CDE Detailed Report | NINDS Common Data Elements

Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: Physical/Neurological Examination
CRF: Physical Examination

Displaying 1 - 8 of 8

CDE ID	CDE Name	Variable Name	Definition	Short Description	Question Text	Permissible Values	Description	Data Type	Disease Specific Instructions	Disease Specific Reference	Population	Classification (e.g., Core)	Version Number	Version Date	CRF Name (CRF Module / Guidance)	Subdomain Name	Domain Name	Size	Input Restrictions	External Id caDSR
C00023	Hand preference type	HandPrefTyp	Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively	Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel	Hand Preference	Left hand;Right hand;Both hands;Unknown	Left hand;Right hand;Both hands;Unknown	Alphanumeric	Choose one. The predominant hand does not have to be the hand that he/she writes with. Unknown should be used in the scenario for infants or other (rare) instances when handedness can not be known or is not yet developed.	Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. Amyotroph Lateral Scler. 2012; 13(5): 430–438.	Adult;Pediatric	Supplemental	3.00	2013-07-25 08:54:08.2	Physical Examination	Physical/Neurological Examination	Assessments and Examinations		Single Pre-Defined Value Selected	2180147
C00312	Body system category	BodySysCat	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	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 system	Body System	Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal (separate from ALS exam);Neurological (separate from ALS exam);Psychiatric;Respiratory	Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Genitourinary;Hematologic/Lymphatic;Integumentary (skin and/or breast);Musculoskeletal (separate from ALS exam);Neurological (separate from ALS exam);Psychiatric;Respiratory	Alphanumeric	Record the appropriate body system for each line of medical history. Each body system is pre-populated on the case report form.	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	Adult;Pediatric	Core	3.00	2013-07-25 08:54:08.2	Physical Examination	Physical/Neurological Examination	Assessments and Examinations		Single Pre-Defined Value Selected	2002895
C01010	Physical exam date and time	PhysExamDateTime	Date (and time if applicable and known) physical exam was performed	Date (and time if applicable and known) physical exam was performed	Date and Time of Exam			Date or Date & Time	Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).	No references available	Adult;Pediatric	Core	3.00	2013-08-28 16:08:00.453	Physical Examination	Physical/Neurological Examination	Assessments and Examinations		Free-Form Entry	2004170
C01012	Physical exam body system result type	PhysExamBodySysResltTyp	Assessment result of each body system examined	Assessment result of each body system examined	Result	Abnormal;Normal;Not examined	Abnormal;Normal;Not examined	Alphanumeric	Choose one. Indicate whether each body system examined had any abnormal findings.	No references available	Adult;Pediatric	Core	3.00	2013-07-25 08:54:08.2	Physical Examination	Physical/Neurological Examination	Assessments and Examinations		Single Pre-Defined Value Selected	2821383
C01013	Physical exam description text	PhysExamDescripTxt	Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined	Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined	Describe Abnormality or Comment if Body System is Not Examined			Alphanumeric	Provide a description of each abnormal result found during the physical exam, or provide an explanation of why the body system was not examined. See the data dictionary for additional information on coding the abnormality using the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT).	SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html)	Adult;Pediatric	Core	3.00	2013-07-25 08:54:08.2	Physical Examination	Physical/Neurological Examination	Assessments and Examinations	255	Free-Form Entry	2201880
C01015	Physical exam performed indicator	PhysExamPerfrmdInd	Indicator of whether a physical exam was performed on the participant/subject	Indicator of whether a physical exam was performed on the participant/subject	Was a physical exam performed on the participant/subject?	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Choose one. Specify whether or not a physical exam was performed on the participant/subject.	No references available	Adult;Pediatric	Core	3.00	2013-07-25 08:54:08.2	Physical Examination	Physical/Neurological Examination	Assessments and Examinations		Single Pre-Defined Value Selected	2201750
C01028	Physical exam condition SNOMED CT code	PhysExamCondSNOMEDCTcode	Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT)	Medical condition/disease found during the physical examination of the participant/subject. Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT)				Alphanumeric	See the data dictionary for additional information on coding the abnormality using the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT).	SNOMED CT CODES - Problem List (http://www.nlm.nih.gov/research/umls/Snomed/core_subset.html)	Adult;Pediatric	Supplemental	3.00	2013-08-28 16:08:00.453	Physical Examination	Physical/Neurological Examination	Assessments and Examinations	255	Free-Form Entry
C18666	Body system category other text	BodySysCatOTH	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	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	Other, specify			Alphanumeric	Record the appropriate body system for each line of medical history. Each body system is pre-populated on the case report form.	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	Adult;Pediatric	Core	1.10	2023-11-07 08:40:35.0	Physical Examination	Physical/Neurological Examination	Assessments and Examinations	4000	Free-Form Entry	2002895