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. 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
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

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CDASH Example.Concomitant Medications-General