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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. 




This is the metadata specifications for Section 1 and 2 of the CRF.  

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were any concomitant medications/products taken?Any Concomitant Medications/ProductsIndicate 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 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category for the concomitant medication/product?Concomitant Medication/Product CategoryRecord the medication/product category, if not pre-printed on the CRF.TextCMCATCMCAT

GENERAL
3What 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.TextCMSPIDCMSPID



4What 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.TextCMTRTCMTRT



5For 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).TextCMINDCCMINDC



6What was the individual dose of the medication/product?DoseRecord the dose of medication/treatment per administration (e.g., 200).TextCMDOSTXT OR CMDOSECMDOSTXT/  CMDOSE



7What is the unit?UnitRecord the dose unit of the dose of medication/product taken (e.g., mg).TextCMDOSUCMDOSU(UNIT)CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug

8What 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.TextCMDOSFRMCMDOSFRM(FRM)AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET

9What was the frequency of the medication/product?FrequencyRecord how often the medication/product was taken (e.g., BID, PRN).TextCMDOSFRQCMDOSFRQ(FREQ)BID; PRN; QD; QID; QM; QOD; TID

10What was the route of administration of the medication/product?RouteProvide the route of administration for the medication/product.TextCMROUTECMROUTE(ROUTE)INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL

11What 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.DateCMSTDTCCMSTDAT



12Is 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.TextCMENRF OR  CMENRTPTCMENRF or CMENRTPT(NY)No; Yes

13What 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.DateCMENDTCCMENDAT








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