Listed below are the details for the data element.
						
							FITBIR
   						
					
				
					1.12
				
			Element Type
						
						
							Common Data Element
						
					
					Body system category other text
				
			
					BodySysOTH
				
			Short Description
				
					Free-text related to Body System category CDE used in the comprehensive assessment of a participant/subject..
				
			Definition
				
					The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems.
				
			Notes
				
					FITBIR|PDBP; Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf
				
			Creation Date
				Historical Notes
				
					linked FS: FamilyHx_FITBIR|InjHx_FITBIR|MedHx_FITBIR|SeriousAdvEvents_FITBIR|IntSCICardioFxnBDS|IntSCIEndoMetabFxnBDS|IntSCIPulmonaryBDS|MedicalAndFamilyHx|PhysicalExamFITBIR|ROS|TBISigHist_EPO
				
			References
				
					ALS/DMD/EPILEPSY/FA/GENERAL/HEADACHE/MG/NMD/SMA/STROKE/TBI: Review of Symptoms from Centers for Medicare and Medicaid Services https: //www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf. MS: Review of Symptoms from Centers for Medicare and Medicaid Services https: //www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf. Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Bieringarensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8): 586-90. Bauman WA, Bieringensen F, Krassioukov A. International spinal cord injury endocrine and metabolic function basic data set. Spinal Cord. 2011 Oct;49(10): 1068-72.
				
			Data Type
				
					Alphanumeric
				
			Input Restrictions
				
					Free-Form Entry
				
			Maximum Character Quantity
						
							4000
						
					Population
				
					Adult and Pediatric
				
			Guidelines/Instructions
				
					Record the appropriate body system for each line of medical history.  Each body system is pre-populated on the case report form. TBI: Choose one. Response is obtained by report of the participant/subject or proxy as soon as possible after visit/admission. Document the date the history was obtained so it can be determined whether this information was obtained prior to study enrolment or later. Recommend collection at least on date of TBI or at time of first medical treatment. Comorbidity prior to injury may influence the disease course and chances of recovery. Serious comorbidity or comorbidity that may influence the assessment of outcome are generally considered exclusion criteria in randomized clinical trials. It is therefore highly relevant to accurately record the significant relevant medical history.
				
			Preferred Question Text
				
					Other, specify
				
			Category Groups and Classifications
				| Disease | Domain | Sub-Domain | 
|---|---|---|
| Traumatic Brain Injury | Participant/Subject History and Family History | General Health History | 
| General (For all diseases) | Participant/Subject History and Family History | General Health History | 
| Parkinson's Disease | Participant/Subject History and Family History | General Health History | 
Classification
				Traumatic Brain Injury:
				
				
					Supplemental
				
				
					
						
						
							Acute Hospitalized
						
					
				
					
						
						
							Epidemiology
						
					
				
					
						
						
							Concussion/Mild TBI
						
					
				
					
						
						
							Moderate/Severe TBI: Rehabilitation
						
					
				
				
			
				General (For all diseases):
				
				
					Supplemental
				
				
					
				
				
			
				Parkinson's Disease:
				
				
					Supplemental
				
				
					
				
				
			Keywords
				
					
						
							Injury_History
						 
					
						
							Medical_History
						 
					
						
							COVID
						 
					
				
			Labels
				
					
						
							NINDS_CDE
						 
					
				
			






