1. The Ethics Committee Secretary receives application documents submitted by sponsors, including the ethical review application form, clinical trial protocol, case report forms, subject informed consent forms, and clinical trial approval documents issued by the National Medical Products Administration.

2. The Secretary conducts formal examination of the submitted materials, determines the review type, reports to the Director of the Ethics Committee Office to assign primary reviewers, and submits the materials to the Chairman of the Ethics Committee.

3. The Ethics Committee holds one routine review meeting every month. Additional meetings may be convened as needed. Emergency meetings shall be organized to conduct urgent ethical review and decision-making in the event of serious adverse reactions or other critical situations occurring during the trial.

4. The Secretary arranges the meeting agenda and verifies the statutory quorum. A valid meeting requires attendance of more than half of all committee members, with a minimum of 11 members present. Attendees shall include medical and pharmaceutical professionals, non-medical professionals, legal experts, external independent members, and members of different genders.

5. The Secretary distributes all pending review materials to each committee member in advance to ensure sufficient time for protocol review.

6. The Chairman presides over the ethics review meeting. The principal investigator may attend the meeting to present the trial protocol and respond to inquiries. The Secretary records and summarizes discussions and review decisions to form meeting minutes, which will be submitted for confirmation at the next ethics meeting. The Secretary is responsible for on-site coordination and full meeting documentation.

7. Review decisions are made by voting. A valid decision requires approval by more than half of all committee members. Any member involved in the corresponding clinical trial shall recuse themselves from voting and discussion.

8. The Secretary drafts the ethical review opinion and official approval document according to the meeting resolution. The review conclusions include the following categories:

(1) Approved;

(2) Approved with revisions;

(3) Resubmission required after revision;

(4) Disapproved;

(5) Suspension or termination of the approved clinical trial.

9. The official approval document shall take effect after being affixed with the official seal of the Ethics Committee.

10. The Secretary delivers the ethical review opinion and signed approval document, verified by the Committee Chairman, to the sponsor in a timely manner.

11. All ethical review records shall be retained for 5 years after the completion of the clinical trial.