The sponsor shall take into account the risk over subjects’ protection and data integrity when establishing a monitoring plan, in order to ensure that the trial is conducted under appropriate monitoring.
The sponsor may choose on-site monitoring, system remote monitoring, or both.
Where the system remote monitoring referred to in the preceding paragraph is adopted, the same shall be implemented only upon a reasonable assessment to verify the adequacy thereof.
The contents of the plan referred to in Paragraph 1 cover the monitoring strategies, the monitoring responsibilities, the monitoring methods and reasons for adoption of the plan, as well as key data and processes to be monitored.

The purposes of trial monitoring are to verify that:
1.The rights and well-being of human subjects are protected.
2.The reported trial data are accurate, complete, and verifiable from source documents.
3.The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with this Regulations, and with the applicable regulatory requirement(s).

Selection and qualifications of monitors should comply with:
1.Monitors should be appointed by the sponsor.
2.Monitors should be appropriately trained, and should have the scientific and clinical knowledge needed to monitor the trial adequately.
3.A monitor’s qualifications should be documented.
4.Monitors should be thoroughly familiar with the investigational product(s), the protocol, informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, this Regulations, and the applicable regulatory requirement(s).

The sponsor should determine the appropriate scope and nature of monitoring. The determination of the scope and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, scale, and endpoints of the trial.
On-site monitoring should be conducted before, during, and after the trial. However, the sponsor may increase some monitoring procedures such as investigators’ training or meetings.
Statistically controlled sampling can be an acceptable method for monitor(s) to select the data to be verified.

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.

The monitor(s) should follow the sponsor’s established written SOPs as well as those procedures that are specified by the sponsor for monitoring a specific trial.

The monitoring report should comply with the following requirements:
1.The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.
2.Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted.
3.Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and actions recommended to secure compliance.
4.The sponsor should designate representatives to record, review and follow-up of the monitoring report.