Abstract TP419: A Common Data Language for Clinical Research Studies: The National Institute of Neurological Disorders and Stroke and National Library of Medicine Cerebral Aneurysms and Subarachnoid Hemorrhage Common Data Elements Version 1.0 Recommendations

Abstract

Introduction: The National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine (NLM) initiated development of cerebral aneurysms and subarachnoid hemorrhage (SAH)-specific Common Data Elements (CDEs) in 2015 as part of a joint project to develop data standards for funded clinical research in neuroscience. Objective: Through the development of these data standards for clinical research, the NINDS and NLM SAH joint CDE initiative strives to improve SAH data collection by increasing efficiency, improving data quality, reducing study start-up time, facilitating data sharing/meta-analyses and helping educate new clinical investigators. Methods: The working group consisted of international members with varied fields of expertise related to SAH and was divided into domains such as subject characteristics and assessments and exams. They developed a set of SAH-specific CDE recommendations by selecting among, refining and adding to existing field-tested data elements. Recommendations, based on reviewing the established Stroke CDEs as well as other disease-specific CDEs, were uploaded to the NIH CDE Repository. Following an internal working group review of recommendations, the SAH CDEs will be vetted during a public review on the NINDS website. Results: Version 1.0 of the SAH CDEs will be available in early 2017. New SAH CDEs and recommendations will include those developed for unruptured intracranial aneurysms and long-term therapies. The NINDS CDE website provides uniform names and structures for each data element, as well as guidance documents and template case report forms using the CDEs. Conclusion: The NINDS encourages the use of CDEs by the clinical research community in order to standardize the collection of research data across studies. The NINDS CDEs are a continually evolving resource, requiring updates as research advancements indicate. These newly developed SAH CDEs will serve to be a valuable starting point for researchers and facilitate streamlining and sharing data. Information provided at this meeting will include examples of how the SAH CDEs may be used by a research study, demonstrations of navigating the NINDS CDE and NIH CDE Repository websites and how users can submit feedback.