Good Clinical Practice data management

Good Clinical Practices, Clinical Safety Data Management)... 

All clinical protocols and supporting documents are reviewed and approved internally by a group of senior Clinical Research Development managers. This group assesses the overall study design and ability of the study to meet its objectives, as well as the quantity and quality of the data. In addition, the group reviews the procedures for the safety and welfare of the subjects to ensure compliance to good clinical practices and ethical principles. 

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. 

E = Efficacy Topics those relating to clinical studies in human subjects. Examples E4 Dose Response Studies. Carcinogenicity Testing, E6 Good Clinical Practices. (Note Clinical Safety Data Management is also classified as an Efficacy topic, E2). 

In study-based quality management systems, such as good laboratory practice (GLP) and good clinical practice (GCP), the study number is considered as the main index variable and any other information along the meta-data model can be derived from it. With the help of the meta-data model (see Box Meta-Data Model), it can be checked easily if the information of the documented GxP-relevant process is complete. 

Society of Clinical Data Management. 2005. Good Clinical Data Management Practices. 4th edition. Milwaukee (USA). Accessed January 1, 2006, at http //www.scdm.org. 

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