[Standards, guidelines and principles for clinical trials: medical products]

In addition to existing legislation there have been valid european and international Good Clinical Practice (GCP) guidelines and standards for the planning management and evaluation of clinical research projects and of clinical investigation of medical products since the 1990's. GCP regulates patient protection, the responsibilities of the sponsors, information management, data processing and quality assurance. The Draft International Standard (ISO/DIS 14155) and the European Standard (CEN/EN 540) stipulate the prerequisites and conditions for the clinical testing of medical products and devices. The essential documents for any research or investigative project include the trial protocol and the investigator's brochure. Observation of the guidelines and standards must be emphasized chiefly for reasons of publication suitability and the international recognition of the research and development findings.