DB43-T 2135-2021药物临床试验受试者招募管理技术服务规范

ICS11.120.99

CCSC01

43

湖南省地方标准

DB43/T2135—2021

药物临床试验受试者招募管理技术

服务规范

Drugclinicaltrialsubjectsrecruitmentmanagement

technicalservicespecification

2021-08-03发布2021-10-03实施

湖南省市场监督管理局发布

DB43/T2135—2021

目次

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

1范围·····················································································································1

2规范性引用文件······································································································1

3术语和定义············································································································1

4缩略语··················································································································2

5基本原则···············································································································2

5.1知情同意原则···································································································2

5.2控制风险原则···································································································3

5.3免费和补偿原则································································································3

5.4保护隐私原则···································································································3

5.5依法赔偿原则···································································································3

5.6特殊保护原则···································································································3

6招募组织/机构········································································································3

7受试者招募············································································································4

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

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

8受试者管理············································································································5

8.1依从性管理······································································································5

8.2出组后跟踪管理································································································5

8.3人文关怀管理···································································································5

9受试者权益和安全···································································································5

9.1受试者权益······································································································5

9.2受试者隐私保护································································································6

10质量控制··············································································································6

10.1数据管理·······································································································6

10.2评价改进·······································································································6

参考文献····················································································································7

I

DB43/T2135—2021

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由湖南省药品监督管理局提出并归口。

本文件起草单位：长沙先领医药科技有限公司、中南大学湘雅医院、中南大学湘雅二医院、中南大

学湘雅三医院、湖南省人民医院、湖南省妇幼保健院、湖南省肿瘤医院、湖南省职业病防治院、湖南省

脑科医院、湖南省胸科医院、长沙都正生物科技股份有限公司、长沙市中心医院、长沙市第一医院、长

沙市第三医院、长沙珂信肿瘤医院、怀化市第一人民医院、怀化市第二人民医院、郴州市第一人民医院、

益阳市中心医院、株洲市中心医院、娄底市中心医院、长沙舍同智能科技有责任公司、长沙市药物评价

产业技术创新战略联盟。

本文件主要起草人：欧阳冬生、李晓晖、严谨、陈桂根、谢秀芬、胡斌、陈露露、袁叶、周淦、

李昕、李卓、李伟、郑姣、阮兴强、徐梦颖、邹志、陈维明。

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DB43/T2135—2021

药物临床试验受试者招募管理技术服务规范

1范围

本文件规定了药物临床试验受试者招募管理技术服务的基本原则、招募组织/机构、受试者招募、

受试者管理、受试者权益和安全和质量控制等。

本文件适用于药物临床试验机构及研究者、伦理委员会、合同研究组织等参与药物临床试验受试者

招募管理的组织和个人。

2规范性引用文件

本文件没有规范性引用文件。

3术语和定义

下列术语和定义适用于本文件。

3.1

药物临床试验机构drugclinicaltrialinstitution

具备相应条件，按照《药物临床试验质量管理规范》（GCP）和药物临床试验相关技术指导原则等要

求，开展药物临床试验的机构。

3.2

临床试验clinicaltrial

以人体（患者或健康受试者）为对象的试验，意在发现或验证某种试验药物的临床医学、药理学以

及其他药效学作用、不良反应，或者试验药物的吸收、分布、代谢和排泄，以确定药物的疗效与安全性

的系统性试验。

3.3

研究者investigator

指实施临床试验并对临床试验质量及受试者权益和安全负责的试验现场负责人。

3.4

伦理委员会ethicscommittee

由医学、药学及其他背景人员组成的委员会，其职责是通过独立地审查、同意、跟踪审查试验方案

及相关文件、获得和记录受试者知情同意所用的方法和材料等，确保受试者的权益、安全受到保护。

3.5

申报者sponsor

指负责临床试验的发起、管理和提供临床试验经费的个人、组织或者机构。

3.6

合同研究组织contractresearchorganization,CRO

指由申办者签订合同授权，执行申办者在临床试验中的某些职责和任务的单位。

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3.7

临床试验现场管理组织sitemanagementorganization,SMO

指协助临床试验机构进行临床试验具体操作的现场管理组织。

3.8

受试者researchparticipant

指参加一项临床试验，并作为试验用药物的接受者，包括患者、健康受试者。

3.9

临床协调员clinicalresearchcoordinator,CRC

指经主要研究者授权在临床试验中协助研究者进行非医学判断的相关事务性工作，是临床试验的参

与者、协调者。

3.10

知情同意informedconsent

指受试者被告知可影响其做出参加临床试验决定的各方面情况后，确认同意自愿参加临床试验的过

程。该过程应以书面的、签署姓名和日期的知情同意书作为文件证明。

3.11

招募组织/机构recruitorganizations/agencies

指符合GCP要求的参与受试者招募的组织机构及个人，应是专业的第三方招募组织或药物临床试验

机构研究者团队及其成员。

3.12

生物等效性试验bioequivalence,BE

是指用生物利用度研究的方法，以药代动力学参数为指标，比较同一种药物的相同或者不同剂型的

制剂，在相同的试验条件下，其活性成份吸收程度和速度有无统计学差异的人体试验。

3.13

I期临床试验phaseIclinicaltrial

初步的临床药理学及人体安全性评价试验。一般在健康受试者或某类患者中进行；具有显著潜在毒

性的药物通常选择患者作为研究对象。

4缩略语

下列缩略语适用于本文件。

GCP：药物临床试验质量管理规范（GoodClinicalPractice）

BE：生物等效性试验（Bioequivalence）

5基本原则

5.1知情同意原则

知情同意原则包括：

——充分告知：充分告知受试者有关临床试验的所有相关事宜，包括但不限定于：临床试验方案、

受试者权益、试验风险及受益、受试者安全性信息保护以及伦理委员会的同意意见等；

——完全理解：知情同意书等提供给受试者的口头和书面资料均应采用通俗易懂的语言和表达方

式，使受试者或者其监护人、见证人易于理解，并给予其充分的时间和机会了解临床试验的详

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细情况，并详尽回答其提出的与临床试验相关的问题；

——完全自愿：不应采用强迫、利诱等不正当的方式影响受试者参加或者继续临床试验，受试者参

加试验是自愿的，可以拒绝参加或者有权在试验任何阶段随时退出试验而不会遭到歧视或者报

复，其医疗待遇与权益不会受到影响。

5.2控制风险原则

优先考虑受试者的安全和健康权益，其次考虑科学和社会获益；权衡预期风险，需满足预期获益大

于风险，力求受试者避免伤害或伤害最小化。

5.3免费和补偿原则

应公平、公正、合理地选择受试者，对参加研究的受试者不得额外收取任何费用，与试验相关的检

查费、住院费、试验药物均应免费，受试者在受试过程中支出的其余合理费用还应给予适当补偿。

5.4保护隐私原则

招募机构应保护受试者个人信息和数据，未经授权不应对受试者个人信息进行查阅、复印、公开、

散播、修改、损毁等。

5.5依法赔偿原则

受试者参加研究受到试验相关损害时，应得到及时、免费治疗，并依据法律法规及双方约定得到赔

偿，申报者可通过购买相关保险提高赔付能力。

5.6特殊保护原则

对研究者的学生和下级、申办者的员工、军人、犯人、无药可救疾病的患者、处于危急状况的患者，

入住福利院的人、流浪者、未成年人和无能力知情同意的人等弱势受试者，应予以特别保护。

6招募组织/机构

6.1符合GCP要求的参与受试者招募的组织机构及个人，应是专业的药物临床试验机构研究者团队或

第三方招募组织。

6.2招募组织/机构的职责：

——征得本人同意，负责项目受试者招募，并保障招募过程的合法性和合规性；

——根据受试者个人意愿，负责受试者相关资料及信息的收集、汇总和整理；

——恪守受试者隐私保护，保障受试者合法权益不受损害；

——协助研究者对受试者相关疑问给予恰当解答；

——协助受试者院内外依从性管理、出组后跟踪管理；

——人文关怀。

6.3招募组织/机构的人员要求：

——对临床试验充分了解，参与GCP培训并取得相关资格证书；

——具有医学、护理学、药学等相关专业大专及以上学历；

——具有良好的信用记录及从业记录，良好的沟通能力等；

——对临床试验项目有充分的了解。

6.4对于第三方招募组织或机构，还需具备：

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——合法营业执照，

——健全的组织架构，

——完善的招募体系。

7受试者招募

7.1招募方式

可采用张贴招募广告/海报、发传单、网络新媒体等方式发布招募信息，公开招募符合条件的受试

者。

7.2招募流程

7.2.1信息发布

所有招募信息发布均应在该项目审核批准所在药物临床试验机构的伦理委员会批准后方可执行。招

募信息内容应包括但不限于：

——试验名称及药物名称，

——入选/排除标准，

——体检项目，

——项目时间安排，

——联系人及联系方式，

——试验机构名称及地址。

招募信息内容不应有以下内容：

——任何声称或暗示试验药物肯定安全或有效或可治愈疾病；

——使用强制、引诱或鼓励性质的图片或符号；

——使用名额有限、先到先得、优先获取等文字；

——强调该临床试验经卫生主管部门或其他部门核准；

——其他经卫生主管部门公告不得刊登的内容。

7.2.2筛查前审核

招募人员负责审核内容包含但不限于：

——受试者个人信息真实性；

——是否自愿报名；

——是否了解项目的相关安排；

——其他需要收集的信息及资料。

筛查前审核过程中，招募人员应口齿清晰，沟通顺畅，保障受试者充分知情，实时记录并耐心解答

受试者相关疑问。当受试者信息与资料信息不一致，经确认后可进行修改，确保信息的完整性和真实性。

7.2.3知情同意/筛查体检

招募人员应在受试者知情同意当天在药物临床试验机构现场协调安排相关流程，告知受试者相关注

意事项。受试者的筛选体检应在根据研究机构的要求签署知情同意书后进行，药物临床试验机构的研究

者负责整个体检过程，招募人员可协助完成以下工作：

——体检前，应充分告知受试者体检时间、体检内容、体检地点等相关注意事项；

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——体检时，现场进行相关指引工作。I期临床试验应使用临床试验受试者数据库对受试者既往试

验史进行筛查，避免受试者短期内重复多次参加，保障受试者权益；

——体检完成后，在受试者离开中心前，应及时告知项目安排等相关注意事项。

7.2.4结果通知

体检结果出来后1个工作日内，第三方招募组织或机构可协助研究者告知受试者项目入选情况，包

括进一步试验安排及相关注意事项。对于I期临床试验，应告知住院时间、入住前以及入住时注意事项。

当受试者对体检结果有疑问时，招募人员应在3个工作日内与研究者联系，协助受试者了解完整体

检信息，消除其疑虑。

8受试者管理

8.1依从性管理

8.1.1责任人

招募人员应在整个试验期间协助研究者进行受试者的依从性管理。

8.1.2院外管理

8.1.2.1与受试者保持通畅的沟通渠道和沟通方式。

8.1.2.2与受试者维系良好的信任关系。

8.1.2.3提醒院外期间的注意事项，当受试者有任何不良事件或对于临床试验的相关疑问等，应及时

记录并及时反馈给研究者或研究者团队成员并积极安抚受试者情绪。

8.1.3院内管理

维持现场筛选体检秩序，协助研究者及期团队进行受试者管理，I期临床试验还需协助研究者进

行受试者身份信息比对、临床试验受试者数据库筛查，协调饮食安排等。

8.2出组后跟踪管理

8.2.1受试者出组后，定期进行跟踪管理，了解受试者身体情况，当出现身体不适、疑问及困惑等问

题，应充分理解并视情况协助解决，有效减轻受试者心理压力。

8.2.2受试者出现身体不适或严重的不良反应，应及时协助解决并及时反馈给研究者及其团队。

8.2.3不定期进行受试者回访，了解受试者近期身体情况，协助相关问题的解决。

8.3人文关怀管理

8.3.1从受试者个人角度出发，充分保障受试者身心健康与权益。

8.3.2与受试者保持良好通畅的沟通，充分减轻受试者心理压力，定期了解近期身体情况。

8.3.3协助解决受试者其他方面的诉求，保障受试者不因参加临床试验而受到任何人歧视或伤害。

9受试者权益和安全

9.1受试者权益

招募人员应遵循自愿原则，允许受试者随时拒绝而不必有任何理由，不应遭到歧视或者报复受试者。

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发生不良事件后，应及时治疗和赔偿，保护受试者的权益。

9.2受试者隐私保护

招募人员在项目执行过程中产生受试者个人信息资料，均需专柜保存、专人管理。

与招募相关的文件以及受试者个人信息应妥善保管至临床试验结束后五年或试验产品上市后五年；

到期后需销毁并记录销毁过程。

10质量控制

10.1数据管理

为规范招募管理服务，切实保障临床试验数据真实、有效、完整及可溯源，实现受试者招募管理全

流程可控，宜采用信息化进行招募数据管理，并确保数据的真实性、完整性和可溯源。

溯源包括但不限于以下层面：

——人员真实性：核实受试者是否真实存在，是否为本人参与试验，受试者资料是否真实；

——过程规范性：招募过程中所产生资料是否真实可靠，流程是否完整、规范；

——信息完整性：从招募广告发起至最后一例受试者完成试验，是否有信息中断现象，相应流程是

否规范。

10.2评价改进

10.2.1评价机构

可由行业主管部门、行业主管部门委托的第三方机构或药物临床试验机构等开展招募评价工作。

招募组织/机构应定期开展自评价。

10.2.2评价内容及方法

开展评价的内容及方法有：

——招募组织/机构的资质：查验是否具备组织/机构相关证书、质量管理体系、人员任职资质；

——招募开展的合法合规性：查验服务过程及相关资料是否违反GCP以及相关伦理指导原则；

——招募能力/满意度：开展服务单位以及受试者的问卷调查。

10.2.3持续改进

招募组织/机构建立有效的评价处理和反馈改进机制，针对相关方问题和意见，进行相应的处理、

整改和反馈并及时记录存档。

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参考文献

[1]涉及人的生物医学研究伦理审查办法（中华人民共和国国家卫生和计划生物委员会令第11

号）

[2]药物临床试验伦理审查工作指导原则（国家食品药品监督管理局2010年）

[3]药物临床试验质量管理规范（国家食品药品监督管理局2020年7月）

[4]朱伟，等.涉及人的健康相关研究国际伦理准则[M].上海：上海交通大学出版社，2019.

[5]李丰杉,冯仕银,陈卓,王晶,邹琴,郭伟一,蔡林芮,苏旭,胡凤,杜丹,杜春凤,郑莹,余勤.生物

等效性试验受试者招募困境与解决方法探讨[J].中国医学伦理学,2020,33（05）:575-578+582.

[6]李婷,刘淑芹,柳艳平,高晓萌,马雅萍,时萍,曹玉.规范生物等效性试验中受试者管理提高临

床试验质量的措施[J].中国医院药学杂志,2019,39（15）:1582-1585.

[7]程毅,布格拉·米吉提,张翌韦,袁明奎,杨建华,鲁瑞萍.医院药物临床试验受试者权益保护及

对策[J].中国医学伦理学,2019,32（01）:55-58.

[8]韩帅玮琦,解染,陈筱,赵侠,崔一民.探讨合理应用受试者数据库管理我国Ⅰ期临床试验筛选

过程[J].中国临床药理学杂志,2016,32（08）:749-752.

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目次

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

1范围·····················································································································1

2规范性引用文件······································································································1

3术语和定义············································································································1

4缩略语··················································································································2

5基本原则···············································································································2

5.1知情同意原则···································································································2

5.2控制风险原则···································································································3

5.3免费和补偿原则································································································3

5.4保护隐私原则···································································································3

5.5依法赔偿原则···································································································3

5.6特殊保护原则···································································································3

6招募组织/机构········································································································3

7受试者招募············································································································4

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

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

8受试者管理············································································································5

8.1依从性管理······································································································5

8.2出组后跟踪管理································································································5

8.3人文关怀管理···································································································5

9受试者权益和安全···································································································5

9.1受试者权益······································································································5

9.2受试者隐私保护································································································6

10质量控制··············································································································6

10.1数据管理·······································································································6

10.2评价改进·······································································································6

参考文献····················································································································7

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