CRDSA’s assets and resources can be found in this section of our site.
Resources designated “Member Access” are available through CRDSA’s member portal and can be accessed by all employees of our member organizations. If you are a member and would like to request a specific asset, you can also send an email to info@crdsalliance.org.
Agentic AI for Clinical Trial Data Harmonization
CRDSA is building an agentic AI data harmonization platform for clinical trial data. The initiative represents an important step toward making secondary use of clinical trial data interoperable and substantially reduce the data management burden for… Read more
External Controls - Evolving Regulatory Approaches
This October 2025 CRDSA white paper, External Controls—Evolving Regulatory Approaches, analyzes how MHRA, EMA, and FDA are approaching the regulatory use of externally controlled clinical trials. It compares the scope and intent of each agency’s… Read more
Data Sharing Assessment
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… Read more
2025 CRDSA Summit: Demystifying the EU Data Sharing Space
The second day of CRDSA's 2025 Summit summit was all about the European data space, covering EHDS, various IHI projects, Darwin, and more. Sessions addressed how the initiatives work together (and where they don’t), with a focus on the role of… Read more
2025 CRDSA Summit: Data Reuse - Navigating the Regulatory Environment
The first day of CRDSA's 2025 Summit explored the current state of patient data reuse in the regulatory approval process. Presentations and the expert panel discussed why responsible data reuse is a critical tool in future trial design, how the… Read more
Data Reuse in Regulatory Submissions: The Role of Data Platforms
This paper examines the benefits and challenges of using supplemental and external controls in regulatory submissions. Data platforms are an integral part of the ecosystem, enabling trial sponsors to access and use patient data from real-world… Read more
CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data
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… Read more
CRDSA Std 1001: Standard for Sharing Clinical Study Data
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… Read more
CRDSA Summit: The Future of the Data Reuse Ecosystem
Drawing from their unique perspectives, CRDSA’s board members discuss the foundational elements needed to support a data reuse ecosystem that best serves patients, accelerates drug discovery, and advances human health. Watch the Future of the Data… Read more
The Patient Data Revolution: From Promise to Realization - Keynote Presentation
This keynote presentation by Mark McClellan, Director of the Duke-Margolis Institute for Health Policy and former commissioner of the U.S. Food and Drug Administration, provides a thought-provoking analysis of the current state of Real-World Data… Read more
Data Governance and Privacy Methodology: Moving from Confusion to Clarity
In this session from our February 2024 Summit, experts from CRDSA and TransCelerate Biopharma discussed how to navigate the complex data protection governance process, and how existing resources like TransCelerate’s methodology can help companies… Read more
Infographic: Navigating Data Protection and Privacy
Operationalizing privacy is challenging, but there are clear steps you can take to devise an operational policy that supports your business goals. This infographic lays out the important decision points in a logical, step-wise flow. Download… Read more
Data Sharing Technology Assessment Framework
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… Read more
JAMA Oncology: Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages
In this original investigation, Dr. Ashley Hopkins (Flinders University) and colleagues, including Frank Rockhold (Duke CRI and CRDSA Board Director) and Aaron Mann (CRDSA), address the utility and completeness of individual-participant data (IPD)… Read more
A Review of Biopharma Sponsor Data Sharing Policies and Protection Methodologies
This whitepaper updates CRDSA’s 2022 systematic review of data contributor policies and data protection methodologies. This update includes information published by 35 biopharma sponsors. Highlights include: The review now covers 35 biopharma… Read more
FDA Draft External Controls Guidance
Innovative trial designs that make use of the totality of available evidence can reduce the burden on patients and meaningfully improve the drug development process. In February 2023, the FDA released for public comment “Considerations for the… Read more
Establishing a Basis for Secondary Use Standards in Clinical Trials
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… Read more
Clinical Data Consortium Seeks to Establish Best Practices for Supplemental Controls
Regulatory Focus, a publication of Regulatory Affairs Professional Society (RAPS), interviews CRDSA CEO Aaron Mann and COTA Healthcare’s Chief Medical Officer C.K. Wang, MD, on CRDSA’s demonstration project that seeks to establish best practices… Read more
Data Sharing Technology Assessment Framework
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… Read more
Unlocking the True Potential of Clinical Research Data
In Teckro’s podcast episode “Unlocking the True Potential of Clinical Research Data,” Aaron Mann discusses the importance of unleashing the power of clinical research data. Aaron explains why he’s optimistic about the potential of data sharing among… Read more
Mind Your Data: The First Rule of Predictive Analytics in Clinical Research
In this episode of the IEEE Standard Association’s “Re-Think Health” Podcast Series, Aaron Mann and Maria Polombini discuss how open data sharing is paving the way to access more quality, real-world and inclusive data to enable predictivity… Read more
Realizing the Promise of Data Sharing: A Multi-Stakeholder Collaboration
This article in Clinical Leader discusses the challenges faced across the clinical data sharing ecosystem and how CRDSA’s Work Streams are addressing these challenges. View the Article