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                "Jos markkinatoimija katsoo vastoin hankintayksik\u00f6n k\u00e4sityst\u00e4 kykenev\u00e4ns\u00e4 toteuttamaan hankinnan ja ett\u00e4 suorahankintaperuste ei pid\u00e4 paikkaansa, markkinatoimijaa pyydet\u00e4\u00e4n viivytyksett\u00e4 ilmoittamaan asiasta osoitteeseen kirjaamo(a)thl.fi viitteell\u00e4: THL\/6257\/2.02.06\/2021. Ilmoituksessa tulee kertoa lyhyesti my\u00f6s selvitys markkinatoimijan n\u00e4kemykseen. N\u00e4in hankintayksikk\u00f6 pystyy nopeasti arvioimaan asian uudelleen ja tarvittaessa keskeytt\u00e4m\u00e4\u00e4n suorahankinnan oma-aloitteisesti.",
                "",
                "Huom! Markkinaoikeuden posti- ja k\u00e4yntiosoite muuttuvat joulukuussa 2021.",
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                "Suorahankinta on v\u00e4ltt\u00e4m\u00e4t\u00f6n seuraavista syist\u00e4:",
                "",
                "\u2022 Sopimuksen tekeminen on v\u00e4ltt\u00e4m\u00e4t\u00f6nt\u00e4, koska kesken tutkimuksen on mahdotonta vaihtaa ohjelmaa, jonka k\u00e4ytt\u00f6\u00f6n perustuvat tutkimuksen aineistonhallinta ja aineistonsiirtosopimus toimeksiantajan kanssa ja jonka validaation toimeksiantaja on tarkastanut ja hyv\u00e4ksynyt. My\u00f6s L\u00e4\u00e4kealan turvallisuus- ja kehitt\u00e4miskeskus Fimea on tehnyt lakis\u00e4\u00e4teisen viranomaistarkastuksen tutkimukseen ja hyv\u00e4ksynyt tutkimuksen jatkamisen l\u00e4htien siit\u00e4, ett\u00e4 tutkimuksen toteutus perustuu nimenomaan t\u00e4h\u00e4n validoituun ohjelmaan.",
                "",
                "\u2022 Teknisest\u00e4 syyst\u00e4 vain OpenClinica voi toteuttaa hankinnan, koska ko. ohjelmalla ei ole muita toimittajia. Lis\u00e4ksi OpenClinica on validoinut version 3.0 erityisesti t\u00e4m\u00e4n tutkimuksen tarpeisiin.",
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                "\u2022 Saman ohjelman on oltava k\u00e4yt\u00f6ss\u00e4 koko tutkimuksen ajan, jota aineistoa voidaan lakis\u00e4\u00e4teisesti tarkastaa. Ohjelmaa ei voida vaihtaa kesken kaiken koska muutoksen liittyy toimintavarmuus- ja luotettavuusriski. Ohjelman validointiketjun on oltava koko tutkimuksen ajan ehe\u00e4, mik\u00e4 on k\u00e4yt\u00e4nn\u00f6ss\u00e4 mahdotonta toteuttaa, jos ohjelmia ja\/tai toimittajia on useita. Validaatiovaatimus kliinisess\u00e4 l\u00e4\u00e4ketutkimuksissa perustuu EU-s\u00e4\u00e4d\u00f6ksiin.",
                "",
                "\u2022 Palveluntarpeen jatkuminen johtuu siit\u00e4, ett\u00e4 koronavirusepidemian takia tutkimusta ei ole voitu toteuttaa suunnitellussa aikataulussa epidemian aikana.",
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                "Kansanterveydellisist\u00e4 syist\u00e4 on t\u00e4rke\u00e4 ett\u00e4 tutkimus saadaan tehty\u00e4 valmiiksi, mik\u00e4 ole ole ollut mahdollista alkuper\u00e4isess\u00e4 m\u00e4\u00e4r\u00e4ajassa koronaepidemiasta johtuvien syiden vuoksi.",
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                "Edell\u00e4 mainituista syist\u00e4 THL katsoo ett\u00e4 sill\u00e4 on lainmukainen oikeus tehd\u00e4 yll\u00e4 mainittu hankinta suorahankintana hankintalain* 40 \u00a7 2 mom. 2 kohdan mukaan; Teknisest\u00e4 tai yksinoikeuden suojaamiseen liittyv\u00e4st\u00e4 syyst\u00e4 vain tietty toimittaja voi toteuttaa hankinnan; lis\u00e4edellytyksen\u00e4 on, ett\u00e4 j\u00e4rkevi\u00e4 vaihtoehtoisia tai korvaavia ratkaisuja ei ole eik\u00e4 kilpailun puuttuminen johdu hankinnan ehtojen keinotekoisesta kaventamisesta.",
                "",
                "* Laki julkisista hankinnoista ja k\u00e4ytt\u00f6oikeussopimuksista (1397\/2016)"
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