Using OpenBIS as a virtual research environment: An ELN-LIMS open-source database tool as a framework within the CRC 1411 Design of Particulate Products

Posted on June 4, 2024 By LabLynx Journal articles

As the ramifications of the FAIR data principles of Wilkinson et al. continue to shape how academic (and industrial) research is performed, it's inevitable that the information management systems used in these research contexts will be scrutinized under those same FAIR data principles. In this case, Plass et al. of FAU Erlangen-Nürnberg describe how they landed upon the open-source electronic laboratory notebook (ELN) and laboratory information management system (LIMS) solution openBIS to address FAIR data management in their multidisciplinary Collaborative Research Centre (CRC). After discussing the current state of research data management (RDM), the authors go into the specifics of their implementation of openBIS, the adjustments they made to the system to address their information management needs, and the experiences they had using the modified system. They ultimately conclude that "this ELN-LIMS could serve as a template solution for other similarly structured collaborative research centers or research groups" given the benefits they saw with their modified version.

The US FDA’s proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing

Posted on May 26, 2024 By LabLynx Journal articles

In this "in press" journal article published in Practical Laboratory Medicine, Smith et al. of ARUP Laboratories provide the results of a survey conducted just prior to the U.S. Food and Drug Administration's (FDA's) April 29 release of their final rule on laboratory-developed tests (LDTs). Polling a select group of its clinical laboratory customers, the authors sought to discover clinical laboratorians' opinions about the then proposed changes to regulate LDTs as medical devices. The survey was conducted in part due to a set of perceived FDA shortcomings that would make it "difficult for the FDA to conduct an accurate quantitative analysis of public opinion in a key sector directly impacted by its proposed rule." The authors describe the structure of their survey and its associated analytical methods before discussing the results. They then provides a full discussion with a brief conclusion: "The majority of clinical laboratorians surveyed do not support the FDA’s proposed rule on LDTs and report having insufficient resources to comply with the rule if it is enacted," and that the FDA had more work to do "to better understand the negative impacts of the proposed rule."