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ICS11.120.99

CCSC01

43

湖南省地方標(biāo)準(zhǔn)

DB43/T2135—2021

藥物臨床試驗(yàn)受試者招募管理技術(shù)

服務(wù)規(guī)范

Drugclinicaltrialsubjectsrecruitmentmanagement

technicalservicespecification

2021-08-03發(fā)布2021-10-03實(shí)施

湖南省市場(chǎng)監(jiān)督管理局發(fā)布

DB43/T2135—2021

目次

前言························································································································Ⅲ

1范圍·····················································································································1

2規(guī)范性引用文件······································································································1

3術(shù)語(yǔ)和定義············································································································1

4縮略語(yǔ)··················································································································2

5基本原則···············································································································2

5.1知情同意原則···································································································2

5.2控制風(fēng)險(xiǎn)原則···································································································3

5.3免費(fèi)和補(bǔ)償原則································································································3

5.4保護(hù)隱私原則···································································································3

5.5依法賠償原則···································································································3

5.6特殊保護(hù)原則···································································································3

6招募組織/機(jī)構(gòu)········································································································3

7受試者招募············································································································4

7.1招募方式·········································································································4

7.2招募流程·········································································································4

8受試者管理············································································································5

8.1依從性管理······································································································5

8.2出組后跟蹤管理································································································5

8.3人文關(guān)懷管理···································································································5

9受試者權(quán)益和安全···································································································5

9.1受試者權(quán)益······································································································5

9.2受試者隱私保護(hù)································································································6

10質(zhì)量控制··············································································································6

10.1數(shù)據(jù)管理·······································································································6

10.2評(píng)價(jià)改進(jìn)·······································································································6

參考文獻(xiàn)····················································································································7

I

DB43/T2135—2021

前言

本文件按照GB/T1.1—2020《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。

本文件起草單位:長(zhǎng)沙先領(lǐng)醫(yī)藥科技有限公司、中南大學(xué)湘雅醫(yī)院、中南大學(xué)湘雅二醫(yī)院、中南大

學(xué)湘雅三醫(yī)院、湖南省人民醫(yī)院、湖南省婦幼保健院、湖南省腫瘤醫(yī)院、湖南省職業(yè)病防治院、湖南省

腦科醫(yī)院、湖南省胸科醫(yī)院、長(zhǎng)沙都正生物科技股份有限公司、長(zhǎng)沙市中心醫(yī)院、長(zhǎng)沙市第一醫(yī)院、長(zhǎng)

沙市第三醫(yī)院、長(zhǎng)沙珂信腫瘤醫(yī)院、懷化市第一人民醫(yī)院、懷化市第二人民醫(yī)院、郴州市第一人民醫(yī)院、

益陽(yáng)市中心醫(yī)院、株洲市中心醫(yī)院、婁底市中心醫(yī)院、長(zhǎng)沙舍同智能科技有責(zé)任公司、長(zhǎng)沙市藥物評(píng)價(jià)

產(chǎn)業(yè)技術(shù)創(chuàng)新戰(zhàn)略聯(lián)盟。

本文件主要起草人:歐陽(yáng)冬生、李曉暉、嚴(yán)謹(jǐn)、陳桂根、謝秀芬、胡斌、陳露露、袁葉、周淦、

李昕、李卓、李偉、鄭姣、阮興強(qiáng)、徐夢(mèng)穎、鄒志、陳維明。

III

DB43/T2135—2021

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

1范圍

本文件規(guī)定了藥物臨床試驗(yàn)受試者招募管理技術(shù)服務(wù)的基本原則、招募組織/機(jī)構(gòu)、受試者招募、

受試者管理、受試者權(quán)益和安全和質(zhì)量控制等。

本文件適用于藥物臨床試驗(yàn)機(jī)構(gòu)及研究者、倫理委員會(huì)、合同研究組織等參與藥物臨床試驗(yàn)受試者

招募管理的組織和個(gè)人。

2規(guī)范性引用文件

本文件沒有規(guī)范性引用文件。

3術(shù)語(yǔ)和定義

下列術(shù)語(yǔ)和定義適用于本文件。

3.1

藥物臨床試驗(yàn)機(jī)構(gòu)drugclinicaltrialinstitution

具備相應(yīng)條件,按照《藥物臨床試驗(yàn)質(zhì)量管理規(guī)范》(GCP)和藥物臨床試驗(yàn)相關(guān)技術(shù)指導(dǎo)原則等要

求,開展藥物臨床試驗(yàn)的機(jī)構(gòu)。

3.2

臨床試驗(yàn)clinicaltrial

以人體(患者或健康受試者)為對(duì)象的試驗(yàn),意在發(fā)現(xiàn)或驗(yàn)證某種試驗(yàn)藥物的臨床醫(yī)學(xué)、藥理學(xué)以

及其他藥效學(xué)作用、不良反應(yīng),或者試驗(yàn)藥物的吸收、分布、代謝和排泄,以確定藥物的療效與安全性

的系統(tǒng)性試驗(yàn)。

3.3

研究者investigator

指實(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。

3.4

倫理委員會(huì)ethicscommittee

由醫(yī)學(xué)、藥學(xué)及其他背景人員組成的委員會(huì),其職責(zé)是通過(guò)獨(dú)立地審查、同意、跟蹤審查試驗(yàn)方案

及相關(guān)文件、獲得和記錄受試者知情同意所用的方法和材料等,確保受試者的權(quán)益、安全受到保護(hù)。

3.5

申報(bào)者sponsor

指負(fù)責(zé)臨床試驗(yàn)的發(fā)起、管理和提供臨床試驗(yàn)經(jīng)費(fèi)的個(gè)人、組織或者機(jī)構(gòu)。

3.6

合同研究組織contractresearchorganization,CRO

指由申辦者簽訂合同授權(quán),執(zhí)行申辦者在臨床試驗(yàn)中的某些職責(zé)和任務(wù)的單位。

1

DB43/T2135—2021

3.7

臨床試驗(yàn)現(xiàn)場(chǎng)管理組織sitemanagementorganization,SMO

指協(xié)助臨床試驗(yàn)機(jī)構(gòu)進(jìn)行臨床試驗(yàn)具體操作的現(xiàn)場(chǎng)管理組織。

3.8

受試者researchparticipant

指參加一項(xiàng)臨床試驗(yàn),并作為試驗(yàn)用藥物的接受者,包括患者、健康受試者。

3.9

臨床協(xié)調(diào)員clinicalresearchcoordinator,CRC

指經(jīng)主要研究者授權(quán)在臨床試驗(yàn)中協(xié)助研究者進(jìn)行非醫(yī)學(xué)判斷的相關(guān)事務(wù)性工作,是臨床試驗(yàn)的參

與者、協(xié)調(diào)者。

3.10

知情同意informedconsent

指受試者被告知可影響其做出參加臨床試驗(yàn)決定的各方面情況后,確認(rèn)同意自愿參加臨床試驗(yàn)的過(guò)

程。該過(guò)程應(yīng)以書面的、簽署姓名和日期的知情同意書作為文件證明。

3.11

招募組織/機(jī)構(gòu)recruitorganizations/agencies

指符合GCP要求的參與受試者招募的組織機(jī)構(gòu)及個(gè)人,應(yīng)是專業(yè)的第三方招募組織或藥物臨床試驗(yàn)

機(jī)構(gòu)研究者團(tuán)隊(duì)及其成員。

3.12

生物等效性試驗(yàn)bioequivalence,BE

是指用生物利用度研究的方法,以藥代動(dòng)力學(xué)參數(shù)為指標(biāo),比較同一種藥物的相同或者不同劑型的

制劑,在相同的試驗(yàn)條件下,其活性成份吸收程度和速度有無(wú)統(tǒng)計(jì)學(xué)差異的人體試驗(yàn)。

3.13

I期臨床試驗(yàn)phaseIclinicaltrial

初步的臨床藥理學(xué)及人體安全性評(píng)價(jià)試驗(yàn)。一般在健康受試者或某類患者中進(jìn)行;具有顯著潛在毒

性的藥物通常選擇患者作為研究對(duì)象。

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(GoodClinicalPractice)

BE:生物等效性試驗(yàn)(Bioequivalence)

5基本原則

5.1知情同意原則

知情同意原則包括:

——充分告知:充分告知受試者有關(guān)臨床試驗(yàn)的所有相關(guān)事宜,包括但不限定于:臨床試驗(yàn)方案、

受試者權(quán)益、試驗(yàn)風(fēng)險(xiǎn)及受益、受試者安全性信息保護(hù)以及倫理委員會(huì)的同意意見等;

——完全理解:知情同意書等提供給受試者的口頭和書面資料均應(yīng)采用通俗易懂的語(yǔ)言和表達(dá)方

式,使受試者或者其監(jiān)護(hù)人、見證人易于理解,并給予其充分的時(shí)間和機(jī)會(huì)了解臨床試驗(yàn)的詳

2

DB43/T2135—2021

細(xì)情況,并詳盡回答其提出的與臨床試驗(yàn)相關(guān)的問(wèn)題;

——完全自愿:不應(yīng)采用強(qiáng)迫、利誘等不正當(dāng)?shù)姆绞接绊懯茉囌邊⒓踊蛘呃^續(xù)臨床試驗(yàn),受試者參

加試驗(yàn)是自愿的,可以拒絕參加或者有權(quán)在試驗(yàn)任何階段隨時(shí)退出試驗(yàn)而不會(huì)遭到歧視或者報(bào)

復(fù),其醫(yī)療待遇與權(quán)益不會(huì)受到影響。

5.2控制風(fēng)險(xiǎn)原則

優(yōu)先考慮受試者的安全和健康權(quán)益,其次考慮科學(xué)和社會(huì)獲益;權(quán)衡預(yù)期風(fēng)險(xiǎn),需滿足預(yù)期獲益大

于風(fēng)險(xiǎn),力求受試者避免傷害或傷害最小化。

5.3免費(fèi)和補(bǔ)償原則

應(yīng)公平、公正、合理地選擇受試者,對(duì)參加研究的受試者不得額外收取任何費(fèi)用,與試驗(yàn)相關(guān)的檢

查費(fèi)、住院費(fèi)、試驗(yàn)藥物均應(yīng)免費(fèi),受試者在受試過(guò)程中支出的其余合理費(fèi)用還應(yīng)給予適當(dāng)補(bǔ)償。

5.4保護(hù)隱私原則

招募機(jī)構(gòu)應(yīng)保護(hù)受試者個(gè)人信息和數(shù)據(jù),未經(jīng)授權(quán)不應(yīng)對(duì)受試者個(gè)人信息進(jìn)行查閱、復(fù)印、公開、

散播、修改、損毀等。

5.5依法賠償原則

受試者參加研究受到試驗(yàn)相關(guān)損害時(shí),應(yīng)得到及時(shí)、免費(fèi)治療,并依據(jù)法律法規(guī)及雙方約定得到賠

償,申報(bào)者可通過(guò)購(gòu)買相關(guān)保險(xiǎn)提高賠付能力。

5.6特殊保護(hù)原則

對(duì)研究者的學(xué)生和下級(jí)、申辦者的員工、軍人、犯人、無(wú)藥可救疾病的患者、處于危急狀況的患者,

入住福利院的人、流浪者、未成年人和無(wú)能力知情同意的人等弱勢(shì)受試者,應(yīng)予以特別保護(hù)。

6招募組織/機(jī)構(gòu)

6.1符合GCP要求的參與受試者招募的組織機(jī)構(gòu)及個(gè)人,應(yīng)是專業(yè)的藥物臨床試驗(yàn)機(jī)構(gòu)研究者團(tuán)隊(duì)或

第三方招募組織。

6.2招募組織/機(jī)構(gòu)的職責(zé):

——征得本人同意,負(fù)責(zé)項(xiàng)目受試者招募,并保障招募過(guò)程的合法性和合規(guī)性;

——根據(jù)受試者個(gè)人意愿,負(fù)責(zé)受試者相關(guān)資料及信息的收集、匯總和整理;

——恪守受試者隱私保護(hù),保障受試者合法權(quán)益不受損害;

——協(xié)助研究者對(duì)受試者相關(guān)疑問(wèn)給予恰當(dāng)解答;

——協(xié)助受試者院內(nèi)外依從性管理、出組后跟蹤管理;

——人文關(guān)懷。

6.3招募組織/機(jī)構(gòu)的人員要求:

——對(duì)臨床試驗(yàn)充分了解,參與GCP培訓(xùn)并取得相關(guān)資格證書;

——具有醫(yī)學(xué)、護(hù)理學(xué)、藥學(xué)等相關(guān)專業(yè)大專及以上學(xué)歷;

——具有良好的信用記錄及從業(yè)記錄,良好的溝通能力等;

——對(duì)臨床試驗(yàn)項(xiàng)目有充分的了解。

6.4對(duì)于第三方招募組織或機(jī)構(gòu),還需具備:

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——合法營(yíng)業(yè)執(zhí)照,

——健全的組織架構(gòu),

——完善的招募體系。

7受試者招募

7.1招募方式

可采用張貼招募廣告/海報(bào)、發(fā)傳單、網(wǎng)絡(luò)新媒體等方式發(fā)布招募信息,公開招募符合條件的受試

者。

7.2招募流程

7.2.1信息發(fā)布

所有招募信息發(fā)布均應(yīng)在該項(xiàng)目審核批準(zhǔn)所在藥物臨床試驗(yàn)機(jī)構(gòu)的倫理委員會(huì)批準(zhǔn)后方可執(zhí)行。招

募信息內(nèi)容應(yīng)包括但不限于:

——試驗(yàn)名稱及藥物名稱,

——入選/排除標(biāo)準(zhǔn),

——體檢項(xiàng)目,

——項(xiàng)目時(shí)間安排,

——聯(lián)系人及聯(lián)系方式,

——試驗(yàn)機(jī)構(gòu)名稱及地址。

招募信息內(nèi)容不應(yīng)有以下內(nèi)容:

——任何聲稱或暗示試驗(yàn)藥物肯定安全或有效或可治愈疾病;

——使用強(qiáng)制、引誘或鼓勵(lì)性質(zhì)的圖片或符號(hào);

——使用名額有限、先到先得、優(yōu)先獲取等文字;

——強(qiáng)調(diào)該臨床試驗(yàn)經(jīng)衛(wèi)生主管部門或其他部門核準(zhǔn);

——其他經(jīng)衛(wèi)生主管部門公告不得刊登的內(nèi)容。

7.2.2篩查前審核

招募人員負(fù)責(zé)審核內(nèi)容包含但不限于:

——受試者個(gè)人信息真實(shí)性;

——是否自愿報(bào)名;

——是否了解項(xiàng)目的相關(guān)安排;

——其他需要收集的信息及資料。

篩查前審核過(guò)程中,招募人員應(yīng)口齒清晰,溝通順暢,保障受試者充分知情,實(shí)時(shí)記錄并耐心解答

受試者相關(guān)疑問(wèn)。當(dāng)受試者信息與資料信息不一致,經(jīng)確認(rèn)后可進(jìn)行修改,確保信息的完整性和真實(shí)性。

7.2.3知情同意/篩查體檢

招募人員應(yīng)在受試者知情同意當(dāng)天在藥物臨床試驗(yàn)機(jī)構(gòu)現(xiàn)場(chǎng)協(xié)調(diào)安排相關(guān)流程,告知受試者相關(guān)注

意事項(xiàng)。受試者的篩選體檢應(yīng)在根據(jù)研究機(jī)構(gòu)的要求簽署知情同意書后進(jìn)行,藥物臨床試驗(yàn)機(jī)構(gòu)的研究

者負(fù)責(zé)整個(gè)體檢過(guò)程,招募人員可協(xié)助完成以下工作:

——體檢前,應(yīng)充分告知受試者體檢時(shí)間、體檢內(nèi)容、體檢地點(diǎn)等相關(guān)注意事項(xiàng);

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——體檢時(shí),現(xiàn)場(chǎng)進(jìn)行相關(guān)指引工作。I期臨床試驗(yàn)應(yīng)使用臨床試驗(yàn)受試者數(shù)據(jù)庫(kù)對(duì)受試者既往試

驗(yàn)史進(jìn)行篩查,避免受試者短期內(nèi)重復(fù)多次參加,保障受試者權(quán)益;

——體檢完成后,在受試者離開中心前,應(yīng)及時(shí)告知項(xiàng)目安排等相關(guān)注意事項(xiàng)。

7.2.4結(jié)果通知

體檢結(jié)果出來(lái)后1個(gè)工作日內(nèi),第三方招募組織或機(jī)構(gòu)可協(xié)助研究者告知受試者項(xiàng)目入選情況,包

括進(jìn)一步試驗(yàn)安排及相關(guān)注意事項(xiàng)。對(duì)于I期臨床試驗(yàn),應(yīng)告知住院時(shí)間、入住前以及入住時(shí)注意事項(xiàng)。

當(dāng)受試者對(duì)體檢結(jié)果有疑問(wèn)時(shí),招募人員應(yīng)在3個(gè)工作日內(nèi)與研究者聯(lián)系,協(xié)助受試者了解完整體

檢信息,消除其疑慮。

8受試者管理

8.1依從性管理

8.1.1責(zé)任人

招募人員應(yīng)在整個(gè)試驗(yàn)期間協(xié)助研究者進(jìn)行受試者的依從性管理。

8.1.2院外管理

8.1.2.1與受試者保持通暢的溝通渠道和溝通方式。

8.1.2.2與受試者維系良好的信任關(guān)系。

8.1.2.3提醒院外期間的注意事項(xiàng),當(dāng)受試者有任何不良事件或?qū)τ谂R床試驗(yàn)的相關(guān)疑問(wèn)等,應(yīng)及時(shí)

記錄并及時(shí)反饋給研究者或研究者團(tuán)隊(duì)成員并積極安撫受試者情緒。

8.1.3院內(nèi)管理

維持現(xiàn)場(chǎng)篩選體檢秩序,協(xié)助研究者及期團(tuán)隊(duì)進(jìn)行受試者管理,I期臨床試驗(yàn)還需協(xié)助研究者進(jìn)

行受試者身份信息比對(duì)、臨床試驗(yàn)受試者數(shù)據(jù)庫(kù)篩查,協(xié)調(diào)飲食安排等。

8.2出組后跟蹤管理

8.2.1受試者出組后,定期進(jìn)行跟蹤管理,了解受試者身體情況,當(dāng)出現(xiàn)身體不適、疑問(wèn)及困惑等問(wèn)

題,應(yīng)充分理解并視情況協(xié)助解決,有效減輕受試者心理壓力。

8.2.2受試者出現(xiàn)身體不適或嚴(yán)重的不良反應(yīng),應(yīng)及時(shí)協(xié)助解決并及時(shí)反饋給研究者及其團(tuán)隊(duì)。

8.2.3不定期進(jìn)行受試者回訪,了解受試者近期身體情況,協(xié)助相關(guān)問(wèn)題的解決。

8.3人文關(guān)懷管理

8.3.1從受試者個(gè)人角度出發(fā),充分保障受試者身心健康與權(quán)益。

8.3.2與受試者保持良好通暢的溝通,充分減輕受試者心理壓力,定期了解近期身體情況。

8.3.3協(xié)助解決受試者其他方面的訴求,保障受試者不因參加臨床試驗(yàn)而受到任何人歧視或傷害。

9受試者權(quán)益和安全

9.1受試者權(quán)益

招募人員應(yīng)遵循自愿原則,允許受試者隨時(shí)拒絕而不必有任何理由,不應(yīng)遭到歧視或者報(bào)復(fù)受試者。

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發(fā)生不良事件后,應(yīng)及時(shí)治療和賠償,保護(hù)受試者的權(quán)益。

9.2受試者隱私保護(hù)

招募人員在項(xiàng)目執(zhí)行過(guò)程中產(chǎn)生受試者個(gè)人信息資料,均需專柜保存、專人管理。

與招募相關(guān)的文件以及受試者個(gè)人信息應(yīng)妥善保管至臨床試驗(yàn)結(jié)束后五年或試驗(yàn)產(chǎn)品上市后五年;

到期后需銷毀并記錄銷毀過(guò)程。

10質(zhì)量控制

10.1數(shù)據(jù)管理

為規(guī)范招募管理服務(wù),切實(shí)保障臨床試驗(yàn)數(shù)據(jù)真實(shí)、有效、完整及可溯源,實(shí)現(xiàn)受試者招募管理全

流程可控,宜采用信息化進(jìn)行招募數(shù)據(jù)管理,并確保數(shù)據(jù)的真實(shí)性、完整性和可溯源。

溯源包括但不限于以下層面:

——人員真實(shí)性:核實(shí)受試者是否真實(shí)存在,是否為本人參與試驗(yàn),受試者資料是否真實(shí);

——過(guò)程規(guī)范性:招募過(guò)程中所產(chǎn)生資料是否真實(shí)可靠,流程是否完整、規(guī)范;

——信息完整性:從招募廣告發(fā)起至最后一例受試者完成試驗(yàn),是否有信息中斷現(xiàn)象,相應(yīng)流程是

否規(guī)范。

10.2評(píng)價(jià)改進(jìn)

10.2.1評(píng)價(jià)機(jī)構(gòu)

可由行業(yè)主管部門、行業(yè)主管部門委托的第三方機(jī)構(gòu)或藥物臨床試驗(yàn)機(jī)構(gòu)等開展招募評(píng)價(jià)工作。

招募組織/機(jī)構(gòu)應(yīng)定期開展自評(píng)價(jià)。

10.2.2評(píng)價(jià)內(nèi)容及方法

開展評(píng)價(jià)的內(nèi)容及方法有:

——招募組織/機(jī)構(gòu)的資質(zhì):查驗(yàn)是否具備組織/機(jī)構(gòu)相關(guān)證書、質(zhì)量管理體系、人員任職資質(zhì);

——招募開展的合法合規(guī)性:查驗(yàn)服務(wù)過(guò)程及相關(guān)資料是否違反GCP以及相關(guān)倫理指導(dǎo)原則;

——招募能力/滿意度:開展服務(wù)單位以及受試者的問(wèn)卷調(diào)查。

10.2.3持續(xù)改進(jìn)

招募組織/機(jī)構(gòu)建立有效的評(píng)價(jià)處理和反饋改進(jìn)機(jī)制,針對(duì)相關(guān)方問(wèn)題和意見,進(jìn)行相應(yīng)的處理、

整改和反饋并及時(shí)記錄存檔。

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參考文獻(xiàn)

[1]涉及人的生物醫(yī)學(xué)研究倫理審查辦法(中華人民共和國(guó)國(guó)家衛(wèi)生和計(jì)劃生物委員會(huì)令第11

號(hào))

[2]藥物臨床試驗(yàn)倫理審查工作指導(dǎo)原則(國(guó)家食品藥品監(jiān)督管理局2010年)

[3]藥物臨床試驗(yàn)質(zhì)量管理規(guī)范(國(guó)家食品藥品監(jiān)督管理局2020年7月)

[4]朱偉,等.涉及人的健康相關(guān)研究國(guó)際倫理準(zhǔn)則[M].上海:上海交通大學(xué)出版社,2019.

[5]李豐杉,馮仕銀,陳卓,王晶,鄒琴,郭偉一,蔡林芮,蘇旭,胡鳳,杜丹,杜春鳳,鄭瑩,余勤.生物

等效性試驗(yàn)受試者招募困境與解決方法探討[J].中國(guó)醫(yī)學(xué)倫理學(xué),2020,33(05):575-578+582.

[6]李婷,劉淑芹,柳艷平,高曉萌,馬雅萍,時(shí)萍,曹玉.規(guī)范生物等效性試驗(yàn)中受試者管理提高臨

床試驗(yàn)質(zhì)量的措施[J].中國(guó)醫(yī)院藥學(xué)雜志,2019,39(15):1582-1585.

[7]程毅,布格拉·米吉提,張翌韋,袁明奎,楊建華,魯瑞萍.醫(yī)院藥物臨床試驗(yàn)受試者權(quán)益保護(hù)及

對(duì)策[J].中國(guó)醫(yī)學(xué)倫理學(xué),2019,32(01):55-58.

[8]韓帥瑋琦,解染,陳筱,趙俠,崔一民.探討合理應(yīng)用受試者數(shù)據(jù)庫(kù)管理我國(guó)Ⅰ期臨床試驗(yàn)篩選

過(guò)程[J].中國(guó)臨床藥理學(xué)雜志,2016,32(08):749-752.

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目次

前言························································································································Ⅲ

1范圍·····················································································································1

2規(guī)范性引用文件······································································································1

3術(shù)語(yǔ)和定義············································································································1

4縮略語(yǔ)··················································································································2

5基本原則···············································································································2

5.1知情同意原則···································································································2

5.2控制風(fēng)險(xiǎn)原則···································································································3

5.3免費(fèi)和補(bǔ)償原則································································································3

5.4保護(hù)隱私原則···································································································3

5.5依法賠償原則···································································································3

5.6特殊保護(hù)原則···································································································3

6招募組織/機(jī)構(gòu)········································································································3

7受試者招募············································································································4

7.1招募方式·········································································································4

7.2招募流程·········································································································4

8受試者管理············································································································5

8.1依從性管理······································································································5

8.2出組后跟蹤管理································································································5

8.3人文關(guān)懷管理···································································································5

9受試者權(quán)益和安全···································································································5

9.1受試者權(quán)益······································································································5

9.2受試者隱私保護(hù)································································································6

10質(zhì)量控制··············································································································6

10.1數(shù)據(jù)管理·······································································································6

10.2評(píng)價(jià)改進(jìn)·······································································································6

參考文獻(xiàn)····················································································································7

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