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)
Congenital Muscular Dystrophy Start-Up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Congenital Muscular Dystrophy study start-up
Congenital Muscular Dystrophy Highlight Summary: Overview of all Congenital Muscular Dystrophy-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
To develop the Congenital Muscular Dystrophy (CMD) CDEs, the CMD CDE Working Group met from April 2014 to October 2014. The recommendations were posted for public comment in November 2014 and version 1.0 was released at the end of February 2015.
Other CMD CDE development:
In 2010, the CMD CDE Project developed CDEs created in collaboration between the NINDS and Cure CMD. These CDEs are tailored specifically for a CMD natural history study and may be reused as appropriate.
Download Congenital Muscular Dystrophy (CMD) Natural History Study CDE Package
Roster
The Congenital Muscular Dystrophy (CMD) CDE Working Group has developed the CDEs for their recommendations. The CMD CDE Working Group is supported by the NINDS CDE Team. The Working Group began meeting by teleconference in May 2014 and held calls every four to six weeks to define the CDEs for their domains and to recommend standardized, validated instruments for CMD research.
The complete CMD CDE Working Group roster is shown below.
Publications
Publications
- Allamand V, Merlini L, Bushby K on behalf of the Consortium for Collagen VI-related myopathies.166th ENMC International Workshop on Collagen type VI related Myopathies, 22-24 May 2009, Naarden, The Netherlands. Neuromuscular Disorders (2010). 20:346-354. PubMed PMID: 20211562.
- Mercuri E, Messina S, Bruno C, Mora M, Pegoraro E, Comi GP, et al. Congenital muscular dystrophies with defective glycosylation of dystroglycan: a population study. Neurology 2009; 26:1802-1809. PubMed PMID: 19299310.
- Lawlor MW, Iannaccone ST, Mathews K, Muntoni F, Alai-Hansen S, Odenkirchen JC, S Feldman R; on behalf of the CMD Working Group. NINDS Common Data Elements for Congenital Muscular Dystrophy Clinical Research: A National Institute for Neurological Disorders and Stroke Project. Journal of Neuromuscular Diseases. 2018; 5(1):75-84. PubMed PMID: 29480213
- Nadeau A, Kinali M, Main M, Jimenez-Mallebrera C, Aloysius A, Clement E, North B, Manzur AY, Robb SA, Mercuri E, Muntoni F. Natural history of Ullrich congenital muscular dystrophy. Neurology 2009 Jul 7;73 (1): 25-31. PubMed PMID: 19564581.
- Bonnemann C G (2009) Congenital Muscular Dystrophy. In: Squire LR (ed.) Encyclopedia of Neuroscience, volume 3, pp. 67-74. Oxford: Academic Press.
Additional References
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.