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Regulacje i polityka gospodarcza · 28.10.2022

Request for Information on Data Collection for Emergency Clinical Trials and Interoperability Pilot

As described in the recent RFI on Clinical Research Infrastructure and Emergency Clinical Trials, the White House Office of Science and Technology Policy (OSTP), in partnership with the National Security Council (NSC), is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites as needed to address outbreaks of disease and other emergencies. In this RFI on Data Collection for Emergency Clinical Trials and Interoperability Pilot, issued in partnership with the Office of the National Coordinator for Health Information Technology (ONC), OSTP and ONC seek input on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs), in the pre-emergency phase as well as in emergency settings. One specific objective for this RFI is to gather information about whether there is value in a pilot or demonstration project to operationalize data capture in the near term, for example within 6-12 months of the close of comments on this RFI.

Source: Federal Register — All DocumentsOpen original release →