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This example shows data about concomitant medications collected during a study. is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in Section 2.8.7.6, Representing References and Relative Timing.
The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document.
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| Order | CDASH Variable | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | 1 | CMCAT | What is the category for the medication? | Concomitant Medication Category | Record the medication category, if not pre-printed on the CRF. | Text | CMCAT | GENERAL | Yes | 2 | CMYN | Were any concomitant medications taken? | Any Concomitant Medications | Indicate if the subject took any concomitant medications/treatments. If Yes, include the appropriate details where indicated on the CRF. | Text | N/A | (NY) | Yes; No | 3 | CMSPID | What is the medication identifier? | CM Number | If collected on the CRF, sponsor may insert instructions to ensure each record has a unique identifier. | Text | CMSPID | prompt | 4 | CMTRT | What was the medication? | Concomitant Medication | Record only one treatment per line. Provide the full trade or proprietary name of the medication/treatment; otherwise, record the generic name . | Text | CMTRT | 6 | CMINDC | For what indication was the medication taken? | Indication | Record the reason the medication 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 | 7 | CMDSTXT | What was the individual dose of the medication? | Dose | Record the dose of medication/treatment per administration (e.g., 200). | Text | CMDOSTXT; CMDOSE | CMDOSTXT/ CMDOSE | prompt | 8 | CMDOSU | What is the unit? | Unit | Record the dose unit of the dose of concomitant medication/treatment taken (e.g., mg). | Text | CMDOSU | (UNIT) | CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug | prompt | 9 | CMDOSFRM | What was the dose form of the medication? | Dose Form | Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the concomitant [medication/treatment/therapy] taken. | Text | CMDOSFRM | (FRM) | AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET | prompt | 10 | CMDOSFRQ | What was the frequency of the medication? | Frequency | Record how often the medication was taken (e.g., BID, PRN). | Text | CMDOSFRQ | (FREQ) | BID; PRN; QD; QID; QM; QOD; TID | prompt | 11 | CMROUTE | What was the route of administration of the medication? | Route | Provide the route of administration for the medication. | Text | CMROUTE | (ROUTE) | INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL | prompt | 12 | CMSTDAT | What was the start date? | Start Date | Record the date the concomitant medication/treatment was first taken using this format (DD-MON-YYYY). If the subject has been taking the concomitant medication/treatment for a considerable amount of time prior to the start of the study, it is acceptable to have an incomplete date. Concomitant medications taken during the study are expected to have a complete start date. Prior concomitant medications that are exclusionary should have both a start date and an end date. | Date | CMSTDTC | prompt | 13 | CMONGO | Is the medication ongoing? | Ongoing | Record the concomitant medication/treatment as ongoing if the subject has not stopped taking the concomitant medication/treatment at the time of data collection and the end date should be left blank. | Text | CMENRF; CMENRTPT | CMENRF or CMENRTPT | (NY) | Yes | checkbox | 14 | CMENDAT | What was the end date? | End Date | Record the date the concomitant medication/treatment was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the concomitant medication/treatment leave this field blank. | Date | CMENDTC | prompt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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