EU Clinical Trial Information System (CTIS)

AstraZeneca ensures clinical research is registered according to all global requirements:

Clinical trial registration

We publish results from all our clinical trials on public registries, open access portal and, as often as possible in peer-reviewed medical and scientific journals, regardless of the outcome to support scientific advancement

Since April 1, 2015, all interventional clinical trials phase 1-4 with new protocols include the production of a Trial Result Summary, also referred to in the EU Clinical Trial Regulation as the Lay Summary of clinical trial results. These are made available to all patients that participate in an AstraZeneca sponsored clinical trial in the same language as their signed Informed Consent Form. All AstraZeneca Trial Result Summaries are posted to 

. 
Trial Result Summary publication timelines on 

Clinical trial results​

In addition to sharing approved clinical documents with researchers on request, AstraZeneca is committed to meeting health authority requirements globally for the publication of clinical documents upon product review.

Both packages include the product Clinical Overview, Clinical Summaries of Safety and Efficacy, Clinical Study Reports and other types of reports such as PK/PD reports, Protocols, sample case report forms (CRFs) and Study Statistical Analysis Plans. The packages are anonymized to remove company confidential information and personal private information in line with global privacy laws.

Clinical Study Protocols

Statistical Analysis Plans

Clinical Study Report synopsis

Clinical documents

. We have a long-standing history of sharing anonymised individual patient level data with qualified researchers from trials of approved products in the US and EU. 

Prior to 2015 we considered requests for de-identified patient level data from external researchers on a case-by-case basis, following consistent criteria to establish if and how the information provided will be used for valid scientific purposes and to benefit patients. 

Since 2015, we support external requests through a more standardized process. We are now members of the Vivli platform and manage our requests as follows: 

How do we prepare the data for sharing?

Why do we use Vivli?

What are our Data sharing Metrics?

Clinical data access

In clinical research, it is important that trial investigators and participants have relevant anonymised information shared with them in order for medical research to progress to its full potential within the best interests of public health. AstraZeneca is committed to transparency for all stakeholders and voluntarily adopted the use of Lay Summaries as defined in the 

For all interventional studies started as of January 1, 2021, we are also committed to providing patients information about their treatment through the distribution of Unblinding cards after the study has completed.

Additionally, participants receive a Thank You Card and additional relevant communications in some studies.

For more information about patient centricity in clinical research at AstraZeneca, please read 

Patient communications​

AstraZeneca has a long-standing commitment to making information about our clinical research publicly available.​

We believe that being transparent about our research and development allows other researchers to access the most up to date and relevant medical evidence, as well as serving the best interests of the people and patients who use our medicines.

We deliver Clinical Trial Transparency by making clinical trial data, documents and results accessible to all within the framework of global regulations, policies, and industry best practices, and ensuring patient privacy and trial integrity. Our clinical trial transparency framework is guided by the 

 (European Federation of Pharmaceutical Industries and Associations) and 

 (Pharmaceutical Research and Manufacturers of America) joint Principles for Responsible Clinical Trial Data Sharing. 

We meet our transparency commitments by publishing information on the registration, results and health authority submission activities relating to new and ongoing AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development and drugs whose further development has been discontinued.

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