chipatala Mayesero

Wochita kafukufuku yemwe ali ndi sensa ya maginito yolumikizidwa ku lilime lawo akuyesa ukadaulo wowongolera lilime. Pamaso pawo, chophimba cha laputopu chikuwonetsa ma chart ndi chithunzi chapakamwa. Chidziwitso chofiyira pazenera chimati: Mangani lilime lanu! Mwatsala ndi masekondi asanu.

Shepherd Center imatenga nawo gawo ku United States Food & Drug Administration (FDA) yoyendetsedwa ndi mayesero azachipatala kuti ayese mphamvu ndi chitetezo cha mankhwala atsopano ndi zida zamankhwala, komanso kukulitsa chidziwitso cha sayansi ndi zamankhwala.

Gulu loyesera zachipatala ku Shepherd Center limathandizira maphunziro ofufuza omwe amalola odzipereka odwala kulandira chithandizo ndi mankhwala kapena chipangizo chomwe chikuyesedwa pa kafukufuku. Kawirikawiri, mankhwala kapena chipangizo chomwe chikuyesedwa sichinavomerezedwe ndi FDA kuti chigwiritsidwe ntchito ndi madokotala ndi anthu onse.

Za maphunziro ofufuza ku Shepherd Center

zothandizira

Mayesero azachipatala amathandizidwa ndi makampani opanga mankhwala ndi biotechnology. Kuthandizira kungabwerenso kuchokera kwa dokotala woyambitsa / wofufuza. Mayesero onse achipatala ali ndi dokotala woyenerera wa Shepherd Center yemwe amagwira ntchito monga wofufuza wamkulu (PI) kuyang'anira phunziroli ndikuphatikiza mankhwala kapena chipangizo chomwe chikuyesedwa kuchipatala.

mogwira

Mayesero achipatala ndi mtundu wa kafukufuku wopangidwa kuti ayankhe mafunso enieni. Kafukufuku amathandizira kudziwa ngati mankhwala atsopano oyesera kapena chipangizo chatsopano ndichabwino komanso chothandiza mwa anthu. Kafukufuku akhoza kupangidwa kuti ayese njira zosiyanasiyana zogwiritsira ntchito mankhwala ndi zipangizo zomwe zilipo panopa zokha komanso/kapena mophatikiza.

Chitetezo chodzipereka

Chiyeso chilichonse chachipatala chimawunikidwa ndikuvomerezedwa ndi Komiti Yowunikira Kafukufuku wa Mbusa isanayambe. Komitiyi ili ndi asayansi, akatswiri azaumoyo komanso anthu wamba ochokera m'deralo. Amateteza ufulu ndi chitetezo cha anthu odzipereka ochita kafukufuku. Amayang'aniranso zoopsa zomwe zingachitike kwa anthu odzipereka ochita kafukufuku mu kafukufukuyu ndikuyang'anira kuti malamulo oyenera azitsatiridwa.

Modzipereka

Shepherd Center imapereka mwayi wambiri kwa anthu kuti adzipereke ku maphunziro ofufuza. Ufulu, chitetezo ndi moyo wabwino wa omwe akuchita nawo kafukufuku nthawi zonse ndizofunikira kwambiri. Odzipereka ochita kafukufuku amawonedwa nthawi ndi nthawi ndi dokotala wofufuza ndi gulu lofufuza kuti ayang'ane zotsatira za thanzi.

Kudzipereka ku kafukufuku wofufuza ndi chisankho chofunikira paumoyo wamunthu. Funsani dokotala wanu za maphunziro ofufuza omwe angagwirizane ndi vuto lanu ndipo kambiranani zomwe mungachite ndi banja lanu ndi anzanu.

Ntchito zoyeserera zachipatala

Gulu la mayesero a zachipatala limayang'anira zochitika zonse zachipatala kuphatikizapo: kufufuza, kuyambitsa, kuphatikizapo ndondomeko yophunzira muzochitika zachipatala; kulembera anthu ntchito ndi kusunga; kusonkhanitsa deta; kuyang'anira; ndi kuphunzira pafupi. Kugwirizana kwapang'onopang'ono ndi magulu amakampani kumawonetsetsa kuti zolinga zonse zikukwaniritsidwa. Wofufuza Wamkulu amapereka utsogoleri ku gulu la mayesero a zachipatala, ndipo amathandizidwa ndi gulu la mayesero a zachipatala pazochitika zonse za mayesero.

Zotsatirazi ndi zitsanzo za ntchito zomwe gulu loyesa zachipatala limapereka kwa othandizira makampani, mabungwe ofufuza za makontrakitala (CROs) ndi Ofufuza Akuluakulu.

  • Kuunikanso ndi kukonza mapangano ofotokozera zinsinsi (CDA)
  • Kuwunika kuthekera kophunzira
  • Ntchito zachipatala ndi ma protocol
  • Kuwunikiranso ndi kuvomerezedwa kwa magwiridwe antchito
  • Kugwirizana kwa maulendo oyenerera ku malo
  • Kumaliza kwa zikalata zothandizira / CRO zosankhidwa kale

  • Kukonzekera ndi kutumiza zikalata zoyendetsera ntchito
  • Kumaliza zolemba za othandizira
  • Kukonzekera kwa fomu yovomerezeka yodziwitsidwa (ICF)
  • Kupereka maphunziro ku Institutional Review Board (IRB)
  • Kuwunikanso ndi kukonza mapangano, kuphatikiza mapangano oyesa zamankhwala, mapangano aukadaulo, madongosolo a ntchito ndi mapangano a ntchito zamaluso
  • Kukula kwa bajeti ndi zokambirana
  • Maphunziro a ogwira ntchito pazabwino zachipatala (GCP)
  • Maphunziro a ogwira ntchito pa maphunziro a chitetezo cha anthu
  • Maphunziro a IRB
  • Kupanga zolemba zoyambira
  • Maphunziro a ogwira ntchito pa protocol yophunzirira

  • Maphunziro a kafukufuku kwa madokotala
  • Kukonza zikalata zowongolera
  • Maphunziro a njira zophunzirira ndi zowunika
  • Kulowetsa deta, kasamalidwe ndi kuthetsa mafunso
  • Kuyankha kwamankhwala / chipangizo
  • Thandizo la pharmacy ndi kuwunika
  • Thandizo la ntchito zolembera anthu
  • Kukhazikitsa akaunti yofufuza
  • Ma invoice a Sponsor
  • Kuyanjanitsa maakaunti a kafukufuku
  • Lipoti la ndalama zomwe zimagwiritsidwa ntchito komanso khama la ogwira ntchito
  • Ndemanga ya kutsata maphunziro
  • Chitsimikizo chadongosolo
  • Kuwunika magawo
  • Kuwunika kwa ogwira ntchito kuchokera kwa othandizira, FDA ndi mabungwe ena owongolera

  • Kubweza/kuwonongeka kwa wofufuza (ngati kuli kotheka)
  • Kumaliza lipoti lomaliza
  • Kulumikizana ndi IRB
  • Kusungirako zikalata zophunzirira

Mayesero amakono a zachipatala

cholinga

Shepherd Center ikuyamba kuyesa kwatsopano kwachipatala motsogozedwa ndi John Lin, MD, Erik Shaw, DO, ndi Angela Beninga, MD Chipangizo cha iovera ° ndi chovomerezeka cha FDA chochiza ululu pogwiritsa ntchito chimfine ku mitsempha yeniyeni ya thupi. Kafukufukuyu adzawonetsa momwe iovera ° imakhudzira mapewa ndi / kapena mkono wa spasticity mwa anthu omwe ali ndi ubongo kapena msana. Ophunzira adzabwera ku Shepherd Center kwa maulendo asanu pafupifupi miyezi inayi kuti awonedwe ndi kulandira chithandizo ndi iovera ° kapena placebo.

Kuyenerera kutenga nawo mbali

  • Khalani azaka 18 kapena kupitilira apo
  • Khalani ndi vuto lakumtunda chifukwa cha ubongo kapena msana miyezi isanu ndi umodzi yapitayo
  • Khalani okhazikika pamankhwala oletsa kupweteka kwapakamwa kwa masabata osachepera anayi
  • Sanakhalepo ndi jakisoni wa neurotoxin m'miyezi itatu yapitayi
  • Palibe pampu ya baclofen

Pitirizani Kuwona