ID
12573
Beskrivning
The main goals of the GRDR (Global Rare Diseases Patient Registry and Data Repository) CDE (Common Data Elements) effort are to: 1) develop a set of CDEs to facilitate data collection for the GRDR in a standardized and meaningful manner; 2) assist organizations that have no patient registry to establish a registry and be able to share data with the GRDR or other databases; 3) facilitate harmonization among the many organizations collecting patient information. NIH has developed Model Registry CDEs (ORDR CDEs) for patient data entry to be used in any rare disease registry, including a subset of CDEs (GRDR CDEs) to collect only de-identified information for the GRDR data repository. ODM derived from: https://ncats.nih.gov/grdr Permission to publish granted by Yaffa Rubinstein.
Länk
Nyckelord
Versioner (2)
- 2015-12-02 2015-12-02 - Julian Varghese
- 2015-12-02 2015-12-02 - Julian Varghese
Rättsinnehavare
GRDR®
Uppladdad den
2 december 2015
DOI
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Licens
Creative Commons BY-NC 3.0
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The GRDR® Registry Model Common Data Elements (CDEs)
The GRDR® Registry Model Common Data Elements (CDEs)
- StudyEvent: ODM
Beskrivning
Socio-Demographic
Alias
- UMLS CUI-1
- C0011298
Beskrivning
GRDR will collect only the year of birth. Source registry must collect year,month and day to assign the GUID ISO 8601 1=4-digit Gregorian year 2=2-digit for month and 2 digit for day-YYYY/MM/DD 3=GRDR will collect only the year of birth. Source registry must collect year,month and day to assign the GUID
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348576
Beskrivning
LOINC Yes/No/Refused/Don't Know 1 – Yes 2 – No 3 – Refused 4 – Don’t know
Datatyp
integer
Alias
- UMLS CUI [1]
- C1148433
Beskrivning
NA If Vital Status "NO" ISO 8601 1=4-digit gregorian year
Datatyp
integer
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Used by the registry to generate the GUID 1-Male 2-Female 3-Other 4-Transsexual 5-Unknown LOINC/NAACCR extended sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0679646
- UMLS CUI [2]
- C1522384
Beskrivning
Race has two levels. The first level includes American Indian/Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, and Other. The second level provides the option for more detailed Asian and Native Hawaiian or Other Pacific Islander assignment. In most cases, we expect that registries will map to the first level only. 1 – American Indian or Alaska Native 2 – Asian 3 – Asian Indian 4 – Chinese 5 – Filipino 6 – Japanese 7 – Korean 8 – Vietnamese 9 – Other Asian 10 – Black or African American 11 – Native Hawaiian or Other Pacific Islander 12 – Native Hawaiian 13 – Guamanian 14 – Chamorro 15 – Samoan 16 – Other Pacific Islander 17 – White 18 – Other/Unknown/Refuse to Answer LOINC Extended Race
Datatyp
integer
Alias
- UMLS CUI [1]
- C0679646
- UMLS CUI [2]
- C0034510
Beskrivning
Ethnicity has two levels. The first level includes Hispanic or Latino, Non-Hispanic or Latino, Ashkenazi Jewish, and Unknown. The second level provides the option for more detailed Hispanic assignment. In most cases, we expect that registries will map to the first level only. 1 – Hispanic or Latino 2 – Central American 3 – Cuban 4 – Dominican (Republic) 5 – Mexican 6 – Puerto Rican 7 – South American 8 – Other Latin American 9 – Other Hispanic/Latino/Spanish 10 – Non-Hispanic or Latino 11 – Ashkenazi Jewish 12 – Unknown/No answer LOINC Ethnicity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
- UMLS CUI [2]
- C0679646
Beskrivning
ISO 3166-1alpha-2 code Select the country code from the International Organization for Standardization (ISO)=Select the country code from the International Organization for Standardization (ISO)
Datatyp
text
Alias
- UMLS CUI [1]
- C0027473
Beskrivning
ISO-3166 Select the country code from the International Organization for Standardization (ISO)=Select the country code from the International Organization for Standardization (ISO)
Datatyp
text
Alias
- UMLS CUI [1]
- C1300001
Beskrivning
Sources will vary for non-US respondents Postal service state names and abbreviations 1=In USA, select from the US Postal Service state abbreviations 2=In Canada, select from Canada Addressing Guidelines 3=In other countries, use the postal service abbreviation for the appropriate state- or province-level region
Datatyp
text
Alias
- UMLS CUI [1]
- C1286281
Beskrivning
Used by the registry to generate the GUID HL7 ST data type
Datatyp
text
Alias
- UMLS CUI [1]
- C0032040
Beskrivning
LOINC Yes/No/Refused/Don't Know 1 – Yes 2 – No 3 – Refused 4 – Don’t know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2029812
Beskrivning
For health insurance coverage outside the USA, please select the categories that most closely describe the source of the participant's health insurance 1 Private health insurance 2 Medicare 3 Medi-gap 4 Medicaid 5 SCHIP (Childrens Health Insurance Program) 6 Military health care (Tricare/VA, Champ-VA) 7 Indian health service 8 State-sponsored health plan 9 Other government program 10 Single service plan (e.g. dental, vision, prescription) 11 No coverage 13 Dont know LOINC Insurance
Datatyp
integer
Alias
- UMLS CUI [1]
- C3172579
Beskrivning
For participants receiving special educational services, please select the grade level assigned by their education provider. 1 - No schooling 2 - Preschool or nursery school 3 - Kindergarten 4 - 1st Grade 5 - 2nd Grade 6 - 3rd Grade 7 - 4th Grade 8 - 5th Grade 9 - 6th Grade 10 - 7th Grade 11 - 8th Grade 12 - 9th Grade 13 - 10th Grade 14 - 11th Grade 15 - 12th Grade 16 - GED 17 - College 30 - Don’t Know
Datatyp
integer
Alias
- UMLS CUI [1]
- C3258351
Beskrivning
LOINC level of education 1 – Eighth grade or less 2 – More than eighth grade, but did not graduate from high school 3 – Went to a business, trade, or vocational school instead of high school 4 – High school graduate 5 – Completed a GED 6 – Went to a business, trade, or vocational school after high school 7 – Went to college, but did not graduate 8 – Graduated from a college or university 9 – Professional training beyond a four-year college or university 10 – He/she never went to school 11 – He/she went to school, but respondent doesn’t know what level 12 – Respondent doesn’t know if he/she went to school 13 – Refused 15 – Don’t know
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013658
Beskrivning
LOINC level of education 1 – Eighth grade or less 2 – More than eighth grade, but did not graduate from high school 3 – Went to a business, trade, or vocational school instead of high school 4 – High school graduate 5 – Completed a GED 6 – Went to a business, trade, or vocational school after high school 7 – Went to college, but did not graduate 8 – Graduated from a college or university 9 – Professional training beyond a four-year college or university 10 – He/she never went to school 11 – He/she went to school, but respondent doesn’t know what level 12 – Respondent doesn’t know if he/she went to school 13 – Refused 15 – Don’t know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2924476
Beskrivning
LOINC level of education 1 – Eighth grade or less 2 – More than eighth grade, but did not graduate from high school 3 – Went to a business, trade, or vocational school instead of high school 4 – High school graduate 5 – Completed a GED 6 – Went to a business, trade, or vocational school after high school 7 – Went to college, but did not graduate 8 – Graduated from a college or university 9 – Professional training beyond a four-year college or university 10 – He/she never went to school 11 – He/she went to school, but respondent doesn’t know what level 12 – Respondent doesn’t know if he/she went to school 13 – Refused 15 – Don’t know
Datatyp
integer
Alias
- UMLS CUI [1]
- C3260565
Beskrivning
1 - Less than $10000 (USD) 2 - $10000 - $14999 3 - $15000 - $19999 4 - $20000 - $24999 5 - $25000 - $29999 6 - $30000 - $34999 7 - $35000 - $39999 8 - $40000 - $44999 9 - $45000 - $49999 10 - $50000 - $54999 11 - $55000 - $59999 12 - $60000 - $74999 13 - $75000 - $84999 14 - $85000 - $99999 15 - $100000 - $149999 16 - $150000 - $199999 17 - $200000 - $249999 18 - $250000 and above 19 - Unknown 20 - Decline to provide
Datatyp
integer
Alias
- UMLS CUI [1]
- C3166654
Beskrivning
GRDR025 Household Size
Datatyp
integer
Alias
- UMLS CUI [1]
- C0682277
Beskrivning
0 - Participant does not live in a group house 2 - 2 3 - 3 4 - 4 5 - 5 6 - 6 7 - 7 8 - 8 9 - 9 10 - 10 11 - 11 12 - 12 13 - 13 14 - 14 15 - 15 16 - 16 17 - 17 18 - 18 19 - 19 20 - 20 # Entered - Other- enter number
Datatyp
integer
Beskrivning
Diagnosis
Alias
- UMLS CUI-1
- C0011900
Beskrivning
Registries may wish to add "Other" with free text to capture additional data. Responses to these free text items will not be uploaded to the GRDR repository. Registry responses are mapped to SNOMED-CT concepts, and the GRDR stores the SNOMED-CT identifiers. SNOMED-CT Each registry pre-defines a set of diagnosis responses that are presented in the survey
Datatyp
text
Alias
- UMLS CUI [1]
- C0678236
Beskrivning
-2 - Prenatal -1 - At birth 0 - Less than 1 year 1 - 89 age in years 90 - 90+ years -3 - Age of diagnosis unknown
Datatyp
integer
Alias
- UMLS CUI [1]
- C1828181
Beskrivning
GRDR028 Age of Symptom Onset
Datatyp
integer
Alias
- UMLS CUI [1]
- C0150907
Beskrivning
LOINC Registry responses are mapped to LOINC IDs, and the GRDR stores the LOINC identifiers. 0 - None Registries may wish to add "Other" with free text to capture additional data. Responses to these free text items will not be uploaded to the GRDR repository. Each registry pre-defines a set of diagnostic testing responses that are presented in the survey
Datatyp
text
Alias
- UMLS CUI [1]
- C0678236
- UMLS CUI [2]
- C0086143
Beskrivning
Family History
Alias
- UMLS CUI-1
- C0241889
Beskrivning
Participant-reported 0 - None 1 – Daughter 2 – Granddaughter 3 – Grandson 4 – Half-brother 5 – Half-sister 6 – Maternal Aunt 7 – Maternal Cousin 8 – Maternal Grandfather 9 – Maternal Grandmother 10 – Maternal Uncle 11 – Brother 12 – Father 13 – Mother 14 – Sister 15 – Nephew 16 – Niece 17 – Paternal Aunt 18 – Paternal Cousin 19 – Paternal Grandfather 20 – Paternal Grandmother 21 – Paternal Uncle 22 – Son LOINC Family Relationships
Datatyp
integer
Alias
- UMLS CUI [1]
- C0241889
- UMLS CUI [2]
- C0678236
Beskrivning
The GRDR will record 2 values: 1. The weight (with units) reported by the registry 2. The weight in grams
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005612
Beskrivning
Units used for measurement of birth weight
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
1 – Yes 2 – No 3 – Refused 4 – Don’t know LOINC Yes/No/Refused/Don't Know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2825543
- UMLS CUI [2]
- C0421451
Beskrivning
-2 - 2 weeks late -1 - 1 week late 0 - On time 1 - 1 week premature 2 - 2 weeks premature 3 - 3 weeks premature 4 - 4 weeks premature 5 - 5 weeks premature 6 - 6 weeks premature 7 - 7 weeks premature 8 - 8 weeks premature 9 - 9 weeks premature 10 - 10 weeks premature 11 - 11 weeks premature 12 - 12 weeks premature 13 - 13 weeks premature 14 - 14 weeks premature 15 - 15 weeks premature 16 - 16 weeks premature 17 - 17 weeks premature 18 - 18 weeks premature 19 - 19 weeks premature 20 - 20 weeks premature If EGA at birth is available, use 40 - EGA
Datatyp
integer
Alias
- UMLS CUI [1]
- C0151526
- UMLS CUI [2]
- C3829314
Beskrivning
GRDR052 Number of Pregnancies
Datatyp
integer
Alias
- UMLS CUI [1]
- C3812254
Beskrivning
GRDR053 Number of Live Births
Datatyp
integer
Alias
- UMLS CUI [1]
- C2114487
Beskrivning
GRDR054 Number of Living Children
Datatyp
integer
Alias
- UMLS CUI [1]
- C2114489
Beskrivning
Anthropometric
Alias
- UMLS CUI-1
- C0003188
Beskrivning
The GRDR will record 2 values: 1. The weight (with units) reported by the registry 2. The weight in grams
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Units used for weight measurement
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Year + partial year in increments of 0.25 i.e 4 + 3-6months = 4.25yrs 4+ 6-9months=4.5yrs ...
Datatyp
float
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0005910
Beskrivning
"The GRDR will record 2 values: 1. The height (with units) reported by the registry 2. The height in centimeters "
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Units used for measurement of height
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Year + partial year in increments of 0.25 i.e 4+3-6months=4.25yrs 4+6-9 months=4.5yrs ...
Datatyp
float
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0005890
Beskrivning
Patient reported outcome
Alias
- UMLS CUI-1
- C2987124
Beskrivning
1- Excellent 2- Very good 3- Good 4- Fair 5- Poor PROMIS SF v1.0 - Global Health:
Datatyp
integer
Alias
- UMLS CUI [1]
- C0424575
Beskrivning
1- Not at all 2- Very little 3- Somewhat 4- Quite a lot 5- Cannot do PROMIS SF v1.0 10a - Physical
Datatyp
integer
Alias
- UMLS CUI [1]
- C0516981
Beskrivning
1- Not at all 2- A little bit 3- Somewhat 4- Quite a bit 5- Very much PROMIS SF v1.0 - Fatigue 6b:
Datatyp
integer
Alias
- UMLS CUI [1]
- C0030193
Beskrivning
Never Rarely Sometimes Often Always PROMIS SF v1.0 - Fatigue 7a:
Datatyp
text
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
PROMIS SF v1.0 - Depression 8b: 1- Never 2- Rarely 3- Sometimes 4- Often 5- Always
Datatyp
integer
Alias
- UMLS CUI [1]
- C0344315
Beskrivning
Devices and Health services
Alias
- UMLS CUI-1
- C0018747
Beskrivning
Registries may wish to add "Other" with free text to capture additional data. Responses to these free text items will not be uploaded to the GRDR repository. Each registry defines a set of responses that are presented in the survey. Registry responses are mapped to RxNorm identifiers specifying the active ingredient(s) and route of administration. RxNorm
Datatyp
text
Alias
- UMLS CUI [1]
- C0746467
Beskrivning
Registries may wish to add "Other" with free text to capture additional data. Responses to these free text items will not be uploaded to the GRDR repository. Each registry defines a set of responses that are presented in the survey. Registry responses are mapped to NDF-RT identifiers. National Drug File - Reference Terminology
Datatyp
text
Alias
- UMLS CUI [1]
- C1519433
Beskrivning
Registries may wish to add "Other" with free text to capture additional data. Responses to these free text items will not be uploaded to the GRDR repository. Each registry pre-defines a set of diagnosis responses that are presented in the survey. Registry responses are mapped to SNOMED-CT surgery concepts, and the GRDR stores the SNOMED-CT identifiers. SNOMED-CT
Datatyp
text
Alias
- UMLS CUI [1]
- C0543467
Beskrivning
1- Yes 2- No 3- Refused 4- Don't know
Datatyp
integer
Alias
- UMLS CUI [1]
- C0019993
Beskrivning
GRDR041 Participant Hospitalization Count
Datatyp
integer
Beskrivning
Registries may wish to add "Other" with free text to capture additional data. Responses to these free text items will not be uploaded to the GRDR repository. Each registry pre-defines a set of diagnosis responses that are presented in the survey. Registry responses are mapped to UMDNS identifiers Universal Medical Device Nomenclature System
Datatyp
text
Alias
- UMLS CUI [1]
- C0872018
Beskrivning
Clinical Research Participation and Biospecimen
Alias
- UMLS CUI-1
- C0008972
- UMLS CUI-3
- C0679823
Beskrivning
Yes No Refused Don’t know LOINC Yes/No/Refused/Don't Know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
LOINC Yes/No/Refused/Don't Know 1 – Yes 2 – No 3 – Refused 4 – Don’t know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
Yes No Refused Don’t know LOINC Yes/No/Refused/Don't Know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
Yes No Refused Don’t know LOINC Yes/No/Refused/Don't Know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347026
- UMLS CUI [2]
- C0080231
Beskrivning
Yes No Refused Don’t know LOINC Yes/No/Refused/Don't Know
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347026
Beskrivning
Blood Saliva/Cheek Swab Urine Other bodily fluid Tissue N/A - No biospecimen donation
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347029
Beskrivning
HL7 TX data type
Datatyp
text
Alias
- UMLS CUI [1]
- C2347026
- UMLS CUI [2]
- C0019994
Beskrivning
Contact and Communication Preferences
Alias
- UMLS CUI-1
- C1997600
Beskrivning
HL7 ST data type Sign language Spoken language Written language http://www.hl7.org/
Datatyp
integer
Alias
- UMLS CUI [1]
- C1997600
Beskrivning
E-mail Mail Phone http://www.hl7.org/
Datatyp
integer
Alias
- UMLS CUI [1]
- C1880174
Beskrivning
Administrative
Alias
- UMLS CUI-1
- C1320722
Beskrivning
This is not asked of registry participants, but generated by the source registry to indicate whether participant’s ID is a GUID or registry specific identifier
Datatyp
text
Alias
- UMLS CUI [1]
- C2985615
Beskrivning
This is not asked of registry participants, but generated by the GRDR. The GRDR will develop and maintain a list of all source registries and use that to populate this field. Each source registry will be assigned a unique 8-digit code.
Datatyp
text
Alias
- UMLS CUI [1]
- C0804617
Beskrivning
This is not asked of registry participants, but generated by the source registry. It is the date when the current registry record was updated or completed. Note that there can be multiple records for each participant, and the registry record date will help identify these temporally. Date including 4-digit year, month, day Date in ISO-8601 format: YYYY-MM-DD ISO 8601
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
The GRDR® Registry Model Common Data Elements (CDEs)
- StudyEvent: ODM
C0850287 (UMLS CUI [2])
C0600420 (UMLS CUI [1,2])
C1522384 (UMLS CUI [2])
C0034510 (UMLS CUI [2])
C0679646 (UMLS CUI [2])
C0086143 (UMLS CUI [2])
C0678236 (UMLS CUI [2])
C0421451 (UMLS CUI [2])
C3829314 (UMLS CUI [2])
C0005910 (UMLS CUI [2])
C0005890 (UMLS CUI [2])
C0679823 (UMLS CUI-3)
C0080231 (UMLS CUI [2])
C0019994 (UMLS CUI [2])