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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: Sport Related Concussion
SubDisease: Comprehensive
Sub-Domain: Drugs
CRF: Medications
Item count: 41 (41 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
C19256
Study protocol name
StudyProtocolName
Name of study protocol
Study Name/ID pre-filled
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/5/2014
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
       
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
Medications
Drugs
Treatment/Intervention Data
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
Medications
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C54123
Medication prescription current take indicator
MedPresCurrentTakeInd
Indicator related to whether the participant/subject is currently taking prescription medications.
Currently Taking Prescription Medications?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/14/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C54124
Medication prescription indication type
MedicationPrescriptionIndicTyp
Type of indication related to prescription medication taken by the subject/participant.
Type of Prescription Medications (check all that apply)
Anti-Depressant;Anti-Anxiety;Anti-Psychotic;Migraine;Anti-Seizure;Cardiovascular;Diabetes;Narcotic Pain Medication;Non-Narcotic Pain Medication;Sleep Aid/Sedative;Psychostimulant (ADHD);Birth Control;Allergy;Asthma;Acid Reflux/Heart Burn;Other;
Anti-Depressant Prescription Medication;Anti-Anxiety Prescription Medication;Anti-Psychotic Prescription Medication;Migraine Prescription Medication;Anti-Seizure Prescription Medication;Cardiovascular Prescription Medication;Diabetes Prescription Medication;Narcotic Pain Prescription Medication;Non-Narcotic Pain Prescription Medication;Sleep Aid/Sedative Prescription Medication;Psychostimulant (ADHD) Prescription Medication;Birth Control Prescription Medication;Allergy Prescription Medication;Asthma Prescription Medication;Acid Reflux/Heart Burn Prescription Medication;Other Prescription Medication;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/14/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Multiple Pre-Defined Values Selected
       
C55382
Medication prescription type text
MedicationPrescriptionTypTxt
The free-text field related to type of prescription medication participant/subject.
If checked, indicate type:
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
5/2/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C54182
Over the counter medication current take indicator
OverTheCounterMedCurntTakeInd
Indicator related to whether the participant/subject is currently taking over-the-counter medications.
Are you currently taking any over-the-counter medications (e.g. Advil/ibuprofen, Claritin, etc)? (Either today or on a regular basis)
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/14/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C54186
Over the counter medicine type
OverTheCounterMedicineTyp
Type of over-the-counter medicine taken by the subject/participant.
Type of over-the-counter medicine
Advil/Ibuprofen;Tylenol/Acetaminophen;Claritin/Allergy medication;Other;
Advil/Ibuprofen;Tylenol/Acetaminophen;Claritin/Allergy medication;Other;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/14/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Multiple Pre-Defined Values Selected
       
C54199
Over the counter medicine other name
OverTheCounterMedOtherName
Name of other over-the-counter medicine currently taken by the subject/participant.
Other OTC, what?
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/16/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
C54204
Over the counter supplement current take indicator
OverTheCounterSuppCurntTakeInd
Indicator related to whether the participant/subject is currently taking over-the-counter supplements.
Are you currently taking any over-the-counter supplements (e.g. protein or vitamins)? (Either today or on a regular basis)
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/14/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C54205
Over the counter supplement type
OverTheCounterSupplementTyp
Type of over-the-counter supplement taken by the subject/participant.
Type of over-the-counter supplement
Protein;Creatine;DHEA;Chromium;Androstenedione;Vitamins;Weight Loss;Other;
Protein;Creatine;DHEA;Chromium;Androstenedione;Vitamins;Weight Loss over-the-counter supplement;Other over-the-counter supplement;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
2/14/2017
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Multiple Pre-Defined Values Selected
       
C02002
Medication prior or concomitant use indicator
MedctnPriorConcomUseInd
Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol
Did the patient/participant take any medications: XX days before or during the study? (If “No”, leave rest of form blank)
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
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant use indicator
 
Single Pre-Defined Value Selected
     
2220500
 
C02014
Medication prior or concomitant name
MedctnPriorConcomName
Name of the prior/concomitant agent or drug administered.
Medication Name (Trade or generic name)
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C02024
Medication prior or concomitant indication text
MedctnPriorConcomIndTxt
Text describing reason for administration of a prior/concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject.
Indication (If given for AE, enter exact term from AE CRF)
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant indication text
4000
Free-Form Entry
     
3158920
 
C02006
Medication prior or concomitant dose
MedctnPriorConcomDose
Dose of prior/concomitant medication taken per administration.
Dose
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose
 
Free-Form Entry
     
3162729
 
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
Dosage unit of measure of the prior or concomitant medication administered.
Dose Units
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure
 
Single Pre-Defined Value Selected
     
3162730
 
C02011
Medication prior or concomitant dose frequency
MedctnPriorConcmtntDoseFreq
Frequency of use of a prior/concomitant medication.
Frequency
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose frequency
 
Single Pre-Defined Value Selected
     
3162733
 
C02015
Medication prior or concomitant route type
MedctnPriorConcomRteTy
Type of access route for the administration of the prior/concomitant medication.
Route
Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify;
Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By Ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant route type
 
Single Pre-Defined Value Selected
     
3162743
 
C18737
Medication prior or concomitant route other text
MedctnPriorConcomRteOTH
The free-text field related to 'Medication prior or concomitant route type' specifying other text. Type of access route for the administration of the prior/concomitant medication.
Other/Specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162743
 
C02016
Medication prior or concomitant start date and time
MedctnPriorConcomStrtDateTime
The date (and time, if applicable and known) on which the prior/concomitant medication usage began.
Start Date (mm/dd/yyyy)
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant start date and time
 
Free-Form Entry
     
3162752
 
C02008
Medication prior or concomitant end date and time
MedctnPriorConcomEndDateTime
The date (and time, if applicable and known) the administration of the prior/concomitant medication ended.
End Date (mm/dd/yyyy)
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant end date and time
 
Free-Form Entry
     
3162753
 
C02003
Medication prior or concomitant ongoing indicator
MedctPrConcomOngoingInd
Indicator of or description that the prior/concomitant medication usage is ongoing.
Ongoing?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
C19180
Steroid administration type
SteroidAdministrationTyp
Type of steroids (methylprednisone/corticosteroids) administered at any point during stay
Any steroids administered: Methylprednisone/Corticosteriods: (at any point during their stay):
NASCIS II (Methylprednisolone or Solumedrol run as an infusion x 23 or 24 hrs);NASCIS III (Methylprednisolone or solumedrol run as an infusion x 47 or 48 hrs);None;Other, specify;Unknown;
NASCIS II (Methylprednisolone or Solumedrol run as an infusion x 23 or 24 hrs);NASCIS III (Methylprednisolone or solumedrol run as an infusion x 47 or 48 hrs);None;Other, specify;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Exploratory
1.0
6/2/2014
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C19181
Steroid administration other text
SteroidAdministrationOTH
The free-text field related to 'Steroid administration type' specifying other text. Type of steroids (methylprednisone/corticosteroids) administered at any point during stay
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Exploratory
1.0
6/2/2014
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C19182
Steroid administration date
SteroidAdministrationDate
Date at which steroids (methylprednisone/corticosteroids) were administered during stay
Date administered: YYYYMMDD
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Exploratory
1.0
6/2/2014
Aliases for variable name not defined
Medications
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
12-15-2018
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