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Re: [Czechlist] Help: zadavatel

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  • Matej Klimes
    I haven t looked at the whole thread - I assumed from your sample that zadavatel was the company making the drug and then requesting SUKL to approve it - I
    Message 1 of 18 , Nov 6, 2007
      I haven't looked at the whole thread - I assumed from your sample that zadavatel was the company making the drug and then requesting SUKL to approve it - I think I have encountered this and solved it with applicant before... but your situation is probably different..

      M


      ----- Original Message -----
      From: Matej Klimes
      To: Czechlist@yahoogroups.com
      Sent: Tuesday, November 06, 2007 7:28 AM
      Subject: Re: [Czechlist] Help: zadavatel


      Well, unless it features somewhere else, I'd go fo applicant here

      M

      ----- Original Message -----
      From: coilinoc
      To: Czechlist@yahoogroups.com
      Sent: Tuesday, November 06, 2007 3:19 AM
      Subject: [Czechlist] Help: zadavatel

      Hi there,
      Can anyone think of a decent English equivalent for the word
      "zadavatel" in terms of its use in the Act on Pharmaceuticals (as SUKL
      calls this legislation), i.e. "Zadavatel je fyzicka nebo pravnicka
      osoba, ktera je odpovedná za zahajeni, rizeni, organizovani, kontrolu,
      popripade financovani klinickeho hodnoceni a za skody zpusobene
      zvlastní povahou hodnoceneho leciva."??
      MTIA for any suggestions
      Coilin

      [Non-text portions of this message have been removed]





      [Non-text portions of this message have been removed]
    • Sabina Králová
      I know I am rather late and I did not follow this - but there is a standard translation for principal investigator - hlavni zkušející sponsor - zadavatel
      Message 2 of 18 , Nov 6, 2007
        I know I am rather late and I did not follow this - but there is a standard
        translation for
        principal investigator - hlavni zkušející
        sponsor - zadavatel
        Sabina
        -----Original Message-----
        From: Czechlist@yahoogroups.com [mailto:Czechlist@yahoogroups.com]On
        Behalf Of Martin Janda
        Sent: Tuesday, November 06, 2007 8:54 AM
        To: Czechlist@yahoogroups.com
        Subject: Re: [Czechlist] Re: Help: zadavatel


        Hi Coilin again,

        Looks like this is either a poorly translated text from English, or the
        writer is a bit behind the current terminology. Anyway, I would suggest
        the following:

        vyzkumnik - Principal Investigator (... who commissioned the study)
        sponzor - Sponsor
        prispevek = prispevky (IMHO no distinction intended)

        hth
        Martin

        coilinoc napsal(a):
        >
        > --- In Czechlist@yahoogroups.com <mailto:Czechlist%40yahoogroups.com>,
        > Martin Janda <mjanda@...> wrote:
        > >
        > > Coilin, can you copy and paste the relevant part(s)?
        >
        > Hi Martin,
        > here is the offending paragraph:
        >
        > Jedna se o vyslovne v bodu dva uvedenou studii vyzkumníka, ktery je
        > jejim zadavatelem a XXX podporuje tuto studii jako financni sponzor, a
        > neni zodpovedny za zahajeni, rizeni, provedeni a vyhodnoceni této
        > studie. XXX nebude v souvislosti s vyse uvedenou vyzkumnou cinnosti
        > udelovat vyzkumnikovi zadné prime instrukce, a take jinak nebude
        > uplatnovat primy vliv na prubeh vyzkumu u vyzkumnika.
        >
        > And here is the "point two above" which the text refers to:
        >
        > XXX bude podporovat výzkumnou činnost po obdobi od listopad 2007 do
        > cervna 2008 a zavazuje se poskytnout prispěvek uvedeny v § 3 této
        > smlouvy. Vyzkumnik se zavazuje tyto prispevky pouzit vylucne pro vyse
        > uvedenou studii. Naklady prevysujici prispevek na studii uhradi
        > vylucne vyzkumnik.
        >
        > Incidentally, is there any reason why "prispevek" can suddenly become
        > "prispevky" in the second sentence or is it a mistake...?
        >
        > Many thanks again
        > Coilin
        >
        > > Martin
        > >
        > > Matej Klimes napsal(a):
        > > >
        > > > Well, unless it features somewhere else, I'd go fo applicant here
        > > >
        > > > M
        > > >
        > > > ----- Original Message -----
        > > > From: coilinoc
        > > > To: Czechlist@yahoogroups.com <mailto:Czechlist%40yahoogroups.com>
        > <mailto:Czechlist%40yahoogroups.com>
        > > > Sent: Tuesday, November 06, 2007 3:19 AM
        > > > Subject: [Czechlist] Help: zadavatel
        > > >
        > > > Hi there,
        > > > Can anyone think of a decent English equivalent for the word
        > > > "zadavatel" in terms of its use in the Act on Pharmaceuticals (as
        SUKL
        > > > calls this legislation), i.e. "Zadavatel je fyzicka nebo pravnicka
        > > > osoba, ktera je odpovedná za zahajeni, rizeni, organizovani,
        kontrolu,
        > > > popripade financovani klinickeho hodnoceni a za skody zpusobene
        > > > zvlastní povahou hodnoceneho leciva."??
        > > > MTIA for any suggestions
        > > > Coilin
        > > >
        > > >
        > >
        >
        >
        > Messages in this topic
        >
        <http://groups.yahoo.com/group/Czechlist/message/34791;_ylc=X3oDMTM1cWNkOXFl
        BF9TAzk3MzU5NzE0BGdycElkAzMyODk2NARncnBzcElkAzE3MDUwNDM1ODgEbXNnSWQDMzQ4MDEE
        c2VjA2Z0cgRzbGsDdnRwYwRzdGltZQMxMTk0MzM0NDUxBHRwY0lkAzM0Nzkx>
        > (0)
        >
        <http://groups.yahoo.com/group/Czechlist/post;_ylc=X3oDMTJwYmRka2R0BF9TAzk3M
        zU5NzE0BGdycElkAzMyODk2NARncnBzcElkAzE3MDUwNDM1ODgEbXNnSWQDMzQ4MDEEc2VjA2Z0c
        gRzbGsDcnBseQRzdGltZQMxMTk0MzM0NDUx?act=reply&messageNum=34801>






        [Non-text portions of this message have been removed]
      • Sabina Králová
        Sorry - hlavní zkoušející Sabina ... From: Czechlist@yahoogroups.com [mailto:Czechlist@yahoogroups.com]On Behalf Of Sabina Králová Sent: Tuesday,
        Message 3 of 18 , Nov 6, 2007
          Sorry - hlavní zkoušející
          Sabina
          -----Original Message-----
          From: Czechlist@yahoogroups.com [mailto:Czechlist@yahoogroups.com]On
          Behalf Of Sabina Králová
          Sent: Tuesday, November 06, 2007 11:21 AM
          To: Czechlist@yahoogroups.com
          Subject: RE: [Czechlist] Re: Help: zadavatel


          I know I am rather late and I did not follow this - but there is a
          standard
          translation for
          principal investigator - hlavni zkušející
          sponsor - zadavatel
          Sabina
          -----Original Message-----
          From: Czechlist@yahoogroups.com [mailto:Czechlist@yahoogroups.com]On
          Behalf Of Martin Janda
          Sent: Tuesday, November 06, 2007 8:54 AM
          To: Czechlist@yahoogroups.com
          Subject: Re: [Czechlist] Re: Help: zadavatel

          Hi Coilin again,

          Looks like this is either a poorly translated text from English, or the
          writer is a bit behind the current terminology. Anyway, I would suggest
          the following:

          vyzkumnik - Principal Investigator (... who commissioned the study)
          sponzor - Sponsor
          prispevek = prispevky (IMHO no distinction intended)

          hth
          Martin

          coilinoc napsal(a):
          >
          > --- In Czechlist@yahoogroups.com <mailto:Czechlist%40yahoogroups.com>,
          > Martin Janda <mjanda@...> wrote:
          > >
          > > Coilin, can you copy and paste the relevant part(s)?
          >
          > Hi Martin,
          > here is the offending paragraph:
          >
          > Jedna se o vyslovne v bodu dva uvedenou studii vyzkumníka, ktery je
          > jejim zadavatelem a XXX podporuje tuto studii jako financni sponzor, a
          > neni zodpovedny za zahajeni, rizeni, provedeni a vyhodnoceni této
          > studie. XXX nebude v souvislosti s vyse uvedenou vyzkumnou cinnosti
          > udelovat vyzkumnikovi zadné prime instrukce, a take jinak nebude
          > uplatnovat primy vliv na prubeh vyzkumu u vyzkumnika.
          >
          > And here is the "point two above" which the text refers to:
          >
          > XXX bude podporovat výzkumnou činnost po obdobi od listopad 2007 do
          > cervna 2008 a zavazuje se poskytnout prispěvek uvedeny v § 3 této
          > smlouvy. Vyzkumnik se zavazuje tyto prispevky pouzit vylucne pro vyse
          > uvedenou studii. Naklady prevysujici prispevek na studii uhradi
          > vylucne vyzkumnik.
          >
          > Incidentally, is there any reason why "prispevek" can suddenly become
          > "prispevky" in the second sentence or is it a mistake...?
          >
          > Many thanks again
          > Coilin
          >
          > > Martin
          > >
          > > Matej Klimes napsal(a):
          > > >
          > > > Well, unless it features somewhere else, I'd go fo applicant here
          > > >
          > > > M
          > > >
          > > > ----- Original Message -----
          > > > From: coilinoc
          > > > To: Czechlist@yahoogroups.com <mailto:Czechlist%40yahoogroups.com>
          > <mailto:Czechlist%40yahoogroups.com>
          > > > Sent: Tuesday, November 06, 2007 3:19 AM
          > > > Subject: [Czechlist] Help: zadavatel
          > > >
          > > > Hi there,
          > > > Can anyone think of a decent English equivalent for the word
          > > > "zadavatel" in terms of its use in the Act on Pharmaceuticals (as
          SUKL
          > > > calls this legislation), i.e. "Zadavatel je fyzicka nebo pravnicka
          > > > osoba, ktera je odpovedná za zahajeni, rizeni, organizovani,
          kontrolu,
          > > > popripade financovani klinickeho hodnoceni a za skody zpusobene
          > > > zvlastní povahou hodnoceneho leciva."??
          > > > MTIA for any suggestions
          > > > Coilin
          > > >
          > > >
          > >
          >
          >
          > Messages in this topic
          >
          <http://groups.yahoo.com/group/Czechlist/message/34791;_ylc=X3oDMTM1cWNkOX
          Fl
          BF9TAzk3MzU5NzE0BGdycElkAzMyODk2NARncnBzcElkAzE3MDUwNDM1ODgEbXNnSWQDMzQ4MD
          EE
          c2VjA2Z0cgRzbGsDdnRwYwRzdGltZQMxMTk0MzM0NDUxBHRwY0lkAzM0Nzkx>
          > (0)
          >
          <http://groups.yahoo.com/group/Czechlist/post;_ylc=X3oDMTJwYmRka2R0BF9TAzk
          3M
          zU5NzE0BGdycElkAzMyODk2NARncnBzcElkAzE3MDUwNDM1ODgEbXNnSWQDMzQ4MDEEc2VjA2Z
          0c
          gRzbGsDcnBseQRzdGltZQMxMTk0MzM0NDUx?act=reply&messageNum=34801>

          [Non-text portions of this message have been removed]






          [Non-text portions of this message have been removed]
        • tomas_barendregt
          ... standard ... I agree but Coilin s predicament stems from the fact that there is both a sponzor and zadavatel in this study, two separate entities. I
          Message 4 of 18 , Nov 6, 2007
            --- In Czechlist@yahoogroups.com, Sabina Králová <Sabina.Kralova@...>
            wrote:
            >
            > I know I am rather late and I did not follow this - but there is a
            standard
            > translation for
            > principal investigator - hlavni zkušející
            > sponsor - zadavatel

            I agree but Coilin's predicament stems from the fact that there is
            both a "sponzor" and "zadavatel" in this study, two separate entities.
            I think that's the confusing part. So we were suggesting maybe in this
            particular case it sounds like the party Coilin's text calls
            "zadavatel" does what usually the "principal investigator" would do.

            Tom
          • James Kirchner
            Has anyone looked on the websites of pharmaceutical development consultants and seen if there s something there? Jamie ... [Non-text portions of this message
            Message 5 of 18 , Nov 6, 2007
              Has anyone looked on the websites of pharmaceutical development
              consultants and seen if there's something there?

              Jamie

              On Nov 6, 2007, at 10:19 AM, tomas_barendregt wrote:

              > --- In Czechlist@yahoogroups.com, Sabina Kr�lov� <Sabina.Kralova@...>
              > wrote:
              > >
              > > I know I am rather late and I did not follow this - but there is a
              > standard
              > > translation for
              > > principal investigator - hlavni zku�ej�c�
              > > sponsor - zadavatel
              >
              > I agree but Coilin's predicament stems from the fact that there is
              > both a "sponzor" and "zadavatel" in this study, two separate entities.
              > I think that's the confusing part. So we were suggesting maybe in this
              > particular case it sounds like the party Coilin's text calls
              > "zadavatel" does what usually the "principal investigator" would do.
              >
              > Tom
              >
              >
              >



              [Non-text portions of this message have been removed]
            • coilinoc
              Thanks for the additional input, guys. The more I look at it, the more I think that zadavatel is indeed the sponsor in the sense of the Act on
              Message 6 of 18 , Nov 6, 2007
                Thanks for the additional input, guys.
                The more I look at it, the more I think that "zadavatel" is indeed the
                "sponsor" in the sense of the Act on Pharmaceuticals in that it
                coordinates all aspects of the study. I'm beginning to think that they
                put this clause in to ensure that this sponsorship is not confused
                with the role of the other party who is simply a financial
                sponsor/backer or patron of the research.
                Still hard to come up with a two different terms in English, though...
                C.


                --- In Czechlist@yahoogroups.com, James Kirchner <jpklists@...> wrote:
                >
                > Has anyone looked on the websites of pharmaceutical development
                > consultants and seen if there's something there?
                >
                > Jamie
                >
                > On Nov 6, 2007, at 10:19 AM, tomas_barendregt wrote:
                >
                > > --- In Czechlist@yahoogroups.com, Sabina Králová <Sabina.Kralova@>
                > > wrote:
                > > >
                > > > I know I am rather late and I did not follow this - but there is a
                > > standard
                > > > translation for
                > > > principal investigator - hlavni zkušející
                > > > sponsor - zadavatel
                > >
                > > I agree but Coilin's predicament stems from the fact that there is
                > > both a "sponzor" and "zadavatel" in this study, two separate entities.
                > > I think that's the confusing part. So we were suggesting maybe in this
                > > particular case it sounds like the party Coilin's text calls
                > > "zadavatel" does what usually the "principal investigator" would do.
                > >
                > > Tom
                > >
                > >
                > >
                >
                >
                >
                > [Non-text portions of this message have been removed]
                >
              • tomas_barendregt
                ... Underwriter (for the financing sponsor)?
                Message 7 of 18 , Nov 6, 2007
                  --- In Czechlist@yahoogroups.com, "coilinoc" <coilinoc@...> wrote:
                  >
                  > Thanks for the additional input, guys.
                  > The more I look at it, the more I think that "zadavatel" is indeed the
                  > "sponsor" in the sense of the Act on Pharmaceuticals in that it
                  > coordinates all aspects of the study. I'm beginning to think that they
                  > put this clause in to ensure that this sponsorship is not confused
                  > with the role of the other party who is simply a financial
                  > sponsor/backer or patron of the research.
                  > Still hard to come up with a two different terms in English, though...

                  Underwriter (for the financing sponsor)?
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