CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: Vital Signs and Other Body Measures
CRF: Vital Signs

Displaying 1 - 15 of 15
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
C01541 Weight measurement WgtMeasr Measurement of participant's weight Measurement of participant's weight Weight Numeric Values

Record the weight of the participant/subject. To be collected at the visit, not self-reported.Indicate whether weight was measured in pounds (lbs) or kilograms (kg). Height and weight are commonly collected at the baseline visit. Depending on the study population and study intervention it may be appropriate to collect height and weight at subsequent study visits.

No references available Adult;Pediatric Core 3.10 2024-02-29 15:49:21.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 500 kilogram 2179689
C01550 Temperature measurement anatomic site TempMeasrAntmicSite Anatomic site on or within the body where the temperature was measured Anatomic site on or within the body where the temperature was measure Temperature Method Oral;Rectal;Tympanic;Axillary Oral;Rectal;Tympanic;Axillary Alphanumeric

Record the location where the temperature was measured (Oral, Rectal, Axillary, or Tympanic). Choose one. This elements is most relevant to pediatric clinical studies.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

3151195
C01553 Blood pressure measurement position type BldPressrMeasrPositionTyp Indicator of the participant's position during the blood pressure measurement Indicator of the participant's position during the blood pressure measurement Blood Pressure: Participant's/Subject's Position Sitting;Standing;Supine;Unknown Sitting;Standing;Supine;Unknown Alphanumeric

Record the position the participant/ subject was in when blood pressure was taken.

No references available Adult;Pediatric Supplemental 3.10 2024-03-11 10:47:19.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2008432
C01565 Blood pressure systolic measurement BldPressrSystMeasr Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Blood Pressure (systolic) Numeric Values

Record the systolic blood pressure of the participant/ subject. The standard unit for measuring blood pressure is mmHg, which is approximately equivalent to Torr. This value should be taken from the Vital Signs CRF to prevent capturing duplicate data in different places.

No references available Adult;Pediatric Core 3.10 2024-03-11 10:40:09.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 300 millimeter of mercury 2004289 C25298
C01580 Temperature unit of measure TempUOM Unit of measure for the temperature numerical value Unit of measure for the temperature numerical value Temperature F;C degrees Fahrenheit;degrees Celsius Alphanumeric

Record the numerical value of the participant/subject's temperature.Indicate the scale used to capture temperature.

Unified Code for Units of Measure - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2956267
C01507 Blood pressure diastolic measurement BldPressrDiastlMeasr Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Blood Pressure (diastolic) Numeric Values

Record the diastolic blood pressure of the participant/ subject. The standard unit for measuring blood pressure is mmHg, which is approximately equivalent to Torr.

No references available Adult;Pediatric Core 3.10 2024-03-11 10:40:54.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 300 millimeter of mercury 2004291
C01581 Weight unit of measure WgtUoM Unit of measure for the weight numerical value Unit of measure for the weight numerical value Weight measurement Pounds;Kilograms Pounds;Kilograms Alphanumeric

Record the weight of the participant/subject. To be collected at the visit, not self-reported.Indicate whether weight was measured in pounds (lbs) or kilograms (kg). Height and weight are commonly collected at the baseline visit. Depending on the study population and study intervention it may be appropriate to collect height and weight at subsequent study visits.

No references available Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2630200
C01519 Vital signs date and time VitalSgnDateTime Date (and time, if applicable and known) the vital signs and other body measurements were taken by indicating the month, day, and year for the date and am, pm, or 24 hour clock for time Date (and time, if applicable and known) the vital signs and other body measurements were taken by indicating the month, day, and year for the date and am, pm, or 24 hour clock for time Date and Time 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.). Record the date vital signs are taken. If the exact month/day is not known, some "unknown" convention should be used. Record the time vital signs are taken. If the exact time is not known, some "unknown" convention should be used. From study inception, specify the manner in which time will be collected. If a twelve hour clock is used, then AM or PM must be designated. If it is your institution's custom to use military time (24-hour clock), that designation will not be necessary.

No references available Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

2829808
C01582 Height unit of measure HgtUOM Unit of measure for the height numerical value for participant Unit of measure for the height numerical value for participant Height measurement Inches;Centimeters Inches;Centimeters Alphanumeric

Record the height of the participant/subject. To be collected at the visit, not self-reported. Also, indicate whether height was measured in inches (in) or centimeters (cm). Height and weight are commonly collected at the baseline visit. Depending on the study population and study intervention it may be appropriate to collect height and weight at subsequent study visits.

No references available Adult;Pediatric Core 3.10 2024-02-29 15:58:54.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Single Pre-Defined Value Selected

2538920
C01521 Heart rate HeartRate The participant's pulse or number of contractions (heart beats) per minute The participant's pulse or number of contractions (heart beats) per minute Heart Rate/Pulse Numeric Values

This value should be taken from the Vital Signs CRF to prevent capturing duplicate data in different places. Results should be recoreded in beats per minute (bpm).

No references available Adult;Pediatric Supplemental 3.10 2024-03-11 10:48:30.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 300 beats per minute 2767073
C11131 Body mass index value BMIVal Value of the participant's body mass index, calculated from height and weight Value of the participant's body mass index, calculated from height and weight Body Mass Index Numeric Values

BMI. This is a derived field that should be calculated using the height and weight measurements.

http://www.cdc.gov/healthyweight/assessing/bmi/ Adult;Pediatric Supplemental 3.10 2024-02-29 15:58:55.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 99
C01522 Height measurement HgtMeasr Measurement of participant's height Measurement of participant's height Height Numeric Values

Record the height of the participant/subject. To be collected at the visit, not self-reported. Also, indicate whether height was measured in inches (in) or centimeters (cm). Height and weight are commonly collected at the baseline visit. Depending on the study population and study intervention it may be appropriate to collect height and weight at subsequent study visits.

No references available Adult;Pediatric Core 3.10 2024-02-29 15:49:20.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 400 centimeter 649
C18767 Temperature measurement other text TempMeasrOTH The free-text field related to 'Temperature measurement anatomic site' specifying other text. Anatomic site on or within the body where the temperature was measured The free-text field related to 'Temperature measurement anatomic site' specifying other text. Anatomic site on or within the body where the temperature was measure Other, specify Alphanumeric

Record the location where the temperature was measured (Oral, Rectal, Axillary, or Tympanic). Choose one. This elements is most relevant to pediatric clinical studies.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations 4000

Free-Form Entry

3151195
C01535 Respiratory rate RespRate Rate of the participant's breathing (inhalation and exhalation) Rate of the participant's breathing (inhalation and exhalation) Respiratory Rate Numeric Values

Record the respiratory rate of the participant/subject in breaths per minute.

No references available Adult;Pediatric Supplemental 3.10 2024-03-11 10:50:02.0 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 120 breaths per minute 2644399
C01539 Temperature measurement TempMeasr Measurement of the participant's/subject's body temperature Measurement of the participant's/subject's body temperatur Temperature Numeric Values

Record the numerical value of the participant/subject's temperature.Indicate the scale used to capture temperature.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Vital Signs Vital Signs and Other Body Measures Assessments and Examinations

Free-Form Entry

0 50 degree Celsius 2644401
CSV