1. 2. 3. 10 C 4. 2 5. Q amp AN0 2 7 6. 6 7 8 2 2 2 2 16o 2 31 7. MM GCP GPSP GVP 0 6 CRO Contract Research Organization CRO CRO 8. 7 E E D 9. B D E AAR 10. Ri 8 DVD 11. RR i D MS 12. P MD A MA 3 Q amp A A 1 2 IA 5 13. C Q amp A NO0 2 17 D C 14. Q amp A No 1 2 3 C 15. 15 A Oi Yi ii0 1 18 1 25 25 19 1 12 16. Q amp A B 7 Q amp A B 9 B D ON 17. OO OO OO 18. Oo OO 4 5 7 19. Q amp A NO 1 26 0 20. SMO Site Management Organization SR ERE NP0 CRO SMO 4 21. D AA 2 E a 5 22. Q amp A NO0 1 NO 2 NO 3 NO 4 24 10 23 3 a A 5 25 2013 23. 24 2012 MAA 14 1 24. Q amp A NO 1 2 4 a 2 FE i D 25. 0 0 A OO a 26. A ED PMDA AED 27. D 12 1 13 gen 28. 24 25 1 24 12 25 20 1 21 1 221 EE 23 24 251