of0
Export
 
CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sub-Domain: Laboratory Tests and Biospecimens/Biomarkers
CRF: Biomarker-Related Sample and Collection Questions
Item count: 69 (69 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C17402
Site name
SiteName
The name of the site for the study
Site Name
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
6/21/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Site name
255
Free-Form Entry
       
C19247
Subject ID
SubIDNam
Subject identification ID
Subject ID
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/5/2014
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C01701
Lab specimen collection date and time
LabSpecmnCollDateTime
Date (and time if applicable and known) when the specimen was collected
Date and time of specimen collection
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/25/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Lab specimen collection date and time
 
Free-Form Entry
     
2004004
 
C58402
Sample collection processing elapse time interval
SmpCllctnPrcessElapsTimeIntrvl
Elapsed time between sample collection and processing
What time elapsed between collection and processing?
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/16/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C55009
Specimen storage temperature value
SpecStorTempVal
The temperature value for the specimen being stored.
What temperature was the sample stored at prior to processing?
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
1.0
4/17/2017
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
  
celsius
    
C58403
Medication baseline modification before study start indicator
MedBaselModifBefStdyStrtInd
Indicator related whether there were modifications to baseline medications prior to study start
Were there any modifications made (by the subject, their physicians, or the researchers) to the subject's BASELINE medications right before the study commenced)?
Yes;No (STOP);Unknown (STOP);
Yes;No (STOP);Unknown (STOP);
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
1.0
1/5/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C57374
Changed medication name text
ChangedMedicationNameTxt
Name of changed medication(s) taken by subject/participant.
If yes, name of the medication or class of medication
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/5/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C57377
Changed medication frequency status
ChangedMedFreqStat
Frequency status of changed medication given to subject/participant
If yes, what changes were made to the medication?
Medication stopped;Dose increased;Dose decreased;Frequency increased;Frequency decreased;Other, specify:;
Medication stopped;Dose increased;Dose decreased;Frequency increased;Frequency decreased;Other, specify: (e.g., route of administration changed);
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/5/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C58405
Changed medication frequency other text
ChangedMedFreqOthTxt
Free-text field to describe change(s) to medication
Other, specify:
  
Alphanumeric
E.g., route of administration changed
No references available
Adult;Pediatric
Supplemental
1.0
1/5/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C58461
Medication initial dose
MedctnInitialDose
Initial dose of medication taken per administration prior to adjustments
Initial dose:
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
     
3162729
 
C57375
Changed medication dose text
ChangedMedicationDoseTxt
Dose of changed medication(s) taken by subject/participant.
Adjusted dose:
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/5/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C58462
Medication initial frequency
MedctnInitialFreq
Initial frequency of medication taken per administration prior to adjustments
Initial frequency:
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
     
3162729
 
C58463
Medication adjusted frequency
MedctnAdjFreq
Adjusted frequency of medication taken per administration prior to adjustments
Adjusted frequency:
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
     
3162729
 
C58406
Change medication time status text
ChangedMedTimeStatTxt
Free-text field to specify changes to medication
If yes, when did the changes occur relative to when a test, treatment, or other intervention was performed?
  
Alphanumeric
e.g., 24 hours before blood draw, 4 weeks prior to treatment, etc.
No references available
Adult;Pediatric
Supplemental
1.0
1/5/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56102
Biomarker specimen type
BiomarkSpecTyp
The type of specimen or specimens collected from the participant/subject for biomarkers.
What type of specimen was collected from the subject/participant?
Blood, specify type;CSF, complete the following;Urine;Saliva;Other, specify;
Blood, specify type;CSF, complete the following;Urine;Saliva;Other, specify;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Multiple Pre-Defined Values Selected
       
C56107
Biomarker specimen other text
BiomarkSpecOthrTxt
The free-text field describing another type of specimen that was collected from the participant/subject.
Other, specify:
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56106
Specimen blood collection type
SpecBldCollTyp
The type of blood component that was collected.
Blood, specify type:
Platelet-free plasma;Platelet-rich plasma;Serum;Whole blood;PBMC;
Platelet-free plasma;Platelet-rich plasma;Serum;Whole blood;PBMC (Peripheral blood mononuclear cell);
Alphanumeric
Choose one
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C10564
Fasting prior to sample collection indicator
FastBeforeLabTestInd
Indicator of whether or not the participant/subject was on fasting prior to blood sample collection
Indicate if subject/participant was fasting when blood was collected
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Fasting prior to sample collection indicator
 
Single Pre-Defined Value Selected
       
C57921
Blood collected volume value
BloodCollectVolVal
Volume of blood collected
Indicate collected volume (ml)
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/15/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
  
milliliters
    
C58407
Blood collection tube volume value
BloodCollectTubeVolVal
Volume of blood collection tube
Indicate collected volume (ml)
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/15/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
1
1000
milliliters
    
C57922
Blood collection system type
BloodCollectSystTyp
Indicate type of system used to collect blood
Indicate collecting system used
Needle;Vacutainer;
Needle;Vacutainer;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/15/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C54753
Specimen collection tube type
SpecimenCollectionTubTyp
Type of tube used for specimen collection.
Specify collection tube:
Polypropylene tubes;Polystyrene tubes;Other, specify;
Polypropylene tubes;Polystyrene tubes;Other, specify;
Alphanumeric
Choose one
No references available
Adult;Pediatric
Supplemental
1.0
4/11/2017
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C54754
Specimen collection tube other text
SpecimenCollectionTubOTH
The free-text field related to other tube for specimen collection.
Other, specify:
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
4/11/2017
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C57923
Blood collection tube additive type
BloodCollectTubeAdditivTyp
Type of additives used in blood collection tube
Specify additives in collection tube:
EDTA;Citrate;Heparin;Lysing/stabilizing media;None;
EDTA;Citrate;Heparin;Lysing/stabilizing media;None;
Alphanumeric
Choose one
No references available
Adult;Pediatric
Supplemental
1.0
1/15/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C58464
Blood collection tube lysing stabilizing media text
BloodCollectTubeLysStbMedTxt
Free-text field to specify lysing/stabilizing media used in blood collection tube
Lysing/stabilizing media, indicate additive
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/15/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C58465
Blood collection tube lysing stabilizing media concentration value
BldCllectTubeLysStbMedConcVal
Free-text field to specify concentration of lysing/stabilizing media used in blood collection tube
Lysing/stabilizing media, indicate concentration
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
1/15/2018
Aliases for variable name not defined
Biomarker-Related Sample and Collection Questions
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
12-14-2018
Page 1 of 3