µðÁöÅз¹ÆÛ·±½º

¹ü¹®¿¡µàÄÉÀ̼ǿ¡¼­ Ãâ°£/Á¦ÀÛÇÑ µµ¼­¿¡ Ãß°¡ Á¦°øµÇ´Â °ü·Ã ÀÚ·áÀÔ´Ï´Ù.

English for Clinical Research Experts

±èÅ¿ø,ÀÓ¿µ¼®,±¸ÇÏ¿µ

ÄÜÅÙÃ÷ º¸±â

Ãß°¡ ÄÜÅÙÃ÷ À¯Çü: VIDEO

Àú ÀÚ: ±èÅ¿ø,ÀÓ¿µ¼®,±¸ÇÏ¿µ
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.
±¸¸ÅÇÑ µµ¼­³»ÀÇ ¡®µµ¼­ÀÎÁõÄÚµå(Access Code)¡¯¸¦ µî·ÏÈÄ ÀÌ¿ëÇÒ ¼ö ÀÖ½À´Ï´Ù.

µµ¼­ ÀÎÁõÄÚµå µî·ÏÇϱâ

Â÷·Ê

ÀúÀÚ ¼Ò°³ iii

ÀúÀÚ ¼­¹® v

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