Dzimwe nguva panguva yekuongororwa kwekliniki kune imwe mishonga, pane zvingave zvakakanganisika zvakanyanya muhurukuro dzakapiwa mishonga, izvo zvingave kana zvingave zvisingabatanidzi mazamu, asi zvisingatarisirwi, sezvo zvisingagumi nemashoko anhasi. Kuzivisa SUSAR chinhu chinokosha chekuongororwa kwemakiriniki kuongororwa kwezvinodhaka kana kutarisirwa kwekliniki uye muenzaniso wekuti izwi iri rinoshandiswa rinotevera:
" Nemhaka yokuti kuongorora kwechipatara kune nyaya yakanyanyisa, vatsva vezvinodhaka zvitsva vaifanira kuisa SUSAR."
Nei SUSAR Matters
A SUSAR inogona kuitika panguva yekuongororwa kwemakiriniki kana kutarisirwa kwekliniki uye kuburitsa kunosiyana nenyika kana nzvimbo zvichienderana nemitemo yakarongwa nehurumende dzinodzora munzvimbo imwe neimwe.
European Union. Kuzivisa kweSUSAR inotenderwa kune vatsvakurudzo vekliniki muEuropean Union. Mushumo unofanirwa kuendeswa kune hurumende yepamusoro yepamutemo mumazuva gumi neshanu (zvichiitika mazuva manomwe kana rufu kana kuti kutyisa upenyu).
USA. MuU.SA, kuzivisa zviitiko zvinotambudza panguva dzekuongorora zvipatara zvinosungirwa, asi panguva yekuchengetedzwa kwechipatara, ndezvekuzvidira. IU.SA FDA ine chirongwa chekuzivisa nezveZviitiko Zvakaipa Zviitiko (SAEs) kuburikidza neAERS (Adverse Event Reporting System). Pakati pekubika uye kuongorora, zvinosarudzwa kana chiitiko chakaipa chakanga chisingatarisirwi. Mitemo yeDAA inoda kuburitsa mukati memazuva gumi nemashanu nekuda kwekuita kupi zvese zvakashata uye zvisingatarisirwi.
Kanadha. MuCanada, kuongororwa kwekliniki vatsigiri vanodiwa kuti vazivise SUSARs kuHealth Canada. Chipatara chirongwa chevashandi vanozivikanwa sevashandi, vanofanira kuzivisa mushure mezuva gumi nematatu (zvakaitika mazuva manomwe kana rufu kana kuti kutyisidzira upenyu) kuHealth Canada chero SUSAR yakaitika mukati nekunze kweCanada apo mishonga iri mumakiriniki muCanada.
Mazuva masere mushure mekuzivisa Health Health yeSUSAR, mushumo wakakwana unosanganisira kuongorora kwekukosha uye kusanganisa kwezvimwe zviwanikwa zvinofanira kuendeswa kuHerld Canada.
Kusagadzikana
Izvo zvakasiyana-siyana zvakasiyana-siyana mumitemo iri pamusoro peSUSAR uye mitemo yekupa mapurisa ehurumende haisi kubvumirana zvakakwana, sezvo nzvimbo dzakasiyana dzakasiyana zvakatarisira pamusoro pehuwandu hwemashoko anopiwa kuvatsvakurudzi nevatongi uye munguva ipi.
Kushaikwa kwekuwirirana pakati penyika kwave kuri kuongororwa neInternational Conference pamusoro pekubatanidza (ICH) kwehafu yenguva yemakumi gumi.
Tsanangudzo ye "Maitiro Akaipa" anoshandiswa neICH "Chiitiko chipi zvacho chisina kubhadharwa kuchipatara kana muchipatara nyaya inongororwa mishonga yemishonga uye iyo haifaniri kunge iine ukama hunokanganisa nekurapa uku . "
Chiito chinopisa chinogona kunge chiri kupindura kune zvisiri izvo zvinoshandiswa zvechirwere uye zviitiko zvinotevera zvinoumba "zvakakomba" zvinopesana, maererano neEU:
- Rufu
- Chiitiko chinopisa upenyu chinoda kupindira pakarepo
- Chiitiko chinokonzerwa nekurapwa kana kuti kunowedzera kushandiswa kwekuchengetwa
- Zviitiko zvinokonzera kusagadzikana kana kusakosha kunokosha kana kuremara
- Chirwere chisina kuberekwa kana kukanganisa kuberekwa
- Chiitiko chinoda kupindira kunodzivirira kukanganisa pamusoro uye / kana kusingaperi kana kukuvadza
Kunyange zvazvo vese vari vatungamiri vezvematongerwo enyika uye vemarudzi akawanda vakazvipira mune imwe nzira yakanyatsoenderana yekuzivisa SUSARs (kune vanoita zvepasi rose vanogadzira mishonga, kune zvikonzero zvekushanda uye zvetsika kuti zvienderane) kunezve nzira yakareba yekuenda pakuenzanisa kusiyana kwedzidziso uye zvigadzirwa zvinoita kuti ripoti rive rakaoma.