CRDSA Std 1001: Standard for Sharing Clinical Study Data

This Data Sharing Assessment App translates the principles in CRDSA’s Standard for Sharing Clinical Study Data into a short, structured instrument that can be applied consistently across data sharing use cases. The assessment app is a 15-question scored rubric designed to objectively measure the completeness and quality of a proposed data sharing plan, commitment, or data contribution.

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.

This paper, published in Applied Clinical Trials, reports on CRDSA’s 2022 survey of biopharma and academic researchers. The paper discusses how common standards can accelerate the reuse of trial data, benefiting both data contributors and the research community. The results of the survey will inform the development of data contribution best practices.