This is an example CRF used to collect general concomitant medications in a study. This CRF was designed to allow the sponsor to use either CMENRF or CMENRTPT to represent an intervention was ongoing.
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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 |
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| 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 |
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| Yes | | 2 | CMOCCUR | Were any Nicotine patches used? | Any Nicotine patches Used? | Indicate if the subject used any Nicotine patches . If Yes, include the appropriate details where indicated on the CRF. | Text | N/A |
| (NY) | Yes; No |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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| | 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 |
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This 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 SDTMIG Section 4.4.7, Use of Relative Timing Variables.
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| Rows 1-6: | The subject reported each instance of aspirin use. The frequency in each record is (CMDOSFRQ) is "ONCE". | | Rows 7-9: | The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice be day. in each nostril. Note that only partial start dates are provided for Diovan and Zoloft. | | Row 10: | The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy in this study. | |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMDOSE | CMDOSTXT | CMDOSU | CMDOSFRM | CMDOSFRQ | CMROUTE | CMSTDTC | CMENDTC | CMENRF |
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| 1 | ABC | CM | ABC-0001 | 1 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-01 | 2004-01-01 |
| | 2 | ABC | CM | ABC-0001 | 2 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-02 | 2004-01-02 |
| | 3 | ABC | CM | ABC-0001 | 3 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-03 | 2004-01-03 |
| | 4 | ABC | CM | ABC-0001 | 4 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-07 | 2004-01-07 |
| | 5 | ABC | CM | ABC-0001 | 5 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-07 | 2004-01-07 |
| | 6 | ABC | CM | ABC-0001 | 6 | ASPIRIN | 100 |
| mg | TABLET | ONCE | ORAL | 2004-01-09 | 2004-01-09 |
| | 7 | ABC | CM | ABC-0002 | 1 | DIOVAN | 20 |
| mg | TABLET | BID | ORAL | 2004 |
| AFTER | | 8 | ABC | CM | ABC-0002 | 2 | ZOLOFT | 50 |
| mg | TABLET | OD | ORAL | 2004-01 |
| AFTER | | 9 | ABC | CM | ABC-0002 | 3 | ASTELIN |
| 2 sprays in each nostril-137 mcg | mcg | SPRAY | BID | NASAL | 2004-01-09 | 2004-06-10 |
| | 10 | ABC | CM | ABC-0003 | 1 | ASPIRIN | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
| AFTER | |
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