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English for Clinical Research Experts
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Ãß°¡ ÄÜÅÙÃ÷ À¯Çü: VIDEO
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ÃâÆÇ³âµµ: 2016-05-20
ISBN 10: 1159430160
ISBN 13: 9791159430169
ÆÇ Çü: PaperBack | 224pages | 150*215mm
DIGITAL REFERENCE ³»ÀÇ ÄÜÅÙÃ÷´Â µµ¼±¸¸ÅÀÚ¿¡ ÇÑÇØ Á¦°øµÇ´Â Ãß°¡ ÀÚ·áÀÔ´Ï´Ù.
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CHAPTER 1 Introduction Auditor ¸ÂÀÌÇϱâ 1
CHAPTER 2 ÀÓ»ó½ÃÇè ¾÷¹« ºÐ´ã Role and Responsibility 5
CHAPTER 3 ´ë»óÀÚ µ¿ÀÇ ¾ò±â Obtaining Informed Consent 10
CHAPTER 4 ½ºÅ©¸®´×°ú À絿ÀÇ °úÁ¤ Screening ; Re-consenting 18
CHAPTER 5 Screening ÁøÇàÇöȲ ¼³¸íÇϱâ 23
CHAPTER 6 µî·ÏµÈ ȯÀÚÀÇ Ã¶È¸ ¹× Áßµµ Å»¶ô Withdrawals and Dropouts of Enrolled Subjects 28
CHAPTER 7 ID¿Í ºñ¹Ð ¹øÈ£ °ü¸® Management of ID and Password 33
CHAPTER 8 SAE º¸°í ¹× ÀÀ±Þ »óȲ SAE Report ; Emergency Situations 37
CHAPTER 9 ÀÓ»ó½ÃÇè¾à º¸°ü Handling Study Drugs/Test Article 45
CHAPTER 10 ¾à±¹ Pharmacy 51
CHAPTER 11 ±³À° ¹× ±³À° ±â·Ï °ü¸® Training ; Training Records 59
CHAPTER 12 SOP ; GCP Standard Operating Procedures ; Good Clinical Practice 65
CHAPTER 13 Quality Control 68
CHAPTER 14 Contingency Plan ; Back-up System 72
CHAPTER 15 Record Retention 79
CHAPTER 16 Review of Study Related Documentation (Medical Records / CRFs etc.) 84
CHAPTER 17 Communication with IRB 88
CHAPTER 18 ¿¬±¸ ½ÃÀÛ ¾Ë¸®±â Informing Study Start-up 93
CHAPTER 19 ƯÁ¤ ±¹°¡¿¡ ¸Â´Â ¹®¼ ÁغñÇϱâ Country-specific template development 96
CHAPTER 20 ¿¬±¸ÀÚ¿¡ ¿¬±¸ ½ÃÀÛ ¾Ë¸®´Â ¸ÞÀÏ ¾²±â 101
CHAPTER 21 ¿¬±¸ ½ÃÀÛ °Ý·Á ¸ÞÀÏ ¾²±â 105
CHAPTER 22 µî·ÏÇöȲ º¸°í À̸ÞÀÏ ¾²±â Enrollment Progress Reporting Sample email 108
CHAPTER 23 ÀÓ»ó½ÃÇè¹®¼ ¹ß¼Û ¹× ¼ö·É ÇöȲ È®ÀÎ Áú¹®Çϱâ Document Status Follow-up Questions 112
CHAPTER 24 ¹®¼ ¿øº» ¹ß¼Û ¹× ¼ö·É È®ÀÎ »ùÇà °ø¹® Sample letters on Document Delivery Status Follow-up 115
CHAPTER 25 ȯÀÚ Ãß°¡ µî·Ï È®ÀÎ Asking questions about subject enrollment 120
CHAPTER 26 ÇÁ·ÎÅäÄÝ °ü·Ã Àǹ®»çÇ× ¸íÈ®È÷ Çϱâ Clarifying misleading information in the protocol 125
CHAPTER 27 ÀÓ»ó½ÃÇè ÇöȲ °ü¸® ¹®¼ ¾÷µ¥ÀÌÆ® Tracker update 131
CHAPTER 28 ¡°Reminder¡±À̸ÞÀÏ º¸³»±â 136
CHAPTER 29 Áö¿¬¿¡ ´ëÇÑ »ç°ú 139
CHAPTER 30 È¿À²ÀûÀÎ ¾÷¹« ÁøÇàÀ» À§ÇØ ¾Ë¾Æ¾ß ÇÒ ¿µ¾î Ç¥Çö 144
CHAPTER 31 ¿¬±¸ ´ã´çÀÚ º¯°æ ¾Ë¸² ¸ÞÀÏ ¾²±â Informing Staff Transition 148
CHAPTER 32 ¿Ü±Ù/ÈÞ°¡½ÃºÎÀç ¾Ë¸² ¸ÞÀÏ ¾²±â Out of office email 151
CHAPTER 33 ¿¬±¸ÆÀ¿ø ¾÷Àû ĪÂù À̸ÞÀÏ ÀÛ¼ºÇϱâ Achievement Recognition 155
CHAPTER 34 Attending Calls/Teleconferences 157
CHAPTER 35 Closing Calls/Teleconferences 161
CHAPTER 36 Áú¹® ¹ÞÀº »çÇ׿¡ ´ëÇØ ´äÇϱâ 164
CHAPTER 37 °èÀýÀλç 167
CHAPTER 38 ÇÐȸ ȤÀº ¿¬±¸ÀÚ ¹ÌÆÃ ÀÏÁ¤ Á¶À² 172
CHAPTER 39 ÇÐȸ ¿¬ÀÚ ÃÊû µî ÃÊ´ë¿¡ ´ëÇÑ °¨»ç ; ¼ö¶ô 178
CHAPTER 40 ÃÊû ³»¿ë¿¡ ´ëÇÑ È®ÀÎ/¹ßÇ¥³»¿ë Á¶À²/ÇÐȸ ¹ßÇ¥¿¡¼ ±â´ëÇÏ´Â ³»¿ë Ä¿¹Â´ÏÄÉÀÌ¼Ç 182
CHAPTER 41 ¹ßÇ¥ ÀÚ·á º¸³»±â °ü·Ã À¯¿ëÇÑ Ç¥Çö 188
CHAPTER 42 ÇÐȸ/¿¬±¸ÀÚ ¹ÌÆÃ¿¡¼ µ¹¾Æ¿Í¼ °¨»ç ÀÎ»ç »ùÇà À̸ÞÀÏ 192
CHAPTER 43 ½ÇÀü AAHRPP ÀÎÁõ ½Ç»ç ´ëºñ ¡ª ÀϹÝÀûÀÎ Áú¹® 197
CHAPTER 44 ½ÇÀü AAHRPP ÀÎÁõ ½Ç»ç ´ëºñ ¡ª ¿¬±¸ÀÚ °ü·Ã Áú¹® 201
CHAPTER 45 ½ÇÀü AAHRPP ÀÎÁõ ½Ç»ç ´ëºñ ¡ª IRB½ÉÀÇÀ§¿ø °ü·Ã Áú¹® 206