Concomitant Medication (CM)

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. The same 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. 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.  

CDASH CM Metadata Specifications

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.	Text	CMDOSFRM	CMDOSFRM	(FRM)	AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET
9	What was the frequency of the medication/product?	Frequency	Record how often the medication/product was taken (e.g., BID, PRN).	Text	CMDOSFRQ	CMDOSFRQ	(FREQ)	BID; PRN; QD; QID; QM; QOD; TID
10	What was the route of administration of the medication/product?	Route	Provide the route of administration for the medication/product.	Text	CMROUTE	CMROUTE	(ROUTE)	INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL
11	What was the start date?	Start Date	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. 

cm.xpt

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.

cm.xpt

cm.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMDECOD	CMINDC	CMCLAS	CMDOSE	CMDOSTXT	CMDOSU	CMDOSFRM	CMDOSFRQ	CMROUTE	CMSTDTC	CMENDTC	CMENRF
1	ABC123	CM	ABC123-0001	1	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-14	2006-10-14
2	ABC123	CM	ABC123-0001	2	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-15	2006-10-15
3	ABC123	CM	ABC123-0001	3	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-16	2006-10-16
4	ABC123	CM	ABC123-0001	4	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-10-17	2006-10-17
5	ABC123	CM	ABC123-0001	5	ASPIRIN	acetylsalicylic acid	MIGRAINE	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2006-01-18	2006-01-18
6	ABC123	CM	ABC123-0002	1	DIOVAN	valsartan	HYPERTENSION	ANTIHYPERTENSIVES	20		mg	TABLET	BID	ORAL	2004		AFTER
7	ABC123	CM	ABC123-0002	2	ZOLOFT	sertraline	PANIC ATTACKS	PSYCHOANALEPTICS	50		mg	TABLET	OD	ORAL	2004-01		AFTER
8	ABC123	CM	ABC123-0002	3	ASTELIN	azelastine	INFLUENZA	NASAL PREPARATIONS		2 sprays in each nostril-137 mcg	mcg	SPRAY	BID	NASAL	2006-02-26		AFTER
9	ABC123	CM	ABC123-0002	4	ASPIRIN	acetylsalicylic acid	PAIN	ANALGESICS	100		mg	TABLET	PRN	ORAL	2004-01-01		AFTER

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