Source Data Agreement Template

A data sharing agreement is an agreement between a party that has useful data (the broadcaster) and a party that seeks data for research on (the recipient) in which the disclosure provider agrees to share its data with the recipient. These could be two universities that would agree to exchange data to collaborate in the field of research, could include one or more private companies active in research or development, and could even include a government agency that works with a private organization. Despite the willingness of investigators to share data, the data exchange process is often hampered by contractual discrepancies and ambiguous standards of data anomaly. Contractual barriers to data sharing, such as restrictive conditions of data use and contribution, as well as inconsistencies in governance procedures for data sharing, delay the integration of data from researchers who use previously collected data (secondary researchers). Ambiguous standards of data anomaly pose additional challenges, as existing guidelines and guidelines remain largely silent in order to anonymize data in a way that preserves scientific utility. As we move towards a landscape where source data, study papers, and published manuscripts are increasingly available, the need for tools to streamline contracting processes, protect participant privacy, and maintain the scientific utility of data is growing. Access to and exchange of clinical research data is essential for the advancement of science. Over the past decade, the movement towards publicly and privately funded research data, which must be openly available, has grown significantly. Data exchange allows sponsors and clinicians to appreciate the essential contributions and volunteerism of clinical trial participants, ensure reproducibility and enable maximum use of data by the research community.

In the absence of strong intellectual property rights that protect data and databases in the United States, data-sharing agreements work best when they are part of a broader agreement between research partners. An individual agreement on data sharing should not replace the larger agreement between the partners, but complement and support a particular aspect of the broader agreement. A detailed overview of the role of a data sharing agreement within a large company between research partners is available at Data Sharing: Creating Agreements, Paige Backlund Jarquín MPH, Colorado Clinical and Translational Sciences Institute & Rocky Mountain Prevention Research Center. In 2014, the MRCT Center carried out with several partners a retrospective analysis of the language of data exchange in consent forms. The MRCT Center then published the draft data contributor agreement and forms for a consent form. In 2017, the MRCT Centre deployed to develop a roadmap to harmonise data anomaly standards with the European Medicines Agency (EMA).