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Access to data

How data are provided on the website

Access to the data needed for the research is provided on a password protected website (multi-sponsor analysis system). The website allows researchers to combine data from different studies, conduct research on the site and download their analyses. Access is provided for 12 months. Extensions may be given when justified up to a maximum of 24 months.

Researchers conduct their research in a private workspace. This workspace is not accessed by study sponsors or other third parties unless researchers provide permission so help can be provided. There are controls in place to prevent researchers downloading the patient level data provided to their computer. These controls further protect research participants' privacy and confidentiality, and also help ensure the data are used for the agreed research purpose.

Statistical software that is provided

Commonly used statistical software “R” and "SAS" are provided on the website so researchers can combine data from different clinical studies and conduct analyses. Please note that “R” is open source software and software support is not provided.

User guides and instructional videos are provided. A video that provides an overview of the website can be viewed here.

Research team use of the statistical software

Fees, including licenses, are paid by the study sponsors for research team members to access data on the website and use the statistical software. The number of licenses for each research proposal may be limited to a maximum of five.

Data and information provided for each study

The anonymised datasets and study documents available are described with each study on this site. The Study sponsors section of this site provides the anonymisation standards used by sponsors.

Support will be available to help researchers navigate the data.

Public disclosure of the research

After signed Data Sharing Agreements are received, the name and affiliation of the lead researcher, the title of the research, the requested studies, the lay summary, funding source and any potential conflicts of interest that were provided in the research proposal are posted in the Metrics section of this site. The publication citation and statistical analysis plan are also included after the research has been published.

The Data Sharing Agreement also includes requirements to post a summary of the analysis plan on a publicly available Internet register or website prior to conducting the research and a summary of results within one year of completing the analysis.

There is also a requirement for the results to be submitted for publication in the peer reviewed literature. Some sponsors require review of the manuscript before submission and other sponsors require the manuscript to be sent after submission; refer to the terms specified in your Data Sharing Agreement. The Lead researcher is also required to provide citations of publications to the Sponsor(s).