Source Data Agreement Template

In the absence of strong intellectual property rights to protect data and databases in the United States, data-sharing agreements work best if they are part of a broader agreement among research partners. An individual agreement on data sharing is not intended to supplant the greater agreement between the partners, but to complement and support a particular aspect of the broader agreement. For a detailed overview of the role of a data-sharing agreement in a larger project among research partners, see Data Sharing: Paige Backlund Jarquin MPH, Colorado Clinical and Translational Sciences Institute – Rocky Mountain Prevention Research Center. Access to clinical data and the exchange of clinical data are essential to the development of science. Over the past decade, the movement towards publicly and privately funded research data, which is supposed to be openly available, has increased considerably. The exchange of data allows sponsors and investigators to pay tribute to the essential contributions and volunteering of clinical trial participants, to ensure reproducibility and to allow the maximum use of data by the research community. A data-sharing agreement is an agreement between a party with useful data (the Discloser) and a party that searches for data for research on (the recipient) under which the public agrees to share its data with the recipient. These could be two universities that agree to share data for research cooperation, one or more private companies active in research or development, and even a government agency working with a private agency. Despite the willingness of investigators to exchange data, the data sharing process is often hampered by contractual discrepancies and ambiguous standards of data anonymization. Contractual barriers to data exchange, such as restrictive data usage and data contribution conditions, as well as inconsistencies in data exchange governance, delay the integration of data by researchers who use previously collected data (secondary researchers).

Ambiguous data anonymization standards pose additional challenges, as existing guidelines and guidelines lead, to a large extent, to implicitly contradicting the data in order to preserve scientific utility. As we move towards a landscape where source data, study papers and published manuscripts are increasingly available, there is a growing need for tools that streamline contract processes, protect participants` privacy and maintain the scientific utility of the data. In 2014, the MRCT Center and several partners introduced a retrospective analysis of the language of data sharing in consenting information forms.

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