\par ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2520 \par }\pard\plain \s15\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 { \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1080\jclisttab\tx1080 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace1080\levelindent0{\leveltext\leveltemplateid67895297 \levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3600\jclisttab\tx3600 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 En cas d'erreur, les informations erron\'e9es seront barr\'e9es d'un simple trait, la donn\'e9 \levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par \par - que cette collection sera r\'e9alis\'e9e conform\'e9ment \'e0 la r\'e9glementation et d\'e9clar\'e9e aupr\'e8s des instances, \widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin360\itap0 \i\f1\fs23\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 \sbasedon0 \snext37 Body Text Indent 2;}{\s38\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \cbpat9 D\'e9finition des \'e9v\'e9nements ind\'e9sirables graves}{ ;}{\levelnumbers\'01;}\chbrdr \levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3600\jclisttab\tx3600 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0 OBJECTIFS{\*\bkmkend _Toc81299922} \leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5760\jclisttab\tx5760 }{\listlevel\levelnfc23 \par \leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3600\jclisttab\tx3600 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0 }{\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden PAGEREF _Toc81299945 \\h }{\lang1024\langfe1024\noproof {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900340035000000}}}{\fldrslt { \leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3960\jclisttab\tx3960 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0 \par {\listtext\pard\plain\s30 \f14 \loch\af14\dbch\af0\hich\f14 \'fc\tab}Contre indication et effets ind\'e9sirables attendus}{\f28 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1800\jclisttab\tx1800 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6120\jclisttab\tx6120 }{\listname ;}\listid1443302981}{\list\listtemplateid-1709309476\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360 {\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden PAGEREF _Toc81299960 \\h }{\lang1024\langfe1024\noproof {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900360030000000}}}{\fldrslt { \lang1024\langfe1024\noproof\webhidden 13}}}}}{\lang1024\langfe1024\noproof ;}{\levelnumbers V.3. ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4680\jclisttab\tx4680 }{\listlevel\levelnfc23\levelnfcn23 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5400\jclisttab\tx5400 }{\listname ;}\listid741372667}{\list\listtemplateid-1685191120\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\i\f28 Justifications, donn\'e9es de la litt\'e9rature scientifique }{\strike\f28 <>>> {\*\bkmkstart _Toc81299929}V. POPULATION ETUDIEE{\*\bkmkend _Toc81299929} \cltxlrtb\clftsWidth3\clwWidth2760 \cellx9120\pard \qj \li0\ri0\sl360\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28 \cell \cell \cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28 \par }\pard\plain \s30\qj \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\i\f28 Frais de gestion\~ Dans le cadre de la mise au point d’un nouveau médicament ou d’une nouvelle molécule, l’étude clinique est une procédure obligatoire avant la commercialisation du produit. }}{\*\pnseclvl2\pnucltr\pnstart1\pnindent720\pnhang{\pntxta . \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{\lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299955"}{\cs26\ul\cf2\lang1024\langfe1024\noproof }{\ul\cf2\lang1024\langfe1024\noproof {\*\datafield \par Si le projet dure plus d\rquote un\~an : indiquer la r\'e9partition du budget par an {\leveltext\leveltemplateid1650493990\'01\u-3844 ? \par }\pard\plain \qj \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 { \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01\u-3913 ? <> 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900360037000000}}}{\fldrslt {\cs26\f28\ul\cf2\lang1024\langfe1024\noproof XIII. \par Elle sera compl\'e9t\'e9e en collaboration avec la personne responsable de l\rquote analyse. }{ article L.1111-6}{\fs24 ,dans les conditions pr\'e9vues ci-dessus. \par \par \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3130 \cellx3060\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 { ses d\'e9crets d\rquote application, la d\'e9claration d'Helsinki et les Bonnes Pratiques Cliniques et les recommandations ICH6. \par Mentionner si le patient/sujet peut ou non \'eatre sous tutelle ou sous curatelle }{\i\f28\fs24 {\*\bkmkend _Toc81299940} ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0 \levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? \par }\pard \s30\qj \li0\ri-290\sl360\slmult1\widctlpar\tx284\aspalpha\aspnum\faauto\adjustright\rin-290\lin0\itap0 {\b - quel sera le devenir des \'e9chantillons s\rquote il est perdu de vue ou s\rquote il sort de l\rquote \'e9tude. Une phase de préparation qui consiste à écrire de manière très précise la question scientifique à laquelle on souhaite répondre et à rédiger le protocole de recherche correspondant. \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{\lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299940"}{\cs26\ul\cf2\lang1024\langfe1024\noproof }{\ul\cf2\lang1024\langfe1024\noproof {\*\datafield \par Pr\'e9ciser notamment la r\'e9 dicament commercialis\'e9 ou la mat\'e9riovigilance s\rquote il s\rquote agit d\rquote un dispositif m\'e9dical. \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3600\jclisttab\tx3600 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par {\listtext\pard\plain\s30 \f14 \loch\af14\dbch\af0\hich\f14 \'fc\tab}Sp\'e9cialit\'e9 \levelspace0\levelindent0{\leveltext\'01\u-3929 ? \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2 }{HYPERLINK \\l "_Toc81299971"}{\cs26\ul\cf2 }{\ul\cf2 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900370031000000}}}{\fldrslt {\cs26\f28\ul\cf2 DEROULEMENT DE L\rquote ETUDE{\*\bkmkend _Toc81299943} Un essai clinique permet d'obtenir des renseignements sur l'innocuité et l'efficacité de nouvelles approches afin de dé Modalit\'e9s de dispensation des traitements{\*\bkmkend _Toc81299941} \par Dans le cadre de cet essai, une assurance en responsabilit\'e9 civile }{\i (compagnie GERLING, num\'e9ro de contrat\~:\'85\'85\'85\'85\'85\'85\'85\'85\'85)}{ a \'e9t\'e9 souscrite par le Promoteur. Traitement contr\'f4le}{\lang1024\langfe1024\noproof\webhidden \tab } \levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \cltxlrtb\clftsWidth3\clwWidth3310 \cellx3240\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth1440 \cellx4680\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \'01\u-3913 ? ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1440\jclisttab\tx1440 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0 \'01\u-3929 ? Quels sont les logiciels qui seront utilis\'e9s\~? \chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1 \fi-360\li2880\jclisttab\tx2880 }{\listlevel\levelnfc4\levelnfcn4\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895321\'02\'04. \levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5760\jclisttab\tx5760 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{\lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299919"}{\cs26\ul\cf2\lang1024\langfe1024\noproof }{\ul\cf2\lang1024\langfe1024\noproof {\*\datafield Un essai clinique comporte quatre étapes successives : 1. ;}{\levelnumbers;}\f14\chbrdr \fi-360\li2520\jclisttab\tx2520 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 {\*\bkmkstart _Toc81299970}XIV. \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3960\jclisttab\tx3960 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895297 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \par \par }\pard \qj \li0\ri-290\widctlpar\tx284\tx5200\tx5440\aspalpha\aspnum\faauto\adjustright\rin-290\lin0\itap0 {\b\i Si les recherches incluent une s\'e9roth\'e8que, DNAth\'e8que, ou toute autre collection, il faut indiquer\~:}{\i \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? \leveltemplateid67895297\'01\u-3913 ? 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900320037000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden 9}}}}}{\lang1024\langfe1024\noproof 7}}}}}{\f0 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900330036000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden 12}}}}}{\lang1024\langfe1024\noproof stream ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5040\jclisttab\tx5040 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6105\jclisttab\tx6105 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? ;}{\levelnumbers PLAN EXPERIMENTAL{\*\bkmkend _Toc81299925} \lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299944"}{\cs26\ul\cf2\lang1024\langfe1024\noproof }{\ul\cf2\lang1024\langfe1024\noproof {\*\datafield D\'e9penses h\'f4teli\'e8res et g\'e9n\'e9rales}{ ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2520\jclisttab\tx2520 }{\listlevel\levelnfc23\levelnfcn23 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \par }\pard\plain \s2\qj \li0\ri0\sb240\sa60\sl360\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \b\f1\fs25\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\i\f28\fs24 \tab }{\f28\fs24 {\*\bkmkstart _Toc81299962} INTRODUCTION ET RATIONNEL}{\webhidden \tab }{\field{\*\fldinst {\webhidden PAGEREF _Toc81299917 \\h }{{\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900310037000000}}}{\fldrslt {\webhidden \levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par {\listtext\pard\plain\s30 \hich\af0\dbch\af0\loch\f0 -\tab}de v\'e9rifier la notification des Ev\'e8nements Ind\'e9sirables Graves, \brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth3\trwWidth10052\trpaddl70\trpaddr70\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 1 Traitement \'e0 l'\'e9tude{\*\bkmkend _Toc81299937} \'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5760\jclisttab\tx5760 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext \par PROMOTEUR\~:\cell }\pard \ql \li0\ri0\sl360\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28\fs22 Nom, {\listname ;}\listid1413164071}{\list\listtemplateid1772901568\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\'01\u-3844 ?