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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: Traumatic Brain Injury
SubDisease: Comprehensive
Sub-Domain: Drugs
CRF: Prior and Concomitant Medications
Item count: 14 (14 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
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
Indicates reported medication use during the time period relevant to the study protocol
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. If this question is answered Yes then at least one prior/concomitant medication record needs to be recorded. Do NOT record study medications taken (if study has a drug intervention) on this form. Add date stamp for when assessed. Recommend collection at least on date of TBI. Refer to the Study Drug Dosing form instructions to record study medications.
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Prior and Concomitant 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.
Name of the prior/concomitant agent or drug administered
  
Alphanumeric
Verbatim name (generic or trade name) of the medication the participant/subject reports taking. Add date stamp for when assessed. Recommend collection at least on date of TBI.
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C02025
Medication prior or concomitant RXNorm code
MedctnPriorConcomRxNormCode
Code for name of the prior/concomitant agent or drug administered.
Code for the name of prior/concomitant agent or drug administered
  
Alphanumeric
Code for the medication the participant/subject reports taking. Add date stamp for when assessed. Recommend collection at least on date of TBI.
RXNorm for the medication codes (http://www.nlm.nih.gov/research/umls/rxnorm/; use the atom unique identifier or RXAUI code)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
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.
Reason for administration of prior/concomitant agent or measure
  
Alphanumeric
Response is obtained from report by participant/subject. If given for an AE, enter exact term from AE CRF.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant 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.
Dosage of prior/concomitant medication taken per administration
  
Numeric Values
Record the strength of the medication the participant/subject is taking. The code list displays the most popular dose unit options.
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose
 
Free-Form Entry
     
3162729
 
C18736
Medication prior or concomitant dose unit of measure other text
MedctnPriorConcomDoseUoMOTH
The free-text field related to 'Medication prior or concomitant dose unit of measure' specifying other text. Dosage unit of measure of the prior or concomitant medication administered.
Other
  
Alphanumeric
Record the units of the medication the participant/subject is taking.
Unified Code for Units of Measure (UCUM): http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
2.0
3/13/2018
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162730
 
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
Dosage unit of measure of the prior or concomitant medication administered.
Dosage unit of measurement
g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA;
gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable;
Alphanumeric
Record the units of the medication the participant/subject is taking.
Unified Code for Units of Measure (UCUM): http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure
 
Single Pre-Defined Value Selected
     
3162730
 
C02013
Medication prior or concomitant dose unit of measure UCUM code
MedctnPriorConcomDoseUOMUCUMCd
Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM).
Code that represents dosage unit of measurement
  
Alphanumeric
Code the units of the medication the participant/subject is taking using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure (UCUM) for the codes for the units of measure: http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
255
Free-Form Entry
       
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
  
Alphanumeric
Choose one route of administration. The code list displays the most popular options.
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162743
 
C02011
Medication prior or concomitant dose frequency
MedctnPriorConcmtntDoseFreq
Frequency of use of a prior/concomitant medication.
Frequency of prior/concomitant medication use
BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;AD;HS;PRN;OTH;UNK;NA;
twice daily;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;one dose in morning;one dose in evening;once daily;alternating day (every other day);at bedtime;as needed;Other, specify;unknown;Not applicable;
Alphanumeric
Record how often the medication is being taken.
The code list displays the most popular options.
CDISC SDTM Frequency Terminology (Code C71113) (http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Prior and Concomitant 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.
Type of access route for administration of prior/concomitant medication
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
Choose one route of administration. The code list displays the most popular options.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant route type
 
Single Pre-Defined Value Selected
     
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.
Medication prior or concomitant start 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.).
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant 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.
Medication prior or concomitant end 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.).
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant 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.
Indicates or describes that prior/concomitant medication usage is ongoing
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
12-11-2018
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