Secondary Use Standards

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.

In 2022, CRDSA released the Data Sharing Technology Assessment Framework to help data contributors, platform owners, and researchers determine the requirements and use cases important to their organization. The Assessment Framework is now publicly available as an R Shiny app for easier use, along with an accompanying introduction and guide.

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.

CRDSA’s Technology and Innovation Work Group has developed a data-sharing technology assessment framework to support stakeholders in their evaluation of technologies and approaches that advance their data-sharing initiatives, whether they are interested in technologies for external data sharing or support an organization’s internal data reuse. The framework is designed to assist stakeholders in determining the requirements and use cases important to their organization. The resulting assessment scores can be used to compare how well different technology approaches or project scopes meet organizational objectives.