Regulations for Good Clinical Practice Article 77
The monitor(s) should carry out the following activities in accordance with the sponsor’s requirements to ensure that the trial is conducted and documented properly:1.Acting as the main line of communication between the sponsor and the investigator.2.Verifying that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.3.Verifying trial staff and the facilities, including laboratories, equipment, are adequate, safely and properly to conduct the trial and remain adequate throughout the trial period.4.Verifying, for the investigational product(s):(1)That storage times and conditions are complies with the requirement(s), and that supplies are sufficient throughout the trial.(2)That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the protocol specified dose(s).(3)That subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product(s).(4)That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and documented adequately.(5)That the disposition of unused investigational product(s) at the trial sites complies with applicable regulatory requirement(s) and is in accordance with the sponsor.5.Verifying that the investigator follows the approved protocol and amendment(s).6.Verifying that informed consent was obtained before each subject's participation in the trial.7.Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly.8.Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial details.9.Verifying that the investigator and the investigator's trial staff are performing the specified trial functions, in accordance with the protocol and any other written agreement between the sponsor and the investigator and the institution, and have not delegated these functions to unauthorized individuals.10.Verifying that the investigator is enrolling only eligible subjects.11.Reporting the subject recruitment rate.12.Verifying that source data, documents and other trial records are accurate, complete, and maintained.13.Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial.14.Checking the accuracy and completeness of the CRF entries, source documents, files and other trial-related records against each other. The monitor specifically should verify that:(1)The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.(2)Any dose or therapy modifications are well documented for each of the trial subjects.(3)Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the protocol on the CRFs.(4)Visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs.(5)All dropout subjects from the trial are reported and explained on the CRFs.15.Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained, and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented and filed.16.Checking all adverse events (AEs) are appropriately reported within the time periods required by Article 106.17.Determining whether the investigator is maintaining the essential documents of the trial.18.Communicating deviations from the protocol, SOPs, this Regulations, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.
中文原文 藥品優良臨床試驗作業準則第77條
監測者應依試驗委託者之要求，進行下列措施，以確保試驗正確執行及紀錄：
一、監測者應擔任試驗委託者及試驗主持人間之主要溝通聯繫者。
二、監測者應確認試驗主持人有適當之資格與資源，並且在試驗過程中仍維持其適當性。
三、監測者應確認試驗相關人員及實驗室、儀器等試驗相關設備，可適當、安全及正確地執行試驗，並且在試驗過程仍維持其適當性。
四、監測者應確認試驗藥品符合下列規定：
（一）符合儲藏時間與條件之要求，且試驗過程中有充分試驗藥品之供給。
（二）試驗藥品僅提供於符合資格之受試者，且其使用劑量符合試驗計畫書之規定。
（三）提供受試者正確使用、處理、儲藏及歸還試驗藥品之必要說明。
（四）試驗場所試驗藥品之接收、使用及歸還，應有管制且有適當紀錄。
（五）試驗場所未使用試驗藥品之處理，應符合相關法規之規定且符合試驗委託者授權之步驟。
五、確認試驗主持人遵守經審查核准之試驗計畫書及其修正書。
六、確認受試者於參與試驗前皆已簽署受試者同意書。
七、確認試驗主持人收到最新版主持人手冊，及正確執行試驗所需之試驗資料與試驗材料。
八、確認試驗主持人與試驗相關人員已被充分告知試驗計畫之各項細節。
九、確認試驗主持人與試驗相關人員依照試驗計畫書及試驗委託者與試驗主持人及試驗機構間之書面協議，執行其被指定之職務，且未將職務指派未授權人員。
十、確認試驗主持人僅收納符合資格之受試者。
十一、報告受試者之收納速度。
十二、確認正確、完整保存原始數據、檔案與其他試驗紀錄。
十三、確認試驗主持人提供所有必要之報告、通報資料、申請書與送審資料，且以上文件皆為正確、完整、即時、字跡清晰、載明日期並可認證此試驗。
十四、核對個案報告表之登錄、原始資料、檔案與其他試驗相關紀錄之正確性與完整性。
監測者應確認以下事項：
（一）試驗計畫書所需之數據已正確登錄於個案報告表，且與原始資料一致。
（二）每位受試者有任何治療劑量或治療方式之變更者，應適當地記錄。
（三）不良事件、併用藥品與併發症，均依照試驗計畫書登錄於個案報告表。
（四）受試者未回診、未做之檢驗與檢查，均已清楚登錄於個案報告表。
（五）所有退出試驗之受試者已登錄於個案報告表，並載明其原因。
十五、通知試驗主持人個案報告表登錄上之錯誤、遺漏或不清楚處，並確定試驗主持人已為更正、新增或刪除，且在更改處註明日期、說明原因及簽名，或由經授權之試驗相關人員代試驗主持人簽名。
簽署授權名單應建檔。
十六、核對是否所有不良事件均已依第一百零六條之規定通報。
十七、確認試驗主持人保存試驗之必要資料。
十八、與試驗主持人溝通不符合試驗計畫書、標準作業程序、本準則與相關法規規定之處，並採取適當措施避免其再發生。
一、監測者應擔任試驗委託者及試驗主持人間之主要溝通聯繫者。
二、監測者應確認試驗主持人有適當之資格與資源，並且在試驗過程中仍維持其適當性。
三、監測者應確認試驗相關人員及實驗室、儀器等試驗相關設備，可適當、安全及正確地執行試驗，並且在試驗過程仍維持其適當性。
四、監測者應確認試驗藥品符合下列規定：
（一）符合儲藏時間與條件之要求，且試驗過程中有充分試驗藥品之供給。
（二）試驗藥品僅提供於符合資格之受試者，且其使用劑量符合試驗計畫書之規定。
（三）提供受試者正確使用、處理、儲藏及歸還試驗藥品之必要說明。
（四）試驗場所試驗藥品之接收、使用及歸還，應有管制且有適當紀錄。
（五）試驗場所未使用試驗藥品之處理，應符合相關法規之規定且符合試驗委託者授權之步驟。
五、確認試驗主持人遵守經審查核准之試驗計畫書及其修正書。
六、確認受試者於參與試驗前皆已簽署受試者同意書。
七、確認試驗主持人收到最新版主持人手冊，及正確執行試驗所需之試驗資料與試驗材料。
八、確認試驗主持人與試驗相關人員已被充分告知試驗計畫之各項細節。
九、確認試驗主持人與試驗相關人員依照試驗計畫書及試驗委託者與試驗主持人及試驗機構間之書面協議，執行其被指定之職務，且未將職務指派未授權人員。
十、確認試驗主持人僅收納符合資格之受試者。
十一、報告受試者之收納速度。
十二、確認正確、完整保存原始數據、檔案與其他試驗紀錄。
十三、確認試驗主持人提供所有必要之報告、通報資料、申請書與送審資料，且以上文件皆為正確、完整、即時、字跡清晰、載明日期並可認證此試驗。
十四、核對個案報告表之登錄、原始資料、檔案與其他試驗相關紀錄之正確性與完整性。
監測者應確認以下事項：
（一）試驗計畫書所需之數據已正確登錄於個案報告表，且與原始資料一致。
（二）每位受試者有任何治療劑量或治療方式之變更者，應適當地記錄。
（三）不良事件、併用藥品與併發症，均依照試驗計畫書登錄於個案報告表。
（四）受試者未回診、未做之檢驗與檢查，均已清楚登錄於個案報告表。
（五）所有退出試驗之受試者已登錄於個案報告表，並載明其原因。
十五、通知試驗主持人個案報告表登錄上之錯誤、遺漏或不清楚處，並確定試驗主持人已為更正、新增或刪除，且在更改處註明日期、說明原因及簽名，或由經授權之試驗相關人員代試驗主持人簽名。
簽署授權名單應建檔。
十六、核對是否所有不良事件均已依第一百零六條之規定通報。
十七、確認試驗主持人保存試驗之必要資料。
十八、與試驗主持人溝通不符合試驗計畫書、標準作業程序、本準則與相關法規規定之處，並採取適當措施避免其再發生。