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°ê®a½Ã¥Í¬ã¨s°|¬°¿n·¥±À®i°ê¤ºÁ{§É¸ÕÅ礧¬ã¨s»Pµo®i¡A©ó¡u»OÆWÀù¯gÁ{§É¬ã¨s¦X§@²Õ´¡v(Taiwan Cooperative Oncology Center, ²ºÙTCOG)¤º³]¥ß°õ¦æ¤¤¤ß¡A¨Ã©ó¥Íª«²Î­p¤Î¥Íª«¸ê°T¬ã¨s²Õ³]¥ß²Î­p¤¤¤ß¡A°£¨î©w¡uÁ{§É¸ÕÅç¸ê®ÆºÞ²z¤§¼Ð·Ç§@·~µ{§Ç¡v¥~¡A¨Ã¦¨¥ß¦h­Ó¤u§@¤p²Õ¡A¤À§O³W¹ºÁ{§É¸ÕÅç³ø§iªí®æ¡]Case Report Form, ²ºÙCRF¡^¤Î³øªí»s§@¡A°Ñ»PÁ{§É¬ã¨s­pµe¤§¼f¬d¡B³]­p¡B°õ¦æ¤Î¤ÀªRµ¥¬ÛÃö§@·~¡A¨Ã«Ø¥ß¡uÁ{§É¸ÕÅç¸ê°TºÞ²z¨t²Î¡v¡]Clinical Research Information Management System,¥H¤U²ºÙCRIMS¡^¥H¦³®ÄºÞ²z¦h¤¤¤ßÁ{§É¸ÕÅçÃe¤j¥B½ÆÂø¤§¸ê®Æ¡A½T«O¸ê®Æ¤§«~½è¡C

©ó¡u«Ø¥ß°ê®aÁ{§É¸ÕÅç»P¬ã¨sÅé¨t¡v¤§¡u«Ø¥ß°ê®aÁ{§É¸ÕÅç¦X§@ºô¸ô¡v­pµe¤¤¡A¦b¸ê®Æ³B²z²Î­p¤¤¤ß¤è­±, ¨ä¤¤¤@¶µ­«ÂI¤u§@¬°±j¤Æ¸ê®ÆºÞ²z¨t²ÎCRIMSªº¥\¯à, ¨Ã¶i¦æ¨t²Î´ú¸Õ¡B¸Ë¸m¥H¤ÎÅçÃÒµ¥¤u§@¡C¥Ñ©ó¥Ø«e°ê¤º¨S¦³¨ã¦³¬ÛÃö¸gÅ窺±M·~¤H¤h¡A¦]¦¹§Ú­Ì§ä¨ì¥Ø«e¥ô¾©óDuke Universityªº©P½å©¾±Ð±Â¡A¾á¥ôCRIMS Validationªº»{ÃÒ±M·~¤H¤h¡C¦bÁ{§É¸ÕÅçµo®i¤¤¡A©P±Ð±Â¦³¬Û·í§¹¾ãªº¾Ç¸g¾ú¡C¦Ó¥B©P±Ð±Â¥»¤H¤]¿Ë¦Û¨ó§UMillennium»PStatPlusµ¥ª¾¦W¤½¥qªºFDA 21 CFR Part 11 Compliance¤u§@¡CÂǥѩP½å©¾±Ð±ÂÂ×´IªºÅçÃÒ¸gÅç¡A¨Ó¨ó§UCRIMS Validationªº¤u§@¡C

CRIMS Validationªº¥Øªº¥D­n¬O¬°½T«OCRIMS¯à°÷²Å¦XÁ{§É¸ÕÅç¬ÛÃöªk³W¡A¥H¤ÎTCOG¨î©wªº¬Fµ¦»Pµ{§Ç¡CÅçÃÒªº¥Ø¼Ð¬O­n´£¨Ñ¬ÛÃö¤å¥ó¨ÓÃÒ©úCRIMS ¨t²Î¹B§@ªº¥¿½T©Ê¡B¤@­P©Ê¡B³sÄò©Ê¡B¥H¤Î²Å¦X¨Ï¥ÎªÌªº»Ý¨D¡C³o¨ÇÃÒ©ú¤å¥ó¥²¶·²Å¦XFDA 21 CFR Part 11 Compliance¬ÛÃöªº³W½d¡C°w¹ïCRIMS softwareÅçÃÒªº½d³ò¥]¬Athe functions and tools used for clinical data management (e.g., database setup, double data entry/verification, data query generation/tracking, data cleaning/database lock, data transfer/archive, etc.), statistical analysis, clinical operations (e.g., individual patient profile, enrollment status, site selection, clinical trial management, etc.), and summary reports generation for clinical studiesµ¥¡C

°w¹ïCRIMS Validation¡A§Ú­Ì§¹¦¨¤F¤U¦C©Ò»Ýªº¤å¥ó¡G
(1) Impact and Risk Analysis
©óCRIMS ¨t²Îµo®i´Á¶¡¡ATCOG²Î­p¤¤¤ß¡BTCOG°õ¦æ¤¤¤ß¡B»P¨t²Îµo®i¼t°Ó¥xùÖ¤½¥q©w´Á¶}·|°Q½×¨t²Îµo®iªº¤@¨ÇÃøÃD¤Î¦p¦ó§ïµ½³o¨Ç²£¥Íªº°ÝÃD¡C¡uImpact and Risk Analysis¡v¥D­n¬O¾ã²z³o¨Ç²£¥Íªº°ÝÃD¨ÓÀ°§UCRIMS Validation¡C¥t¥~¦¹¥÷¤å¥ó¤]¾ã²z¤F³o¨Ç°ÝÃD¹ïCRIMSªº½ÄÀ»¡A¥H¤Î¨ä©Ò³y¦¨ªº­·ÀI¡C

(2) User and Functional Requirements Specification
¦¹³¡¥÷¤å¥ó¦C¥XºÞ²zÁ{§É¸ê°Tªº¨Ï¥ÎªÌ©Ò»Ý¥\¯à¤Wªº»Ý¨D¡C³o¨Ç¥\¯à²[»\¤FÁ{§É¸ê®ÆºÞ²z¡B²Î­p¤ÀªR¡BÁ{§É¸ÕÅç¹B§@¡B³øªí¾ã²z¡C³o¨Ç»Ý¨D±N¤ä°t¾ã­ÓCRIMS Validation¡C

(3) Validation Master Plan (Protocol)
¦¹¥÷¤å¥ó¸ü©úCRIMS¨t²ÎÅçÃÒªº¤èªk¡BCRIMS Validation©Ò»Ý­nªº¤u§@»P³d¥ô¤º®e¡A¨Ã«ü¥X¦p¦ó´£¨Ñ¬ÛÃö¤å¥ó¨ÓÃÒ©úCRIMS ¨t²Î¹B§@ªº¥¿½T©Ê¡B¤@­P©Ê¡B³sÄò©Ê¡B¥H¤Î²Å¦X¨Ï¥ÎªÌªº»Ý¨D¡C

(4) Installation/Operation Qualification (IOQ) for CRIMS
¦¹³¡¥÷¤å¥ó¸Ô­zCRIMS ¨t²ÎÅ禬ªº¤èªk¡BÅ禬¶µ¥Ø¡BÅ禬¹Lµ{¡B¥H¤Î©Ò¦³Ãö©óCRIMS ¹B§@¬ÛÃö°ÝÃD¡C

(5) Computer Systems Implementation SOP
¦¹§Þ³NºÞ²z¤â¥U¥D­n¬O´£¨Ñµ¹¨t²ÎºÞ²z¤H­û¡C¤º®e¥]¬A¨t²Î¦p¦ó¬[³]¡B¨t²ÎÀÉ®×»¡©ú¡B­«­n§Þ³N»¡©ú¡B¸ê®Æ®wºÞ²zµ¥¡C

(6) 15 TCOG Clinical Operations SOPs & 14 TCOG Statistical Center SOPs
TCOG°õ¦æ¤¤¤ß»P²Î­p¤¤¤ß»Ý­n¦³¤@®M§¹¾ãªº¼Ð·Ç§@·~¬yµ{(SOP)¡A¥H½T«OÁ{§É¸ÕÅ窺°õ¦æ¡A§¹¥þ²Å¦XGood Clinical Practice (GCP)ªº­ì«h¡C

(7) CRIMS Validation Summary Report
¦¹¥÷¤å¥ó¥D­n¬O¸ü©úCRIMS¨t²ÎÅçÃÒµ²ªG¡CValidation Consultant©P½å©¾³Õ¤h¡A°w¹ï§Ú­Ì·Ç³Æªº©Ò¦³¬ÛÃö¤å¥ó¡A¨ävalidationªºµ²½×¬°¡G

¡§Based on the test results from all of the test protocols as described in the CRIMS Validation Master Plan (TCOG-VAL-SC003-01), we conclude that CRIMS is validated. In other words, CRIMS performs all the intended functions such as clinical data management, statistical analysis, clinical operations, and summary reports generation for clinical studies accurately and reliably with a high degree of assurance.¡¨

¦Ü¦¹¡ACRIMS Software Validationªº²Ä¤@¶¥¬q¤u§@¤j­P§¹¦¨¡C©ó¤G¤ë¤Q¥|¤é©Ò¥l¶}ªº½Ã¥Í¸p¡uÁ{§É¸ÕÅç»P¬ã¨s±À°Ê¤p²Õ¡v²Ä¤G¦¸·|ij¤¤¡A§Ú­Ì¤]³ø§i¤FCRIMS Validationªº¤u§@¶i«×¡C½Ã¥Í¸p³¯¦A®Ê°Æ¸pªøı±o©P½å©¾±Ð±ÂªºÅçÃÒµ²½×¬Û·í­«­n¡A¨Ã´Á³\§Ú­Ì³t«×­n¥[§Ö¡A¦P®ÉÀ³ª`·NCRIMS¨Ï¥Îªº¤è«K©Ê(user friendly)¡CCRIMS Validation ªº²Ä¤G¶¥¬q¤u§@²[»\¾ã­ÓTCOG¡A¥Íª«²Î­p»P¥Íª«¸ê°T¬ã¨s²Õ¡A¥H¤Î¬ã¨s¸ê·½³Bªº¸ê°T²Õ¡C¥D­n¬O°w¹ïCRIMSªºPerformance Qualification¡A»P¸ê°Tªº¦w¥þ©Ê¡C³o³¡¤À¤u§@¥Ø«e¤´¦b¶i¦æ¤¤¡C

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Dr. Paul J. Farrell
Professor of Tumor Virology, Division of Investigative Science, Medicine, Imperial College, UK
Dr. Joseph S. Pagano
Director and Professor of Tumor Virology, Dept. of Microbiology and Immunology, University of North Carolina at Chapel Hill, USA
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¥Íª«²Î­p»P¥Íª«¸ê°T¬ã¨s²Õ¾Ç³NºtÁ¿¡ÐDr. David R.Cox

¥DÁ¿¤H¡GDr. David R.Cox, M.D.,Ph.D.
(PERLEGEN SCIENCES, INC. Chief Scientific Officer)
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®É¶¡¡G2006¦~2¤ë24¤é(¬P´Á¤­) 2:30 PM
¦aÂI¡G6th meeting room, B1 Administration Building, NHRI Zhunan
Campus
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