CDE Detailed Report

Disease: content
Subdomain Name: General Health History
CRF: welcome

Displaying 1 - 33 of 33
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 Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C16145 Family history relative birth date FmlyHistReltvBirthDate The date of birth of a related family members to the participant/subject The date of birth of a relative to a participant/subject Date of Birth Date or Date & Time

Complete for all relatives diagnosed with MS. 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 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C17450 MS first cousin diagnosis total count MS1stCousinDiagTtlCt The total number of first cousins that were diagnosed with Multiple Sclerosis The total number of first cousins that were diagnosed with Multiple Sclerosi Specify total number of cousins Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C00720 Family history medical condition type FamHistMedclCondTyp Type of medical condition or health related event for which the family history is taken Type of medical condition or health related event for which the family history is taken Condition Alphanumeric

This CDE should be collected along with the "Family history medical condition indicator". It is strongly recommended that the immediate family history of Friedreich's ataxia and ataxia be collected but collecting the family history of the other conditions is optional. Answer for first and second degree blood relatives. The majority of the medical conditions are Supplemental with the exception of the following which are Core: Developmental Delays; Epilepsy (pediatric only); Seizures without epilepsy diagnosis (pediatric only); Heart Disease; Muscle Disease; Peripheral Neuropathy For MS: The value for this CDE is "multiple sclerosis (MS)". This CDE should be collected along with the "Family history medical condition indicator".

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 4.00 2024-02-29 15:42:34.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

3165585
C19051 Parents biologically related other text PrntsBioRltdOTH The free-text field related to 'Parents biologically related type' specifying other text. Type of relation of the biologically related parents The free-text field related to 'Parents biologically related type' specifying other text. Type of relation of the biologically related parents Other, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History 4000

Free-Form Entry

C16146 Family history relative age at death value FmlyHistReltvAgeDeathVal Age at death of the participant/subject's relative, if applicable Age at death of the participant/subject's relative, if applicable Age at Death Numeric Values

Age should be captured in years. Complete for all relatives diagnosed with MS. Leave age at death blank and check Not Applicable if relative is still living.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

0 130 year
C17451 MS aunt diagnosis total count MSAuntDiagTtlCt The total number of aunts that were diagnosed with Multiple Sclerosis The total number of aunts that were diagnosed with Multiple Sclerosi Specify total number of aunts with MS Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C00721 Family history medical condition indicator FamHistMedclCondInd Indicator of whether a family member or first and second degree blood relatives of the participant has had a history of the particular medical condition or health related event Indicator of whether a family member or first and second degree blood relatives of the participant has had a history of the particular medical condition or health related event Condition Yes;No;Unknown Yes;No;Unknown Alphanumeric

If there is a history of this condition in the first or second degree family, indicate YES, otherwise choose NO. For MS: Choose one based on whether there is a history of MS for the relative type.

No references available Adult;Pediatric Supplemental 4.00 2024-02-29 15:42:36.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

3165788
C16147 Family history relative death cause text FmlyHistRltvDeathCauseTxt Cause of death of the participant/subject's relative, if applicable Cause of death of the participant/subject's relative, if applicable Cause of Death Alphanumeric

Complete for all relatives diagnoses with MS. If relative is still living, leave cause of death blank and check Not Applicable

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History 255

Free-Form Entry

C17452 MS aunt uncle diagnosis indicator MSAuntUncleDiagInd The indicator of whether any aunts and/or uncles were diagnosed with Multiple Sclerosis The indicator of whether any aunts and/or uncles were diagnosed with Multiple Sclerosi Do you have any aunts and/or uncles who have been diagnosed with MS Yes;No;Unknown;Not applicable Yes;No;Unknown;Not applicable Alphanumeric

Yes, medical record confirmed: Confirmed by medical records or autopsy report. Study design/diagnostic criteria choice can dictate degree of certainty to call an individual affected.
Yes, per patient history: Relative is affected according to patient.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00722 Family history medical condition relative type FamHistMedclCondReltvTyp Relationship of the family member or ancestor with the medical condition or health related event to the participant Relationship of the family member or ancestor with the medical condition or health related event to the participant Relationship Mother;Father;Full sibling;Half sibling;Child;Maternal grandmother;Paternal grandmother;Maternal grandfather;Paternal grandfather;Maternal aunt;Paternal aunt;Maternal uncle;Paternal uncle;Maternal niece/nephew;Paternal niece/nephew;Grandchild;Other, specify;Maternal cousin;Paternal cousin;Great-grandchild Mother;Father;Full sibling;Half sibling;Child;Maternal grandmother;Paternal grandmother;Maternal grandfather;Paternal grandfather;Maternal aunt;Paternal aunt;Maternal uncle;Paternal uncle;Maternal niece/nephew;Paternal niece/nephew;Grandchild;Other, specify;Maternal cousin;Paternal cousin;Great-grandchild Alphanumeric

Answer the family history items for each relative type. Select the relationship from the options of the family members listed. Record/choose more than one family member, if applicable. For MS: Use this element along with "Family history relative type biological sample in repository indicator" (C08001) to record which relatives had a DNA sample banked in a repository. For HD: If no first degree relatives have been diagnosed with HD, do not complete family history for second degree relatives. If either or both of the participant's/subject's parents have been diagnosed with HD, complete family history for second degree relatives by considering only the parent(s) diagnosed with HD to determine maternal/paternal relationship.

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 4.00 2024-03-18 15:21:17.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

3165810
C16148 Biological parent twin indicator BioPrntTwinInd Indicates whether the biological parent is a twin Indicates whether the biological parent is a twin Is the parent a twin Yes;No;Unknown Yes;No;Unknown Alphanumeric

Complete for both biological parents

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17453 MS relative description text MSReltvDescrText The free-text field for describing the relationship of relative with Multiple Sclerosis The free-text field for describing the relationship of relative with Multiple Sclerosi Relationship Details Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History 255

Free-Form Entry

C08080 Twin sibling indicator TwinSiblingInd Indicator of whether the participant/subject has a twin brother or sister Indicator of whether the participant/subject has a twin brother or sister Are you a twin Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16149 Biological parent twin type BioPrntTwinTyp Type of twin the biological parent has Type of twin the biological parent has Type of twin Identical;Not identical (fraternal);Unknown i.e., monozygotic;i.e., dizygotic; Alphanumeric

Complete for both biological parents. Only answer if "Is this parent a twin?" is answered Yes

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17454 MS sibling diagnosis indicator MSSiblingDiagInd The indicator of whether a sibling was diagnosed with Multiple Sclerosis The indicator of whether a sibling was diagnosed with Multiple Sclerosi Have any of your siblings been diagnosed with MS (yes/no/unknown) Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C08081 Twin sibling type TwinSiblingTyp Type of twin the participant/subject has Type of twin the participant/subject has What type of twin Identical;Not identical (fraternal) Identical;Not identical (fraternal) Alphanumeric

Only answer if "Are you a twin?" is answered Yes. Choose all that apply

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16150 Adopted age value AdoptedAgeVal Age at time of adoption if participant/subject was adopted Age at time of adoption if participant/subject was adopted Age at time of adoption Numeric Values

Record age at time of adoption. Only answered if "Yes" is answered for "Are you adopted?"

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C17455 MS spouse diagnosis indicator MSSpouseDiagInd The indicator of whether a spouse was diagnosed with Multiple Sclerosis The indicator of whether a spouse was diagnosed with Multiple Sclerosi Has your spouse been diagnosed with MS (yes/no/unknown/not applicable) Yes;No;Unknown;Not applicable Yes;No;Unknown;Not applicable Alphanumeric

Yes, medical record confirmed: Confirmed by medical records or autopsy report. Study design/diagnostic criteria choice can dictate degree of certainty to call an individual affected.
Yes, per patient history: Relative is affected according to patient.

No references available Adult Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C08085 Sibling alive indicator SiblingAliveInd Indicator of whether the participant's/subject's sibling is still living Indicator of whether the participant's/subject's sibling is still living Is your twin alive Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16151 Child adopted before age one indicator ChildAdptdBeforeAgeOneInd Indicates whether participant/subject has any adopted children who were adopted before one year of age Indicates whether participant/subject has any adopted children who were adopted before one year of age Do you have any adopted children who were adopted before age 1 Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17456 MS uncle diagnosis total count MSUncleDiagTtlCt The total number of uncles that were diagnosed with Multiple Sclerosis The total number of uncles that were diagnosed with Multiple Sclerosi Specify total number of uncles with MS Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C10813 Adopted indicator AdoptedInd Indicator of whether the participant was adopted Indicator of whether the participant was adopted Are you adopted Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.10 2024-02-29 15:42:33.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16152 Sibling adopted before age one indicator SiblingAdptdBeforeAgeOneInd Indicates whether participant/subject has any adopted siblings who were adopted before one year of age Indicates whether participant/subject has any adopted siblings who were adopted before one year of age Do you have any adopted siblings who were adopted before age 1 Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17458 MS first cousin diagnosis indicator MS1stCousinDiagInd The indicator of whether any first cousins were diagnosed with Multiple Sclerosis The indicator of whether any first cousins were diagnosed with Multiple Sclerosi Do you have any first cousins who have been diagnosed with MS Yes;No;Unknown Yes;No;Unknown Alphanumeric

Yes, medical record confirmed: Confirmed by medical records or autopsy report. Study design/diagnostic criteria choice can dictate degree of certainty to call an individual affected.
Yes, per patient history: Relative is affected according to patient.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10814 Parents biologically related indicator ParntsBioRltdInd The indicator whether the subject's/participant's parents are biologically related The indicator whether the subject's/participant's parents are biologically relat Is your biological mother a relative of your biological father Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16153 Family history relative type with MS number FmlyHistRltveTypMSNum For the specified relative type, the total number of relatives diagnosed with multiple sclerosis (MS) For the specified relative type, the total number of relatives diagnosed with multiple sclerosis (MS) Sib # Numeric Values

Complete for all relative types that have at least one MS diagnosis.

No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C17459 MS offspring diagnosis indicator MSOffspringDiagInd The indicator of whether children were diagnosed with Multiple Sclerosis The indicator of whether children were diagnosed with Multiple Sclerosi Do you have any children who have been diagnosed with MS Yes;No;Unknown Yes;No;Unknown Alphanumeric

Yes, medical record confirmed: Confirmed by medical records or autopsy report. Study design/diagnostic criteria choice can dictate degree of certainty to call an individual affected.
Yes, per patient history: Relative is affected according to patient.

No references available Adult Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14144 Family history assessment date FamlyHistAssmtDate Date family history was collected from the participant/ subject, family member/friend, and/or the medical record Date family history was collected from the participant/ subject, family member/friend, and/or the medical record Date pedigree 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 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

C16159 Family history relative age at onset value FmlyHistRltveAgeOnsetVal Age the participant's relative experienced the onset of the disease or disorder Age the participant's relative experienced the onset of the disease or disorder Age at onset of MS Numeric Values

Record age of MS onset in years. Complete for all relatives diagnosed with MS.

No references available Adult;Pediatric Supplemental 3.10 2024-02-29 15:41:31.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Free-Form Entry

year
C18678 Family history medical condition type other text FamHistMedclCondTypOTH The free-text field related to 'Family history medical condition type', specifying other text. Type of medical condition or health related event for which the family history is taken The free-text field related to 'Family history medical condition type', specifying other text. Type of medical condition or health related event for which the family history is taken Other, specify Alphanumeric

This CDE should be collected along with the "Family history medical condition indicator". It is strongly recommended that the immediate family history of Friedreich's ataxia and ataxia be collected but collecting the family history of the other conditions is optional. Answer for first and second degree blood relatives. The majority of the medical conditions are Supplemental with the exception of the following which are Core: Developmental Delays; Epilepsy (pediatric only); Seizures without epilepsy diagnosis (pediatric only); Heart Disease; Muscle Disease; Peripheral Neuropathy For MS: The value for this CDE is "multiple sclerosis (MS)". This CDE should be collected along with the "Family history medical condition indicator".

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 1.10 2024-02-29 15:42:35.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History 4000

Free-Form Entry

3165585
C16143 Parents biologically related type PrntsBioRltdTyp Type of relation of the biologically related parents Type of relation of the biologically related parents Relationship First cousin;Niece;Other, specify First cousin;Niece;Other, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16206 Family history gender type FmlyHistGendTyp Reported gender of the relative. Gender is the socially constructed identity of sex Reported gender of the relative. Gender is the socially constructed identity of sex Gender Female;Male Female;Male Alphanumeric

Complete for each relative diagnosed with MS where not readily apparent. Choose one.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 - http://grants.nih.gov/grants/funding/women_min/women_min.htm . Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. Mushkudiani et al J Neurotrauma 2007;24:329-37. Do women fare worse: a meta-analysis of gender differences in traumatic brain injury outcome. Farace et al, J Neurosurg 2000;93:539-545. Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History

Single Pre-Defined Value Selected

2200604
C18679 Family history medical condition relative type other text FamHistMedclCondReltvTypOTH The free-text field related to 'Family history medical condition relative type', specifying other text. Relationship of the family member or ancestor with the medical condition or health related event to the participant The free-text field related to 'Family history medical condition relative type', specifying other text. Relationship of the family member or ancestor with the medical condition or health related event to the participant Other, specify Alphanumeric

Answer the family history items for each relative type. Select the relationship from the options of the family members listed. Record/choose more than one family member, if applicable. For MS: Use this element along with "Family history relative type biological sample in repository indicator" (C08001) to record which relatives had a DNA sample banked in a repository. For HD: If no first degree relatives have been diagnosed with HD, do not complete family history for second degree relatives. If either or both of the participant's/subject's parents have been diagnosed with HD, complete family history for second degree relatives by considering only the parent(s) diagnosed with HD to determine maternal/paternal relationship.

Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Supplemental 1.10 2024-02-29 15:42:37.0 Family History - Affected Relatives and Pedigree General Health History Participant History and Family History 4000

Free-Form Entry

3165810
CSV