The sponsor shall develop, implement, and manage the clinical trial(s), ensuring the completeness of the data and the rights, safety, and well-being of the subjects.

The sponsor shall complete the following preclinical studies for investigational medical device. The preclinical data and clinical evaluation results shall be comprehensive and adequate to justify the proposed clinical trial:
1. Product design,
2. Safety and functionality testing,
3. Risk analysis, and
4. Other necessary preclinical studies.

The sponsor shall register the following information of the clinical trial on the webpage designated by the central competent authority within 30 days of obtaining approval referred to Paragraph 1, Article 4:
1. The name of the clinical trial institution,
2. The name of the sponsor,
3. The name of the investigator,
4. The name of the clinical trial,
5. Serial number of the official document certifying the approval of the clinical trial,
6. The date of approval,
7. The purpose of the clinical trial,
8. The inclusion and exclusion criteria,
9. The number of subjects,
10. The name of the investigational medical device,
11. The stages of the clinical trial, and
12. Other items required to be registered.
The sponsor shall update registration information within 30 days of receiving approval for the amendments.
During the clinical trial period, the sponsor shall regularly update the registration information in June and December every year.

The sponsor shall prepare the Investigator’s Brochure, clinical investigation plan, informed consent form, case report forms, relevant standard operating procedure (SOP), and other terms and regulations.

The sponsor shall be held liable for medical care, compensation for damages and losses, and other legal responsibilities in the event of injury, death, or other losses of the clinical trial subjects.
Under any of the following circumstances, the sponsor shall be exempted from the compensation liability for damages and losses specified in the preceding paragraph:
1. The subject consent form has listed the possible adverse reactions, side effects, or risks in the clinical trial.
2. The sponsor can prove that the due care in carrying out a medical procedure has been exercised.
3. The sponsor can prove that such harm is not caused by willful act or negligence.
If the clinical trial is initiated by the investigator, provisions of the preceding two paragraphs shall apply to the clinical trial institution.

Prior to commencement of the clinical trial, the sponsor shall obtain written agreement with the clinical trial institutions and the investigator regarding division of tasks, related expenses, and the principles by which injuries, death, or other losses shall be dealt with if they result from the trial.

The agreement between the sponsor and the contract research organization shall be established in written form. The ultimate responsibility for the quality and integrity of the clinical trial data shall reside with the sponsor.

When planning a multicenter clinical trial, the sponsor shall designate a coordinating investigator from all investigators. The sponsor shall also delegate tasks among the coordinating investigator and other investigators and produce a written record.

The sponsor shall prepare all investigational medical devices and label them as “for clinical trial use only”.
The development and manufacture of the devices specified in the preceding paragraph shall comply with the requirements of the Regulations Governing Medical Device Quality Management System.

Before the IRB and central competent authority approve the clinical investigation plan in accordance with Paragraph 1, Article 4, the sponsor shall not supply clinical trial institutions and investigators with investigational medical devices.

The sponsor shall produce and maintain documents and records regarding the investigational medical device; the documents and records shall include the date of production, product batch number, and conditions of product delivery, reception, storage, installation, recycle, and disposal.

The sponsor shall notify all clinical trial institutions and investigators of following information and take corresponding responses:
1. Information that affects the safety and soundness of the clinical trial and other critical information affecting the subjects’ rights,
2. Device deficiencies that could have led to adverse effects, and
3. Other key information related to the clinical trial.
The sponsor shall amend the clinical investigation plan, the Investigator’s Brochure, the informed consent form, and related regulations, if required, and submit the amendments for IRB’s approval for any of the situations specified in the preceding paragraph.

The sponsor shall perform on-site monitoring visits to verify the following items:
1. Investigation site team, laboratories, equipment and other related facilities are adequate, safely, and properly to conduct the clinical trial.
2. The compliance of the clinical trial institutions and investigators with the approved clinical investigation plan, applicable regulatory requirements, and the present Regulations.
3. Subject recruitment progress and the signed and dated informed consent forms have been obtained from each subject.
4. The accurate and completeness of recording of the following items on the case report form and other trial-related records:
4.1 Cover page/login page, page header or footer/identification number of electronic case report form, items of case report form;
4.2 Trial withdrawals, tests that are not conducted, and examinations or follow ups that are not performed,
4.3 Adverse events or other special reactions and their reporting;
5. The appropriateness of provision, usage, maintenance, delivery, reception, storage, and recycle of the investigational medical device;
6. The regular maintenance and calibration of equipment used in the clinical trial; and
7. Confirmation that the investigators and investigation site team have received the most up-to-date documents related to the clinical trial.
The sponsor may assign external professionals (hereinafter “the monitor”) to perform monitoring activities specified in the preceding paragraph.

The monitor shall submit a written report containing the following information to the sponsor after each site visit:
1. The date and investigation site of the monitoring,
2. The name of the monitor,
3. The name of the investigator,
4. Progress of the clinical trial,
5. Deviations or drawbacks,
6. Evaluation results of the monitoring, and
7. Recommended actions to be secure compliance.

The sponsor shall appoint institutions or staff members who are independent of the clinical trial team and the monitor to conduct audit. The audit shall verify that the clinical trial conduct and compliance with the clinical investigation plan, SOPs, the present Regulations, applicable regulatory requirements, and ethics.

Audit of a clinical trial referred to in the preceding article shall be conducted in accordance with the following provisions:
1. The sponsor shall formulate an audit plan and standard operating regulations in accordance with the importance of the clinical trial, number of subjects, trial type, complexity of the trial, and degree of risk.
2. Comply with the audit plan and standard operating regulations referred to in the preceding paragraph.
3. The auditor’s observations, findings, and conclusions shall be recorded in writing.

The sponsor shall immediately suspend or terminate the clinical trial under any of the following circumstances, and thereafter shall be handled in accordance with Article 64 of the present Regulations:
1. Changing the content of the clinical trial without obtaining approval from the IRB or the central competent authority, as stipulated by applicable regulations;
2. Obvious evidence that the subjects’ rights or safety have been affected;
3. Obvious abnormal frequency or irregular degree of severity of adverse effects;
4. Events that may affect evaluation of the clinical trial results; and
5. Specific facts exists before the completion of the clinical trial proving that the clinical trial has no substantial benefits, higher risks than potential benefits, or substantial benefits that are disadvantageous to the control group.

The sponsor shall maintain all relevant documents of the clinical trial, including all versions of the documents. The preservation period shall be either 3 years after the completion of the clinical trial, or 3 years after the approval of the marketing application of the investigational medical device in accordance with this Act. Whichever date is later shall prevail.

If the clinical trial uses an electronic data processing system, the followings shall be performed:
1. Set the requirements for the system specifications;
2. Ensure that the system complies with the requirements specified per the previous subsection;
3. Ensure the accuracy, completeness, reliability and consistency of inputted data;
4. Ensure the correctness of the reports outputted;
5. Ensure that all data changes are documented, the raw data and previous data revisions cannot be deleted, and that audit trail, data trail, and edit trail are maintained;
6. Maintain the protection system to prevent unauthorized parties from accessing the data;
7. Maintain a list of individuals authorized who have access to the system as well as records regarding their permissions and period of usage;
8. Ensure that the case report form are signed by the investigator or authorized designee;
9. Regularly backup system information; and
10. Train system users regarding proper use of the system.

For clinical trials initiated by an investigator, the Regulations regarding the sponsor should be applicable to the investigator.