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Example ML Variable Metadata [MLDECOD]
Variable | Label | Type | Codelist |
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| DEDECOD | Standardized Meal Name | text | IMDRFANNEXA |
Example External Dictionaries
| Xformpusher |
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| Order | CDASHIG Variable | Question Text | Prompt | Data Type | CRF Completion Instructions | SDTMIG Target | SDTM Variable Mapping | Controlled Terminology Codelist Name | Permissible Values | Pre-populated Value | Query Display | List Style | Hidden |
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| 1 | SPDEVID | What device experienced the event? | Device Experienced Event | text | Indicate the device that was involved in the incident. | SPDEVID |
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| HTDDEV |
| radio |
| | 2 | DESPID | What is the device event identifier? | Device Event Identifier | text |
| DESPID |
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| Sponsor-defined |
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| Y | | 6 | DETERM | Describe the device event. | Device Event | text | Record a description of the device event that occurred. | DETERM |
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| | 7 | DESTDAT | What was the start date when the event first occurred or was identified? | Start Date | text | Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY). | DESTDTC |
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| | 10 | DEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the incident occurred. | DEPATT |
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| Single Event; Intermittent; Continuous |
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| radio |
| | 11 | DEACNDEV | What action was taken with the study device? | Action Taken With Device | text | Record what action was taken with the device as a result of the incident. | DEACNDEV |
| (DEACNDEV) | No change; Device replaced;
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| | 12 | DEAENO(n) | What was the identifier for the primary adverse event(s) associated with or related to this device event? | Related Adverse Event ID | text | Record the ID of the primary AE associated with the device event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC |
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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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| 1 | TOB07 | DI | HTDDEV | 1 | DEVTYPE | Device Type | Heatstick System Holder and Charger | | 2 | TOB07 | DI | HTDDEV | 2 | MANUF | Manufacturer | Reliable Devices | | 3 | TOB07 | DI | HTDDEV | 3 | MODEL | Model Number | |
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| Dataset wrap |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DESEQ | DETERM | DEDECOD | DEMODIFY | DEVACT | DESTDTC |
| DEIMDRDC | DEIMDRFL2 | DEIMDRFL1 |
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1 | TB005 | DE | 2029 | HTDDEV | 1 | Broken Heater | Mechanical Problem | Mechanical Problem | Device Replaced | 2009-12-28 |
| A05 | Mechanical Problem | Mechanical Problem |
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2 | TB005 | DE | 1059 | HTDDEV | 1 | Won’t charge | | Charging Problem | Battery Replaced | 2009-01-05 |
| A0706 | Charging Problem | Electrical /Electronic Property Problem |
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3 | TB005 | DE | 3067 | HTDDEV | 1 | Battery Malfunction | Battery Problem | Battery Problem | Battery Replaced | 2009-01-05 |
| A0705 | Battery Problem | Electrical /Electronic Property Problem |
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