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.
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| title | CDASH CM Metadata Specifications |
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| Metadataspec |
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| Order | Question Text | Prompt | CRF Completion Instructions | Type | CDASH Variable | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 | CMCAT | What is the category for the concomitant medication/product? | Concomitant Medication/Product Category | Record the medication/product category, if not pre-printed on the CRF. | Text | CMCAT |
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| GENERAL | | 2 | CMSPID | What is the medication/product line number? | CM Line Number | If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier. | Text | CMSPID |
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| | 3 | CMTRT | What was the medication/product? | Concomitant Medication/Product | Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name. | Text | CMTRT |
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| | 4 | CMINDC | For what indication was the medication/product taken? | Indication | Record 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). | Text | CMINDC |
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| | 5 | CMDSTXT | What was the individual dose of the medication/product? | Dose | Record the dose of medication/treatment per administration (e.g., 200). | Text | CMDOSTXT; CMDOSE | CMDOSTXT/ CMDOSE |
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| | 6 | CMDOSU | What is the unit? | Unit | Record the dose unit of the dose of medication/product taken (e.g., mg). | Text | CMDOSU |
| (UNIT) | CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug |
| | 7 | CMDOSFRM | What was the dose form of the medication/product? | Dose Form | Record the pharmaceutical dosage form (e.g., TABLET CAPSULE, SYRUP) of delivery for the medication/product taken. | Text | CMDOSFRM |
| (FRM) | AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET |
| | 8 | CMDOSFRQ | What was the frequency of the medication/product? | Frequency | Record how often the medication/product was taken (e.g., BID, PRN). | Text | CMDOSFRQ |
| (FREQ) | BID; PRN; QD; QID; QM; QOD; TID |
| | 9 | CMROUTE | What was the route of administration of the medication/product? | Route | Provide the route of administration for the medication/product. | Text | CMROUTE |
| (ROUTE) | INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL |
| | 10 | CMSTDAT | What was the start date? | Start Date | Record 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. | Date | CMSTDTC |
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| | 11 | CMONGO | Is the medication ongoing? | Ongoing | Record 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. | Text | CMENRF; CMENRTPT | CMENRF or CMENRTPT | (NY) | Yes |
| | 12 | CMENDAT | What was the end date? | End Date | Record the date the medication/product was stopped using this format If the subject has not stopped taking the medication/product leave this field blank. | Date | CMENDTC |
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