Clinical Data Management: Strategies for unregulated data

Abstract

Unlike data curation, clinical data management (CDM) is a recognized area of expertise and a defined career path. The highly regulated clinical trials environment has produced effective and efficient practices that can be generalized to other areas of research. Good Clinical Practice (GCP) is an international standard developed by the International Conference on Harmonisation that specifies how clinical trials should be conducted and defines the roles and responsibilities of various sponsors, investigators, and monitors. These practices address many of the issues at the core of data curation and sharing. Much academic research is not rigidly structured in the manner of clinical trials. Relevant practices within CDM and GCP must be reinterpreted for non-clinical research so that they can inform general data management, sharing, and preservation practice. This lightning talk will highlight effective strategies from CDM and GCP that promote data integrity, facilitate data preservation and sharing, and facilitate reproducibility of results.