Data Transfer Agreement Clinical Trial

December 6, 2020

This guide defines the procedures of the clinical school, which govern the transmission of registrations between the clinical school and an organization of beneficiaries, both from the clinical school and in detail. Agreement between organizations that regulates the transfer of one or more datasets from owner/supplier to a third party. DTAs, which must be obtained by external party researchers for incoming data sets, MUST be verified by a member of the contract team at the research office prior to the transfer of the data, as the conditions must be carefully checked with the applicable funding conditions that a DtA must be set up by a member of the contract team at the research office prior to the transfer of data in order to reduce confusion as to what constitutes protected health information (“PHI”) (health information containing additional information that can be used to identify the data). A researcher should understand that HIPAA identifiers are defined as one of the following: to comply with information governance, a data transfer agreement must be put in place to cover the transfer of records between institutions. We generally expect that only anonymized data will be transferred whenever possible, it is a good practice that the search is done on coded or completely anonymized data. In the event that identifiable information is requested by third parties or staff, it is important to ensure that any duty of trust is not breached. The terms of the initial consent should be reviewed to determine whether the proposed use is covered by third parties and, if not, authorization should be obtained if necessary. It should be noted that personal data should not be transmitted unless consent is available and the storage area is secure In summary, it is designed only as a complete guide for the transfer or use of data- In general, the transfer and use of data is subject to several important considerations, including those referring to Duke IRB rules, the Health Insurance Portability and Accountability Act of 1996 as amended (“HIPAA”), ethical considerations, that the transfer and/or use of the data be subject to contractual restrictions, and intellectual property issues. A researcher wishing to transfer or use data should be prepared to discuss with the ORC, among other things: the purpose of transmission; The identities of the taker and sound; The nature of the data to be transmitted (personal data? contain identifiers?) Whether the data was collected as part of a research study or standard of care and, in the case of a research study, whether there are third-party restrictions; Whether a consent form applies to informed information allows the use or transfer of proposed data; How data should be transferred Whether patents are data-related and whether samples are sent with or in conjunction with the data. The transfer and use of personal data is a complex matter that cannot be adequately addressed on this site.

Duke researchers who wish to transfer or use personal data should contact the ORC to initiate a debate on the transfer or use of the proposed data. The eighth data protection principle (see list of the Data Protection Act) requires that personal data cannot be transmitted outside the European Economic Area (EU Member States as well as Iceland, Norway and Liechtenstein), unless the country or territory on which the data is to be transferred provides an adequate level of protection for personal data.

Data Transfer Agreement Clinical Trial · December 6, 2020 · 11:59 am
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