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uuringuprogrammi rakendamise üldine kirjeldus
overall description on the implementation of the survey programme
Ultimo aggiornamento 2014-11-03
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kliinilise uuringuprogrammi käigus koges ligikaudu 47% patsientidest kõrvaltoimeid.
approximately 47% of patients experienced adverse reactions in the clinical trial programme.
Ultimo aggiornamento 2012-04-11
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vaheanalüüsi raportid esitatakse igal aastal alates 2015 aasta iv kvartalist kuni uuringuprogrammi lõppemiseni.
interim analyses reports provided annually beginning q4 2015 until completion of the study program.
Ultimo aggiornamento 2017-04-26
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ligikaudu 1% osalejatest katkestas kuumahoogude tõttu ii/iii faasi kliinilise uuringuprogrammi.
about 1% of subjects discontinued in the phase 2/3 clinical programme due to hot flushes.
Ultimo aggiornamento 2017-04-26
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krüopiriinist põhjustatud perioodiliste sündroomide uuringuprogrammi raames raviti 8 noorukit vanuses 12–17 aastat kuni 18 kuud.
in the clinical program for caps, 8 adolescents aged 12-17 were treated for up to 18 months.
Ultimo aggiornamento 2017-04-26
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ka siinkohal kutsub komitee komisjoni üles esitama selge uuringuprogrammi ja analüüs, mis koostatakse koostöös vkede esindusorganisatsioonidega, et võtta arvesse ettevõtete vajadusi
once again, the eesc calls for the commission to support a clear study and analysis programme, which is drawn up in cooperation with sme representative organisations, to cater to the needs of enterprises.
Ultimo aggiornamento 2017-04-06
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liikmesriigid, kes soovivad niisugustes uuringuprogrammides osaleda, esitavad eelnevalt komisjonile kavandatava uuringuprogrammi üksikasjalikud andmed, kaasa arvatud selle kavandatav kestus.
member states wishing to engage in such test programmes shall provide the commission in advance with full details of the proposed test programme, including its intended duration.
Ultimo aggiornamento 2014-11-21
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toll võib ajavahemikuks, mis on vältimatult vajalik, et ellu viia uuringuprogrammi automaatse andmetöötluse meetodeid kasutavate võimalike lihtsustuste hindamiseks, loobuda järgnevate andmete esitamise nõudest:
for test programmes using data-processing techniques designed to evaluate possible simplifications, the customs authorities may, for the period strictly necessary to carry out the programme, waive the requirement to provide the following information:
Ultimo aggiornamento 2014-11-21
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liikmesriigid võivad siiski anda tootjatele loa alustada kõnealuseid kliinilisi uuringuid enne 60päevase ajavahemiku lõppemist, kui vastav eetikakomitee on kõnealuse uuringuprogrammi, sh läbivaadatud kliinilise uuringu plaani kohta esitanud oma pooldava arvamuse.
member states may however authorize manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, in so far as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including the reviewed clinical investigation plan.
Ultimo aggiornamento 2017-04-06
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"liikmesriigid võivad siiski anda tootjale loa alustada kõnealuseid kliinilisi uuringuid enne 60päevase ajavahemiku lõppemist, kui vastav eetikakomitee on kõnealuse uuringuprogrammi kohta esitanud oma pooldava arvamuse."
'member states may however authorize manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethical committee concerned has delivered a favourable opinion with respect to the investigation programme in question.',
Ultimo aggiornamento 2014-10-23
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Attenzione: contiene formattazione HTML nascosta
active uuringuprogrammi eraldi uuringutesse active-w ja active-a kaasati südamekodade virvendusega (af) patsiente, kellel oli vähemalt üks vaskulaarsete haigusjuhtude riskifaktor.
the active-w and active-a studies, separate trials in the active program, included patients with atrial fibrillation (af) who had at least one risk factor for vascular events.
Ultimo aggiornamento 2017-04-26
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erandina lõike 1 punktist f ning lõigetest 2 ja 4, võidakse neis ette nähtud 40- ja 45päevaseid tähtaegu siiski lühendada 30 päevale, kui liikmesriik on vastavalt diagnoosimisjuhendile rakendanud intensiivse proovivõtu- ja uuringuprogrammi, mis võimaldab välistada sigade aafrika katku esinemise kõnealuses majandis.
however, by way of derogation from paragraphs 1(f), and from paragraphs 2 and 4, the 40- and 45-day periods stipulated therein may be reduced to 30 days if, in accordance with the diagnostic manual, the member states have applied an intensive sampling and testing programme making it possible to rule out the presence of african swine fever on the holding in question.