Contents

Part 3: Trial Monitoring Activities

Part 4: Summary of Key Points

Part 3: Trial Monitoring Activities   试验监察活动

BEFORE   之前

Site Initiation   场地启动

Initiation visits occur before a research site begins participant recruitment for protocol participation and after the necessary IRB approvals are obtained. During a site initiation visit, study monitors review trial documents to ensure that they are complete and in order. A listing of documents to be retained by sites before, during, and after a trial can be found in ICH GCP Section 8. They will also inspect sites to ensure that the facilities are appropriate, that the work and storage space necessary to conduct the trial are available, and that equipment, medication, and supplies needed to start the trial are available. They ensure that adequate staff is available and properly trained.

启动访问发生在研究地点开始招募参与方案的参与者之前，以及获得必要的IRB批准之后。在现场启动访问期间，研究监督员审查试验文件，以确保它们是完整和有序的。在ICH GCP第8节中，可以找到试验前、试验中和试验后应由现场保存的文件清单。他们还将视察场地，以确保设施适当，提供进行试验所需的工作和储存空间，以及提供开始试验所需的设备、药物和用品。他们确保有足够的工作人员并接受适当的培训。

Study monitors will document action items that need to be performed by the site prior to site activation. Research sites cannot begin participant recruitment until the Investigator(s) and sponsor have provided their approval.

研究监督员将记录现场激活前需要现场执行的行动项目。在研究者和赞助者提供批准之前，研究站点不得开始招募参与者。

IN PROGRESS   进行中

Interim/Routine Monitoring Visits   临时/例行监测访问

The requirements for monitoring while a trial is in progress are documented in the Monitoring Plan. In general, monitors perform the following activities while a trial is in progress:

试验进行期间的监测要求记录在监测计划中。通常，在试验过程中，监控者执行以下活动：

Ⅰ、Assess the trial’s progress.

Ⅱ、Verify that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP guidelines, and with applicable regulatory requirements.

Ⅲ、Verify that participant rights and well-being are protected.

Ⅳ、Verify the reported trial data (including source documents) are attributable, legible, contemporaneous, original, accurate, and complete. All data must be verifiable from source documents.

Ⅴ、Verify that the site has the adequate resources to continue the trial.

1、评估试验进展情况。

2、验证试验的进行是否符合当前批准的方案/修正案、GCP指南和适用的监管要求。

3、核实参与者的权利和福利受到保护。

4、验证报告的试验数据（包括原始文件）是否具有可归因性、易读性、同期性、原始性、准确性和完整性。所有数据必须可从源文档中验证。

5、验证现场是否有足够的资源继续试验。

Click here for a list of specific monitoring functions during an interim visit.

单击此处查看临时访问期间特定监控功能的列表。

Click here for a list of documents and activities that monitors may review during an interim site visit.

单击此处可查看监控人员在临时现场访问期间可能审查的文件和活动列表。

COMPLETED   已完成

Closeout   收尾

After the trial is completed, study monitors must conduct a closeout site visit to ensure that:

试验完成后，研究监督员必须进行一次收尾现场考察，以确保：

Ⅰ、Drug accountability records have been finalized.

Ⅱ、Unused medication has been destroyed or returned, or alternatively disposed of as per the study sponsor and regulatory requirements (see 21 CFR 312.59 ).

Ⅲ、All sponsor-provided trial equipment and supplies have been returned to the sponsor and/or supplier.

Ⅳ、All data queries have been resolved.

Ⅴ、All trial documentation are complete and ready for storage, and the sponsor has been notified of their final storage location.

Ⅵ、Notice of trial closure and all required reports are filed with the proper entities (e.g., the sponsor and Institutional Review Boards).

1、药品问责记录已定稿。

2、未使用的药物已被销毁或退回，或根据研究发起人和监管要求（见21 CFR 312.59）进行处理。

3、发起人提供的所有试验设备和用品已退还给发起人和/或供应商。

4、所有数据查询均已解决。

5、所有试验文件均已完成并准备好存放，发起人已被告知其最终存放位置。

6、审判结束通知和所有要求的报告都提交给适当的实体（如发起人和机构审查委员会）。

Interactive: Quality Assurance Strategies   质量保证策略

QA is the responsibility of every member of the research team. The role of monitoring is to support and assist members of the research team in adhering to high quality standards.

QA是研究团队每个成员的责任。监测的作用是支持和协助研究团队成员遵守高质量标准。

Users are instructed as follows:

The following list includes seven strategies, some to assist every team member in assuring quality in clinical trials as well as other strategies that are not helpful. For each strategy listed, choose Yes to indicate that the strategy is helpful for assuring quality or No if it is not. Then, consider the feedback.

下面的列表包括七种策略，其中一些策略帮助每个团队成员确保临床试验的质量，还有一些策略没有帮助。对于列出的每个策略，选择“是”表示该策略有助于确保质量，如果没有，则选择“否”。然后，考虑反馈。

Strategy 1: Thoroughly reviewing the research protocol, operations manual, standard operating procedures (SOPs), training manuals and materials, and other relevant documents before the trial begins.

策略1：在试验开始之前，彻底审查研究方案、操作手册、标准操作程序（SOP）、培训手册和材料以及其他相关文件。

Strategy 2: Choosing to monitor research sites arbitrarily, instead of developing and following a monitoring plan.

策略2：选择任意监控研究地点，而不是制定并遵循监控计划。

Strategy 3: Following all instructions specified in the research protocol, operations manual, and SOPs, and doing so in a timely manner.

策略3：遵循研究方案、操作手册和SOP中规定的所有指示，并及时执行。

Strategy 4: Requesting clarification of any instructions that are confusing or unclear.

策略4：要求澄清任何令人困惑或不清楚的指示。

Strategy 5: Communicating openly with other members of the protocol team.

策略5：与协议团队的其他成员公开沟通。

Strategy 6: Documenting all actions.

策略6：记录所有行动。

Strategy 7: Avoid following Good Clinical Practice guidelines.

策略7：避免遵循良好的临床实践指南。

Feedback 1: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.

反馈1：该策略是否有助于确保临床试验的质量：是或否？正确答案是肯定的。

Feedback 2: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is No.

反馈2：该策略是否有助于确保临床试验的质量：是或否？正确答案是否定的。

Feedback 3: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.

反馈3：该策略是否有助于确保临床试验的质量：是或否？正确答案是肯定的。

Feedback 4: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.

反馈4：该策略是否有助于确保临床试验的质量：是或否？正确答案是肯定的。

Feedback 5: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.

反馈5：该策略是否有助于确保临床试验的质量：是或否？正确答案是肯定的。

Feedback 6: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.

反馈6：该策略是否有助于确保临床试验的质量：是或否？正确答案是肯定的。

Feedback 7: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is No.

反馈7：该策略是否有助于确保临床试验的质量：是或否？正确答案是否定的。

Additionally, sponsor organizations can help to assure quality by:

此外，发起人可以通过以下方式帮助确保质量：

Ⅰ、Providing all research team members with adequate training before the trial begins.

Ⅱ、Monitoring progress early in the trial to assess the quality of screening, recruitment, randomization, and documentation practices (for example, after the first few participants have been randomly assigned to a treatment group). This helps to ensure that any deficiencies are detected early and at the source (i.e., at the site where the research is performed), that inefficiencies and wasteful procedures are eliminated, and that any necessary retraining is performed in a timely fashion. Early monitoring also helps to reduce the likelihood that errors will occur later in the trial, by providing additional information to help troubleshoot for future risk mitigation strategies and risk-based monitoring of the study.

Ⅲ、Increasing the frequency of monitoring when necessary to correct any deficiencies in the conduct of the trial or to provide technical support.

1、在试验开始前，为所有研究团队成员提供充分的培训。

2、在试验早期监测进展，以评估筛选、招募、随机化和记录实践的质量（例如，在前几个参与者被随机分配到治疗组后）。这有助于确保在早期和源头（即在进行研究的现场）发现任何缺陷，消除效率低下和浪费程序，并及时进行任何必要的再培训。早期监测也有助于减少试验后期出现错误的可能性，因为它提供了额外的信息，帮助排除未来风险缓解策略和基于风险的研究监测的故障。

3、必要时增加监测频率，以纠正试验过程中的任何缺陷或提供技术支持。

Part 4: Summary of Key Points

Ⅰ、Quality Assurance (QA) consists of planned, systematic activities conducted to ensure that a trial is performed―and that trial data are generated, documented, and reported―in compliance with the protocol and with Good Clinical Practice (GCP) and all other applicable regulatory requirement(s).

1、质量保证（QA）包括有计划的、系统的活动，以确保试验按照方案、良好临床实践（GCP）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。

Ⅱ、QA is the responsibility of every member of the research team. The role of QA staff is to support and assist members of the research team in adhering to high quality standards.

2、质量保证（QA）是研究团队每个成员的责任。QA人员的作用是支持和协助研究团队成员遵守高质量标准。

Ⅲ、The purposes of monitoring are to verify that:

   i、The rights and well-being of human participants are protected.

   ii、Reported trial data are attributable, legible, contemporaneous, original, accurate, and complete.

   iii、The trial is conducted in compliance with the currently approved protocol (including any amendments), as well as with GCP and all other applicable regulatory requirement(s).

3、监测的目的是核实:

（1）人类参与者的权利和福祉得到保护。

（2）报告的试验数据是可归属的、清晰的、同时的、原始的、准确的和完整的。

（3）试验按照当前批准的方案（包括任何修订）以及GCP和所有其他适用的监管要求进行。

Ⅳ、Monitoring can occur on-site and/or remotely (via centralized monitoring), and it is required before, during, and after completion of a trial.

4、监测可以在现场和/或远程进行（通过集中监测），并且在试验之前、期间和之后都需要进行。