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eetikakomitee
ethics committee
Last Update: 2014-11-21
Usage Frequency: 3
Quality:
eetikakomitee(de) nõustamistegevus
consultation of committee(s) on ethics
Last Update: 2014-11-21
Usage Frequency: 3
Quality:
eetikakomitee positiivne arvamus;
the favourable opinion of the ethics committee;
Last Update: 2014-11-21
Usage Frequency: 2
Quality:
d) eetikakomitee positiivne arvamus;
(d) the favourable opinion of the ethics committee;
Last Update: 2014-10-23
Usage Frequency: 1
Quality:
ajutise eetikakomitee volituste suurendamine.
reinforcement of the remit of the ad hoc ethical committee.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
liikmesriikide heakskiit ja pädeva eetikakomitee arvamus
national approvals and opinions of competent ethics committee
Last Update: 2014-11-21
Usage Frequency: 1
Quality:
oma arvamuse kujundamisel võtab eetikakomitee arvesse eelkõige järgmist:
in preparing its opinion, the ethics committee shall consider, in particular:
Last Update: 2014-11-21
Usage Frequency: 3
Quality:
kutsub üles lisama määrusesse loamenetluse osana selgesõnaliselt sõltumatu eetikakomitee hinnangud;
calls for explicit inclusion in the regulation of assessments by the independent ethics committee in the framework of the authorisation process;
kliinilisele katsele ei tohiks heakskiitu anda enne, kui sõltumatu eetikakomitee on avaldanud heakskiitva arvamuse.
an approval of a clinical trial should not be granted until an independent ethics committee has issued a favourable opinion.
kliiniliste uuringute sooritamise eesmärgil võtavad liikmesriigid meetmed, mida on vaja eetikakomitee loomiseks ja toimimiseks.
for the purposes of implementation of the clinical trials, member states shall take the measures necessary for establishment and operation of ethics committees.
sponsor teavitab viivitamatult pädevaid asutusi nendest uutest asjaoludest ja võetud meetmetest ning tagab ka eetikakomitee samaaegse teavitamise;
the sponsor shall forthwith inform the competent authorities of those new events and the measures taken and shall ensure that the ethics committee is notified at the same time;
artikli 6 lõikes 3 osutatud üksikasjade alusel ja kooskõlas artikliga 7 esitab eetikakomitee oma arvamuse maksimaalselt 35 päeva jooksul alates vormikohase muudatusettepaneku saamisest.
on the basis of the details referred to in article 6(3) and in accordance with article 7, the ethics committee shall give an opinion within a maximum of 35 days of the date of receipt of the proposed amendment in good and due form.
juhtimise eetikakoodeksi ülesanne auditi direktoraadi nassat, kes vastutab oma teatises, ajakohastamist ja rakendamist, samuti nõustab eetikakomitee oma otsustes.
the management of the code of ethics is a function of the audit directorate nassat, which is responsible for its communication, updating and implementation, as well as advise the ethics committee in its decisions.
c) uurivad siseriiklikus korras asutatavad eetikakomitee ja/või pädevad asutused biomeditsiinilistest või meditsiinilistest uuringutest tingitud meditsiinikiiritust;
(c) medical exposure for biomedical and medical research shall be examined by an ethics committee, set up in accordance with national procedures and/or by the competent authorities.
aja jooksul, mil eetikakomitee uurib taotlust arvamuse kujundamiseks, võib ta saata ainult ühe taotluse saada teavet lisaks sellele, mida taotluse esitaja on juba esitanud.
within the period of examination of the application for an opinion, the ethics committee may send a single request for information supplementary to that already supplied by the applicant.
Üldiselt peaks loa andmine olema kaudne, st kui eetikakomitee on hääletanud positiivselt ja pädev asutus ei ole ettenähtud aja jooksul vastuväiteid esitanud, peaks olema võimalik kliinilisi uuringuid alustada.
as a rule, authorisation should be implicit, i.e. if there has been a vote in favour by the ethics committee and the competent authority has not objected within a given period, it should be possible to begin the clinical trials.
g) uuringuplaani on kinnitanud asjaomase haiguse ja patsientide alal pädev või asjaomase haiguse ja patsientidega seotud kliiniliste, eetiliste ja psühhosotsiaalsete küsimuste suhtes nõu küsinud eetikakomitee;
(g) the ethics committee, with expertise in the relevant disease and the patient population concerned or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;