English for Clinical Research Experts
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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...