The first principle is that clinical trials should be conducted in accordance with the ethical principles derived from the Declaration of Helsinki, as well as with clinical trial quality management practices and local regulations.
The second principle is that, before conducting a clinical trial, foreseeable risks and inconveniences should be weighed against the potential benefits to subjects and society. Clinical trials should be initiated and continued only when the foreseeable benefits outweigh the risks.
The third principle is that the rights, safety and health of the subjects will be the primary consideration, and that they should take precedence over the interests of society and science.
Fourth principle: The available preclinical and clinical information on the drug to be tested must be sufficient to support the proposed clinical trial.
Fifth principle: Clinical trials must be scientifically sound and clearly described in the trial protocol. The requirements for trial protocols are also stated in the ICH GCP guidelines.
The sixth principle: Clinical trials must be conducted in accordance with a protocol that has been approved or supported by an institutional review board or independent ethics committee. This means that a clinical trial cannot be initiated until it has been approved by an ethics committee.
The seventh principle is that it is always the responsibility of the qualified physician or dentist to provide medical care and make medical decisions for the subject. This means that no matter who the principal investigator is, it must be a qualified physician who provides medical care to the subject.
The eighth principle: Every person involved in a clinical trial should have certain qualifications, such as relevant education, training, and previous work experience. It is usually the sponsor's responsibility to determine that all participants in a clinical trial have been qualified through education, training, and experience, and this is often accomplished prior to the trial through site visits, meeting and interviewing investigators, and by reviewing the investigator's curriculum vitae (CV).
The ninth principle: voluntary informed consent should be obtained from each subject prior to participation in a clinical trial. This is very important, and informed consent must be obtained from subjects given voluntarily before the clinical trial begins, or they cannot be screened or enrolled.
The tenth principle: All clinical trial information should be recorded, disposed of, and stored in such a way that it can be accurately reported, interpreted, and verified.
The eleventh principle: Records that identify subjects should be kept confidential.
The twelfth principle: The preparation, handling and storage of medicinal products for use in clinical trials should be consistent with applicable Good Manufacturing Practices (GMPs), which predate GCPs and for which many countries around the world have established GMP standards for the preparation and handling of medicinal products for use in trials. The use of drugs in clinical trials should be consistent with the approved trial protocol. Within the trial protocol, there is a section dedicated to providing detailed guidance on the disposal and preservation of trial medicinal products.
Principle 13: Systems and procedures to ensure quality in all aspects of the clinical trial should be implemented, which is usually the responsibility of the sponsor.
2. Introduction
The purpose of the ICH-GCP Guidelines is to provide harmonized standards for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by these regulatory authorities within their competence.
The Good Clinical Practice (GCP) is the international ethical and scientific quality standard for the design, conduct, documentation, and reporting of trials designed for the participation of human subjects. Adherence to this standard provides public assurance of the protection of the rights, safety, and health of subjects, of consistency with the principles derived from the Declaration of Helsinki, and of the credibility of clinical trial data.