The Concomitant Medication (CM) domain is based on the Interventions General Observation class. The CM domain is used to represent information relating to concomitant and prior medications used by the subject, such as those given on an as-needed basis or condition-appropriate medications. Thesame basic data collection variables should be collected for all medications, treatments, and therapies (prior, general concomitant medications, and medications of interest). Reacreational substances are not represented in this domain (see Section Prior Usage of Recreational Products (Including Tobacco Products(. However, medical proudcts recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacement patches).
Example
This is an example CRF used to collect general concomitant medications/products in a study. This CRF was designed to allow the applicant to use either CMENRF or CMENRTPT to represent an intervention was ongoing. In order to save space, some of the example permissible values are only shown in the metadata specifications.
This is the metadata specifications for Section 1 and 2 of the CRF.
Section 1
Order
Question Text
Prompt
Case Report Form Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instructions
Controlled Terminology CodeList Name
Permissible Values
Pre-Populated Value
1
Were any concomitant medications/products taken?
Any Concomitant Medications/Products
Indicate if the subject took any concomitant medications/products. If Yes, include the appropriate details where indicated on the CRF.
Text
Not Submitted
(NY)
Section 2
Order
Question Text
Prompt
Case Report Form Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instructions
Controlled Terminology CodeList Name
Permissible Values
Pre-Populated Value
2
What is the category for the concomitant medication/product?
Concomitant Medication/Product Category
Record the medication/product category, if not pre-printed on the CRF.
Text
CMCAT
CMCAT
GENERAL
3
What is the medication/product line number?
CM Line Number
If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.
Text
CMSPID
CMSPID
4
What was the medication/product?
Medication/Product
Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.
Text
CMTRT
CMTRT
5
For what indication was the medication/product taken?
Indication
Record the reason the medication/product was taken based on clinical investigator's evaluation. If taken to treat a condition, and a diagnosis was made, the indication should be the diagnosis. If taken to treat a condition, and no diagnosis was made, the indication should be the signs and symptoms. If taken as prophylaxis, report as "Prophylaxis for " and include a description of the condition(s).
Text
CMINDC
CMINDC
6
What was the individual dose of the medication/product?
Dose
Record the dose of medication/treatment per administration (e.g., 200).
Text
CMDOSTXT OR CMDOSE
CMDOSTXT/ CMDOSE
7
What is the unit?
Unit
Record the dose unit of the dose of medication/product taken (e.g., mg).
Text
CMDOSU
CMDOSU
(UNIT)
CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug
8
What was the dose form of the medication/product?
Dose Form
Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product taken.
Record the date the medication/treatment was first taken using this format. If the subject has been taking the medication/product for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Medications/Products taken during the study are expected to have a complete start date. Prior medications/products that are exclusionary should have both a start date and an end date.
Date
CMSTDTC
CMSTDAT
12
Is the medication ongoing?
Ongoing
Record the medication/product as ongoing if the subject has not stopped taking the medication/product at the time of data collection and the end date should be left blank.
Text
CMENRF OR CMENRTPT
CMENRF or CMENRTPT
(NY)
No; Yes
13
What was the end date?
End Date
Record the date the medication/product was stopped using this format. If the subject has not stopped taking the medication/product leave this field blank.
Date
CMENDTC
CMENDAT
This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in Section 2.8.7.6, Representing References and Relative Timing.
The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document.
Rows 1-4:
The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 6-8:
The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft.
Row 9:
The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating the product in this study.
