The CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data (v1.0) aims to help researchers conduct robust analyses and objectively interpret the findings generated from the use of shared patient data. The standard encompasses the end-to-end research process, and its application will reduce the risk of inadvertent errors or bias that may lead to conclusions potentially detrimental to scientific understanding and patient care.

CRDSA’s process for standards development can be found here.

The CRDSA Std 1001: Standard for Sharing Clinical Study Data (v1.0) promotes data completeness, consistency, interoperability, and information transparency. These qualities are essential for the research community and, equally important, benefit data contributors by ensuring that their investment in data preparation time and resources will maximize research outcomes.

CRDSA’s process for standards development can be found here.