Umuhuzabikorwa w’ubushakashatsi bw’igerageza ry’ubuvuzi

Heritage Alliance Ltd ni ikigo cy’ubushakashatsi ku buzima n’ubumenyi bw’amakuru gifite icyicaro mu Bubiligi, gikorana n’abafatanyabikorwa muri Afurika no ku rwego mpuzamahanga.

Abo turi bo

Duhuza ubuhanga mu buvuzi, mu mikorere no mu makuru kugira ngo dukore ubushakashatsi dufatanyije n’ibigo by’ubuzima n’abafatanyabikorwa bo mu mashuri makuru, cyane cyane ahari amikoro make.

Ubumenyi bw'Amakuru y'Ubuzima n'Isesengura Rihanitse: Gushyigikira ikusanywa rihamye ry'amakuru y'ubushakashatsi, gukemura ibibazo ku gihe no guhuza itegurwa ry'ibyegeranyo by'amakuru byo gusesengura.

Ubushakashatsi bw'Ubuvuzi Bugoye, harimo Igerageza ry'Ubuvuzi n'Ubumenyi bwo Gushyira mu Bikorwa: Guhuza ubushakashatsi bugerageza ubuvuzi n'ubwitegereza, igerageza ryo mu buzima busanzwe n'ubushakashatsi ku ishyirwa mu bikorwa mu bigo byitabiriye.

Guhanga udushya no kubaka sisitemu z’ubuzima bw’ikoranabuhanga: Gutangiza ibikoresho by’inyigo by’ikoranabuhanga n’uburyo bwo gutanga raporo bijyanye n’ibikenewe n’amatsinda y’ubushakashatsi n’abitabira.

Ahantu ho gukorera hashingiye ku ntego: Gira uruhare mu bushakashatsi bukemura ibibazo by’ubuzima by’ingenzi mu baturage babwitabira.

Ikoranabuhanga rigezweho: Gukoresha uburyo bwo gukusanya amakuru hakoreshejwe ikoranabuhanga, sisitemu zo gucunga ubushakashatsi n'ibikoresho by'ikoranabuhanga byo gukurikirana.

Ubunararibonye mpuzamahanga: Korana n’abashakashatsi, abaterankunga, laboratwari n’abafatanyabikorwa bo mu bihugu bitandukanye.

Amahirwe yo gutera imbere no kuyobora: yobora ibikorwa by'ubushakashatsi, komeza amatsinda y'ibigo kandi unoze uburyo bwo gukora ubushakashatsi.

Uyu mwanya urimo guhuza ibikorwa by’ibigo bitandukanye kandi usaba ubushobozi bugaragara bwo gucunga ubushakashatsi. Ukwiriye umunyamwuga w’ubushakashatsi ufite uburambe ushobora guteganya ibibazo by’imikorere, gusobanura neza ababazwa inshingano no gufasha amatsinda y’ibigo gukemura ibibazo.

Uzahuza imirimo n'abashakashatsi bakuru, umuterankunga cyangwa abamuhagarariye bashyizweho, n'amatsinda y'ubushakashatsi yo ku bigo. Inshingano zizakurikiza itangwa ry'inshingano ryanditse n'amasezerano. Abashakashatsi n'umuterankunga bazakomeza kubazwa inshingano zabo; ibyemezo by'ubuvuzi bizakomeza gufatwa n'abashakashatsi n'abavuzi bafite ubumenyi bubikwiriye.

• Tegura uko ubushakashatsi buzakorwa: Hindura amabwiriza y’ubushakashatsi gahunda z’ibikorwa, intambwe z’ingenzi, abakozi bakenewe n’igitabo cy’ibyago; suzuma niba ahakorerwa ubushakashatsi hakwiye kandi hiteguye hamwe n’abashakashatsi n’abafatanyabikorwa.
• Guhuza itangizwa ry'ubushakashatsi: Gukurikirana dosiye z'imyitwarire myiza n'iz'ubugenzuzi, ivugururwa, amasezerano, inyandiko z'ubwishingizi, iyandikisha n'ibisabwa kugira ngo aho ubushakashatsi bukorerwa hatangire; kugenzura ibyemezo bisabwa mbere y'uko ibikorwa by'ubushakashatsi bitangira.
• Cunga ibikorwa byo ku rwego rukuru: komeza gahunda ihujwe n'igenzura ry'ingengo y'imari, huza abatanga ibikoresho n'ibyo abafatanyabikorwa bagomba gutanga, kemura ibintu ibigo bishingiranaho kandi umenyeshe ubuyobozi ibibazo by'amikoro cyangwa imikorere.
• Gufasha amatsinda y'aho ubushakashatsi bukorerwa: Gutegura amahugurwa yo gutangira no kwibukiranya; kubungabunga ibitabo by'ubushakashatsi, amabwiriza ngengamikorere n'inyandiko zo gutanga inshingano; guhuza inama z'abashakashatsi no gukurikirana ibikorwa byumvikanyweho.
• Fasha inzira abitabira banyuramo: Fasha ibigo gushyira mu bikorwa uburyo bwemewe bwo gushaka abitabira, kwemera nyuma yo gusobanurirwa no gukurikirana; ukurikirane kugumana abitabira, gahunda basibye n’imbogamizi zo kwitabira, hitabajwe abaturage mu buryo bukwiye.
• Guhuza ibikorwa by’umutekano: Kwemeza ko ibibazo bitifuzwa n’ibikomeye bitifuzwa bigezwa vuba ku mushakashatsi n’itsinda ry’umutekano ryabigenewe; gukurikirana amakuru y’inyongera n’igihe ntarengwa cyo gutanga raporo hakurikijwe porotokole n’ibisabwa.
• Bika inyandiko z'ubushakashatsi: komeza dosiye nkuru y'igerageza n'inyandiko z'ibigo zuzuye, zivuguruye kandi zibonwa, harimo ibyemezo, inyandiko z'amahugurwa, ubutumwa n'ibikoresho by'ubushakashatsi bifite igenzura rya verisiyo.
• Huza amakuru n’ibikoresho by’ikoranabuhanga: Korana n’abacunga amakuru ku gukusanya amakuru hakoreshejwe ikoranabuhanga, impapuro za raporo z’abarwayi, uburenganzira bwo kugera ku makuru, gukemura ibibazo no kwitegura gufunga ububiko bw’amakuru; ubungabunge amateka y’ibikorwa by’igenzura, ibanga n’ihishwa ry’amatsinda y’ubuvuzi.
• Gufasha mu kugenzura ireme: Guhuza igenzura rijyanye n'ibyago hamwe n'abagenzuzi bashyizweho, gukurikirana ibitubahirijwe n'ibikorwa byo gukosora no gukumira, no gutegura ahakorerwa ubushakashatsi kwakira ubugenzuzi kandi hakagumaho igenzura ryigenga.
• Huza ibikoresho n’ingendo by’ubushakashatsi: Korana n’amatsinda ya farumasi na laboratwari ku igenzura ry’ibicuruzwa bigeragezwa, gufata neza ibipimo, ibikoresho n’ubwikorezi; ukomeze gahunda zo gushyira abantu mu matsinda ku buryo bwa tombola no guhisha amatsinda y’ubuvuzi aho bikenewe.
• Gutanga raporo no gusoza inyigo: Tegura ibibaho by’amakuru ku kwinjiza abitabira, ukwuzura kw’amakuru n’intambwe z’ingenzi; huza gusoza, kubika, kuvugurura rejisitiri no gutangaza ibisubizo ufatanyije n’abashakashatsi n’umuterankunga.

Ingendo no gukorera aho ubushakashatsi bukorerwa: Gusura aho bukorerwa mu gutangiza, guhuza imirimo, guhugura no gusoza, hakurikijwe ibikenewe mu bushakashatsi.

Iby'Ingenzi

• Impamyabumenyi mu buvuzi, ubuforomo, farumasi, siyansi y’ibinyabuzima n’ubuvuzi, ubuzima rusange, ubushakashatsi bw’ubuvuzi cyangwa indi nyigisho bifitanye isano. Impamyabumenyi ya master ijyanye n’akazi ni inyongera.
• Uburambe buhagije mu bushakashatsi mu buvuzi, burimo ubuhamya bwo guhuza igerageza ry’ubuvuzi rikorerwa mu bigo byinshi no kugira inshingano rusange kuri gahunda, imikorere y’ahakorerwa ubushakashatsi n’irangizwa ryabwo.
• Amahugurwa agezweho y'Imikorere Myiza y'Ubuvuzi (GCP) n'ubumenyi ngiro bw'amabwiriza ya International Council for Harmonisation (ICH) E6(R3), bikoreshwa hamwe n'ibisabwa n'ibihugu n'ubushakashatsi bireba.
• Uburambe ngiro mu gutanga dosiye z'imyitwarire myiza, uburyo bwo kwemera, inyandiko z'ingenzi z'ubushakashatsi, kutubahiriza amabwiriza y'ubushakashatsi, uburyo bwo gutanga raporo z'umutekano no gukurikirana ubugenzuzi.
• Ubushobozi bwo gukoresha ibikoresho byo gukusanya amakuru hakoreshejwe ikoranabuhanga no gucunga ubushakashatsi, urugero nka REDCap, OpenClinica cyangwa sisitemu bihwanye, hamwe n’ubumenyi bukomeye bwo gukoresha impapuro z’ibarurishamibare no gukora raporo.
• Ubushobozi bwagaragajwe bwo gufata ibyemezo bijyanye n'ikigo, gukurikirana ingengo y'imari, guhuza abafatanyabikorwa no kugeza ku bayobozi ibibazo bigira ingaruka ku bitabiriye, ku ireme ry'amakuru cyangwa ku gihe cy'ubushakashatsi.
• Kwandika neza inyandiko za siyansi n’iz’imikorere, kuvuga neza Icyongereza, kumenya neza Igifaransa no kwemera kujya ahakorerwa ubushakashatsi.
• Kwiyandikisha mu rugaga rw’umwuga rubishinzwe igihe inshingano zirimo ubuvuzi bugengwa n’amategeko; uruhushya rwo kuvura si itegeko rusange ku mwanya w’ubuyobozi.

Byifuzwa

• Ubunararibonye mu bigo by’ubushakashatsi byo muri Afurika, inyigo ku ndwara zandura, igerageza mu buzima busanzwe, ubushakashatsi ku ishyirwa mu bikorwa cyangwa inyigo zireba abantu bari mu kaga kurusha abandi.
• Ubunararibonye mu bushakashatsi buterwa inkunga na leta cyangwa u Burayi, kwandikisha igerageza no gutangaza ibisubizo, cyangwa sisitemu y’amakuru y’igerageza ry’ubuvuzi ya EU aho bikenewe.
• Icyemezo cyemewe mu bushakashatsi bw'ubuvuzi cyangwa mu micungire y'imishinga, n'uburambe bwo kuyobora abahuza ibikorwa mu bigo byinshi.

Umushahara: Uganirwaho hakurikijwe ubunararibonye, inshingano, aho ukorera n’amasezerano.

Iterambere mu kazi: Guteza imbere ubumenyi mu bikorwa by'igerageza ry'ubuvuzi, ireme ry'ubushakashatsi no mu buyobozi bukuru bw'ubushakashatsi, hamwe n'amahirwe yo kubaka no gutoza amatsinda y'ubushakashatsi.

Aho gukorera: Ubufatanye mu nzego zitandukanye, kugera ku bikoresho bya tekiniki bikenewe n’amahirwe yo kugira uruhare mu bushakashatsi mpuzamahanga ku buzima. Inyungu n’uburyo bwo gukora bizasobanurwa mu nyandiko iguha akazi.

Abagore barashishikarizwa gusaba.