Compliance with the GCP is monitored by the internal audit departments of research companies and government drug registration and inspection authorities. According to the GCP guidelines, all clinical trials must have a scientific basis and a plan (the so-called protocol). This document is subject to rigorous ethical and substantive review by independent ethics committees. Not only the content of the information addressed to the patient is evaluated, but also its form – so that the patient can be understood.
The ethical evaluation of the study and its registration is carried out in parallel in Poland (according to European Union standards). To begin a clinical study, several formal conditions must be met. The first is a positive opinion from the ethics committee responsible for the research coordinator. Approval by the Bioethics Commission for a clinical trial means a positive screening of both the investigator and the research center.
The Bioethics Committee evaluates the following aspects of a clinical trial:
- Justification, feasibility and design of a clinical trial
- Analysis of the expected benefits and risks of an audit
- Correctness of the test report
- Correctness of the choice of the researcher and the members of the research team.
- The quality of the investigator’s brochure
- The quality of the resort
Correctness and completeness of written information for the patient. Correctness of the procedure for obtaining informed consent from the patient. The amount of compensation or compensation for the patient. Researcher and center reward. Principles of patient recruitment. Sponsor and liability insurance investigator. Consent to initiate a clinical trial must also be expressed by the FDA President, issuing an authorization to conduct the study after evaluating the submitted design documentation.