{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \par }\pard\plain \s18\ql \li240\ri0\widctlpar\tqr\tldot\tx9060\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{ ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 {\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900310038000000}}}{\fldrslt {\lang1024\langfe1024\noproof\webhidden 7}}}}}{\lang1024\langfe1024\noproof Le comit\'e9 s\rquote assure, si n\'e9cessaire, que les sujets/patients participant \'e0 la recherche ont \'e9t\'e9 inform\'e9 \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4320\jclisttab\tx4320 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext \levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01\u-3913 ? \levelindent0{\leveltext\leveltemplateid67895311\'02\'00. D\'e9 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext essai, toute modification substantielle de celui-ci \'e0 l'initiative de l\rquote investigateur doit \'eatre soumise tout d\rquote abord au promoteur. ;}{\levelnumbers;}\f3\chbrdr \levelspace284\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? \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 Le plan exp\'e9rimental d\'e9pend des objectifs et de la question pos\'e9e. \'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 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6480\jclisttab\tx6480 }{\listname ;}\listid1333147506} \levelspace360\levelindent0{\leveltext\leveltemplateid1650493990\'01\u-3844 ? \jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? \par }\pard\plain \s15\ql \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28 \par {\listtext\pard\plain\f14 \loch\af14\dbch\af0\hich\f14 \'fc\tab}apparition d'un effet ind\'e9sirable grave. IX.3. riels invasifs non invasifs, g\'e9n\'e9tique, autres\'85.\cell }\pard \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28 \trowd \trgaph70\trrh713\trleft-70\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb \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 Argumenter chaque poste. \trgaph70\trleft-70\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth3\trwWidth9190\trautofit1\trpaddl70\trpaddr70\trpaddfl3\trpaddfr3 \clvertalc\clbrdrt Clinique motoneurone - Sclérose Latérale Amyotrophique (SLA) Essais thérapeutiques sur la SLA. ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6480\jclisttab\tx6480 }{\listname ;}\listid2072803821} \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2 }{HYPERLINK \\l "_Toc81299965"}{\cs26\ul\cf2 }{\ul\cf2 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900360035000000}}}{\fldrslt {\cs26\f28\ul\cf2 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li360\jclisttab\tx360 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360 \par {\listtext\pard\plain\s30 \f14 \loch\af14\dbch\af0\hich\f14 \'fc\tab}Sp\'e9cialit\'e9 res secondaires. \par {\listtext\pard\plain\s30 \hich\af0\dbch\af0\loch\f0 -\tab}la transmission des EIG au promoteur. {\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5400\jclisttab\tx5400 } 2. \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1440\jclisttab\tx1440 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace284\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par {\listtext\pard\plain\s30 \f14 \loch\af14\dbch\af0\hich\f14 \'fc\tab}}\pard \s30\qj \fi-340\li1040\ri0\sl360\slmult1\widctlpar\jclisttab\tx1060\aspalpha\aspnum\faauto\ls38\adjustright\rin0\lin1040\itap0 {\b\i\f28 En cas d'anesth\'e9sie, le protocole d'an ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23 examen par deux personnes en aveugle du traitement pris et estimer la concordance de cette double lecture. ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3589\jclisttab\tx3589 }{\listlevel\levelnfc23\levelnfcn23 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5040\jclisttab\tx5040 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28 \trowd \trgaph70\trrh1069\trleft-70\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5380\jclisttab\tx5380 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 V.4. 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900310039000000}}}{\fldrslt {\cs26\f28\ul\cf2\lang1024\langfe1024\noproof I.2. \leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6120\jclisttab\tx6120 }{\listlevel\levelnfc23 \par \par }\pard\plain \s1\ql \li0\ri0\sb240\sa60\sl360\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \b\f1\fs31\ul\lang1043\langfe1036\kerning32\cgrid\langnp1043\langfenp1036 {\f28\fs24\lang1036\langfe1036\langnp1036 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5040\jclisttab\tx5040 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0 \par }\pard\plain \s2\ql \li0\ri0\sb240\sa60\sl360\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \b\f1\fs25\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28\fs24 \tab {\*\bkmkstart _Toc81299951} \cltxlrtb\clftsWidth3\clwWidth2760 \cellx9120\row }\trowd \trgaph70\trrh1069\trleft-70\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-340\li1048\jclisttab\tx1068 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 Indiquer modalit\'e9s d\rquote information (le plus souvent, par courrier). ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3960\jclisttab\tx3960 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \s7\qc \li0\ri0\sl360\slmult1\keepn\widctlpar\intbl\aspalpha\aspnum\faauto\outlinelevel6\adjustright\rin0\lin0 \b\fs28\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\b0\f28\fs24 Tel\'e9phone l "_Toc81299929"}{\cs26\ul\cf2 }{\ul\cf2 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900320039000000}}}{\fldrslt {\cs26\f28\ul\cf2 V. POPULATION ETUDIEE}{\webhidden \tab } Connaissance scientifique actuelle et questions restant en suspens V.3. \par Le \'85\'85. ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2880\jclisttab\tx2880 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360 rification de la compliance du sujet au traitement. \par }\pard \s30\qj \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f28\ul C}{\f28 es amendements sont rattach\'e9s \'e0 la version originale du protocole. \'01\u-3913 ? diaires sont \'e0 r\'e9aliser. ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4320\jclisttab\tx4320 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 {\leveltext\'01\u-3913 ? \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 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3960\jclisttab\tx3960 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \jclisttab\tx3304 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace284\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3240\jclisttab\tx3240 }{\listlevel \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\i\f28 Epid\'e9miologique, physiopathologique, pharmacologique (pr\'e9ciser la phase), sur des mat\'e9riels invasifs non invasifs, g\'e9n\'e9tique, autres\'85. \par }\pard\plain \ql \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li360\jclisttab\tx360 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr \chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1080\jclisttab\tx1080 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895301 \levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1440\jclisttab\tx1440 }{\listlevel\levelnfc23\levelnfcn23\leveljc0 \par }\pard\plain \s2\ql \fi709\li0\ri0\sb240\sa60\sl360\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \b\f1\fs25\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28\fs24 {\*\bkmkstart _Toc81299950} \'ab\~prudence\~\'bb\~: contre-indication \'e0 l\rquote un des traitements \'e9tudi\'e9s ou associations m\'e9dicamenteuses incompatibles, contre-indication \'e0 une exploration fonctionnelle, sujet en p\'e9riode d\rquote exclusion (d\'e9termin\'e9 \levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1440\jclisttab\tx1440 }{\listlevel\levelnfc23\levelnfcn23 \par {\listtext\pard\plain\s30 \f14 \loch\af14\dbch\af0\hich\f14 \'fc\tab}Sp\'e9cialit\'e9 \clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3300 \cellx6360\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \brdrs\brdrw10 \trftsWidth3\trwWidth10052\trpaddl70\trpaddr70\trpaddfl3\trpaddfr3 \clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3310 \cellx3240\clvertalt\clbrdrt ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li720\jclisttab\tx720 }{\listlevel\levelnfc23\levelnfcn23 {\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2505\jclisttab\tx2505 }{\listlevel\levelnfc23 \'01\u-3913 ? \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 \par }\pard \qj \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f28 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5380\jclisttab\tx5380 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5040\jclisttab\tx5040 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 Dans ce cas, \'e9tablir un consentement sp\'e9cial suppl\'e9mentaire adapt\'e9 \'e0 l\rquote ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1800\jclisttab\tx1800 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace1080\levelindent0{\leveltext ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6480\jclisttab\tx6480 }{\listname ;}\listid1553157620}{\list\listtemplateid-1527850394\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 Randomisation}{\lang1024\langfe1024\noproof\webhidden \tab }{\field{\*\fldinst { \par Raison du type et du pourquoi de l'\'e9tude. \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li720\jclisttab\tx720 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2 Proc\'e9dure \'e0 suivre en cas d'effets ind\'e9sirables graves}{\i\f28\fs24 {\*\bkmkend _Toc81299955}
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