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ADVERSE EVENTS 17. 11. OVERSIGHT ARRANGEMENTS 17. 11.1 INSPECTION OF RECORDS 17. 11.2 STUDY MONITORING AND AUDIT 18. 12. GOOD CLINICAL PRACTICE 18. 12.1 ETHICAL CONDUCT 18. 12.2 INVESTIGATOR RESPONSIBILITIES 18. 12.2.1 Informed Consent 18. 12.2.2 Study Site Staff 18. 12.2.3 Data Recording 18. 12.2.4 Investigator Documentation 19. 12.2.5 GCP ... ................
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