Concomitant Medication (Including Products Related to Nicotine Dependency) (CM, FACM)

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

Example

In this example, the applicant collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The applicant only collected details on the last attempt to reduce nicotine dependency for each type of product used. These products are represented in the Concomitant Medication (CM) domain.

CDASH CM Metadata Specifications

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	What was the medically recognized product name?	Medication		Text	CMTRTC	CMTRT				DRUG USED IN  NICOTINE DEPENDENCE
2		Pre-Specified Intervention		Text	CMPRESP	CMPRESP				Y
3	Did the subject previously use medically recognized products to reduce nicotine dependency?	Any Medically Rrecognized Products Taken For Nicotine Dependency	Indicate if the subject had used any medically recognized products to attempt to reduce nicotine dependency	Text	CMOCCUR	CMOCCUR		(NY)	No;Yes;Not Done
4	How many times did the subject attempt to use use medically recognized products to reduce nicotine dependency	Times the Subject Attempted to Reduce Nicotine Dependency	Record the number of times a subject attempted to use medically recognized products to reduce nicotine dependency	Text	FAORRES	FAORRES	FAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "
5		Category		Text	FACAT	FACAT				ATTEMPTS TO REDUCE NICOTINE DEPENDENCE

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
6	What is the category of the medication/product the subject used to attempt to reduce nicotine dependency?	Medication		Text	CMTRT	CMCAT			NICOTINE REPLACEMENT THERAPY: NOT A NRT
7	What is the medication/product subcategory, if not pre-printed on the CRF.	Subcategory	Applicant Defined	Text	CMSCAT	CMSCAT			LAST ATTEMPTED USE WITH THIS MEDICATION
8	What was the name of the medication/product the subject used to reduce nicotine dependency?	Medication	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
9	What was the duration of the medication/product used to reduce nicotine dependency for the last attempt?	Collected Duration	Provide the duration of the medication/product used.	Text	CMCDUR	CMDUR
10	What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt?	Collected Duration Unit	Select the appropriate duration unit of the medication/product used.	Text	CMCDURU	CMDUR		(UNIT)	DAYS; MONTHS; YEARS

Example

In this example, data were collected on the previous use of smoking cessation products at the baseline visit. This example illustrates the use of CMOCCUR and CMPRESP. The reason why a product was discontinued and any use in the last 14 days was of interest.  

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. In order to save space, some of the permissible values are only shown in the metadata specifications. 

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	What is the category for the medication?	Concomitant Medication Category		Text	CMCAT					SMOKING CESSATION PRODUCT
2	Were any smoking cessation products taken?	Any Smoking Cessation Products Taken	Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR	CMOCCUR;		(NY)	No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  

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
3	What was the smoking cessation product used?	Smoking Cessation Product	Select the smoking cessation product.	Text	CMTRT	CMTRT	CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.		NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4	Did the subject previously use the selected medication/product for smoking cessation?	Smoking Cessation Product Used	Indicate if the subject had used the selected smoking cessation product	Text	CMOCCUR	CMOCCUR		(NY)	No; Yes
5	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of product previously used.	Text	CMTRTO	CMTRT
6	Was the smoking cessation product discontinued due to an adverse experience?	Reason Smoking Cessation Product Discontinued	Indicate if the product was discontinued due to an Adverse Experience	Text	CMRSDISC	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EXPERIENCE"	(NY)	No:Yes:
7	What was the last date the product was used?	Last Date Smoking Cessation Product Used	Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded.	Date	CMENDAT	CMENDTC