PART 2
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation Good Clinical Practice Guideline
1. Clinical trials shall be conducted in accordance with the ethical principles that are consistent with good clinical practice and the requirements of this Act.
2. Before the clinical trial is started, foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial should be started and continued only if the anticipated benefits justify the risks.
3. The rights, safety, and well-being of the subjects are the most important considerations and prevails over interests of science and society.
4. The available non-clinical and clinical information on an investigational medicinal product or investigational medical device must be adequate to support the clinical trial.
5. Clinical trials must be scientifically sound, and described in a clear, detailed protocol.
6. A clinical trial shall be conducted in compliance with the protocol that has a favourable opinion from the Ethics Committee.
7. The medical care given to, and medical decisions made on behalf of, subjects shall always be the responsibility of an appropriately qualified health practitioner.
8. Each individual involved in conducting a clinical trial shall be qualified by education, training, and experience to perform his or her respective task.
9. Subject to the other provisions of this Schedule relating to consent, freely given informed consent shall be obtained from every subject prior to clinical trial participation.
10. All clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
11. The confidentiality of records that could identify subjects shall be protected, respecting the privacy and confidentiality rules in accordance with the requirements of any law relating to data protection or confidentiality.
12. Investigational medicinal products or investigational medical devices used in the clinical trial must be —
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(a) manufactured or imported, and handled and stored, in accordance with the principles and guidelines of good manufacturing practice; and
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(b) used in accordance with the approved protocol.
13. Systems with procedures that assure the quality of every aspect of the clinical trial must be implemented.
14. A clinical trial shall be started only if the Ethics Committee and the National Competent Authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored.
15. The rights of each subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with any law relating to data protection are safeguarded.
16. Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial.