Part 4: Summary of Key Points
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.
啟動訪問發生在研究地點開始 招募參與方案的參與者之前 ，以及 獲得必要的IRB批準之後 。在現場啟動訪問期間，研究監督員 審查試驗文件 ，以確保它們是完整和有序的。在ICH GCP第8節中，可以找到試驗前、試驗中和試驗後應由現場保存的 文件清單 。他們還將 視察場地 ，以確保 設施 適當，提供進行試驗所需的工作和儲存 空間 ，以及提供開始試驗所需的 設備 、 藥物 和 用品 。他們確保有足夠的工作人員並接受適當的 培訓 。
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.
研究監督員將記錄現場激活前需要現場執行的行動項目 。在研究者和贊助者提供批準之前，研究站點不得開始招募參與者。
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:
試驗進行期間的監測要求記錄在 監測計劃 中。通常，在試驗過程中，監控者執行以下活動：
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、 評估試驗進展情況 。
2、 驗證試驗的進行是否符合當前批準 的 方案/修正案 、 GCP指南 和 適用的監管要求 。
3、核實 參與者的權利 和 福利受到保護 。
4、 驗證報告的試驗數據 （包括原始文件）是否具有 可歸因性 、 易讀性 、 同期性 、 原始性 、 準確性 和 完整性 。所有數據必須可從源文檔中驗證。
5、 驗證現場是否有足夠的資源繼續試 驗。
Click here for a list of specific monitoring functions during an interim visit.
單擊此處查看 臨時訪問期間特定監控功能 的列表。
Click here for a list of documents and activities that monitors may review during an interim site visit.
單擊此處可查看監控人員在 臨時現場訪問期間可能審查的文件 和活動列表。
After the trial is completed, study monitors must conduct a closeout site visit to ensure that:
試驗完成後，研究監督員必須進行壹次 收尾現場考察 ，以確保：
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、 藥品問責記錄 已定稿。
2、 未使用的藥物 已被銷毀或退回，或根據研究發起人和監管要求（見21 CFR 312.59）進行處理。
3、發起人提供的 所有試驗設備和用品 已退還給發起人和/或供應商。
4、所有 數據查詢 均已解決。
5、所有 試驗文件 均已完成並準備好存放，發起人已被告知其最終存放位置。
6、 審判結束通知和所有要求的報告 都提交給適當的實體（如發起人和機構審查委員會）。
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是研究團隊每個成員的責任。 監測的作用是支持和協助研究團隊成員遵守高質量標準 。
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.
下面的列表包括七種策略，其中壹些策略幫助每個團隊成員確保臨床試驗的質量，還有壹些策略沒有幫助。對於列出的每個策略，選擇“是”表示該策略有助於確保質量，如果沒有，則選擇“否”。然後，考慮反饋。
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 ：在試驗開始之前，徹底審查 研究方案 、 操作手冊 、 標準操作程序（SOP） 、 培訓手冊 和 材料 以及 其他相關文件 。
Strategy 2:? Choosing to monitor research sites arbitrarily, instead of developing and following a monitoring plan.
策略2 ：選擇任意監控研究地點，而不是制定並遵循監控計劃。
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 、 操作手冊 和 SOP中規定的所有指示 ，並及時執行。
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 ：與協議團隊的其他成員公開溝通。
Strategy 6 : Documenting all actions.
策略6 ：記錄所有行動。
Strategy 7 : Avoid following Good Clinical Practice guidelines.
策略7 ：避免遵循良好的臨床實踐指南。
Feedback 1: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.
反饋1 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是肯定的。
Feedback 2: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is No.
反饋2 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是否定的。
Feedback 3: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.
反饋3 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是肯定的。
Feedback 4: Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.
反饋4 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是肯定的。
Feedback 5 : Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.
反饋5 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是肯定的。
Feedback 6 : Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is Yes.
反饋6 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是肯定的。
Feedback 7 : Is this strategy helpful for assuring quality in clinical trials: Yes or No? The correct answer is No.
反饋7 ：該策略是否有助於確保臨床試驗的質量：是或否？正確答案是否定的。
Additionally, sponsor organizations can help to assure quality by:
此外，發起人可以通過以下方式幫助確保質量：
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、在試驗開始前，為所有研究團隊成員提供充分的 培訓 。
2、在 試驗早期監測進展 ， 以評估篩選、招募、隨機化和記錄實踐的質量 （例如，在前幾個參與者被隨機分配到治療組後）。這有助於確保在早期和源頭（即在進行研究的現場） 發現任何缺陷，消除效率低下和浪費程序，並及時進行任何必要的再培訓 。早期監測也有助於 減少試驗後期出現錯誤的可能性 ，因為它提供了額外的信息， 幫助排除未來風險緩解策略和基於風險的研究監測的故障 。
3、必要時 增加監測頻率 ，以糾正試驗過程中的任何缺陷或提供技術支持。
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、質量保證（QA）包括有計劃的、系統的活動，以確保 試驗按照方案 、 良好臨床實踐（GCP ）和 所有其他適用的監管要求進行 ， 並生成、記錄和報告試驗數據 。
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、質量保證（QA）是研究團隊每個成員的責任。QA人員的作用是 支持和協助研究團隊成員遵守高質量標準 。
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、監測的目的是核實:
（1） 人類參與者的權利和福祉 得到保護。
（2）報告的 試驗數據 是可歸屬的、清晰的、同時的、原始的、準確的和完整的。
（3） 試驗按照當前批準 的方案（包括任何修訂）以及GCP和所有其他適用的 監管要求進行 。
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、監測可以在 現場 和/或 遠程進行 （通過集中監測），並且在試驗之前、期間和之後都需要進行。