ICH-GCP 6.1 Quality Assurance（1）
Part 1: IntroductionPart 2: QA and Monitoring Role
Quality Assurance (QA) in clinical trials consists of planned, systematic activities that are conducted to ensure that a trial is performed―and that trial data are generated, documented, and reported―in compliance with the protocol, Good Clinical Practice (GCP) guidelines, and all other applicable regulatory requirement(s).
临床试验中的 质量保证（QA）包括计划的、系统的活动 ， 这些活动旨在确保试验按照方案、良好临床实践（GCP）指南和所有其他适用的监管要求进行，并生成、记录和报告试验数据 。
Research that is not conducted according to high standards of quality yields invalid data. It is also unethical because it may put research participants at risk. (Protection of the safety, rights, and well-being of research participants is discussed in the Introduction, Institutional Review Boards, Informed Consent, and Participant Safety and Adverse Events modules.)
没有按照高质量标准进行的研究会产生无效数据 。这也是 不道德的 ，因为它可能使研究参与者处于危险之中。（引言、机构审查委员会、知情同意书以及参与者安全和不良事件模块中讨论了研究参与者的安全、权利和福利保护）
Audits conducted by the U.S. Food and Drug Administration (FDA) find that several problems commonly occur in research studies.
由美国食品和药物管理局(FDA)进行的审计发现，在研究中常见的几个问题。
Quality data are critical to ensure that the results of studies are interpreted correctly. Sloppy or incorrect data can lead to misleading conclusions. Careful attention to standards of quality also ensures that studies are completed in a timely fashion. Timely completion of high quality studies bridges the gap between research and practice by bringing effective new treatments to clients more quickly.
质量数据对于确保正确解释研究结果至关重要。 草率或不正确的数据可能导致误导性结论。对质量标准的认真关注也确保了及时完成研究。 及时完成高质量的研究，通过更快地为客户提供有效的新疗法，弥合研究与实践之间的差距。
All members of the protocol team are responsible for QA.
协议团队的所有成员 都负责QA。
While it is common for QA and monitoring-related duties and functions to be transferred to a CRO, the sponsor has ultimate responsibility for implementing and maintaining QA systems. (ICH GCP 5.1.1) This responsibility includes oversight of all QA systems as well as any trial-related functions performed or managed by other parties (i.e. the CRO, or a subcontractor to the CRO) on behalf of the Sponsor (ICH GCP 5.2.2)
虽然将QA和监控相关职责和职能移交给CRO是常见的，但发起人对实施和维护QA系统负有最终责任。 （ICH GCP 5.1.1）该责任包括监督所有 QA系统以及由其他方 （即CRO或CRO的分包商）代表发起人执行或管理的任何试验相关功能（ICH GCP 5.2.2）
Investigators and every member of the protocol team are expected to perform his or her duties diligently and thoroughly, thus ensuring that the trial is conducted according to the highest possible standards of quality.
研究人员和方案小组的每一位成员都应勤勉、彻底地履行其职责，从而确保试验按照尽可能高的质量标准进行。
Click to view Clinical Trial Network（CTN） related content
点击查看临床试用网络（CTN）相关内容
The sponsor is responsible for ensuring the trial’s integrity and for developing a risk-based monitoring plan. As the sponsor of all studies conducted by the network, NIDA CTN has transferred the regulatory responsibility of all monitoring to the Clinical Coordinating Center (CCC).
申办方 有责任确保试验的完整性， 并制定基于风险的监测计划 。作为该网络开展的所有研究的发起者，NIDA CTN已将所有监测的监管责任移交给临床协调中心(CCC)。
The CCC develops systematic, prioritized, and risk-based (ICH GCP E6(R2) 5.18.3) monitoring plans to be utilized for each CTN study. This plan is customized for each trial and describes the strategy, methods, responsibilities, and requirements for monitoring the trial (ICH GCP E6(R2) 1.64). Additionally, the plan provides operational guidelines to ensure the quality and integrity of data collected in accordance with CTN protocols. This document also ensures consistency in the conduct of CTN studies across multiple sites and protocols. This monitoring plan:
CCC为每项CTN研究制定系统的、优先的和基于风险的(ICH GCP E6(R2) 5.18.3)监测计划。本计划为每个试验定制，并描述了 监测试验的策略、方法、职责和要求 (ICH GCP E6(R2) 1.64)。此外，该计划还提供了操作指南，以确保根据CTN协议收集的数据的质量和完整性。本文件还确保了跨多个站点和协议进行CTN研究的一致性。这个监测计划:
Ⅰ、Emphasizes the monitoring of critical data and processes.
Ⅱ、Ensures the quality and integrity of CTN clinical studies.
Ⅲ、Ensures the protection of human participants.
Ⅳ、Advances collaboration between treatment and research staff at CTN sites.
1、强调对 关键数据 和 过程 的监控。
2、确保 CTN临床研究的质量 和 完整性 。
3、确保 对人类参与者的保护 。
4、促进 CTN现场治疗 和 研究人员之间的合作 。
The Lead Investigator (LI) is a CTN-specific role for the investigator that has overall responsibility for the entire study. The LI convenes a Protocol Team that assists with all aspects of the development and operation of the study. In other studies outside of the CTN, this role may be considered the Principal Investigator.
首席研究者（LI）是CTN特定的研究者角色，对整个研究负全面责任 。LI 召集了一个方案小组，协助研究开发和运作的各个方面 。在CTN以外的其他研究中，该角色可能被视为主要研究者。
The Project Director (or Protocol Coordinator) is the LI’s “right hand.” He or she is responsible for coordinating and carrying out day–to–day study operations. The Project Director is a member of the Protocol Team and is the primary contact for questions about the overall study. Other roles and responsibilities represented on the Protocol Team usually include, but may not be limited to, the following:
项目总监(或协议协调员) 是 LI 的“得力助手”，他或她 负责协调和进行日常学习活动 。项目总监是协议小组的成员， 是整个研究问题的主要联系人 。协议团队中代表的其他角色和职责通常包括但不限于以下内容：
Ⅰ、Data Management
Ⅱ、Quality Assurance
Ⅲ、Training
Ⅳ、Regulatory Affairs
1、数据管理
2、质量保证
3、培训
4、监管事务
The Node PI (or grantee) is another CTN-specific role that is responsible to NIDA for study performance at his or her Node. He or she works with Node staff, the Site Principal Investigator(s), and the Lead Investigator to implement the study at that Node. The Node PI is responsible for ensuring that the study runs smoothly at his or her Node and for taking appropriate action when necessary to assist the Site PI(s) and the Lead Investigator. Other responsibilities of the Node PI include:
节点PI（或受让人）是另一个CTN特定角 色，负责NIDA在其节点的研究表现。 他或她与节点工作人员、现场首席研究员和首席研究员合作，在该节点实施研究 。节点PI负责确保研究在其节点顺利进行， 并在必要时采取适当措施协助现场PI和首席研究员 。节点PI的其他职责包括：
Ⅰ、Appointing the Site PI and Study Coordinator.
Ⅱ、Managing the Node budget and staff.
Ⅲ、Appointing a monitor to conduct Quality Assurance visits at research sites within the Node.
Ⅳ、Ensuring that study staff receives appropriate training to conduct the study.
Ⅴ、Ensuring that the study receives all necessary IRB approvals and follows all applicable regulations. Knowing the policies of his or her institution/university and ensuring compliance at the Node with these policies.
1、 任命现场PI 和 研究协调员 。
2、 管理节点预算和人员 。
3、指定一名监督员 对节点内的研究地点进行质量保证访问 。
4、确保研究人员接受 适当的培训 进行研究。
5、确保本研究获得 所有必要的IRB批准 并遵守所有适用的法规。了解他或她的机构/大学的政策，并确保节点遵守这些政策。
The monitoring plan sets out monitoring strategies, the monitoring responsibilities of all parties involved, the various monitoring methods to be used, and the rationale for their use. It also describes monitoring procedures, types of visits, what is involved in the conduct of those visits, and the quantity or percentage of each type of document to be monitored. These procedures can be further defined on a protocol basis depending on the purpose, design, size, complexity, and primary outcome measures of the trial (ICH GCP E6(R2) 5.18.3).
监测计划规定了监测战略、所有相关方的监测责任、将使用的各种监测方法以及使用这些方法的理由 。它还描述了 监控程序 、 访问类型 、 访问过程中涉及的内容 ，以及 需要监控的各类文件的数量或百分比 。这些程序可根据试验的目的、设计、规模、复杂度和主要结果指标在方案基础上进一步定义（ICH GCP E6(R2) 5.18.3).
According to GCP guidelines, “the Sponsor may choose on-site monitoring, a combination of on-site and centralized (remote) monitoring, or, where justified, centralized monitoring alone…Centralized monitoring processes provide additional monitoring capabilities that can complement or reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data without the need for total source data verification” (ICH GCP 5.18.3). The rationale for the chosen monitoring strategy is documented in the monitoring plan.
根据GCP指南，“ 主办方可以选择现场监测，现场监测和集中(远程)监测相结合 ，或者，在合理的情况下， 集中监测过程提供额外的监测能力 ， 可补充或减少现场监测的范围和/或频率 ，并有助于区分可靠数据和可能不可靠的数据，而无需核实全部来源数据”(ICH GCP 5.18.3)。所选择的监控策略的基本原理已记录在监控计划中。
In general, on-site monitoring is required and remote monitoring may occur at any given research site before a trial begins, while it is in progress, and after it concludes or is terminated. In many instances, study monitors may visit each site after the first one to two participants are enrolled and then schedule subsequent visits based on multivariate criteria, such as the rate of enrollment, volume of data to review, site performance, and other considerations.
一般来说，需要进行现场监测， 在试验开始前、进行中、结束或终止后，可以在任何给定的研究地点进行远程监测 。在许多情况下，研究监测人员可能会在 前一到两名参与者登记后访问每个位点，然后根据多变量标准安排后续访问 ，如 登记率 、 回顾数据量 、 位点表现 和 其他考虑 。
Study monitors conduct site visits according to the procedures describes in the monitoring plan and in accordance with Good Clinical Practice (GCP) guidelines.
研究监测人员根据 监测计划 中描述的程序并按照良好临床实践(GCP)指南进行现场访问。
The Good Clinical Practice guidelines state that the sponsor is responsible for selecting monitors and for ensuring that the following criteria are met (see ICH GCP 5.18.2).
《良好临床实践指南》规定， 申办方负责选择监护仪 ，并确保符合以下标准（见ICH GCP 5.18.2）。
Ⅰ、Monitors are appropriately trained and have the scientific or clinical knowledge needed to monitor the trial adequately. Monitors qualifications should be documented.
Ⅱ、Monitors are thoroughly familiar with the investigational product(s), protocol, written informed consent form, and any other written information about the trial to be provided to study participants, the Sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).
1、监护人受过适当的 培训 ，具备充分监护试验所需的科学或临床知识。监控人员的资格应该记录在案。
2、监护者完全熟悉 试验药物 、 方案 、 书面知情同意书 以及向 研究参与者提供的有关试验的任何其他书面信息 、 申办方的SOP 、 GCP 和 适用的监管要求 。
QA/study monitors perform the following study activities:
QA/研究监督员执行以下研究活动：
Ⅰ、Conduct initiation, interim, and closeout visits.
Ⅱ、Conduct centralized monitoring, as applicable.
Ⅲ、Provide training on protocol-specific issues and Good Clinical Practice, when needed or appropriate.
Ⅳ、Follow-up on issues identified during earlier monitoring visits.
Ⅴ、File reports with the sponsor and other applicable parties, as required.
1、开展 启动 、 临时 和 收尾访问 。
2、进行 集中监控 （如适用）。
3、在需要或适当的时候，提供关于 方案特定问题 和 良好临床实践的培训 。
4、跟进 早期监测 访问中发现的问题。
5、根据需要向发起人和其他适用方提交报告。
Monitoring responsibilities are described in detail in ICH GCP 5.18.4. Click here for a summary.
ICH GCP 5.18.4中详细描述了监控职责。点击这里查看摘要。
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