How It Works

Access to Data

Provision of Data

Following receipt of a signed Data Sharing Agreement (DSA), Researchers are provided access to anonymized patient-level data and supporting documentation in a secure data access system, known as the SAS Clinical Trial Data Transparency (CTDT) system. Providing data through this system further safeguards the privacy of patients and helps to ensure that a Researcher’s use of the data adheres to the provisions contained within the signed Data Sharing Agreement (DSA). Some Sponsors (e.g. GSK) may provide data directly to Researchers where they are assured that the data will be secure – see the Sponsor specific pages for more information.

Access to data is provided for a 12-month period. Sponsors may extend access when justified for up to 24 months.

About the Clinical Trial Data Transparency (CTDT) System

The CTDT system is hosted by SAS and provides a secure research environment for Researchers to conduct their research.

Research teams are provided with a private research project area containing the anonymised patient level data and supporting documentation where they can create and run programs and store their outputs. This research project area is not accessed by Sponsors or other third parties unless Researchers request support. There are controls in place to prevent Researchers exporting the data and supporting documentation provided by a Sponsor. Researcher’s use of the data must adhere to the access and usage conditions required by SAS – see link to the CTDT Portal.

Pre-installed Statistical Software

The following statistical software is made available to Researchers within the SAS CTDT research environment.

  • R (note that “R” is open source software and software support is not provided)
  • SAS
  • PLINK

All fees, including licenses, for the pre-installed statistical software indicated above are paid by the Sponsors. The number of licenses for each Research Project may be limited to a maximum of five.

Support

SAS provides technical support to assist Researchers using the CTDT system.

User guides and instructional videos are provided on the CTDT Portal.

In addition, some Sponsors provide support to assist Researchers in understanding the datasets provided. Further information can be found on the Sponsor specific pages.

Public disclosure of the research

After the Data Sharing Agreement is executed the title of the research proposal, name and affiliation of the lead researcher, research proposal summary, requested studies, funding source and potential conflicts of interest that are provided will be posted on this website. The publication citation and statistical analysis plan will be included after the research has been published.

The Data Sharing Agreement includes requirements to disclose the results of the Analysis in a scientific journal in a manner consistent with the research proposal publication plan. If for any reason the Analysis cannot be disclosed in a manner consistent with the publication plan, a brief summary of any activity performed, any outcome of the Analysis, and reason for non-completion, as applicable, should be disclosed in an open access journal or on a publishing platform with a link provided on this website.

All Publications are to acknowledge the appropriate Sponsor(s) or Funder(s) and www.ClinicalStudyDataRequest.com as sources of data.