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Book Info VOD  
CHAPTER
  1. Introduction Auditor ¸ÂÀÌÇϱâ
2. ÀÓ»ó½ÃÇè ¾÷¹« ºÐ´ã Role and Responsibility
3. ´ë»óÀÚ µ¿ÀÇ ¾ò±â Obtaining Informed Consent
4. ½ºÅ©¸®´×°ú À絿ÀÇ °úÁ¤ Screening & Re-consenting
5. Screening ÁøÇàÇöȲ ¼³¸íÇϱâ
6. µî·ÏµÈ ȯÀÚÀÇ Ã¶È¸ ¹× Áßµµ Å»¶ô Withdrawals and Dropouts of Enrolled Subjects
7. ID¿Í ºñ¹Ð ¹øÈ£ °ü¸® Management of ID and Password
8. SAE º¸°í ¹× ÀÀ±Þ »óȲ SAE Report & Emergency Situations
9. ÀÓ»ó½ÃÇè¾à º¸°ü Handling Study Drugs/Test Article
10. ¾à±¹ Pharmacy
11. ±³À° ¹× ±³À° ±â·Ï °ü¸® Training & Training Records
12. SOP & GCP Standard Operating Procedures & Good Clinical Practice
13. Quality Control
14. Contingency Plan & Back-up System
15. Record Retention
16. Review of Study Related Documentation (Medical Records / CRFs etc.)
17. Communication with IRB
18. ¿¬±¸ ½ÃÀÛ ¾Ë¸®±â Informing Study Start-up
19. ƯÁ¤ ±¹°¡¿¡ ¸Â´Â ¹®¼­ ÁغñÇϱâ Country-specific template development
20. ¿¬±¸ÀÚ¿¡ ¿¬±¸ ½ÃÀÛ ¾Ë¸®´Â ¸ÞÀÏ ¾²±â
21. ¿¬±¸ ½ÃÀÛ °Ý·Á ¸ÞÀÏ ¾²±â
22. µî·ÏÇöȲ º¸°í À̸ÞÀÏ ¾²±â Enrollment Progress Reporting Sample email
23. ÀÓ»ó½ÃÇè¹®¼­ ¹ß¼Û ¹× ¼ö·É ÇöȲ È®ÀÎ Áú¹®Çϱâ Document Status Follow-up Questions
24. ¹®¼­ ¿øº» ¹ß¼Û ¹× ¼ö·É È®ÀÎ »ùÇà °ø¹® Sample letters on Document Delivery Status Follow-up
25. ȯÀÚ Ãß°¡ µî·Ï È®ÀÎ Asking questions about subject enrollment
26. ÇÁ·ÎÅäÄÝ °ü·Ã Àǹ®»çÇ× ¸íÈ®È÷ Çϱâ Clarifying misleading information in the protocol
27. ÀÓ»ó½ÃÇè ÇöȲ °ü¸® ¹®¼­ ¾÷µ¥ÀÌÆ® Tracker update
28. ¡°Reminder¡±À̸ÞÀÏ º¸³»±â
29. Áö¿¬¿¡ ´ëÇÑ »ç°ú
30. È¿À²ÀûÀÎ ¾÷¹« ÁøÇàÀ» À§ÇØ ¾Ë¾Æ¾ß ÇÒ ¿µ¾î Ç¥Çö
31. ¿¬±¸ ´ã´çÀÚ º¯°æ ¾Ë¸² ¸ÞÀÏ ¾²±â Informing Staff Transition
32. ¿Ü±Ù/ÈÞ°¡½ÃºÎÀç ¾Ë¸² ¸ÞÀÏ ¾²±â Out of office email
33. ¿¬±¸ÆÀ¿ø ¾÷Àû ĪÂù À̸ÞÀÏ ÀÛ¼ºÇϱâ Achievement Recognition
34. Attending Calls/Teleconferences
35. Closing Calls/Teleconferences
36. Áú¹® ¹ÞÀº »çÇ׿¡ ´ëÇØ ´äÇϱâ
37. °èÀýÀλç
38. ÇÐȸ ȤÀº ¿¬±¸ÀÚ ¹ÌÆÃ ÀÏÁ¤ Á¶À²
39. ÇÐȸ ¿¬ÀÚ ÃÊû µî ÃÊ´ë¿¡ ´ëÇÑ °¨»ç & ¼ö¶ô
40. ÃÊû ³»¿ë¿¡ ´ëÇÑ È®ÀÎ/¹ßÇ¥³»¿ë Á¶À²/ÇÐȸ ¹ßÇ¥¿¡¼­ ±â´ëÇÏ´Â ³»¿ë Ä¿¹Â´ÏÄÉÀ̼Ç
41. ¹ßÇ¥ ÀÚ·á º¸³»±â °ü·Ã À¯¿ëÇÑ Ç¥Çö
42. ÇÐȸ/¿¬±¸ÀÚ ¹ÌÆÃ¿¡¼­ µ¹¾Æ¿Í¼­ °¨»ç ÀÎ»ç »ùÇà À̸ÞÀÏ
43. ½ÇÀü AAHRPP ÀÎÁõ ½Ç»ç ´ëºñ¡ª ÀϹÝÀûÀÎ Áú¹®
44. ½ÇÀü AAHRPP ÀÎÁõ ½Ç»ç ´ëºñ¡ª ¿¬±¸ÀÚ °ü·Ã Áú¹®
45. ½ÇÀü AAHRPP ÀÎÁõ ½Ç»ç ´ëºñ¡ª IRB½ÉÀÇÀ§¿ø °ü·Ã Áú¹®
Introduction
English for Clinical Research Experts
Àú    ÀÚ : ±èÅ¿ø, ÀÓ¿µ¼®, ±¸ÇÏ¿µ
ÃâÆÇ³âµµ : 2016³â 5¿ù 20ÀÏ
I S B N : 979-11-5943-016-9
 
 
 

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English for Clinical Research Experts´Â ÀÓ»ó½ÃÇè¿¡ °ü¿©ÇÏ´Â ÀÇ·áÁøÀ» ºñ·ÔÇÏ¿© ÀÓ»ó½ÃÇè½Ç½Ã±â°ü ¹× Á¦¾à»ç, ÀÓ»ó½ÃÇè¼öʱâ°ü µîÀÇ ÀÓ»ó½ÃÇè ´ã´çÀÚµéÀ» À§ÇØ ¸¸µé¾îÁ³½À´Ï´Ù.

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