The risk points in the implementation of clinical trials do include the violation of the ethical principles of GCP (Good Quality Management Practice for Drug Clinical Trials). GCP is the basic norm and guiding principle of clinical trials, which stipulates the ethical norms and operating norms of clinical trials to ensure the rights and safety of subjects.
Violation of the ethical principles of GCP during clinical trials may lead to the following risks:
1. Impaired rights and interests of subjects: Clinical trials must follow ethical principles, including respecting the subjects' rights to informed consent, privacy and safety. If these principles are violated, the rights and interests of the subjects may be damaged.
2. Inaccurate test results: GCP requires that clinical trials must be conducted in strict scientific procedures, including trial design, data collection and data analysis. If these principles are violated, the test results may be inaccurate, thus affecting the reliability of the research.
3. Increased safety risk of subjects: Clinical trials involve the use of drugs and the health status of subjects. If the ethical principles of GCP are violated, the safety risks of the subjects may increase, and even serious adverse reactions may occur. Therefore, in the process of clinical trials, we must strictly abide by the ethical principles of GCP, ensure the rights and safety of the subjects, and ensure the accuracy and reliability of the test results.
Other related
ClinicalTrial refers to any systematic study of drugs in human body (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions and/or absorption, distribution, metabolism and excretion of experimental drugs, so as to determine the efficacy and safety of experimental drugs. Clinical trials are generally divided into phase I, II, III and IV clinical trials and EAP clinical trials.
According to the definition of clinical trial in the Quality Management Standard for Drug Clinical Trials issued by the US Food and Drug Administration, clinical trial refers to any systematic study of drugs in human body (patients or healthy volunteers) for the purpose of confirming or revealing the effects, adverse reactions and/or absorption, distribution, metabolism and excretion of experimental drugs, and for the purpose of determining the efficacy and safety of experimental drugs.