AstraZeneca Group of Companies – Data Request Portal
We have a full disclosure statement about our approach to data transparency on our Clinical Trials website www.astrazenecaclinicaltrials.com. In addition our policy on Clinical Trial Transparency describes the key mechanisms through which we are meeting the FDAAA 801 requirements, European Clinical Trial Regulations, The European Medicines Agency policy, and the EFPIA/PhRMA responsible data sharing principles.
Note: You will be required to complete all entries of the form, which will take approximately 15-30 minutes. Please compile all required information before you begin. For more details, please refer to the FAQ document.
- New users need to register for a new account
When you are ready to submit a Data Request, please have the following information ready:
- Data Request Title
Primary Researcher Contact Information
(Name, Title, Institution, City, State, Country, Phone, Fax, Email)
Primary Research Team Information
(Name, Title, Institution)
Statisticians Contact Information
(Name, Title, Institution)
(Rationale, Objectives, Information Requested, Hypothesis, Study Design, Primary/Secondary Endpoints, Statistical Analysis Plan)
- Publication Plan
- Research Funding
- Potential Conflicts of Interest
In order to submit a request for clinical trial data, please follow the steps below:
- Login in to the system with your user credentials
- Select New Request from the left navigation panel
- Complete the Data Request form and submit the request
Note: You will be required to complete all entries of the form, which will take approximately 15-30 minutes. Please compile all required information before you begin. For a more detailed list please see the FAQ document.
Prior to AstraZeneca investing in the activity to anonymize the requested information (Clinical data, documents, etc.) for a request, researchers must enter into a data sharing agreement with us. The data sharing agreement commits the individual researchers to use the data only for the stated research purposes and not to disclose the data to third parties. This is in line with data privacy legislation. In addition, researchers are expected to commit to transparency in the publication of their work. A copy of the Data Sharing Agreement can be found here. Please note that the Data Sharing Agreement is a non-negotiable contract and no modifications to the agreement will be accepted. Researchers are encouraged to sign the Data Sharing Agreement and submit through the portal along with their CV and other required documents as part of the initial request.
AstraZeneca seeks to support researchers by providing data with the highest levels of clinical utility, whilst ensuring patient privacy obligations are met. The AstraZeneca Guidelines for de-identification of patient level data are derived from the industry best practices today provided by organizations such as PhUSE and TransCelerate, and updated as they continue to evolve to achieve anonymization of clinical data.
In the case of sharing de-identified patient level data, please note that the full dataset may not be shared based on our obligations to protect patient privacy. Some potential reasons for partial datasets include:
- Clinical consent for some countries prohibit secondary use of the data
- Patients may withdraw their consent for participation in the trial at any point
- Less than three quasi identifiers are shared per patient
- Other aspects might also be taken into consideration to protect patient privacy as necessary on a per study basis (e.g. review of rare clinical events where information is aggregated to a higher-level before sharing)
Researchers will be notified via the system when it is anticipated that the data for their request will be made available. Time for accessing clinical data depends on the complexity of the Research Request which is influenced by several variables, including: number of studies requested, when were those studies initiated, if the request is in scope for Scientific Review Board (SRB) review. Decision will be communicated in the system approximately 90 calendar days from a Research Request being submitted.
Finally, AstraZeneca shares clinical data through the SAS Multi-Sponsor Environment, which is also an industry best practice solution. This tool allows researchers access to the data and use of a variety of analytical tools such as SAS, R, and other standards through a remote desktop solution. This environment allows AstraZeneca to fulfil our legal and ethical obligations as a good data steward, protecting the data from download and potential misuse. Transfer of data outside this environment is not supported.