CDE Detailed Report

Disease: General (For all diseases)
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 15 of 15
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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/subject's medical history Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history End Date Date or Date & Time

If the condition is not ongoing, record the date (and time) the medical condition/disease stopped. 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.) and in the format acceptable to the study database.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

3145557
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/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Start Date Date or Date & Time

Record the date themedical condition/disease started. 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.) and in the format acceptable to the study database

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2543596
C00319 Medical history condition ongoing indicator MedclHistCondOngoingInd Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Indicator of whether a medical condition/disease experienced by the participant/subject 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 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2736881
C00001 Gestational age value GestatnlAgeVal Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. Gestational Age Numeric Values

Record the gestational age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies.

No references available Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

0 52 week 3192017
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
C00002 Post conceptional age value PostConceptnAgeVal Gestational age plus postnatal age of the participant/subject Gestational age plus postnatal age of the participant/subject Post Conceptional Age (PCA) Numeric Values

Record the post conceptional age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies. This field is not needed if Gestational Age and Post Natal Age are captured since it can be derived from those data.

No references available Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Free-Form Entry

day 3182713
C00723 APGAR ten minute score APGARTenMinuteScore Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. 10 minute APGAR score 0;1;2;3;4;5;6;7;8;9;10 0;1;2;3;4;5;6;7;8;9;10 Numeric Values

Record the APGAR score (0 - 10 points, inclusive) assessed at 10 minutes

No references available Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3181701
C00003 Postnatal age value PostnatalAgeVal Time elapsed after birth of the participant/subject Time elapsed after birth of the participant/subject Post Natal Age (PNA) Numeric Values

Record the post natal age of the participant/subject in weeks and days. This element is intended for pediatric clinical studies.

No references available Pediatric Supplemental 3.00 2013-07-24 11:36:20.083 Medical History General Health History Participant History and Family History

Free-Form Entry

day 3182608
C00724 APGAR five minute score APGARFiveMinuteScore Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness. 5 minute APGAR score 0;1;2;3;4;5;6;7;8;9;10 0;1;2;3;4;5;6;7;8;9;10 Numeric Values

Record the APGAR score (0 - 10 points, inclusive) assessed at 5 minutes

No references available Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2738533
C00311 Birth weight value BirthWgtVal Birth weight according to the participant's/subject's medical report or reported by the parent or legal guardian Birth weight according to the participant's/subject's medical report or reported by the parent or legal guardian Birth Weight Numeric Values

Record the birth weight of the participant/subject. This element is intended for pediatric clinical studies.

No references available Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Free-Form Entry

0 9000 gram 3201400;2179689
C18666 Body system other text BodySysOTH 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 Free-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. Other, specify Alphanumeric

Record the appropriate body system for each line of medical history.

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 1.00 2014-05-27 13:34:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
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 systems. 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.

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 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
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

Code each of the medical history conditions 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

C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant/subject's medical history was taken Date (and time, if applicable and known) the participant/subject's medical history was taken Date Medical History Taken Date or Date & Time

Record the date (and time) the medical history was taken. 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.) and in the format acceptable to the study database

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2179659
C00315 Medical history global assessment indicator MedclHistGlobalAssmtInd Indicator of whether the participant/subject has a history of any medical problems/conditions Indicator of whether the participant/subject 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 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3145578
CSV