Cov txheej txheem:

Leej twg yog lub luag haujlwm rau kev tshawb nrhiav tshuaj tshiab tshiab?
Leej twg yog lub luag haujlwm rau kev tshawb nrhiav tshuaj tshiab tshiab?

Video: Leej twg yog lub luag haujlwm rau kev tshawb nrhiav tshuaj tshiab tshiab?

Video: Leej twg yog lub luag haujlwm rau kev tshawb nrhiav tshuaj tshiab tshiab?
Video: Peb Yog Leej Twg 2024, Kaum ib hlis
Anonim

FDA cov cai (21 CFR Tshooj 312.3) txhais "Sponsor" ntawm daim ntawv thov IND yog "tus neeg siv lub luag haujlwm rau thiab pib qhov kev soj ntsuam kuaj mob. Tus neeg txhawb nqa yuav yog ib tus neeg lossis tuam txhab tshuaj, tsoomfwv lub koomhaum, lub tsev kawm ntawv, lub koomhaum ntiag tug, lossis lwm lub koomhaum.

Ib yam li ntawd, tog twg yog lub luag haujlwm tshaj tawm ncaj qha rau FDA?

LUB SPONSOR yog lub luag haujlwm qhia ncaj qha rau FDA , tus neeg tshawb nrhiav nyiaj txiag txaus siab nrog tus neeg txhawb nqa. Tus neeg tshawb nrhiav yuav tsum muab tus neeg txhawb nqa nrog cov ntaub ntawv tsim nyog thiab tus neeg txhawb nqa yuav qhia qhov no ncaj qha mus rau FDA.

kev lav phib xaub tshuaj yog dab tsi? Kev lav phib xaub tshuaj suav nrog: kawm tshuaj khaws cia, tuav, xa tawm, thiab cov ntaub ntawv ntawm kev tswj hwm, rov qab thiab / lossis kev puas tsuaj ntawm cov ntaub ntawv tshuaj . A tshuaj accountability txheej txheem yuav tsum tau pib rau txhua txoj kev tshawb fawb uas siv cov kev kawm- muab tshuaj.

Tsis tas li ntawd, qhov twg yog lub luag haujlwm ntawm tus neeg saib xyuas kev txhawb nqa ua kev kawm IND?

Lub luag haujlwm suav rau IND cov neeg txhawb nqa suav nrog: xaiv tsim nyog cov neeg tshawb nrhiav , muab cov ntaub ntawv lawv xav tau kev coj ib kev tshawb nrhiav kom raug, xyuas kom raug saib xyuas ntawm cov kev tshawb nrhiav (s), xyuas kom meej tias cov kev tshawb nrhiav (s) yog ua raws li kev tshawb nrhiav dav dav

Peb hom kev tshawb nrhiav tshuaj tshiab yog dab tsi?

Kev Tshawb Fawb Tshiab Tshuaj (INDs) poob rau hauv ob pawg:

  • Kev Lag Luam: xa los ntawm cov tuam txhab nrhiav kev pom zoo rau kev lag luam rau cov tshuaj tshiab.
  • Kev tshawb fawb (tsis yog lag luam): feem ntau ntawm INDs raug xa mus rau kev tshawb fawb tsis yog lag luam thiab yog peb hom tseem ceeb - Investigator IND, Emergency Use IND, thiab Treatment IND.

Pom zoo: