During the pilot phase TCGA generated almost 7 terabytes (TB) of data, spanning biospecimen information, patient information, and genome, exome and epigenetic data for both tumor and normal specimens per patient. The ability to ensure data completeness associated with each specimen required a coordinated effort across numerous institutions and information systems. This coordination will become increasingly difficult and important as the program grows by 8 fold in the coming five years. The value of the data generated in TCGA will lie in its quality, as all subsequent analyses and research outcomes will be dependent on the quality of the information generated. The Quality Management System (QMS) will serve as the basis by which the quality and value of the TCGA data may be measured. Key to the program will be the establishment of a process and system to ensure data completeness and quality. To facilitate expansion of the program, TCGA focuses on quality as a best management practice, and is seeking support to define and implement a Quality Management System (QMS). The rest of this statement of work document outlines the purpose, requirements and scope of the TCGA QMS. The objective of this project is to establish a Quality Management System (QMS) across the funded activities of the TCGA program, with the goal of identifying non-conforming data in a timely fashion to ensure data released to the public is of the highest quality possible.
