DB43-T 2896-2023 藥物臨床試驗(yàn)主要研究者實(shí)踐培訓(xùn)基地建設(shè)與運(yùn)行管理規(guī)范

ICS

.120.9CCS

C

43湖 南 省 地 方 標(biāo) 準(zhǔn)DB43/T

2896—2023藥物臨床試驗(yàn)主要研究者實(shí)踐培訓(xùn)基地建設(shè)與運(yùn)行管理規(guī)范Construction

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operation

management

standards

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training

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principalinvestigatorof

drug

clinicaltrials2023

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12

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20

發(fā)布

2024

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實(shí)施湖南省市場(chǎng)監(jiān)督管理局

發(fā)

布DB43/T

— 前言························································································································

Ⅲ1

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規(guī)范性引用文件······································································································13

術(shù)語(yǔ)和定義············································································································14

縮略語(yǔ)··················································································································25

建設(shè)資質(zhì)···············································································································26

設(shè)施設(shè)備···············································································································27

師資條件···············································································································38

培訓(xùn)體系···············································································································39

運(yùn)營(yíng)管理···············································································································39.1 進(jìn)修信息發(fā)布···································································································39.2進(jìn)修審核與管理································································································

39.3進(jìn)修培訓(xùn)·········································································································49.4 考核···············································································································49.5 信息管理·········································································································410 質(zhì)量評(píng)價(jià)與改進(jìn)

····································································································410.1質(zhì)量監(jiān)督檢查

·································································································410.2 評(píng)價(jià)方式與內(nèi)容

······························································································

510.3持續(xù)改進(jìn)

·······································································································5DB43/T

— 本文件按照

GB/T

—《標(biāo)準(zhǔn)化工作導(dǎo)則 第

1

部分：標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)定起草。請(qǐng)注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機(jī)構(gòu)不承擔(dān)識(shí)別專利的責(zé)任。本文件由湖南省藥品監(jiān)督管理局提出并歸口。學(xué)附屬第一醫(yī)院、南華大學(xué)附屬第二醫(yī)院、懷化市第一人民醫(yī)院、婁底市中心醫(yī)院、湘潭市中心醫(yī)院、岳陽(yáng)市人民醫(yī)院。華、孫學(xué)雄、劉靖、朱芳、張靜、劉黎。IIDB43/T

—1

運(yùn)營(yíng)管理、質(zhì)量評(píng)價(jià)與改進(jìn)等要求。本文件適用于藥物臨床試驗(yàn)主要研究者實(shí)踐培訓(xùn)基地的建設(shè)與運(yùn)行管理。2

規(guī)范性引用文件文件。DB43/T

2135—2021藥物臨床試驗(yàn)受試者招募管理技術(shù)服務(wù)規(guī)范3

術(shù)語(yǔ)和定義3.1

下列術(shù)語(yǔ)和定義適用于本文件。藥物臨床試驗(yàn)機(jī)構(gòu) drug

clinical

trial

（

GCP（求，開(kāi)展藥物臨床試驗(yàn)的機(jī)構(gòu)。[來(lái)源：DB43/T

2135—，3.1]3.2臨床試驗(yàn) clinical

trial的系統(tǒng)性試驗(yàn)。[來(lái)源：DB43/T

2135—，3.2]3.3主要研究者principal

實(shí)施臨床試驗(yàn)并對(duì)臨床試驗(yàn)質(zhì)量及受試者權(quán)益和安全負(fù)責(zé)的試驗(yàn)現(xiàn)場(chǎng)負(fù)責(zé)人。[來(lái)源：DB43/T

2135—，3.3]3.4主要研究者實(shí)踐培訓(xùn)基地 principal

practical

training

符合相關(guān)條件，可為主要研究者提供藥物臨床試驗(yàn)理論與實(shí)踐培訓(xùn)服務(wù)的藥物臨床試驗(yàn)機(jī)構(gòu)。3.5進(jìn)修人員

取得

DB43/T

—研究者。3.6標(biāo)準(zhǔn)操作規(guī)程

operating

為保證某項(xiàng)特定操作一致性而制定的詳細(xì)書面要求。3.7不良事件adverse

events常，但不一定與試驗(yàn)用藥品有因果關(guān)系。3.8嚴(yán)重不良事件

events治療或者延長(zhǎng)住院時(shí)間，以及先天性異?；蛘叱錾毕莸炔涣坚t(yī)學(xué)事件。3.9可疑且非預(yù)期嚴(yán)重不良反應(yīng)

suspected

unexpected

serious

adverse

已有資料信息的可疑并且非預(yù)期的嚴(yán)重不良反應(yīng)。4

縮略語(yǔ)下列縮略語(yǔ)適用于本文件。GCP:藥物臨床試驗(yàn)質(zhì)量管理規(guī)范（Good

Clinical

Practice）PI:主要研究者

Investigator)AE:不良事件（

）SAE:嚴(yán)重不良事件（

Adverse

Events）SUSAR:可疑且非預(yù)期嚴(yán)重不良反應(yīng)（Suspected

Reaction）基地：主要研究者實(shí)踐培訓(xùn)基地

（Principal

Investigator

Practical

Training

Base）5

建設(shè)資質(zhì)基地建設(shè)資質(zhì)應(yīng)符合以下要求：——在國(guó)家藥物臨床試驗(yàn)機(jī)構(gòu)平臺(tái)備案；——正常運(yùn)行至少

3

年；——備案專業(yè)數(shù)至少

5

——啟動(dòng)非同類型同專業(yè)項(xiàng)目數(shù)至少

5

個(gè)/——通過(guò)國(guó)家項(xiàng)目核查數(shù)至少

5

個(gè)；——實(shí)施注冊(cè)類臨床項(xiàng)目數(shù)至少

20

個(gè)；——無(wú)違法記錄。6

設(shè)施設(shè)備基地設(shè)施設(shè)備應(yīng)符合以下要求：——應(yīng)符合

GCP

法規(guī)要求；DB43/T

———應(yīng)有獨(dú)立辦公場(chǎng)所且配套設(shè)施齊全；——應(yīng)有臨床試驗(yàn)培訓(xùn)場(chǎng)所，具備開(kāi)展臨床試驗(yàn)項(xiàng)目的條件。7

師資條件7.1 基地主要負(fù)責(zé)人應(yīng)符合以下條件：——本科以上學(xué)歷；——應(yīng)具備醫(yī)藥相關(guān)專業(yè)背景；——具有相關(guān)管理工作經(jīng)驗(yàn)；——無(wú)違法違規(guī)記錄。7.2 基地帶教導(dǎo)師應(yīng)符合以下條件：——應(yīng)為

；——應(yīng)具有相關(guān)部門組織的臨床試驗(yàn)項(xiàng)目監(jiān)督、檢查工作經(jīng)驗(yàn)；——無(wú)違法違規(guī)記錄；——基地至少配備

3

名專（兼）職管理人員，并持有

GCP

證書。8

培訓(xùn)體系8.1 基地應(yīng)建立覆蓋藥物臨床試驗(yàn)全過(guò)程的管理制度和標(biāo)準(zhǔn)操作規(guī)程，定期修訂且不斷完善。8.2

基地應(yīng)制定各崗位人員的崗位職責(zé)并實(shí)施培訓(xùn)，內(nèi)容包括但不限于職業(yè)道德、相關(guān)政策法規(guī)及管理服務(wù)技能等。8.3 基地應(yīng)建立進(jìn)修人員培訓(xùn)管理制度。8.4 基地應(yīng)建立進(jìn)修人員理論培訓(xùn)和實(shí)踐培訓(xùn)課程體系。8.5 基地應(yīng)建立防范和處理藥物臨床試驗(yàn)中突發(fā)事件的管理機(jī)制與應(yīng)急預(yù)案。9

運(yùn)營(yíng)管理9.1進(jìn)修信息發(fā)布基地應(yīng)及時(shí)公開(kāi)相關(guān)信息，內(nèi)容至少應(yīng)包括：——營(yíng)業(yè)執(zhí)照；——地理位置；——進(jìn)修流程；——設(shè)施設(shè)備概況；——主要服務(wù)項(xiàng)目情況；——投訴途徑。9.2 進(jìn)修審核與管理基地進(jìn)修審核與管理，應(yīng)包含以下內(nèi)容：——基地審核并收集報(bào)名信息，公示錄取名單并發(fā)送培訓(xùn)通知書，告知報(bào)到流程及要求；——基地應(yīng)有專人負(fù)責(zé)收集、更新和公示各類服務(wù)信息，確保信息的準(zhǔn)確、完整和安全；DB43/T

—?jiǎng)?wù)、合同變更與解除，違約責(zé)任、爭(zhēng)議解決方式等；——基地應(yīng)根據(jù)進(jìn)修人員情況指定帶教導(dǎo)師；——基地應(yīng)制定培訓(xùn)計(jì)劃并建立溝通匯報(bào)機(jī)制，便于進(jìn)修人員提前了解進(jìn)修安排及反饋進(jìn)修成果。9.3進(jìn)修培訓(xùn)9.3.1 進(jìn)修培訓(xùn)應(yīng)包括理論培訓(xùn)與實(shí)踐培訓(xùn)。9.3.2 理論培訓(xùn)應(yīng)包括以下內(nèi)容：——

法規(guī)；——

工作職責(zé)；——臨床試驗(yàn)流程；——臨床方案設(shè)計(jì)原則；——

記錄及判定原則；——

及

SUSAR

處理及上報(bào)流程等內(nèi)容。9.3.3實(shí)踐培訓(xùn)應(yīng)涵蓋臨床試驗(yàn)全流程，應(yīng)至少參與授權(quán)

3

項(xiàng)注冊(cè)臨床試驗(yàn)項(xiàng)目相關(guān)工作，每個(gè)項(xiàng)目授權(quán)時(shí)間至少

1

個(gè)月。內(nèi)容包括立項(xiàng)準(zhǔn)備階段、實(shí)施階段、結(jié)題階段：——立項(xiàng)準(zhǔn)備階段。了解并熟悉項(xiàng)目立項(xiàng)資料審核要點(diǎn)、方案設(shè)計(jì)要點(diǎn)、科室評(píng)估能力評(píng)估要點(diǎn)、倫理資料提交流程、臨床試驗(yàn)合同管理要點(diǎn)，至少參加

1

次倫理審查會(huì)；點(diǎn)、倫理委員會(huì)溝通注意事項(xiàng)等，不應(yīng)為研究醫(yī)生、研究護(hù)士及

；——結(jié)題階段。了解并熟悉項(xiàng)目小結(jié)、總結(jié)報(bào)告撰寫流程及要點(diǎn)，項(xiàng)目結(jié)題流程。9.4考核9.4.1基地負(fù)責(zé)組織考核，包含理論考核、實(shí)踐考核和結(jié)業(yè)考核。9.4.2 理論考核包含以下內(nèi)容：——應(yīng)以閉卷形式組織考核；——不及格者應(yīng)組織重新學(xué)習(xí)，允許補(bǔ)考

1

——補(bǔ)考不及格者，應(yīng)延長(zhǎng)培訓(xùn)時(shí)間或取消培訓(xùn)資格。9.4.3 實(shí)踐考核應(yīng)有具體的實(shí)踐考核記錄。日常匯報(bào)由導(dǎo)師根據(jù)學(xué)員參與的具體工作表現(xiàn)進(jìn)行評(píng)估。9.4.4 結(jié)業(yè)考核應(yīng)在理論學(xué)習(xí)考核及實(shí)踐學(xué)習(xí)考核均通過(guò)后進(jìn)行，包含以下內(nèi)容：——結(jié)業(yè)考核應(yīng)以現(xiàn)場(chǎng)問(wèn)答模式進(jìn)行，評(píng)委現(xiàn)場(chǎng)打分；——結(jié)業(yè)考核通過(guò)后，應(yīng)收集

3

個(gè)注冊(cè)性臨床研究的授權(quán)表以及進(jìn)修證，基地發(fā)放證書。9.5信息管理基地應(yīng)建立進(jìn)修人員培訓(xùn)檔案，推薦采用信息化進(jìn)行數(shù)據(jù)管理。10

質(zhì)量評(píng)價(jià)與改進(jìn)10.1 質(zhì)量監(jiān)督檢查10.1.1 應(yīng)建立基本服務(wù)、管理的相關(guān)制度和流程。10.1.2 應(yīng)建立質(zhì)量考核制度，制定各崗位考核細(xì)則。DB43/T

—10.1.3應(yīng)采用多種方式，不定期檢查服務(wù)質(zhì)量，發(fā)現(xiàn)問(wèn)題及時(shí)整改。10.2 評(píng)價(jià)方式與內(nèi)容10.2.1 評(píng)價(jià)方式分為自我評(píng)價(jià)和第三方評(píng)價(jià)。10.2.2 自我評(píng)價(jià)的內(nèi)容與方法應(yīng)符合以下要求：——應(yīng)向進(jìn)修人員開(kāi)展?jié)M意度測(cè)評(píng)，測(cè)評(píng)至少每年

1

次；——每年應(yīng)對(duì)制度、流