Submission Guidelines

1. Principal Investigator Qualifications

1. Project Principal Investigator and Co‑Investigator Information

   • Cases within the scope of human trials as defined by the Medical Law (new drugs, new medical technologies, and new medical devices): must have specialist physician qualifications at our institution (National Military Kaohsiung General Hospital, Pingtung Branch, and Outpatient Center).

   • Nursing research cases: require a chief nurse, lecturer, or qualifications of master’s degree or higher at our institution.

   • Other cases (questionnaires, etc.): must have independent operational capability and qualifications of master’s degree or lecturer level at our institution; other public or private medical institutions must also have independent operational capability and qualifications of master’s degree or lecturer level.

2. Project PI and Co‑PI GCP or medical ethics related course certification:

   • Physicians, dentists, or traditional Chinese medicine doctors who hold a practicing license and have been engaged in clinical practice for more than five years.

   • Within the past six years, received at least 30 hours of training related to human trials; for investigators of somatic cell or gene therapy human trials, an additional more than five hours of relevant training.

   • Within the past six years, completed at least nine hours of medical ethics related courses.

   • Those who have been subject to disciplinary action as a physician, or who have been suspended for more than one month or had their medical license revoked due to violations of human trial regulations, are not eligible to serve as principal investigators.

3. Qualifications for principal investigators of other projects not involving human trials.

   • Within the past three years, must not have been a trial principal investigator who committed major or repeated GCP violations.

   • Must attend at least 9 hours of medical ethics related courses every three years.

   • Must participate in IRB (including GCP) related courses for at least 9 hours every three years.

2. Scope of Application

• Cases within the scope of human trials as defined by the Medical Law must be submitted to the Human Trial Review Committee for review and may be implemented only after approval by our institution and the Ministry of Health and Welfare. Definitions are as follows:

1. Human trials refer to experimental research conducted by medical institutions on humans, based on medical theory, involving new medical technologies, drugs, or medical devices.

2. New medical technologies are defined as:
   a. Medical technologies that have undergone laboratory or animal research domestically or abroad, have substantial published literature, and are eligible for human testing.
   b. Medical technologies that are still in the human trial phase in major foreign countries.
   c. Medical technologies announced by the Central Health Authority as requiring human trials.

3. New drugs and medical devices refer to the following drug components or medical devices that have not been approved for inspection and registration by the Central Health Authority:
   a. Drug components or medical devices that have undergone laboratory and animal research domestically or abroad, have substantial published literature, and are eligible for human testing.
   b. Drug components or medical devices that are still in the human trial phase in major foreign countries.
   c. Components that have been approved for market in the country of manufacture, but whose safety and efficacy have not been recognized by our regulatory authority and therefore still require human trials.

4. For drugs or medical devices approved for human use in the country of manufacture but whose medical efficacy or safety has not been verified, the Central Health Authority may require human trials before granting inspection and registration approval.

• For cases not falling within the above-defined human trial scope of the Medical Law, if any of the following situations apply, the principal investigator may also apply to the Human Trial Review Committee:

1. Intending to publish in foreign journals.

2. When the National Health Research Institutes, National Science Council, Ministry of Health and Welfare, etc., require issuance of a human trial consent certificate.

3. If a drug component or medical device that has been approved for inspection and registration by the Ministry of Health and Welfare is for a new indication or new usage pathway, it must still undergo review by the Human Trial Review Committee.

4. For nursing research cases, please contact the Nursing Department Research Development Committee; if necessary, forward to this committee.

3. Points to Note When Drafting the Informed Consent Form

1. The committee’s consent form may use a self‑designed format or the hospital’s standard consent form format (refer to the participant consent form). The self‑designed format must have “National Military Kaohsiung General Hospital” in the header. The content should be written at a junior high school level, avoiding excessive technical terminology (refer to the participant consent form drafting guidelines).

2. When submitting for review, the first page of the participant consent form must be signed by the project principal investigator.

3. Compensation for damages section: please draft according to the consent form template provided by this committee, and you may also refer to the Ministry of Health and Welfare’s announced “Clinical Trial Participant Informed Consent Form Sample.”

4. Points to Note for Participant Recruitment

Please refer to the Ministry of Health and Welfare’s announcement No. 0960317637 dated June 6, 2007. The “Clinical Trial Participant Recruitment Principles” can be downloaded from this committee’s “Domestic Regulations” section for reference.

5. Points to Note for Follow‑up Review

Our IRB approval letters are issued for one year only. Within the two months prior to expiration, please submit the interim report form, participant list, a copy of the participant consent form (required for the first participant), and SAE-related documents for review; after approval, the approval will be extended for another year. Upon project completion, submit the final report form and final analysis data (for cases approved by the Ministry of Health and Welfare, submit the DOH version), SAE-related data, and participant list to the IRB for filing, and, if necessary, to the Ministry of Health and Welfare for filing. If the principal investigator terminates or stops the trial early, they must inform this committee of the reasons for termination or suspension, and also provide a summary of the trial results completed before early termination for the committee’s records.

6. Adverse Event Reporting

If adverse side effects or other changes occur during the implementation of the project, they must be reported according to the Ministry of Health and Welfare’s schedule and notified to this committee. Any matters affecting the rights of trial participants should also be reported to this committee, the participants, or the Ministry of Health and Welfare. Upon request by this committee or the Ministry of Health and Welfare, the informed consent acquisition process may be monitored during the project, or other related incident reports may be submitted at any time. If any of the above matters pose a safety risk, the project should be immediately suspended or terminated. The reasons for suspension or termination and the trial results must be reported. The specific procedures and reporting methods may be further defined by the secretariat.

7. Research Adverse Event Reporting

When the principal investigator, Data and Safety Monitoring Committee (DSMB), trial sponsor, on‑site monitor, committee members, or other relevant parties report a death or life‑threatening SAE, it must be reported to the National Adverse Drug Reaction Reporting Center and this committee’s secretariat within seven calendar days, and the reporting information must be completed within the subsequent eight calendar days. Other SAEs must be reported to the National Adverse Drug Reaction Reporting Center within fifteen calendar days, and the SAE case must be reported to this committee’s secretariat by fax or written correspondence.

8. Others

These regulations are implemented after approval by the Human Trial Committee and after being reported to the hospital administration for filing. If any matters are not covered and revisions are needed, the same procedure applies. Additional submission guidelines may be established by the secretariat as needed for coordination and promotion.