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. The code list to be used for unit is specified by the applicant.
Section 1
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In order to save space, some of the example permissible values are only shown in the metadata specifications.
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This is the metadata specifications for Section 1 and 2 of the CRF.
Section 2
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| title | CDASH CM Metadata Specifications |
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Section 1 | Metadataspec |
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metadataspec| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 | Were any concomitant medications/products taken? | Any Concomitant Medications/Products | Indicate if the subject took any concomitant medications/products. If Yes, include the appropriate details where indicated on the CRF. | Text |
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| Not Submitted | (NY) |
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| title | CDASH CM Metadata Specifications |
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| Section 2 | Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 2 | 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 | CMCAT |
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| GENERAL |
| | 3 | 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 | CMSPID |
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| | 4 | 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 | CMTRT |
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| | 5 | 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 | CMINDC |
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| | 6 | What was the individual dose of the medication/product? | Dose | Record the dose of medication/treatment per administration (e.g., 200). |
CMDSTXT| Text | CMDOSTXT OR CMDOSE | CMDOSTXT/ CMDOSE |
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| | 7 | What is the unit? | Unit | Record the dose unit of the dose of medication/product taken (e.g., mg). | Text | CMDOSU | CMDOSU | (UNIT) | CAPSULE; g; IU; mg; mL; PUFF; TABLET; ug |
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| | 8 | 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 | CMDOSFRM | (FRM) | AEROSOL; CAPSULE; CREAM; GAS; GEL; OINTMENT; PATCH; POWDER; SPRAY; SUPPOSITORY; SUSPENSION; TABLET |
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| | 9 | What was the frequency of the medication/product? | Frequency | Record how often the medication/product was taken (e.g., BID, PRN). | Text | CMDOSFRQ | CMDOSFRQ | (FREQ) | BID; PRN; QD; QID; QM; QOD; TID |
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| | 10 | What was the route of administration of the medication/product? | Route | Provide the route of administration for the medication/product. | Text | CMROUTE | CMROUTE | (ROUTE) | INTRALESIONAL; INTRAMUSCULAR; INTRAOCULAR; INTRAPERITONEAL; NASAL; ORAL; RECTAL; RESPIRATORY (INHALATION); SUBCUTANEOUS; TOPICAL; TRANSDERMAL; VAGINAL |
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| | 11 | 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. |
CMSTDAT| Date | CMSTDTC | CMSTDAT |
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| | 12 | 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. |
CMONGO| Text | CMENRF OR CMENRTPT | CMENRF or CMENRTPT | (NY) | No; Yes |
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| | 13 | What was the end date? | End Date | Record the date the medication/product was stopped using this |
format | format. If the subject has not stopped taking the medication/product leave this field blank. |
CMENDAT |
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