CDASH Example.Concomitant Medications-General

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.

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
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?	Concomitant 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

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CDASH Example.Concomitant Medications-General