GOST R 52379-2005 Good clinical practice (GCP)《良好临床试验规范(GCP)》.pdf

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7、5cG25fG25eG25fG267G262G279G3G268G3G26bG26cG25aG267G25eG25aG26aG26cG25fG14G3G249G248G23eG23dG248G24cG248G23cG245G23fG247G3G23aG26bG26bG268G270G262G25aG270G262G25fG263G3G266G25fG260G25eG26dG267G25aG26aG268G25eG267G275G26fG3G26eG25aG26aG266G25aG270G25fG25cG26cG262G271G25fG26bG264G262G26fG3G269G26aG268G

8、262G261G25cG268G25eG262G26cG25fG265G25fG263G3GbG24G2cG33G30GcGfG3G246G25fG260G10G25eG26dG267G25aG26aG268G25eG267G268G263G3G264G268G267G26eG25fG25eG25fG26aG25aG270G262G25fG263G3G268G25bG273G25fG26bG26cG25cG3G269G268G26cG26aG25fG25bG262G26cG25fG265G25fG263G3GbG244G268G267G26eG248G249GcGfG3G24aG268G26b

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11、6aG26bG26cG25cG25fG267G267G275G25fG3G26bG26aG25fG25eG26bG26cG25cG25aGaaG16G3G24dG24cG23cG23fG24aG240G23eG23fG247G3G249G26aG262G264G25aG261G268G266G3G24eG25fG25eG25fG26aG25aG265G276G267G268G25dG268G3G25aG25dG25fG267G26cG26bG26cG25cG25aG3G269G268G3G26cG25fG26fG267G262G271G25fG26bG264G268G266G26dG3G26a

12、G25fG25dG26dG265G262G26aG268G25cG25aG267G262G278G3G262G3G266G25fG26cG26aG268G265G268G25dG262G262G268G26cG3G15G1aG3G26bG25fG267G26cG279G25bG26aG279G3G15G13G13G18G3G25dG11G3G28bG3G15G16G15G10G26bG26cG17G3G247G25aG26bG26cG268G279G273G262G263G3G26bG26cG25aG267G25eG25aG26aG26cG3G262G25eG25fG267G26cG262G2

13、71G25fG267G3G24aG26dG264G268G25cG268G25eG26bG26cG25cG26dG3G269G268G3G267G25aG25eG265G25fG260G25aG273G25fG263G3G264G265G262G267G262G271G25fG26bG264G268G263G3G269G26aG25aG264G26cG262G264G25fG3GbG26G52G51G56G52G4fG4cG47G44G57G48G47G2aG58G4cG47G48G4fG4cG51G48G3G49G52G55G3G2aG52G52G47G3G26G4fG4cG51G4cG46

14、G44G4fG3G33G55G44G46G57G4cG46G48GcG3G246G25fG260G25eG26dG267G25aG26aG268G25eG267G268G263G3G264G268G267G26eG25fG26aG25fG267G270G262G262G3G269G268G3G25dG25aG26aG266G268G267G262G261G25aG270G262G262G3G26cG25fG26fG267G262G271G25fG26bG264G262G26fG3G26cG26aG25fG25bG268G10G25cG25aG267G262G263G3G264G3G26aG25

15、fG25dG262G26bG26cG26aG25aG270G262G262G3G26eG25aG26aG266G25aG270G25fG25cG26cG262G271G25fG26bG264G262G26fG3G269G26aG268G25eG26dG264G26cG268G25cGfG3G269G26aG25fG25eG267G25aG261G267G25aG271G25fG267G267G275G26fG3G25eG265G279G3G269G26aG262G266G25fG267G25fG267G262G279G3G271G25fG265G268G25cG25fG264G268G266G

16、3GbG2cG51G57G48G55G10G51G44G57G4cG52G51G44G4fG3G26G52G51G49G48G55G48G51G46G48G3G52G51G3G2bG44G55G50G52G51G4cG5dG44G57G4cG52G51G3G52G49G3G37G48G46G4bG51G4cG46G44G4fG3G35G48G54G58G4cG55G48G50G48G51G57G56G3G49G52G55G3G35G48G4aG4cG56G57G55G44G57G4cG52G51G3G52G49G3G33G4bG44G55G50G44G46G48G58G57G4cG46G44G

17、4fG56G3G49G52G55G2bG58G50G44G51G3G38G56G48G1eG3G2cG26G2bGcG249G26aG262G3G269G26aG262G266G25fG267G25fG267G262G262G3G267G25aG26bG26cG268G279G273G25fG25dG268G3G26bG26cG25aG267G25eG25aG26aG26cG25aG3G26aG25fG264G268G266G25fG267G25eG26dG25fG26cG26bG279G3G262G26bG269G268G265G276G261G268G25cG25aG26cG276G3G2

18、5cG266G25fG26bG26cG268G3G26bG26bG275G265G268G271G267G275G26fG3G266G25fG260G25eG26dG267G25aG10G26aG268G25eG267G275G26fG3G26bG26cG25aG267G25eG25aG26aG26cG268G25cG3G26bG268G268G26cG25cG25fG26cG26bG26cG25cG26dG278G273G262G25fG3G262G266G3G267G25aG270G262G268G267G25aG265G276G267G275G25fG3G26bG26cG25aG267G

19、25eG25aG26aG26cG275G3G24aG268G26bG26bG262G263G26bG264G268G263G3G24eG25fG25eG25fG26aG25aG270G262G262G18G3G23cG23cG23fG23eG23fG247G3G23cG249G23fG24aG23cG255G23fG242G267G26eG268G26aG266G25aG270G262G279G3 G268G25bG3 G262G261G266G25fG267G25fG267G262G279G26fG3 G264G3 G267G25aG26bG26cG268G279G273G25fG266G2

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21、G265G276G267G275G25fG3G26bG26cG25aG267G25eG25aG26aG26cG275GaaGfG3G25aG3G26cG25fG264G26bG26cG3G262G261G266G25fG267G25fG267G262G263G3G262G3G269G268G269G26aG25aG25cG268G264G3Gb2G3G25cG3G25fG260G25fG266G25fG10G26bG279G271G267G268G3G262G261G25eG25aG25cG25aG25fG266G275G26fG3G262G267G26eG268G26aG266G25aG27

22、0G262G268G267G267G275G26fG3G26dG264G25aG261G25aG26cG25fG265G279G26fG3Ga9G247G25aG270G262G268G267G25aG265G276G267G275G25fG3G26bG26cG25aG267G25eG25aG26aG26cG275GaaG11G3G23cG3G26bG265G26dG271G25aG25fG3G269G25fG26aG25fG26bG266G268G26cG26aG25aGbG261G25aG266G25fG267G275GcG3G262G265G262G3G268G26cG266G25fG2

23、67G275G3G267G25aG26bG26cG268G279G273G25fG25dG268G3G26bG26cG25aG267G25eG25aG26aG26cG25aG3G26bG268G268G26cG25cG25fG26cG26bG26cG25cG26dG278G273G25fG25fG3G26dG25cG25fG25eG268G266G265G25fG267G262G25fG3G25bG26dG25eG25fG26cG3G268G269G26dG25bG265G262G264G268G25cG25aG267G268G25cG3 G25fG260G25fG266G25fG26bG27

24、9G271G267G268G3 G262G261G25eG25aG25cG25aG25fG266G268G266G3 G262G267G26eG268G26aG266G25aG270G262G268G267G267G268G266G3 G26dG264G25aG261G25aG26cG25fG265G25fG3Ga9G247G25aG270G262G268G267G25aG265G276G267G275G25fG3G26bG26cG25aG267G25eG25aG26aG26cG275GaaG11G3 G24bG268G268G26cG25cG25fG26cG26bG26cG10G25cG26

25、dG278G273G25aG279G3G262G267G26eG268G26aG266G25aG270G262G279GfG3G26dG25cG25fG25eG268G266G265G25fG267G262G25fG3G262G3G26cG25fG264G26bG26cG275G3G26aG25aG261G266G25fG273G25aG278G26cG26bG279G3G26cG25aG264G260G25fG3G25cG3G262G267G26eG268G26aG266G25aG270G262G268G267G267G268G263G3G26bG262G26bG26cG25fG266G25

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28、G3G267G25fG3G266G268G260G25fG26cG3G25bG275G26cG276G3G269G268G265G267G268G26bG26cG276G278G3G262G265G262G3G271G25aG26bG26cG262G271G267G268G3G25cG268G26bG269G26aG268G262G261G25cG25fG25eG25fG267GfG3G26cG262G26aG25aG260G262G26aG268G25cG25aG267G3G262G3G26aG25aG26bG10G269G26aG268G26bG26cG26aG25aG267G25fG26

29、7G3G25cG3G264G25aG271G25fG26bG26cG25cG25fG3G268G26eG262G270G262G25aG265G276G267G268G25dG268G3G262G261G25eG25aG267G262G279G3G25bG25fG261G3G26aG25aG261G26aG25fG272G25fG267G262G279G3G24eG25fG25eG25fG26aG25aG265G276G267G268G25dG268G3G25aG25dG25fG267G26cG26bG26cG25cG25aG3G269G268G3G26cG25fG26fG267G262G27

30、1G25fG26bG264G268G266G26dG26aG25fG25dG26dG265G262G26aG268G25cG25aG267G262G278G3G262G3G266G25fG26cG26aG268G265G268G25dG262G262G23dG248G24bG24cG3G24aG3G18G15G16G1aG1cGb2G15G13G13G18G2cG2cG26G268G25eG25fG26aG260G25aG267G262G25fG248G25bG265G25aG26bG26cG276G3G269G26aG262G266G25fG267G25fG267G262G279G11G3G

31、11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G

32、11G3G11G3G11G3G11G3G11G3G14G14G3G24cG25fG26aG266G262G267G275G3G262G3G268G269G26aG25fG25eG25fG265G25fG267G262G279G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11

33、G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G14G15G3G249G26aG262G267G270G262G269G275G3G267G25aG25eG265G25fG260G25aG273G25fG263G3G264G265G262G267G262G271G25fG26bG264G268G263G3G269G26aG25aG264G26cG262G264G262G3GbG2aG26G33GcG

34、11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G19G16G3G257G264G26bG269G25fG26aG26cG267G275G263G3G26bG268G25cG25fG26cG3G268G26aG25dG25aG267G262G261G25aG270G26

35、2G262G12G247G25fG261G25aG25cG262G26bG262G266G275G263G3G277G26cG262G271G25fG26bG264G262G263G3G264G268G266G262G26cG25fG26cG3GbG257G24bG248G12G247G257G244GcG11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G19G3G3G16G11G14G3G248G25bG279G261G25aG267G267G268G26bG26

36、cG262G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3

37、G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G19G3G3G16G11G15G3G24bG268G26bG26cG25aG25cGfG3G26eG26dG267G264G270G262G262G3G262G3G269G268G26aG279G25eG268G264G3G26aG25aG25bG268G26cG275G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G

38、3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1aG3G3G16G11G16G3G249G26aG268G270G25fG25eG26dG26aG275G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3

39、G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1bG3G3G16G11G17G3G23eG268G264G26dG266G25fG267G26cG25aG270G262G279G11G3G11G

40、3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G

41、3G11G3G11G3G11G3G11G3G11G3G1bG17G3G242G26bG26bG265G25fG25eG268G25cG25aG26cG25fG265G276G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G

42、3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1bG3G3G17G11G14G3G3G244G25cG25aG265G262G26eG262G264G25aG270G262G279G3G262G3G268G25bG279G261G25aG26cG25fG265G276G26bG26cG25cG25aG3G262G26bG26bG265G25fG25eG268G25cG25aG26

43、cG25fG265G279G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1bG3G3G17G11G15G3G3G24bG268G268G26cG25cG25fG26cG26bG26cG25cG26dG278G273G262G25fG3G26aG25fG26bG26

44、dG26aG26bG275G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1cG3G3G17G1

45、1G16G3G3G248G264G25aG261G25aG267G262G25fG3G266G25fG25eG262G270G262G267G26bG264G268G263G3G269G268G266G268G273G262G3G26bG26dG25bG274G25fG264G26cG25aG266G3G262G26bG26bG265G25fG25eG268G25cG25aG267G262G279G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3

46、G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1cG3G3G17G11G17G3G3G244G268G267G26cG25aG264G26cG275G3G26bG3G257G24bG248G12G247G257G244G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11

47、G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1cG3G3G17G11G18G3G3G24bG268G25bG265G278G25eG25fG267G262G25fG3G269G26aG268G26cG268G264G268G265G25aG11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3

48、G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1cG3G3G17G11G19G3G3G242G26bG26bG265G25fG25eG26dG25fG266G275G25fG3G269G26aG268G2

49、5eG26dG264G26cG275G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G1

50、1G3G11G3G14G13G3G3G17G11G1aG3G3G24aG25aG267G25eG268G266G262G261G25aG270G262G279G3G262G3G26aG25aG26bG264G26aG275G26cG262G25fG3G264G268G25eG25aG11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G3G11G