Before conducting the clinical trial, the clinical trial institution shall evaluate the characteristics of the investigational medical device as well as the human resources, space, facilities, and equipment of the clinical trial institution for the proper conduct of the clinical trial and produce an evaluation report based on this information.

Prior to conduct the clinical trial, the clinical trial institution shall be reviewed and approved by the IRB of the clinical trial institution of interest, the IRB of another institution, or any other IRB agreed upon by all interested parties.

An investigator shall possess the following qualifications:
1. Being a licensed physician with 5 or more years of experience in clinical treatment. However, according to Paragraph 1, Article 37 of this Act, clinical trials that do not involve significant risks may be conducted by professional medical personnel who hold a medicine-related professional certificate of the specialist category issued by the Competent Authority and have engaged in related practice for 5 years or more.
2. Having received 30 hours of clinical trials related training within the past 6 years, including at least 9 hours of related training courses each for clinical trial of medical devices, and medical ethics.
3. Possessing necessary ability to operate the investigational medical device and related certificates;
Individuals who have been subject to medical personnel disciplinary action, or whose license have been suspended for more than 1 month or abolished due to any violation of laws and regulations related to clinical trials shall not serve as an investigator specified in the previous paragraph.

The investigator shall strictly conduct the clinical trial in compliance with the clinical investigation plan, except in cases of emergency where necessary measures must be taken.
Such proviso demands that the investigator state his or her reason within 7 days of completing the treatment and report the event to the IRB and the sponsor for review.

Clinical trial data shall be accurately, completely, and immediately recorded on the case report form. When revisions are made, the content of the revision and the name of the reviser shall be documented, and information regarding the original content shall be retained. The investigator shall sign the case report form and ensure the data correctness.

The clinical trial institution and the investigator shall maintain clinical trial related records, documents, and information for at least 3 years after the completion of the clinical trial. However, in cases where other laws and regulations stipulate a preservation period longer than 3 years, record preservation shall accord with the longer preservation period.

The clinical trial institution and investigator shall appropriately maintain the investigational medical device and ensure that it is only used in the approved clinical trial.

The investigator or his/her authorized designee shall fully inform the subjects of all pertinent aspects of the clinical trial, the contents of the informed consent form, or any known or potential adverse effects. The investigator, or his/her authorized designee, shall ensure the information was well understood, signed and dated by the subject.

The investigator shall record every adverse event or any investigational medical device deficiency.

The clinical trial institution and investigator shall provide adequate medical care to a subject during and after a subject’s participation in a clinical trial in the case of adverse events.

If the clinical trial institution or the investigator discovers that the risks to the subject outweighing the expected benefits, or identifies any factors that may affect the appropriateness of the clinical trial, they shall immediately suspend or terminate the clinical trial and report to the IRB and the sponsor.

The central competent authority may inspect the clinical trial institution and the investigator and demand clinical trial-related information.
The clinical trial institution and the investigator shall not obstruct, evade, or refuse the aforementioned inspection or demands.