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臺灣高等法院109年度上字第503號

關鍵資訊

109503 109 261083409 110119 446125513 1700,1631075195 10820267108220108) 104410BioThin daily disposable soft contact lens1051061074187a107040671743387,7131086271687,5501700,16341700,163 10862710452-223-24-34-5 2-32-18 7TMF4CRF13QueryForm254816 7 1511,273 1538,817702,71110819836,106107765161,3461082205 274277 104410Project extension Permonth charge 105106 5 1687,550 107717 1071227Randomization co de list1081716Randomization code list 10818 108 6271045 TMF4CRF12 13Query Form2 1086111083703608 108754192019612調 2019627 1 201971 1081031 55 411700,163 415 退(107) 107717107717 10862710453226,393152 153 1700,1633,226,393×1.051,687,550=1,700,163 (153) 94321 10862732933133433510862745 2-22 2-22TaskSite managementActivitymanaging site miscellaneous issues and proactively follow-up with site issues and project planning 117 (150)2-22 332 2-222-222-222-22811,800 2-221058231061011 146,372 10324714981044102-222-221045227410582310610112-22 169 332 2-221077172-22106 1011 3-2 3-2TaskPr oject managementActivitymanaging project miscellaneous issues and proactively follow-up with project issues and project planning117 ( 150)3323333-2 3-23-23-2714,000 3-2105541061011 157,5003-2CRO 33221044103-2 333 3-2 150 3-2 1077173-2 4-3 4-3TaskMa intain trial master fileActivitymaintain TMF117 GCP(150)review form (3334-34-364,770 4-3105541061011 28,875103 2 review form 33313 4-3 4-5 4-5TaskActivi tyMaintain site files 117 TMF2( 150)3333344-5IRB75.4837.7411328)4-5 4-5124,550 4-51058 231061011 22,77010322 10451586964-5 review form 3333344-5104522 2-32-18 528 8427022-32-18 travelreview and approvevisit reportpreparation, write report, follow-up116117 7147148 TMF4CRF13 Query Form2 5481 54817147148TMF4CRF13Query Form2 1591702212651071227 Randomization code list 1711743263283303321091124 FDA1099905387 24 48 DATE OF FIRST ENROLLMENT May 04,2016( 4124157211055472Date of ICF Signed [Y/M/D]( [//]) 201654(ID00-000-00000-000-000)461086111083703608225 10817 69 697a9045退107717412 15107 121 Milestones/Event6upon last su bjet out17upon database lock8 upon clinical study report 1st draft de livered to sponsor稿9upon clinical study report finaliz ed稿6789782 293110812910794107829 89335 451700,163108 2205951538,8173161,3462 45044927846339023922         110    2     2    2020466 112         110    2     3