viewers *
Italian term
25 years experience
Native in: English
Works in: French to English, Italian to English, Spanish to English
scioglimento della riserva
Italian to English
Medical
Medical: Pharmaceuticals
terminology used in a clinical trial
"Lo scioglimento della riserva è affidato a:"
This term appears in information about a clinical trial. I know that it means withdrawing the reservation about a certain aspect of the trial but I'm not sure of the correct term for this. I have looked at the other queries and responses but don't feel they are conclusive. Can anyone help?
This term appears in information about a clinical trial. I know that it means withdrawing the reservation about a certain aspect of the trial but I'm not sure of the correct term for this. I have looked at the other queries and responses but don't feel they are conclusive. Can anyone help?
Proposed translations
(English)
| 4 +4 | lifting of restrictions |
liz askew
|
| 3 | lifting of the caveat |
Adrian MM.
|
References
| comment |
liz askew
|
| Changes in protocol |
Tomasso
|
Change log
Jul 12, 2022 12:42: liz askew Created KOG entry
Proposed translations
+4
18 hrs
Selected
lifting of restrictions
Conduct of Clinical Trials of Medical Products During COVID ...
https://www.fda.gov › media › download
30 Aug 2021 — For questions on clinical trial conduct during the COVID-19 pandemic, ... Re-monitoring after pandemic-related restrictions are lifted .
Peer comment(s):
| agree |
tradu-grace
: or as pointed out by Tomasso *Removal of restriction* (singular)
5 hrs
|
| agree |
Andrew Bramhall
9 hrs
|
| agree |
Cillie Swart
: Thanks for sharing !!
20 hrs
|
| agree |
Luigi Argentino
23 hrs
|
| neutral |
Adrian MM.
: You have basically 'lifted' my answer and 'pandemic-related restrictions' is incongruously non-specific to the asker's context,
4 days
|
4 KudoZ points awarded for this answer.
Comment: "Thank you for prompt and useful answer"
16 hrs
Adrian MM.
Austria
Austria
Native in English
Austria
Retd.T&I, Barrister & Austro-Advokat
Native in: English (Variants: Scottish, British) 
Works in: Spanish to English, English to Spanish, French to English, and 5 more.
lifting of the caveat
doubles as a translation for lifting of a probate caveat in Englkish law: namely a *stop* on the proving of a Will.
Example sentence:
Chemotherapy and Venetoclax in Elderly Acute Myeloid Leukemia Trial (CAVEAT):
Influence of a Randomized Clinical Trial on Practice by Participating Investigators: Lessons From the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT)
Peer comment(s):
| neutral |
Andrew Bramhall
: What does probate law have to do with a context of clinical drug trials?
10 hrs
|
|
Another rhetorical question. Caveat is usable for both medical & probate, whereas a regd. caution is used in UK conveyancing-only (which, again, you wouldn't know).
|
Reference comments
22 mins
Reference:
comment
again, I think you should post at least a couple of sentences in Italian with your phrase.
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Note added at 24 mins (2022-07-02 17:14:02 GMT)
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https://www.proz.com/kudoz/italian-to-english/law-general/30...
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Note added at 24 mins (2022-07-02 17:14:02 GMT)
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https://www.proz.com/kudoz/italian-to-english/law-general/30...
Note from asker:
| It is difficult to provide useful sentences because the file consists of a list of titles rather than any block of text, e.g. "safety form per studi osservazionali" (safety form for observational studies), or "lettera di trasmissione" (cover letter) and the phrase I've queried is just one of them. |
7 hrs
Reference:
Changes in protocol
***Changes in a protocol**** are typically not implemented before review and approval
by the IRB/IEC, and in some cases, by FDA. Sponsors and clinical investigators
are encouraged to engage with IRBs/IEC as early as possible when urgent or
***emergent changes ***to the protocol or informed consent are anticipated as a result (dissolution of reserve, the italian patient in other discussion had developed a serious disease)
of COVID-19. Such changes to the protocol or investigational plan to minimize
or eliminate immediate hazards or to protect the life and well-being of research
participants (e.g., to limit exposure to COVID-19) may be implemented without
IRB approval or before filing an amendment to the investigational new drug
(IND) or investigational device exemption (IDE), but are required to be reported
afterwards.5
FDA encourages sponsors and investigators to work with their IRBs
to prospectively ***define procedures to prioritize reporting of deviations*** that may
impact the safety of trial participants.
(searching document for the word CHANGE )Sponsors, clinical investigators, and IRBs should consider establishing and
implementing policy and procedures, or revise existing policy and procedures, to
describe approaches to be used to protect trial participants and manage study
conduct during possible disruption of the study as a result of COVID-19 control
measures at study sites. Changes to policy and procedures could address, but not
be limited to, impact on the informed consent process, study visits and
procedures, data collection, study monitoring, adverse event reporting, and
changes in investigator(s), site staff, and/or monitor(s) secondary to travel
restrictions, quarantine measures, or COVID-19 illness itself.
--------------------------------------------------
Note added at 7 hrs (2022-07-03 00:25:02 GMT)
--------------------------------------------------
Pues hay mucho, buscando por los 3 frases ///scioglimento della riserva safety form per studi osservazionali lettera di trasmissione////buscando en GOOGLE. https://www.google.com/search?q=scioglimento della riserva s...
by the IRB/IEC, and in some cases, by FDA. Sponsors and clinical investigators
are encouraged to engage with IRBs/IEC as early as possible when urgent or
***emergent changes ***to the protocol or informed consent are anticipated as a result (dissolution of reserve, the italian patient in other discussion had developed a serious disease)
of COVID-19. Such changes to the protocol or investigational plan to minimize
or eliminate immediate hazards or to protect the life and well-being of research
participants (e.g., to limit exposure to COVID-19) may be implemented without
IRB approval or before filing an amendment to the investigational new drug
(IND) or investigational device exemption (IDE), but are required to be reported
afterwards.5
FDA encourages sponsors and investigators to work with their IRBs
to prospectively ***define procedures to prioritize reporting of deviations*** that may
impact the safety of trial participants.
(searching document for the word CHANGE )Sponsors, clinical investigators, and IRBs should consider establishing and
implementing policy and procedures, or revise existing policy and procedures, to
describe approaches to be used to protect trial participants and manage study
conduct during possible disruption of the study as a result of COVID-19 control
measures at study sites. Changes to policy and procedures could address, but not
be limited to, impact on the informed consent process, study visits and
procedures, data collection, study monitoring, adverse event reporting, and
changes in investigator(s), site staff, and/or monitor(s) secondary to travel
restrictions, quarantine measures, or COVID-19 illness itself.
--------------------------------------------------
Note added at 7 hrs (2022-07-03 00:25:02 GMT)
--------------------------------------------------
Pues hay mucho, buscando por los 3 frases ///scioglimento della riserva safety form per studi osservazionali lettera di trasmissione////buscando en GOOGLE. https://www.google.com/search?q=scioglimento della riserva s...
Example sentence:
removal of proviso, restrictions, or allowing changes in clinical rules, protocols.
Reference:
Discussion
premesso
• che il figlio del ricorrente è affetto dalla malattia di Niemann Pick di Tipo C,
patologia con prognosi infausta e per la quale, allo stato attuale, non esistono cure
efficaci;
• che era in atto una collaborazione tra l’ospedale convenuto e la Stamina Foundation
“al fine di produrre linee cellulari staminali adulte di tipo mesenchimale/stromale per
utilizzo autologo o eterologo da utilizzare nell’ambito della medicina rigenerativa per
singoli casi al di fuori della sperimentazione clinica in base al D.M. 5/12/2006” (Io no capisco molto bene, removal of proviso? requirement?