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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 |
Record the route of administration. Acceptable responses for Route are shown below the medication table. |
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 | |||||||
| 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. | Start Date | Date or Date & Time |
Record the date (and time if applicable to the study) the participant/subject started taking the medication. 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.) and in the format acceptable to the study database. Start Date can be used to distinguish between prior medications and concomitant medications. Studies that need to collect Start Time will need to add fields for time to the form template. |
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 | Dose | 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. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM). |
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 | Indication | Alphanumeric |
Record the reason the participant/subject gives for taking the medication. If given for an AE, enter exact term from Adverse Event 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 | Did the participant/subject take any medications _ days before or during the study? | 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. Refer to the Study Drug Dosing form 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 | Medication Name | Alphanumeric |
Code the verbatim name (generic or trade name) of the medication using RXNorm. |
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 | 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 | Ongoing? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. Answer YES if the participant/subject is still taking the medication or NO if the participant/subject has stopped taking the medication. |
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, specify | Alphanumeric |
Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM). |
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 | Dose | Numeric Values |
Record the strength and units of the medication the participant/subject is taking. |
No references available | 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, specify | Alphanumeric |
Record the route of administration. Acceptable responses for Route are shown below the medication table. |
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. | End Date | Date or Date & Time |
Record the date (and time if applicable to the study) the participant/subject stopped taking the medication. 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.) and in the format acceptable to the study database. End Date should be recorded if Continuing Medication is answered NO. Conversely, End Date should remain blank if Continuing Medication is answered YES. Studies that need to collect End Time will need to add fields for time to the form template. |
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 | 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. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology. |
CDISC SDTM Frequency Terminology (Code C71113) - 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) | Dose Units | Alphanumeric |
Code the unit of measure of the medication dosage using Unified Code for Units of Measure (UCUM). |
Unified Code for Units of Measure (UCUM) - 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 | Medication Name | Alphanumeric |
Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm. |
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 |
