GCP is consistent with the principles of Helsinki Declaration, which not only protects the rights and interests, safety and health of the subjects, but also ensures the accuracy, authenticity and credibility of the test data.
Gcp certificate generally refers to the certificate issued by SFDA (State Food and Drug Administration) training institution, which can generally pass 800 yuan/times and online exams.
rule
Chapter one? general rule
Rule number one In order to ensure that the clinical trial process of drugs is standardized, the results are scientific and reliable, the rights and interests of subjects are protected, and their safety is guaranteed, this specification is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and with reference to internationally recognized principles.
Article 2 The management norms of drug clinical trials are the normative provisions on the whole process of clinical trials, including scheme design, organization, implementation, supervision, inspection, recording, analysis, summary and report.
Rule three. Clinical trials of all drugs, including human bioavailability or bioequivalence tests, must be conducted in accordance with this specification.
Article 4? All people-oriented research must conform to the ethical principles of the Helsinki Declaration and the International Ethical Guidelines on Biomedical Research of People issued by the Committee of International Organization of Medical Sciences, namely, fairness, respect for personality, efforts to maximize the benefits of subjects and avoid harm as much as possible.
Refer to the above contents: Baidu Encyclopedia-Quality Management Standards for Drug Clinical Trials