Promoting quality of clinical trials’ databases

Abstract

This Bachelor s Thesis is focused in the management of Clinical Trials data, based in my professional experience. The main responsibilities of the Clinical Data Management (CDM) roles are exposed in this Thesis. Examples of activities performed at trial level are also presented, as well as some projects developed with the objective of defining the expected database data quality and their associated processes and to implement international DB structures to to allow for an efficient programming and to meet the regulatory requirements. Finally a discussion section summarizes this work and includes some reflections and recommendations looking forward.