DB43-T 2135-2021 药物临床试验受试者招募管理技术服务规范

ICS

11.120.99CCS

C

43湖 南 省 地 方 标 准DB43/T

2135—2021药物临床试验受试者招募管理技术服务规范Drug

clinical

trial

subjects

recruitment

managementtechnical

service

specification2021

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08

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03

发布

2021

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实施湖南省市场监督管理局

发

布DB43/T

2135— 前言························································································································

Ⅲ1 ·····················································································································

12 规范性引用文件······································································································13术语和定义············································································································14 缩略语··················································································································

25 基本原则···············································································································25.1 知情同意原则···································································································25.2 控制风险原则···································································································35.3 免费和补偿原则································································································

35.4 保护隐私原则···································································································35.5 依法赔偿原则···································································································35.6 特殊保护原则···································································································36 招募组织/········································································································37 受试者招募············································································································47.1招募方式·········································································································47.2招募流程·········································································································48 受试者管理············································································································58.1依从性管理······································································································58.2 出组后跟踪管理································································································

58.3 人文关怀管理···································································································59受试者权益和安全···································································································59.1 受试者权益······································································································59.2 受试者隐私保护································································································

610质量控制··············································································································610.1 数据管理

·······································································································610.2 评价改进

·······································································································6参考文献····················································································································

7DB43/T

2135— 本文件按照

GB/T

—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。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。IIIDB43/T

2135—1

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。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 drug

clinical

trial

（

GCP（求，开展药物临床试验的机构。3.2临床试验 clinical

trial的系统性试验。3.3研究者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ethics

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 contract

organization,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。DB43/T

2135—3.7临床试验现场管理组织

management

organization,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

participant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 clinical

与者、协调者。3.10知情同意

consent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

organizations/agencies指符合

GCP

机构研究者团队及其成员。3.12生物等效性试验 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。3.13I

期临床试验 phase

I

clinical

trial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（Good

Clinical

Practice）BE：生物等效性试验

（）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DB43/T

2135—细情况，并详尽回答其提出的与临床试验相关的问题；复，其医疗待遇与权益不会受到影响。5.2 控制风险原则于风险，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/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：DB43/T

2135———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。7.2.3 知情同意/筛查体检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；DB43/T

—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

I

3

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DB43/T

—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；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