|About||AstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide. Driven by innovative science and our entrepreneurial culture, we are focused on the delivery of life-changing medicines that are fueling growth and contributing value to patients and society.|
|How we share on the Vivli Platform||AstraZeneca is committed to delivering on the principles of clinical trial transparency as set out in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing including sharing patient level data in compliance with global legal and regulatory requirements.
To access data from AstraZeneca Sponsored clinical studies, researchers should use the Vivli platform to submit a request. Data approved for sharing will subsequently be anonymized and be shared through the Vivli research platform.
|Studies Listed for Sharing||AstraZeneca-sponsored clinical trials conducted in patients for products approved in the EU and US.
For additional details on AstraZeneca’s data sharing policy, please refer to our disclosure commitments.
|Exceptions||• Studies where data sharing is prohibited by the consent, legal, regulatory, or contractual constraints on data sharing
• Studies where there is a risk of subjects being re-identified (for example, single center studies, or rare indications with a small patient population)
• Studies where the data or documents are not in English
• Studies where a significant proportion of subjects must be removed due to national regulations.
|When Studies are Available for sharing||AstraZeneca will review listed studies quarterly.|
|Additional Conditions for Access||Research teams must include a biostatistician.|
|What information will be provided||We may share any or all of the following types of clinical data upon request and review: anonymized patient data, aggregated clinical data, other types of data, and/or Anonymized Clinical Study Reports (CSR).|
|Questions or enquiries||Data-Request-Portal-Technical-Support@astrazeneca.com|
|Review Criteria for Data Requests||AstraZeneca will complete due diligence in reviewing each data request. Due diligence includes, but is not limited to reviewing the research proposal, publication plan, applicable global laws and regulations, legal basis for sharing, data availability, business activities, and legal contracts.|
|Data Request Review Process||Data requests are assessed first by AstraZeneca to establish if the data can be shared based on established review criteria. The request and research proposal are then reviewed by the Independent Review Panel appointed by the Wellcome Trust.|
|Access to study documents without participant-level data||AstraZeneca makes study level documents such as the CSR Synopsis, Statistical Analysis Plan and Protocols available on our clinical study website. Additionally, AstraZeneca published Clinical Document Packages per Health Canada’s PRCI and EMA’s Policy 0070 on agency controlled websites.|
|Anonymization Standards||We use qualitative and quantitative risk management practices to create anonymized datasets and clinical study documents. We seek to prioritize the important data elements to deliver a data set to support an approved research project, balancing risk and utility for researchers.
AstraZeneca Guidelines for anonymizing patient level data are derived from the industry best practices provided by organizations such as PhUSE, TransCelerate, and Regulatory Guidance from EMA and Health Canada. Our guidelines are updated as knowledge, tools and best practices continue to evolve in order to achieve anonymization of clinical data.
Anonymizing datasets enables us to fulfill our legal and ethical obligation to protect our patients whilst at the same time, utilizing patient’s data in progressing medical research to its full potential in the best interests of public health.
|Clinical Study Register or Website||www.astrazenecaclinicaltrials.com|