Good clinical practice integration

The logistics of large phase 3a trials are extremely complicated and require considerable manpower in the headquarters and in the field. Full compliance to Good Clinical Practice (GCP) as well as scientific integrity are prerequisites for the acceptability of these trials to the regulatory authorities, and the pivotal trials undergo detailed inspection to safeguard these... 

To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, the FDA performs inspections of clinical trial study sites and anyone involved in the research, says David A. Lepay, M.D., Ph.D., senior advisor for clinical science and director of the FDA s Good Clinical Practice Program. Lepay says that the quality of clinical trials has improved markedly since the agency started inspecting them back in 1977. 

Good Clinical Practice (GCP) The standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity, and confidentiality of subjects are protected. [Defined for this book.]... 

The aim of this chapter is to describe the general framework for conducting good clinical practices (GCP)-compliant clinical research. As it is difficult to cover this broad topic in such a short chapter, the authors will focus on those areas that are most discussed, most problematic and most critical to achieving a GCP-compliant clinical study. Thus, there is particular emphasis on ethical issues, source data verification and data integrity, monitoring and safety review, and study medication/device management. 

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