Clinical Data Sharing Agreement Template

The University of Warwick wishes to formally acknowledge its explicit commitment to preserving the confidentiality, security, security and integrity of all data to which the organization owns and which may be retained under its tutelage. If the repository is no longer required, all data is deleted from the servers. Deleting data is irreversible and involves separating the database and destroying all data and transaction files using a secure deletion application. The data come from completed randomized controlled studies. All data is anonymous and no patient-identifying information is disclosed. 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. In 2014, the MRCT Center and several partners introduced a retrospective analysis of the language of data sharing in consenting information forms. The MRCT Center then published projects from Data Contributor Agreement and Information Consent Form Templates. In 2017, the MRCT Centre set out to develop a roadmap for harmonising data anonymisation standards with the European Medicines Agency (EMA).

In 2017/2018, we continued and expanded in collaboration with the Patient-Centered Outcomes Research Institute (PCORI). In collaboration with the PCORI Open Science Pilot project, the MRCT Center has developed three harmonized governance tools for data exchange. Once the data has been received, the original source is moved to an encrypted reader. A copy of the processed data is imported into a secure database. Individual patient data with descriptions of variable coding This agreement begins at [INSERT DATE] and ends on [INSERT DATE], unless it is renewed in writing between the parties and, at this stage, the University of Warwick publishes an amendment to replace this document. [INSERT INSTITUTION NAME] provides all anonymous test data from [INSERT TRIAL NAME]. Necessary data: Despite the willingness of investigators to exchange data, the data exchange 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. Patel S, Hee SW, Mistry D, et al.; repository Group. Identification of subgroups of back pain: development and application of approaches using individual patient data collected during clinical trials.

Southampton (UK): NIHR Journals Library; 2016 Jul.