Quality AssuranceClosed
NeuroCure Clinical Research Center – BrainLab Project cRDM
Research Data Management (cRDM)
The NeuroCure Clinical Research Center (NCRC) with its embedded BrainLab module aims to translate preclinical NeuroCure research into proof-of-concept studies in humans. In cooperation with BIH QUEST Center, the NCRC will introduce and implement two novel complementary structural elements in the BrainLab project, Patient & Stakeholder Engagement (PSE) and Clinical Research Data Management (cRDM), called “PSE@NCRC and cRDM@NCRC: Keeping NeuroCure at the forefront of responsible translational neuroscience”. Funding of these two projects is granted by NeuroCure.
Clinical Research Data Management (cRDM) @NCRC
Whenever clinical trial data are shared, new opportunities arise for reanalysis and pooling of data that add tremendous value, e.g., for personalized medicine as well as rare disease research. This makes data sharing an ethical imperative. In addition, funders have begun to require FAIR (findable, accessible, interoperable, reusable) research data sharing. However, sharing study data is not a standard part of trial workflows. Clinical researchers are highly motivated to manage and share their data if there are clear instructions and a sustainable infrastructure in combination with various support options. However, the needed support, resources, and training are often not yet available.
In this pilot, the Clinical Research Data Manager (cRDM) will work closely with principal investigators (PIs) at the NCRC to improve the management of their clinical trial data according to FAIR criteria. These data are often captured in REDCap, and transferring the data to the BIH Virtual Research Environment (VRE) will allow researchers to make them available in a secure and searchable manner within their research group, with collaborative partners, and ideally beyond.
To this end, the cRDM will develop workflows and templates to enable secure and complete data transfer to the VRE, followed by anonymization procedures, quality checks, and metadata enrichment. Necessary data protection regulations and measures will also be addressed.
Additionally, consulting services and training formats will be provided and project results will be made publicly available. Standard operation procedures (SOPs), video tutorials, and other materials will be made freely available under open licenses. Where appropriate, these materials will be integrated into the broader VRE documentation to improve visibility and reuse.
You can find more information on the PSE and cRDM projects @ NCRC here.
Further information on the PSE@NCRC can also be found in the QUEST homepage here.