Contents

Part 1: Introduction

Part 2: QA and Monitoring Role

Part 1: Introduction

What is quality assurance?

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).

臨床試驗中的質(zhì)量保證（QA）包括計劃的补鼻、系統(tǒng)的活動疯潭，這些活動旨在確保試驗按照方案灭美、良好臨床實踐（GCP）指南和所有其他適用的監(jiān)管要求進行程癌，并生成村视、記錄和報告試驗數(shù)據(jù)。

Why is QA important?? ?為什么質(zhì)量保證很重要焰雕？

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.)

沒有按照高質(zhì)量標準進行的研究會產(chǎn)生無效數(shù)據(jù)舵变。這也是不道德的，因為它可能使研究參與者處于危險之中逸月。（引言栓撞、機構(gòu)審查委員會、知情同意書以及參與者安全和不良事件模塊中討論了研究參與者的安全碗硬、權(quán)利和福利保護）

Audits conducted by the U.S. Food and Drug Administration (FDA) find that several problems commonly occur in research studies.

由美國食品和藥物管理局(FDA)進行的審計發(fā)現(xiàn)瓤湘，在研究中常見的幾個問題。

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.

質(zhì)量數(shù)據(jù)對于確保正確解釋研究結(jié)果至關(guān)重要恩尾。草率或不正確的數(shù)據(jù)可能導致誤導性結(jié)論弛说。對質(zhì)量標準的認真關(guān)注也確保了及時完成研究。及時完成高質(zhì)量的研究翰意，通過更快地為客戶提供有效的新療法木人，彌合研究與實踐之間的差距。

Who is responsible for QA?? ?

All members of the protocol team are responsible for QA.

協(xié)議團隊的所有成員都負責QA冀偶。

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)

雖然將QA和監(jiān)控相關(guān)職責和職能移交給CRO是常見的醒第，但發(fā)起人對實施和維護QA系統(tǒng)負有最終責任。（ICH GCP 5.1.1）該責任包括監(jiān)督所有QA系統(tǒng)以及由其他方（即CRO或CRO的分包商）代表發(fā)起人執(zhí)行或管理的任何試驗相關(guān)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.

研究人員和方案小組的每一位成員都應勤勉进鸠、徹底地履行其職責稠曼，從而確保試驗按照盡可能高的質(zhì)量標準進行。

Click to view Clinical Trial Network（CTN）?related content

點擊查看臨床試用網(wǎng)絡（CTN）相關(guān)內(nèi)容

QA Roles and Responsibilities in the NIDA Clinical Trials Network? ?NIDA臨床試驗網(wǎng)絡中的QA角色和責任

The CTN Policies and Procedures on QA? ?關(guān)于質(zhì)量保證的CTN政策和程序

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).

申辦方有責任確保試驗的完整性客年，并制定基于風險的監(jiān)測計劃霞幅。作為該網(wǎng)絡開展的所有研究的發(fā)起者漠吻，NIDA CTN已將所有監(jiān)測的監(jiān)管責任移交給臨床協(xié)調(diào)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為每項CTN研究制定系統(tǒng)的司恳、優(yōu)先的和基于風險的(ICH GCP E6(R2) 5.18.3)監(jiān)測計劃侥猩。本計劃為每個試驗定制，并描述了監(jiān)測試驗的策略抵赢、方法欺劳、職責和要求(ICH GCP E6(R2) 1.64)。此外铅鲤，該計劃還提供了操作指南划提，以確保根據(jù)CTN協(xié)議收集的數(shù)據(jù)的質(zhì)量和完整性。本文件還確保了跨多個站點和協(xié)議進行CTN研究的一致性邢享。這個監(jiān)測計劃:

Ⅰ鹏往、Emphasizes the monitoring of critical data and processes.

Ⅱ、Ensures the quality and integrity of CTN clinical studies.

Ⅲ骇塘、Ensures the protection of human participants.

Ⅳ伊履、Advances collaboration between treatment and research staff at CTN sites.

1、強調(diào)對關(guān)鍵數(shù)據(jù)和過程的監(jiān)控款违。

2唐瀑、確保CTN臨床研究的質(zhì)量和完整性。

3插爹、確保對人類參與者的保護哄辣。

4、促進CTN現(xiàn)場治療和研究人員之間的合作赠尾。

Roles and responsibilities of the Lead Investigator? ?首席研究員的角色和職責

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特定的研究者角色力穗，對整個研究負全面責任。LI召集了一個方案小組当窗，協(xié)助研究開發(fā)和運作的各個方面寸宵。在CTN以外的其他研究中嘶朱，該角色可能被視為主要研究者。

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:

項目總監(jiān)(或協(xié)議協(xié)調(diào)員)是 LI 的“得力助手”倘零，他或她負責協(xié)調(diào)和進行日常學習活動。項目總監(jiān)是協(xié)議小組的成員袖瞻，是整個研究問題的主要聯(lián)系人聋迎。協(xié)議團隊中代表的其他角色和職責通常包括但不限于以下內(nèi)容：

Ⅰ、Data Management

Ⅱ、Quality Assurance

Ⅲ伟葫、Training

Ⅳ、Regulatory Affairs

1夺姑、數(shù)據(jù)管理

2盏浙、質(zhì)量保證

3竹海、培訓

4斋配、監(jiān)管事務

Roles and Responsibilities of the Node Principal Investigator? ?節(jié)點首席調(diào)查員的角色和職責

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:

節(jié)點PI（或受讓人）是另一個CTN特定角色，負責NIDA在其節(jié)點的研究表現(xiàn)鸠匀。他或她與節(jié)點工作人員、現(xiàn)場首席研究員和首席研究員合作爬范，在該節(jié)點實施研究。節(jié)點PI負責確保研究在其節(jié)點順利進行，并在必要時采取適當措施協(xié)助現(xiàn)場PI和首席研究員蘸炸。節(jié)點PI的其他職責包括：

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峭火、Ensuring that study staff receives appropriate training to conduct the study.

Ⅴ毁习、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、任命現(xiàn)場PI和研究協(xié)調(diào)員卖丸。

2纺且、管理節(jié)點預算和人員。

3稍浆、指定一名監(jiān)督員對節(jié)點內(nèi)的研究地點進行質(zhì)量保證訪問载碌。

4猜嘱、確保研究人員接受適當?shù)呐嘤?/b>進行研究。

5恐仑、確保本研究獲得所有必要的IRB批準并遵守所有適用的法規(guī)泉坐。了解他或她的機構(gòu)/大學的政策，并確保節(jié)點遵守這些政策裳仆。

The Monitoring Plan? ?監(jiān)察計劃

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).

監(jiān)測計劃規(guī)定了監(jiān)測戰(zhàn)略腕让、所有相關(guān)方的監(jiān)測責任、將使用的各種監(jiān)測方法以及使用這些方法的理由歧斟。它還描述了監(jiān)控程序纯丸、訪問類型、訪問過程中涉及的內(nèi)容静袖，以及需要監(jiān)控的各類文件的數(shù)量或百分比觉鼻。這些程序可根據(jù)試驗的目的、設(shè)計队橙、規(guī)模坠陈、復雜度和主要結(jié)果指標在方案基礎(chǔ)上進一步定義（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.

根據(jù)GCP指南，“主辦方可以選擇現(xiàn)場監(jiān)測捐康，現(xiàn)場監(jiān)測和集中(遠程)監(jiān)測相結(jié)合仇矾，或者，在合理的情況下解总，集中監(jiān)測過程提供額外的監(jiān)測能力贮匕，可補充或減少現(xiàn)場監(jiān)測的范圍和/或頻率，并有助于區(qū)分可靠數(shù)據(jù)和可能不可靠的數(shù)據(jù)花枫，而無需核實全部來源數(shù)據(jù)”(ICH GCP 5.18.3)刻盐。所選擇的監(jiān)控策略的基本原理已記錄在監(jiān)控計劃中。

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.

一般來說劳翰，需要進行現(xiàn)場監(jiān)測敦锌，在試驗開始前、進行中佳簸、結(jié)束或終止后供屉，可以在任何給定的研究地點進行遠程監(jiān)測。在許多情況下溺蕉，研究監(jiān)測人員可能會在前一到兩名參與者登記后訪問每個位點，然后根據(jù)多變量標準安排后續(xù)訪問悼做，如登記率疯特、回顧數(shù)據(jù)量漓雅、位點表現(xiàn)和其他考慮。

Study monitors conduct site visits according to the procedures describes in the monitoring plan and in accordance with Good Clinical Practice (GCP) guidelines.

研究監(jiān)測人員根據(jù)監(jiān)測計劃中描述的程序并按照良好臨床實踐(GCP)指南進行現(xiàn)場訪問抱冷。

Part 2: QA and Monitoring Roles? ?質(zhì)量保證和監(jiān)督作用

Monitoring Role for Sponsors? ?贊助者的監(jiān)督作用

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).

《良好臨床實踐指南》規(guī)定崔列，申辦方負責選擇監(jiān)護儀旺遮，并確保符合以下標準（見ICH GCP 5.18.2）赵讯。

Ⅰ、Monitors are appropriately trained and have the scientific or clinical knowledge needed to monitor the trial adequately. Monitors qualifications should be documented.

Ⅱ组底、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娘锁、監(jiān)護人受過適當?shù)?b>培訓饺鹃，具備充分監(jiān)護試驗所需的科學或臨床知識缝驳。監(jiān)控人員的資格應該記錄在案拼弃。

2吻氧、監(jiān)護者完全熟悉試驗藥物祟滴、方案埠偿、書面知情同意書以及向研究參與者提供的有關(guān)試驗的任何其他書面信息冠蒋、申辦方的SOP、GCP和適用的監(jiān)管要求甥温。

Quality Assurance (QA)/Study Monitor Role? ?質(zhì)量保證（QA）/研究監(jiān)測作用

QA/study monitors perform the following study activities:

QA/研究監(jiān)督員執(zhí)行以下研究活動：

Ⅰ加叁、Conduct initiation, interim, and closeout visits.

Ⅱ倦沧、Conduct centralized monitoring, as applicable.

Ⅲ、Provide training on protocol-specific issues and Good Clinical Practice, when needed or appropriate.

Ⅳ它匕、Follow-up on issues identified during earlier monitoring visits.

Ⅴ刀脏、File reports with the sponsor and other applicable parties, as required.

1、開展啟動超凳、臨時和收尾訪問愈污。

2、進行集中監(jiān)控（如適用）轮傍。

3暂雹、在需要或適當?shù)臅r候，提供關(guān)于方案特定問題和良好臨床實踐的培訓创夜。

4杭跪、跟進早期監(jiān)測訪問中發(fā)現(xiàn)的問題。

5驰吓、根據(jù)需要向發(fā)起人和其他適用方提交報告涧尿。

Monitoring responsibilities are described in detail in ICH GCP 5.18.4. Click here for a summary.

ICH GCP 5.18.4中詳細描述了監(jiān)控職責。點擊這里查看摘要檬贰。