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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. 


OrderCDASH VariableQuestion TextPromptCRF Completion InstructionsSDTMIG Target VariableSDTMIG Target MappingControlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1CMCATWhat is the category for the concomitant medication/product?Concomitant Medication/Product CategoryRecord the medication/product category, if not pre-printed on the CRF.CMCAT


GENERAL
2CMSPIDWhat is the medication/product line number?CM Line NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.CMSPID



3CMTRTWhat was the medication/product?Concomitant Medication/ProductRecord only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.CMTRT



4CMINDCFor what indication was the medication/product taken?IndicationRecord 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).CMINDC



5CMDSTXTWhat was the individual dose of the medication/product?DoseRecord the dose of medication/treatment per administration (e.g., 200).CMDOSTXT OR CMDOSECMDOSTXT/  CMDOSE


6CMDOSUWhat is the unit?UnitRecord the dose unit of the dose of medication/product taken (e.g., mg).CMDOSU
(UNIT)CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug
7CMDOSFRMWhat was the dose form of the medication/product?Dose FormRecord the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product  taken.CMDOSFRM
(FRM)AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET
8CMDOSFRQWhat was the frequency of the medication/product?FrequencyRecord how often the medication/product was taken (e.g., BID, PRN).CMDOSFRQ
(FREQ)BID; PRN; QD; QID; QM; QOD; TID
9CMROUTEWhat was the route of administration of the medication/product?RouteProvide the route of administration for the medication/product.CMROUTE
(ROUTE)INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL
10CMSTDATWhat was the start date?Start DateRecord 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.CMSTDTC



11CMONGOIs the medication ongoing?OngoingRecord 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.CMENRF OR  CMENRTPTCMENRF or CMENRTPT(NY)Yes
12CMENDATWhat was the end date?End DateRecord the date the  medication/product was stopped using this format  If the subject has not stopped taking the  medication/product leave this field blank.CMENDTC





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