SDTM Example.Concomitant Medication

NEED TO GET THE CORRECT REFERNCES More information can be found in SDTMIG Section 4.4.7, Use of Relative Timing Variables.

This is an example CRF used to collect general concomitant medications in a study. This CRF was designed to allow the sponsor to use either CMENRF or CMENRTPT to represent an intervention was ongoing.

	Concomitant Medication Category CMCAT Hidden/pre-populated	GENERAL
Indicate if the subject used any Nicotine patches . If Yes, include the appropriate details where indicated on the CRF.	Were any Nicotine patches used? CMOCCUR Not Submitted	Yes No <NY codelist>
If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.	CM Number CMSPID	_________________
Record only one treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name .	What was the medication? CMTRT	_________________
Record the reason the medication 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).	For what indication was the medication taken? CMINDC	_________________
Record the dose of medication/treatment per administration (e.g., 200).	Dose CMDSTXT CMDOSTXT/ CMDOSE	_________________
Record the dose unit of the dose of concomitant medication/treatment taken (e.g., mg).	Unit CMDOSU	<UNIT codelist>
Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy] taken.	Dose Form CMDOSFRM	<FRM codelist>
Record how often the medication was taken (e.g., BID, PRN).	Frequency CMDOSFRQ	<FREQ codelist>
Provide the route of administration for the medication.	Route CMROUTE	<ROUTE codelist>
Record the date the concomitant medication/treatment was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant medication/treatment for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant medications taken during the study are expected to have a complete start date. Prior concomitant medications that are exclusionary should have both a start date and an end date.	Start Date CMSTDAT CMSTDTC	_ _ / _ _ _ / _ _ _ _
Record the concomitant medication/treatment as ongoing if the subject has not stopped taking the concomitant medication/treatment at the time of data collection and the end date should be left blank.	Is the medication ongoing? CMONGO CMENRF or CMENRTPT	Yes <NY codelist>
Record the date the concomitant medication/treatment was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant medication/treatment leave this field blank.	End Date CMENDAT CMENDTC	_ _ / _ _ _ / _ _ _ _

Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTMIG Target Mapping	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	CMCAT	What is the category for the medication?	Concomitant Medication Category	Record the medication category, if not pre-printed on the CRF.	Text	CMCAT				GENERAL			Yes
2	CMOCCUR	Were any Nicotine patches used?	Any Nicotine patches Used?	Indicate if the subject used any Nicotine patches . If Yes, include the appropriate details where indicated on the CRF.	Text	N/A		(NY)	Yes; No
3	CMSPID	What is the medication identifier?	CM Number	If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier.	Text	CMSPID					prompt
4	CMTRT	What was the medication?	Concomitant Medication	Record only one treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name .	Text	CMTRT
6	CMINDC	For what indication was the medication taken?	Indication	Record the reason the medication 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
7	CMDSTXT	What was the individual dose of the medication?	Dose	Record the dose of medication/treatment per administration (e.g., 200).	Text	CMDOSTXT; CMDOSE	CMDOSTXT/ CMDOSE				prompt
8	CMDOSU	What is the unit?	Unit	Record the dose unit of the dose of concomitant medication/treatment taken (e.g., mg).	Text	CMDOSU		(UNIT)	CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug		prompt
9	CMDOSFRM	What was the dose form of the medication?	Dose Form	Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy] taken.	Text	CMDOSFRM		(FRM)	AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET		prompt
10	CMDOSFRQ	What was the frequency of the medication?	Frequency	Record how often the medication was taken (e.g., BID, PRN).	Text	CMDOSFRQ		(FREQ)	BID; PRN; QD; QID; QM; QOD; TID		prompt
11	CMROUTE	What was the route of administration of the medication?	Route	Provide the route of administration for the medication.	Text	CMROUTE		(ROUTE)	INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL		prompt
12	CMSTDAT	What was the start date?	Start Date	Record the date the concomitant medication/treatment was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant medication/treatment for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant medications taken during the study are expected to have a complete start date. Prior concomitant medications that are exclusionary should have both a start date and an end date.	Date	CMSTDTC					prompt
13	CMONGO	Is the medication ongoing?	Ongoing	Record the concomitant medication/treatment as ongoing if the subject has not stopped taking the concomitant medication/treatment at the time of data collection and the end date should be left blank.	Text	CMENRF; CMENRTPT	CMENRF or CMENRTPT	(NY)	Yes			checkbox
14	CMENDAT	What was the end date?	End Date	Record the date the concomitant medication/treatment was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant medication/treatment leave this field blank.	Date	CMENDTC					prompt

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 SDTMIG Section 4.4.7, Use of Relative Timing Variables. The sponsor include CMDECOD. The sponsor is required to provide the dictionary name and version in the Define-XML document.

Rows 1-6:	The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 7-9:	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 10:	The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy in this study.

cm.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMDECOD	CMCLAS	CMDOSE	CMDOSTXT	CMDOSU	CMDOSFRM	CMDOSFRQ	CMROUTE	CMSTDTC	CMENDTC	CMENRF
1	ABC	CM	ABC-0001	1	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-01	2004-01-01
2	ABC	CM	ABC-0001	2	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-02	2004-01-02
3	ABC	CM	ABC-0001	3	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-03	2004-01-03
4	ABC	CM	ABC-0001	4	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-07	2004-01-07
5	ABC	CM	ABC-0001	5	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-07	2004-01-07
6	ABC	CM	ABC-0001	6	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	ONCE	ORAL	2004-01-09	2004-01-09
7	ABC	CM	ABC-0002	1	DIOVAN	valsartan	ANTIHYPERTENSIVES	20		mg	TABLET	BID	ORAL	2004		AFTER
8	ABC	CM	ABC-0002	2	ZOLOFT	sertraline	PSYCHOANALEPTICS	50		mg	TABLET	OD	ORAL	2004-01		AFTER
9	ABC	CM	ABC-0002	3	ASTELIN	azelastine	NASAL PREPARATIONS		2 sprays in each nostril-137 mcg	mcg	SPRAY	BID	NASAL	2004-01-09	2004-06-10
10	ABC	CM	ABC-0003	1	ASPIRIN	acetylsalicylic acid	ANALGESICS	100		mg	TABLET	PRN	ORAL	2004-01-01		AFTER

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SDTM Example.Concomitant Medication