General Standards - NINDS Common Data Elements

General CDE Standards

The initial focus of the Common Data Element (CDE) Project was the development of General CDEs. The General CDEs were first published (i.e., Version 1.0) on this site in 2007. The General CDE Standards are designed to be applied across neurological disease areas. Some examples of the types of elements included in the General CDEs are: demographic data, medical history data, treatment/intervention data, and safety data. Investigators are encouraged to collect these data elements if appropriate for their clinical research studies. For more information, please visit the Project Overview page.

Data Standards

Data standards encompass the 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 below are organized into categories of data which are common to clinical research studies. Choose the category of data you are interested in to find the related data standards.

Participant/Subject Characteristics

Participant/Subject Characteristics General CDE Recommendations
Category	Name of Standard	CDEs	CRF Module or Guideline
Demographics	Demographics		58KB

Participant/Subject History and Family History

Participant/Subject History and Family History General CDE Recommendations
Category	Name of Standard	CRF Module or Guideline
General Health History	Medical History - Review of Systems at Baseline	105KB
	Family History at Baseline	108KB
	Surgical History at Baseline	49KB
	Behavioral History at Baseline	53KB

Assessments and Examinations

Assessments and Examinations General CDE Recommendations
Category	Name of Standard	CDEs	CRF Module or Guideline
Physical/ Neurological Exam	Physical Exam		63KB
Vital Signs and Other Body Measures	Vital Signs, Weight and Height		60KB
Laboratory Tests and Biospecimens/ Biomarkers	Laboratory Tests		78KB
	Laboratory Tracking		111KB
	Coriell's Control Data Elements	N/A	Coriell Institute
Non-Imaging Diagnostics	Electrocardiogram (ECG)		74KB

Treatment/Intervention Data

Treatment/Intervention Data General CDE Recommendations
Category	Name of Standard	CRF Module or Guideline
Drugs	Prior and Concomitant Medications	70KB
	Study Drug Dosing	61KB
	Study Drug Compliance	47KB

Protocol Experience

Protocol Experience General CDE Recommendations
Category	Name of Standard	CDEs	CRF Module or Guideline
Participant/Subject Identification, Eligibility, and Enrollment	Screening Log	N/A	66KB
	Inclusion and Exclusion Criteria		51KB
	Informed Consent and Enrollment		57KB
Protocol Deviations	Protocol Deviations	N/A	49KB
Off Treatment / Off Study	Study Discontinuation / Completion		62KB
Study Management	Participant/Subject Contact Information	N/A	43KB
	Visit Checklist	N/A	52KB
	Visit Schedule	N/A	66KB

Safety Data

Safety Data General CDE Recommendations
Category	Name of Standard	CDEs	CRF Module or Guideline
Adverse Events	Adverse Events		83KB
Adverse Events	Serious Adverse Events	N/A	69KB

Outcomes and End Points

Outcomes and End Points General CDE Recommendations
Category	Name of Standard	CRF Module or Guideline
Global Outcomes	Rankin Scale (Modified)	51KB
Global Outcomes	Trail Making Score	46KB
End Points	Death Report	40KB

Update History

General CDE Change Log

Acknowledgements

Please note that the institutions for all individuals acknowledged in this section were those they belonged to when the group was initially formed.

CDE Oversight Committee

The NINDS CDE Project Team began work to develop the General CDEs in early 2006. As the Project Overview explains, the Team identified the initial draft set of General CDEs by reviewing the literature, case report forms (CRFs) from large NINDS-funded studies, other clinical data standards, and regulatory requirements. They convened a meeting on April 26, 2006 to present the draft set of General CDE materials to a small group of experienced clinical research investigators in neurology:

Gary Cutter, PhD - University of Alabama School of Public Health
Yang Faan, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
Chelsea Kidwell, MD - Georgetown University
Karl Kieburtz, MD, MPH - University of Rochester
Roger Kurlan, MD - University of Rochester
Yuko Palesch, PhD - Medical University of South Carolina
Ralph Sacco, MD, MS - University of Miami
Barbara Tilley, PhD - University of Texas School of Public Health

At the meeting and for sometime afterwards, the researchers listed above offered direction and guidance to the overall NINDS CDE Project and also provided more specific feedback about the General CDEs.

In late 2008, the Project Team invited a few other researchers to provide critical feedback about the General CDEs, given their involvement on related projects:

Roderick Corriveau, PhD (NINDS Genetics Repository) - Coriell Institute for Medical Research
Laurie Gutmann, MD (NINDS Genetics Repository) - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
Andrew Maas, MD, PhD (International Mission for Prognosis and Analysis of Clinical Trials in TBI and the TBI CDE Project - IMPACT) - University Hospital Antwerp, Belgium

The aforementioned individuals have all served on the CDE Oversight Committee. As several disease-specific CDEs will soon be published on this Web site, the NINDS is planning to formalize the role and expand the membership of the CDE Oversight Committee. More information about the reinstated CDE Oversight Committee will be forthcoming.

NINDS CDE Team

The following NINDS CDE Team members also helped develop the General CDEs:

John Marler, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
Kristy Miller, MPH - KAI Research, Inc
Stacie Grinnon, MS - KAI Research, Inc
Selma Kunitz, PhD - KAI Research, Inc
Yun Lu, PhD - KAI Research, Inc

Feedback

The NINDS welcomes feedback about these data standards. The NINDS CDE Team is currently working to add an interactive form to this Website that allows visitors to submit their feedback about the General CDEs. In the interim, please email your comments and suggestions about these data standards to NINDSCommonData@kai-research.com.