If the trial is suspended or terminated, the investigator and the institution shall promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects.
Under the circumstances referred to in the preceding paragraph, the investigator and the institution shall inform the Competent Authority of the reasons for suspension or termination of the trial in writing.

If the investigator suspended or terminated a trial without prior agreement of the sponsor, the investigator and the institution shall promptly inform the sponsor and the Ethics Committee, and provide detailed written reports.

If the sponsor suspended or terminated a trial, the sponsor shall promptly inform the investigators, the institutions, the Ethics Committee, and the Competent Authority and the reason(s) for the termination or suspension, and provide detailed written reports.

If the Ethics Committee terminated or suspended a trial, the investigator and the institution shall promptly inform the sponsor, and provide the detailed written reports.

If the investigator or the institution seriously or repeatedly violates the protocol, the sponsor should stop the investigator or the institution from conducting the trial and promptly notify the Competent Authority.