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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 | 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 |
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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.
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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. | | 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. | |
| Dataset2 |
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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 | 2004-01-01 |
| ONGOING | | 8 | ABC | CM | ABC-0002 | 2 | ZOLOFT | 50 |
| mg | TABLET | OD | ORAL | 2004-01-07 |
| ONGOING | | 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 | 2004-01-09 |
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