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.
Date: October 20, 2025
Work Group: Innovative Trial Design
Type: Publication,White Paper
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 It compares the scope and intent of each agency’s draft guidance, highlighting MHRA’s broader inclusion of hybrid and augmented trial designs as a more flexible, patient-centered model. The paper also outlines implications for sponsors and regulators seeking globally harmonized standards, consistent evaluation frameworks, and reproducible methodologies.Date: September 17, 2025
Work Group: Secondary Use Standards,Technology & Innovation
Type: Framework & Tools,Standards
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.Date: February 4, 2025
Work Group: General Resources
Type: Webinars & Videos
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 industry, both as data providers and data users.
- Demystifying the EU Data Space (Keynote)
- EHDS: What’s in store for the European Health Data Space (Presentation)
- Individual Patient Data Sharing in the EU (Panel Discussion)
Date: February 4, 2025
Work Group: General Resources
Type: Webinars & Videos
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 totality of evidence can inform the drug development process, and what’s needed to meet regulatory use challenges.
- C-Path’s use of patient-level data in the regulatory pathway (Keynote)
- The Intersection of Data Sharing and Equitable Healthcare: Challenges and Opportunities (Presentation)
- Innovative Trial Design: Data Reuse Opportunities and Regulatory Considerations (Panel)
Date: October 21, 2024
Work Group: Innovative Trial Design
Type: White Paper
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 settings and prior clinical trials. The paper recommends specific steps data platforms can take to support sponsors in meeting health authority expectations.Date: September 25, 2024
Work Group: Secondary Use Standards
Type: 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.
Date: September 25, 2024
Work Group: Secondary Use Standards
Type: Standards
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.
Date: February 29, 2024
Work Group: General Resources
Type: Webinars & Videos
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.
Date: February 29, 2024
Work Group: Innovative Trial Design
Type: Webinars & Videos
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 and Evidence in regulatory use. Major themes include “regulatory grade” RWD/E, audit readiness and data fitness, learning health systems, and fit-for-purpose clinical trial design.
Following the keynote, a panel of experts discussed what’s on the regulatory horizon, from the use of alternative data sources to novel trial designs to AI-generated evidence.
Date: February 29, 2024
Work Group: Data Protection
Type: Webinars & Videos
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 efficiently enable data privacy while improving secondary use.
Date: January 31, 2024
Work Group: Data Protection
Type: Framework & Tools,Infographic
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.Date: October 26, 2023
Work Group: Technology & Innovation
Type: Framework & Tools
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.Date: October 5, 2023
Work Group: General Resources
Type: Articles
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) and the supporting documents provided from industry-sponsored clinical trials. The study includes IPD packages received from 70 of 91 eligible clinical oncology trials (77%) for a planned meta-analysis. The analysis indicated substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.
Date: September 28, 2023
Work Group: Data Protection
Type: Webinars & Videos
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 sponsors, a 20% increase from 2022.
- The consistency of dataset- and documentation-sharing policy commitments establish a reference benchmark for all data contributing organizations.
- Challenges remain in the areas of data transformation transparency and data protection methodology.
Date: August 22, 2023
Work Group: Innovative Trial Design
Type: Publication,Webinars & Videos
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 Design and Conduct of Externally Controlled Trials for Drug and Biological Products” (Docket FDA-2022-D-2983).The draft guidance received over 200 responses from industry sponsors, patient advocacy organizations, academic research institutions, nonprofit consortia, and patients. In July 2023, CRDSA convened a roundtable panel of experts to discuss issues raised by commenting organizations and explore ways to ensure the expanded use of alternative control trial designs in regulatory submissions. The August 2023 report, “FDA Draft External Controls Guidance: Situation Analysis and Recommendations,” summarizes the roundtable discussion, key regulatory challenges, and recommended actions.
Date: March 8, 2023
Work Group: Secondary Use Standards
Type: Standards
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.
Date: February 15, 2023
Work Group: General Resources
Type: Articles
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 around the use of clinical trial and real-world data (RWD) in building supplemental control arms.
Date: November 14, 2022
Work Group: Technology & Innovation
Type: Framework & Tools
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.
Date: September 23, 2022
Work Group: General Resources
Type: Podcasts
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 sponsors to revolutionize trial design and improve patient recruitment – and why he believes patients really want their data to be shared.
Date: June 17, 2022
Work Group: General Resources
Type: Podcasts
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 analytics to be more accurate, resourceful, and utilitarian in the world of clinical research.
Date: January 3, 2022
Work Group: General Resources
Type: Articles
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.
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 settings and prior clinical trials. The paper recommends specific steps data platforms can take to support sponsors in meeting health authority expectations.
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.
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.
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 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:
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 “