Data Standards
Organized by domains and subdomains often used in clinical studies, data standards include:
- CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
- CRF Modules — Template forms that logically organize CDEs for data collection
- Guidance Documents — Provide further information about the CDEs
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage study start-up
Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage Highlight Summary: Overview of all Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage-specific CDE recommendations as they appear on the website
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
Overview
The Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) Common Data Element (CDE) Working Group, along with the National Institute of Neurological Disorders and Stroke (NINDS) and National Library of Medicine (NLM) CDE Team, released Version 1.0 of the SAH CDEs in 2017.
To develop the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage CDEs, the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:
- Subject Characteristics
- Assessments and Examinations
- Hospital Course and Acute Therapies
- Biospecimens and Biomarkers
- Imaging
- Long-Term Therapies
- Unruptured Intracranial Aneurysms
- Outcomes and Endpoints
Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.
Roster
The Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) CDE Working Group (WG) was comprised of eight different subgroups and a Steering Committee. Chairs were appointed to lead the overall Steering Committee and the individual subgroups. Superusers, who had the capability to create and revise CDEs on the NIH Repository website, were also appointed for each WG. The WG members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The SAH CDE WG was supported by the NINDS and National Library of Medicine (NLM) CDE Team. The complete SAH CDE Working Group roster and the rosters by Subgroup are shown below:
Publications
- Suarez JI, Macdonald RL. The End of the Tower of Babel in Subarachnoid Hemorrhage: Common Data Elements at Last. Neurocrit Care. 2019 Jun;30(Suppl 1):1-3.
- Suarez JI, Sheikh MK, Macdonald RL, Amin-Hanjani S, Brown RD Jr, de Oliveira Manoel AL, Derdeyn CP, Etminan N, Keller E, Leroux PD, Mayer SA, Morita A, Rinkel G, Rufennacht D, Stienen MN, Torner J, Vergouwen MDI, Wong GKC; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators. Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project. Neurocrit Care. 2019 Jun;30(Suppl 1):4-19.
- Bijlenga P, Morita A, Ko NU, Mocco J, Morel S, Murayama Y, Wermer MJH, Brown RD Jr; Unruptured Cerebral Aneurysms and SAH CDE Project Investigators. Common Data Elements for Subarachnoid Hemorrhage and Unruptured Intracranial Aneurysms: Recommendations from the Working Group on Subject Characteristics. Neurocrit Care. 2019 Jun;30(Suppl 1):20-27.
- Chou SH, Macdonald RL, Keller E; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators. Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations. Neurocrit Care. 2019 Jun;30(Suppl 1):46-59.
- de Oliveira Manoel, A.L., van der Jagt, M., Amin-Hanjani, S. et al. Neurocrit Care (2019) 30(Suppl 1): 36. https://doi.org/10.1007/s12028-019-00726-3
- Hackenberg KAM, Algra A, Salman RA, Frösen J, Hasan D, Juvela S, Langer D, Meyers P, Morita A, Rinkel G, Etminan N; Unruptured Aneurysms and SAH CDE Project Investigators. Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019 Jun;30(Suppl 1):87-101.
- Hackenberg KAM, Etminan N, Wintermark M, Meyers PM, Lanzino G, Rüfenacht D, Krings T, Huston J 3rd, Rinkel G, Derdeyn C; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators. Common Data Elements for Radiological Imaging of Patients with Subarachnoid Hemorrhage: Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019 Jun;30(Suppl 1):60-78.
- Stienen MN, Visser-Meily JM, Schweizer TA, Hänggi D, Macdonald RL, Vergouwen MDI; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators. Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019 Jun;30(Suppl 1):102-113.
- Wong GKC, Daly JJ, Rhoney DH, Broderick J, Ogilvy C, Roos YB, Siddiqui A, Torner J; Unruptured Intracranial Aneurysm and SAH CDE Project Investigators. Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research: Recommendations from the Working Group on Long-Term Therapies. Neurocrit Care. 2019 Jun;30(Suppl 1):79-86.
Updates
Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.
Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage CDEs Revision History