Schedule 1

FIRST SCHEDULERegulation 2(1)Principles of good clinical practice

1. Clinical trials must be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with good clinical practice and the requirements of these Regulations.

2. Before a clinical trial is initiated, foreseeable risks and inconveniences must be weighed against the anticipated benefit for the subject and society, and a trial must be initiated and continued only if the anticipated benefits justify the risks.

3. The rights, safety, and wellbeing of the subjects of a clinical trial are the most important considerations and must prevail over interests of science and society.

4. The available non‑clinical and clinical information on an investigational product must be adequate to support the proposed clinical trial.[S 107/2021 wef 01/03/2021]5. A clinical trial must be scientifically sound, and described in a clear and detailed protocol.

6. A clinical trial must be conducted in compliance with a protocol that has been approved by the relevant institutional review board.

7. The medical and dental care given to, and medical and dental decisions made on behalf of, subjects must always be the responsibility of a qualified practitioner with the relevant training and experience.

8. Each individual involved in conducting a clinical trial must be qualified by education, training, and experience to perform the individual’s respective task.

9. Subject to these Regulations, freely given informed consent must be obtained from every subject prior to clinical trial participation.

10. All clinical trial information must 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 must be protected, respecting the privacy and confidentiality rules in accordance with any applicable written law or rule or principle of law.

12. Investigational products must be —