Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 138

The scheme for undertaking a clinical trial process begins with a sponsor who has developed and prepared, in the form of a clinical trial plan including a scientifically sound protocol, an approach to conducting human research to gather data demonstrating that an investigational product is safe and effective for a specified indication. In all countries and regions with established regulatory authorities, the sponsor must obtain the agreement of the regulatory authority before activating that clinical trial plan and protocol for pharmaceutical drug product clinical trials.

The agreement of the regulatory authority is usually given in the form of an approval or permission to proceed. In the United States, the U.S. Food and Drug Administration implements this permission pursuant to the regulations governing Investigational New Drug Applications (IND) – 21 CFR 312. In the EU, the competent authority for each of the 27 member State implements the permission as part of their Clinical Trial Authorization (CTA) process. Under the EU CTR 536, the trial authorization process has been harmonized to increase efficiency. In these and in most similar situations, the regulatory authority is the decision maker. Therefore, it is up to the applicant or sponsor to submit a complete and convincing submission requesting permission to undertake the clinical trial investigation and providing the information and data specified by the regulations governing the application process. The sponsor or applicant is the primary point of contact for the regulator in the application submission process since that entity, be it a firm, institution, or person, is held responsible for the study being conducted in conformance with regulatory requirements including GCP.

Figure 11.1 Regulatory Authority’s interaction with other players.