CDE Detailed Report | NINDS Common Data Elements

Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: General Health History
CRF: Medical History

Displaying 1 - 18 of 18

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
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);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:	Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;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	3.00	2013-07-25 08:54:08.2	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected	2002895
C10982	Childbearing potential sterile reason	ChldbrngPotentSterilRsn	Explanation of why the female participant/subject is not of childbearing potential	Explanation of why the female participant/subject is not of childbearing potentia	If no, check appropriate box	Surgically sterile;Non-surgically sterile;Post menopausal for at least one year	Surgically sterile;Non-surgically sterile;Post menopausal for at least one year	Alphanumeric	Only answered if "Is the subject of childbearing potential?" is answered No. Choose one.	No references available	Adult	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected
C00313	Medical history condition SNOMED CT code	MedclHistCondSNOMEDCTCode	Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject	Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject	Medical History Term			Alphanumeric	Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT.	SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)	Adult;Pediatric	Core	3.00	2013-07-25 08:54:08.2	Medical History	General Health History	Participant History and Family History	255	Free-Form Entry
C10983	Childbearing potential surgically sterile type	ChldbrngPotentSurgSterilTyp	Type of surgical procedure that rendered the participant/subject sterile	Type of surgical procedure that rendered the participant/subject steril	If surgicially sterile, check one	Hysterectomy;Tubal ligation;Other, specify	Hysterectomy;Tubal ligation;Other, specify	Alphanumeric	Only answered if "Is the subject of childbearing potential?" is answered No, and "Surgically sterile" is checked as the reason. Choose one.	No references available	Adult	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected
C00314	Medical history taken date and time	MedclHistTakenDateTime	Date (and time, if applicable and known) the participant's medical history was taken	Date (and time, if applicable and known) the participant 's medical history was taken	Date Medical History Taken			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	Supplemental	3.20	2024-02-29 15:42:39.0	Medical History	General Health History	Participant History and Family History		Free-Form Entry	2179659
C17770	Allergy diagnosis indicator	AllergyDiagnInd	Indicator of whether the participant/subject has allergies	Indicator of whether the participant/subject has allergie	Does the subject have any allergies?	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric		No references available	Adult	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected
C00315	Medical history global assessment indicator	MedclHistGlobalAssmtInd	Indicator of whether the participant has a history of any medical problems/conditions	Indicator of whether the participant has a history of any medical problems/conditions	Does the participant/subject have a history of any medical problems/conditions in the following body systems?	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Choose one. If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded.	No references available	Adult;Pediatric	Supplemental	3.10	2024-02-29 15:42:39.0	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected	3145578
C17771	Allergy diagnosis type	AllergyTyp	Type of allergy the participant/subject experiences	Type of allergy the participant/subject experienc	If yes, check which type	Seasonal;Food;Medication	Seasonal;Food;Medication	Alphanumeric		No references available	Adult	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History		Multiple Pre-Defined Values Selected
C00316	Medical history condition end date and time	MedclHistCondEndDateTime	Date (and time, if applicable and known) for the end of an event in the participant's medical history	Date (and time, if applicable and known) for the end of an event in the participant's medical history	End Date			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	Supplemental	3.10	2024-02-29 15:42:44.0	Medical History	General Health History	Participant History and Family History		Free-Form Entry	3145557
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	Supplemental	1.10	2023-11-07 08:40:35.0	Medical History	General Health History	Participant History and Family History	4000	Free-Form Entry	2002895
C00317	Medical history condition start date and time	MedclHistCondStrtDateTime	Date (and time, if applicable and known) for the start of an event in the participant's medical history	Date (and time, if applicable and known) for the start of an event in the participant's medical history	Start Date			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	3.10	2024-02-29 15:42:43.0	Medical History	General Health History	Participant History and Family History		Free-Form Entry	2543596
C18817	Birth control method other text	BirthCntrlMethdOTH	The free-text field related to 'Birth control method type' specifying other text. The female participant's/subject's method of birth control	The free-text field related to 'Birth control method type' specifying other text. The female participant's/subject's method of birth control	Other, specify			Alphanumeric	Only answered if "Is the subject of childbearing potential?" is answered Yes. Choose all that apply.	No references available	Adult;Pediatric	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History	4000	Free-Form Entry
C00319	Medical history condition ongoing indicator	MedclHistCondOngoingInd	Indicator of whether a medical condition/disease experienced by the participant is ongoing	Indicator of whether a medical condition/disease experienced by the participant is ongoing	Ongoing	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Check Yes or No to indicate if the medical condition/disease is still present.	No references available	Adult;Pediatric	Supplemental	4.00	2024-02-29 15:42:44.0	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected	2736881
C18818	Childbearing potential surgically sterile other text	ChldbrngPotentSurgSterilOTH	The free-text field related to 'Childbearing potential surgically sterile type' specifying other text. Type of surgical procedure that rendered the participant/subject sterile	The free-text field related to 'Childbearing potential surgically sterile type' specifying other text. Type of surgical procedure that rendered the participant/subject steril	Other, specify			Alphanumeric	Only answered if "Is the subject of childbearing potential?" is answered No, and "Surgically sterile" is checked as the reason. Choose one.	No references available	Adult	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History	4000	Free-Form Entry
C00321	Medical history for body system indicator	MedclHistBodySysInd	Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system	Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body syste	Does the participant/subject have a history of any medical problems/conditions in the following body systems?	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Choose one for each body system.	No references available	Adult;Pediatric	Core	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected
C00322	Medical history condition text	MedclHistCondTxt	Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history	Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history	Medical History Term			Alphanumeric	Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT.	SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)	Adult;Pediatric	Core	3.00	2013-07-25 08:54:08.2	Medical History	General Health History	Participant History and Family History	4000	Free-Form Entry	2003874
C10980	Childbearing potential indicator	ChldbrngPtntlInd	Indicator of whether the participant is of childbearing potential	Indicator of whether the participant is of childbearing potential	Is the subject of childbearing potential?	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Choose one. No should be chosen if the participant/subject is a male.	No references available	Adult;Pediatric	Supplemental	3.00	2013-07-22 16:57:17.79	Medical History	General Health History	Participant History and Family History		Single Pre-Defined Value Selected
C10981	Birth control method type	BirthCntrlMethdTyp	The participant's method of birth control	The participant's method of birth control	If yes, check box for birth control measure	Oral contraceptives – combined pill;Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Implantable devices with hormone;Abstinence;Hormonal (e.g., oral, implanted, injected);Intrauterine device in place for greater than or equal to 3 months;Adequate barrier method in conjunction with spermicide;None of these;Other, specify:	Oral contraceptives – combined pill;Oral contraceptives – progestin-only pill;Transdermal patch;Shot/injection;Vaginal ring;Implantable devices with hormone;Abstinence;Hormonal (e.g., oral, implanted, injected);Intrauterine device in place for greater than or equal to 3 months;Adequate barrier method in conjunction with spermicide;None of these;Other, specify:	Alphanumeric	Only answered if "Is the subject of childbearing potential?" is answered Yes. Choose all that apply.	No references available	Adult;Pediatric	Supplemental	4.00	2024-03-18 15:21:17.0	Medical History	General Health History	Participant History and Family History		Multiple Pre-Defined Values Selected