CDE Detailed Report
Subdomain Name: Drugs
CRF: Prior and Concomitant Medications
Displaying 1 - 14 of 14
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02016 | Medication prior or concomitant start date and time | MedctnPriorOrConcmStrtDateTime | The date (and time, if applicable and known) on which the prior/concomitant medication usage began | 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 | 3.10 | 2022-08-02 16:58:56.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162752 | |||||||||
| C02022 | Medication prior or concomitant dose unit of measure | MedctnPriorOrConcomDoseUOM | Dosage unit of measure of the prior or concomitant medication administered | 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 | 3.10 | 2022-08-02 14:36:00.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162730 | |||||||
| 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 | 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/subjec | 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 | 3.00 | 2013-08-28 16:08:00.453 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3158920 | ||||||||
| 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 | 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 | 3.00 | 2013-07-22 16:57:17.79 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
2220500 | |||||||
| C02025 | Medication prior or concomitant RXNorm code | MedctnPriorConcomRxNormCode | Code for name of the prior/concomitant agent or drug administered | Code for name of the prior/concomitant agent or drug administere | 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 | 3.00 | 2013-08-28 16:08:00.453 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
3162728 | ||||||||
| C02003 | Medication prior or concomitant ongoing indicator | MedctPrConcomOngoingInd | Indicator of or description that the prior/concomitant medication usage is ongoing | Indicator of or description that the prior/concomitant medication usage is ongoin | 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 | 3.00 | 2013-08-28 16:08:00.453 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
2321822 | |||||||
| C18736 | Medication prior or concomitant dose unit of measure other text | MedctnPriorOrConcomDoseUoMOTH | 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 | 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 administere | 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 | 2.10 | 2022-08-02 14:27:44.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162730 | ||||||||
| C02006 | Medication prior or concomitant dose | MedctnPriorOrConcomDose | Dose of prior/concomitant medication taken per administration | 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 | 3.10 | 2022-08-02 14:33:32.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162729 | |||||||||
| C18737 | Medication prior or concomitant route type other text | MedctnPriorOrConcomRteTypOTH | 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 | 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 | 2.00 | 2022-08-02 16:52:05.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162743 | ||||||||
| C02008 | Medication prior or concomitant end date and time | MedctnPriorOrConcomEndDateTime | The date (and time, if applicable and known) the administration of the prior/concomitant medication ended | 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 | 3.10 | 2022-08-02 16:59:51.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162753 | |||||||||
| C02011 | Medication prior or concomitant dose frequency | MedctnPriorConcmtntDoseFreq | Frequency of use of a prior/concomitant medication | Frequency of use of a prior/concomitant medicatio | Frequency of prior/concomitant medication use | BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;alt. d.;HS;PRN;OTH;UNK;NA | twice a day;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;every morning;every evening;one a day;every other day (on alternate days);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 | 3.00 | 2013-07-24 21:00:23.88 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162733 | |||||||
| C02013 | Medication prior or concomitant dose unit of measure UCUM code | MedctnPriorOrConDseUOMUCUMCode | 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 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 | 3.10 | 2022-08-02 14:42:09.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
|||||||||
| C02014 | Medication prior or concomitant name | MedctnPriorConcomName | Name of the prior/concomitant agent or drug administered | Name of the prior/concomitant agent or drug administere | 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 | 3.00 | 2013-08-28 16:08:00.453 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162728 | ||||||||
| C02015 | Medication prior or concomitant route type | MedctnPriorOrConcomRteTyp | Type of access route for the administration of the prior/concomitant medication | 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 | 3.10 | 2022-08-02 14:44:16.0 | Prior and Concomitant Medications | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162743 |
