Good clinical practice (GPC)
How clinical trials are conducted In clinical trials, patient safety and patient rights are essential, so all studies should be performed in accordance with Good Clinical Practice (GCP) guidelines, ie Good Clinical Practice (GCP).
The main hypotheses of KDP are:
- The well-being, rights and safety of the patient are above the interests of science and society.
- The data obtained must be reliable and accurate.
Detailed guidelines for good clinical practice:
Clinical trials are conducted in accordance with ethical principles (including the 1964 Declaration of Helsinki, as amended), in accordance with ICH GCP standards and in accordance with the provisions of applicable law.
- The benefits to the patient of participating in a clinical trial must outweigh the associated risks.
- Patient safety and rights are paramount
Complete information about the investigational medicinal product should be available to the investigator. The research should have a significant scientific purpose and a clear and understandable protocol. The study must be performed in full accordance with the protocol approved by the Bioethics Committee. Qualified physicians must provide medical assistance to the trial participant. Survey staff should be trained and experienced.
The patient’s consent to participate in a clinical investigation must be obtained before inclusion in the clinical investigation. The data obtained must be recorded and stored properly so that reports, conclusions and verified data can be drawn up. The data, including the personal data of the participants, must be kept confidential.
The investigational medicinal product must be manufactured, delivered on site, stored and distributed in accordance with GMP. Procedures should be established to ensure that all aspects of research are of high quality.