\par Pr\'e9ciser si un d\'e9lai de r\'e9flexion est n\'e9cessaire entre l\rquote information et la signature du consentement et indiquer quelle est la dur\'e9e de ce d\'e9lai. {\*\bkmkstart _Toc81299916}{\*\bkmkstart _Toc81299917} ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4811\jclisttab\tx4811 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \par - facteurs histologiques, ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \par {\listtext\pard\plain\f3 \loch\af3\dbch\af0\hich\f3 \'b7\tab}}\pard \ql \fi-360\li1069\ri0\sl360\slmult1\widctlpar\tx900\aspalpha\aspnum\faauto\ls54\adjustright\rin0\lin1069\itap0 {\i\f28 D\'e9crire la r\'e9alisation des examens compl\'e9mentaires n\'e9 \par }\pard\plain \ql \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\i �I|�ۦ6f���40Tš)���Z��?%�/�+��R��Ku e{(E@��p)�F !$����YxHӨQ���5w�,j�:-:l����m��$^�/�tE�:ᆧ�uV�\�JN?o���F$§�zTjnB��e��FDB����M'�,�1�I�K�jcz�8�l�=�bG��)�5�ά@Y��/aD-�2�F׳�c�dK�e� ���Z϶��\��i"%kl�"�@�9�S��y ��A���l5�2�`l7n��tR�Z5�-+ �ܔ���핚�����Xm~�=�x� G�t�K��J����P�˅ѯ��F�BPkC Ep}���l�A����PYA�����Dlno�7[���|� 1ݓ�P�J����m�xJ�1c�2vfN��NO$�զ�k�g忪sƘ�ã��>j�Kh�9�lMAI��2�����W����pnR�~S���~���s�K����j�?�WţDC:�����9��P���||��0 VI.2. ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2880\jclisttab\tx2880 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace284\levelindent0{\leveltext Objectif principal. \par S\rquote il n\rquote y a pas de p\'e9riode d\rquote exclusion, cette mention doit figurer. \par \cellx9142\pard\plain \s15\ql \li0\ri0\widctlpar\intbl\tqc\tx4536\tqr\tx9072\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f1\fs23 \cell \cell date\~:\cell }\pard\plain \chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1 \fi-360\li2880\jclisttab\tx2880 }{\listlevel\levelnfc4\levelnfcn4\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895321\'02\'04. \par }\pard \s18\ql \li240\ri0\widctlpar\tx2880\tqr\tldot\tx9060\aspalpha\aspnum\faauto\adjustright\rin0\lin240\itap0 {\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{\lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299932"}{ \par M\'e9l\~: }{\field{\*\fldinst {\b\f28 HYPERLINK "mailto:llau.me@chu-toulouse.fr" }{\b\f28 {\*\datafield D\'e9finition des \'e9v\'e9nements ind\'e9sirables graves}{ ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6480\jclisttab\tx6480 }{\listname ;}\listid1714190258}{\list\listtemplateid440957774\listhybrid{\listlevel\levelnfc23 \listoverridecount0\ls18}{\listoverride\listid726957902\listoverridecount0\ls19}{\listoverride\listid1816028832\listoverridecount0\ls20}{\listoverride\listid267321840\listoverridecount0\ls21}{\listoverride\listid1101923154\listoverridecount0\ls22} \par {\listtext\pard\plain\hich\af0\dbch\af0\loch\f0 -\tab}}\pard \ql \fi-360\li1420\ri0\sl360\slmult1\widctlpar\jclisttab\tx1420\aspalpha\aspnum\faauto\ls58\adjustright\rin0\lin1420\itap0 {\f28 Quelles sont les variables prises en compte dans l\rquote Modalit\'e9 de recrutement}{\cs26\i\f28\ul\cf2\lang1024\langfe1024\noproof . {\listname ;}\listid980310021}{\list\listtemplateid1006028200\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? {\*\pnseclvl5\pndec\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl6\pnlcltr\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl7\pnlcrm\pnstart1\pnindent720\pnhang{\pntxtb (}{\pntxta )}}{\*\pnseclvl8 \leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par \'01\u-3929 ? \levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1440\jclisttab\tx1440 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \'01\u-3929 ? \chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3600\jclisttab\tx3600 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895301 \par }\pard\plain \ql \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28 La randomisation s\rquote effectue apr\'e8s v\'e9rification des crit\'e8res d\rquote \listoverridecount0\ls63}{\listoverride\listid1399746160\listoverridecount0\ls64}{\listoverride\listid673580357\listoverridecount0\ls65}{\listoverride\listid1062217840\listoverridecount0\ls66}{\listoverride\listid36782126\listoverridecount0\ls67} \levelindent0{\leveltext\leveltemplateid-652049444\'01-;}{\levelnumbers;}\loch\af0\hich\af0\dbch\af0\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1068\jclisttab\tx1068 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6480\jclisttab\tx6480 }{\listname ;}\listid208609701}{\list\listtemplateid109105928\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 Seront mentionn\'e9s le pourcentage de sujets/patients inclus \'e0 \par }\pard\plain \qj \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 { \'01\u-3929 ? Description des visites de suivi. l "_Toc81299935"}{\cs26\ul\cf2 }{\ul\cf2 {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900330035000000}}}{\fldrslt {\cs26\f28\ul\cf2 VI. \par {\listtext\pard\plain\s30 \hich\af0\dbch\af0\loch\f0 -\tab}}\pard \s30\qj \fi-360\li720\ri0\sl360\slmult1\widctlpar\jclisttab\tx720\aspalpha\aspnum\faauto\ls59\adjustright\rin0\lin720\itap0 {\f28 de contr\'f4ler le respect du protocole, Nombre de sujets/patients n\'e9cessaires{\*\bkmkend _Toc81299932} \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 \clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3310 \cellx3240\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 {\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden PAGEREF _Toc81299937 \\h }{\lang1024\langfe1024\noproof {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900330037000000}}}{\fldrslt { \par \par }{\ul Madame, Monsieur, ;}{\levelnumbers ;}{\levelnumbers;}\f14\chbrdr ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01\u-3913 ? \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 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2160\jclisttab\tx2160 } urer dans le dossier source du sujet. \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4320\jclisttab\tx4320 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? ;}{\levelnumbers;}\f3\chbrdr \par {\listtext\pard\plain\s30 \hich\af0\dbch\af0\loch\f0 -\tab}R\'e9actifs de laboratoire ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4320\jclisttab\tx4320 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0 \par Les personnes charg\'e9es du contr\'f4le de qualit\'e9 d\rquote une recherche biom\'e9dicale et d\'fbment mandat\'e9es \'e0 cet effet par le promoteur ont acc\'e8s, sous r\'e9serve de l\rquote accord des personnes concern\'e9es, aux donn\'e9 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4680\jclisttab\tx4680 }{\listlevel\levelnfc23\levelnfcn23 \levelstartat1\levelspace0\levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5760\jclisttab\tx5760 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 \'01\u-3929 ? Randomisation}{\lang1024\langfe1024\noproof\webhidden \tab }{\field{\*\fldinst { \ql \li0\ri0\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f1\fs23 \trowd \trgaph70\trrh343\trleft-70\trkeep\trbrdrt\brdrs\brdrw10 \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6600\jclisttab\tx6600 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3371\jclisttab\tx3371 }{\listlevel\levelnfc23 es. ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-340\li1020\jclisttab\tx1040 }{\listlevel\levelnfc23\levelnfcn23 \chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1 \fi-360\li5040\jclisttab\tx5040 }{\listlevel\levelnfc4\levelnfcn4\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895321\'02\'07. ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 {\field{\*\fldinst {\lang1024\langfe1024\noproof\webhidden PAGEREF _Toc81299939 \\h }{\lang1024\langfe1024\noproof {\*\datafield 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900330039000000}}}{\fldrslt { \jclisttab\tx4680 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? \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 \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 \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6480\jclisttab\tx6480 }{\listname ;}\listid1477263951}{\list\listtemplateid1630287638\listhybrid{\listlevel\levelnfc0\levelnfcn0\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360 \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 \par }\pard\plain \qj \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {Je pourrai \'e0 tout moment demander des informations compl\'e9mentaires au Docteur \'85\'85\'85\'85\'85\'85 Body Text;}{\s31\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \i\fs23\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 \sbasedon0 \snext31 Body Text 2;}{\*\cs32 \additive \ul\cf12 \sbasedon10 FollowedHyperlink;}{\*\cs33 \sbasedon0 \snext0 \sautoupd toc 3;}{\s20\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 \sbasedon0 \snext0 \sautoupd toc 4;}{ \levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par Mentionner si le patient/sujet peut ou non \'eatre sous tutelle ou sous curatelle ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 VI.3. ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4320\jclisttab\tx4320 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 \'01\u-3929 ? \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5760\jclisttab\tx5760 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01\u-3929 ? ;}{\levelnumbers \par - ATCD personnels et/ou familiaux, \jclisttab\tx3960 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth2760 \cellx9120\row }\pard \qj \li0\ri0\sl360\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28 \cell \cell \cell }\pard \par }\pard\plain \ql \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f006300380031003200390039003900340039000000}}}{\fldrslt {\cs26\f28\ul\cf2\lang1024\langfe1024\noproof VII.1. 08d0c9ea79f9bace118c8200aa004ba90b02000000080000000d0000005f0054006f0063003800310032003900390039003100360000000000000000000000000000000000}}}{\fldrslt {\cs26\f28\ul\cf2 I. \par {\listtext\pard\plain\f28 \hich\af28\dbch\af0\loch\f28 B)\tab}Description du m\'e9dicament exp\'e9rimental \listoverridecount0\ls27}{\listoverride\listid980310021\listoverridecount0\ls28}{\listoverride\listid2056656936\listoverridecount0\ls29}{\listoverride\listid730661722\listoverridecount0\ls30}{\listoverride\listid945965345\listoverridecount0\ls31} \chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li6440\jclisttab\tx6440 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301 \f28 Statut du m\'e9dicament contr\'f4le utilis\'e9 dans l\rquote essai\~: AMM ou non, nom de la sp\'e9cialit\'e9, appartenance au groupe ATC, statut \'e9ventuel de m\'e9dicament orphelin Crit\'e8re principal}{\cs26\i\f28\ul\cf2\lang1024\langfe1024\noproof . \trbrdrl\brdrs\brdrw10 \trbrdrb\brdrs\brdrw10 \trbrdrr\brdrs\brdrw10 \trbrdrh\brdrs\brdrw10 \trbrdrv\brdrs\brdrw10 \trftsWidth3\trwWidth9212\trpaddl70\trpaddr70\trpaddfl3\trpaddfr3 \clvmgf\clvertalt\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> crire le nouveau traitement ou la nouvelle prise en charge propos\'e9e{\*\bkmkend _Toc81299920} \par {\*\bkmkstart _Toc81299935}VI. \brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3960\jclisttab\tx3960 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace1080\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2 \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{\lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299962"}{\cs26\ul\cf2\lang1024\langfe1024\noproof }{\ul\cf2\lang1024\langfe1024\noproof {\*\datafield ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li7160\jclisttab\tx7160 }{\listname ;}\listid730661722}{\list\listtemplateid-1624594008\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0 \levelspace0\levelindent0{\leveltext\'01\u-3913 ? \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 ;}{\levelnumbers;}\f14\chbrdr ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li1800 \par {\listtext\pard\plain\s30 \f3 \loch\af3\dbch\af0\hich\f3 \'2d\tab}Etude multicentrique (et dans ce cas, nationale ou internationale) ou monocentrique \par {\listtext\pard\plain\s30 \f2 \hich\af2\dbch\af0\loch\f2 o\tab}Les lieux d'analyse. \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 \widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\f28\fs22 TITRE:\cell }\pard \ql \li0\ri0\sl360\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28\fs22 \cell \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2880\jclisttab\tx2880 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \cltxlrtb\clftsWidth3\clwWidth3130 \cellx3060\clvertalc\clbrdrt\brdrs\brdrw10 \clbrdrl\brdrs\brdrw10 \clbrdrb\brdrs\brdrw10 \clbrdrr\brdrs\brdrw10 \par }\pard\plain \s36\ql \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\cf2\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\i\f28\cf0 Indiquer comment le recrutement est pr\'e9 \rquote Autorit\'e9 comp\'e9tente en ce qui concerne un audit ou une inspection de l\rquote essai. \par ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5040\jclisttab\tx5040 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0 ;}{\levelnumbers;}\f14\chbrdr \par Pour les crit\'e8res de jugement }{\i\f28\ul principal et secondaires}{\i\f28 , pr\'e9ciser les outils d'\'e9valuation qui seront utilis\'e9s pendant l'\'e9tude, par exemple\~: ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li2880\jclisttab\tx2880 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0 \par ;}\listid470443769}{\list\listtemplateid-2046949056\listhybrid{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\'01\u-3913 ? \levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3240\jclisttab\tx3240 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3240\jclisttab\tx3240 }{\listlevel\levelnfc23 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li5380\jclisttab\tx5380 } \par }{\field\fldedit{\*\fldinst {\cs26\ul\cf2\lang1024\langfe1024\noproof }{\lang1024\langfe1024\noproof HYPERLINK \\l "_Toc81299951"}{\cs26\ul\cf2\lang1024\langfe1024\noproof }{\ul\cf2\lang1024\langfe1024\noproof {\*\datafield \'01\u-3929 ? \cltxlrtb\clftsWidth3\clwWidth5302 \cellx9982\pard \qc \li0\ri0\sl360\slmult1\widctlpar\intbl\aspalpha\aspnum\faauto\adjustright\rin0\lin0 {\f28\fs22 sultats globaux de la recherche au sujet (loi 4 mars 2002 relative aux droits des malades) le plus souvent par un courrier. \leveltemplateid67895297\'01\u-3913 ? {\leveltext\'01\u-3929 ? \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li4320\jclisttab\tx4320 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895297\'01\u-3913 ? inclusion et elle doit conduire \'e0 l\rquote inclusion du nombre de sujets/patients n\'e9cessaires dans les groupes \'e9tudi\'e9s. 2 - Sandra Perrault est responsable du recrutement des volontaires sains à l'Institut de pharmacologie clinique Roche à Strasbourg. \levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895301\'01\u-3929 ? \par }\pard\plain \s30\qj \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 {\b\i\f28 Dans le cas d'une \'e9tude multicentrique}{\i\f28 ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li3225\jclisttab\tx3225 } \par }\pard \qc \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f28 \par {\listtext\pard\plain\s30 \hich\af0\dbch\af0\loch\f0 -\tab}}\pard\plain \s30\qj \fi-360\li1065\ri0\sl360\slmult1\widctlpar\jclisttab\tx1065\aspalpha\aspnum\faauto\ls63\adjustright\rin0\lin1065\itap0 \fs24\lang1036\langfe1036\cgrid\langnp1036\langfenp1036 ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \par }\pard \qj \li0\ri0\sl360\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i\f28 est pas obligatoire) il faut pr\'e9ciser le montant pr\'e9vu pour la totalit\'e9 de l\rquote \'e9tude. \levelindent0{\leveltext\'01\u-3929 ? par le promoteur (ARC promoteur), visitera de fa\'e7on r\'e9guli\'e8re chaque centre de l\rquote \'e9tude lors de la mise en place de l\rquote essai, une ou plusieurs fois en cours d\rquote essai selon le rythme des inclusions et en fin d\rquote essai. \fi-360\li4680\jclisttab\tx4680 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace360\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \'01\u-3913 ? \par }\pard\plain \s17\ql \li0\ri0\sl360\slmult1\widctlpar\tqr\tldot\tx9060\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1024\langfe1024\cgrid\noproof\langnp1036\langfenp1036 {\field\fldedit{\*\fldinst {\f28 TOC \\o "1-3" \\h \\z } ;}{\levelnumbers;}\f14\chbrdr\brdrnone\brdrcf1 \par \par }\pard\plain \s17\ql \li0\ri0\sl360\slmult1\widctlpar\tqr\tldot\tx9060\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f1\fs24\lang1024\langfe1024\cgrid\noproof\langnp1036\langfenp1036 {\field\fldedit{\*\fldinst {\cs26\ul\cf2 }{HYPERLINK \\ ;}{\levelnumbers;}\f3\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \fi-360\li360\jclisttab\tx360 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1 (examen de suivi, analyses compl\'e9mentaires, {\*\bkmkstart _Toc41819284}modalit\'e9s de suivi\'85) \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 ? \lang1024\langfe1024\noproof\webhidden 12}}}}}{\lang1024\langfe1024\noproof \jclisttab\tx700 }{\listlevel\levelnfc23\levelnfcn23\leveljc0\leveljcn0\levelfollow0\levelstartat1\levelspace0\levelindent0{\leveltext\leveltemplateid67895299\'01o;}{\levelnumbers;}\f2\chbrdr\brdrnone\brdrcf1 \chshdng0\chcfpat1\chcbpat1\fbias0 \leveltemplateid67895297\'01\u-3913 ?