This is an example of a study were where the sponsor collected events associated with the operation of the electronic cigarette device. Events not specifically associated with the device should not be represented in this domain.
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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 | SPTOBID | What was the tobacco product identifier? | Tobacco Product Identifier | text | Indicate |
the tobacco product involved in incident| event. | SPTOBID |
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| VAPE-Z01 |
| radio |
| | 6 | PITERM | What was the event associated with this |
tobacco product Tobacco Product | Event | text | Record a description of the event that occurred. | PITERM |
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| | 7 | PISTDAT | What was the start date when the event first occurred or was identified? | Start Date | text | Record the date that the event first occurred or was noted using this format (DD-MON-YYYY). | PISTDTC |
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| | 10 | PIEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the event occurred. | PIPATT |
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| Single Event; Intermittent; Continuous |
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| radio |
| | 11 | PIACNDEV | What action was taken with the |
study | device? | Action Taken With Device | text | Record what action was taken with the |
tobacco product | device as a result of the event. | PIACNDEV |
| (DEACNDEV) | No Change; |
Tobacco Product Battery Replaced
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| radio |
| | 12 | PIAENO(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 event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC |
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The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study. Note this identifier also describes any device use by the subject to deliver the tobacco.
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Sponsor may use standardized or dictionary-derived text for the description of an product a device event/problem. CDISC does not provided provide information on the what standardized or dictionary-derived text should be used.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | PISEQ | PILNKID | PITERM | PIDECOD | PIMODIFY |
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PIACTPIACNDEV | PISTDTC |
| PIIMDRCD | PIIMDRL2 | PIIMDRL1 |
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1 | TB005 | PI | 2029 | VAPE-Z01 | 1 |
| Broken Heater | Mechanical Problem | Mechanical Problem | Device Replaced | 2009-12-28 |
| A05 | Mechanical Problem | Mechanical Problem |
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2 | TB005 | PI | 1059 | VAPE-Z01 | 1 |
| Won’t charge | | Charging Problem | Battery Replaced | 2009-01-05 |
| A0706 | Charging Problem | Electrical /Electronic Property Problem |
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3 | TB005 | PI | 3067 | VAPE-Z01 | 1 | 1 | Battery Malfunction | Battery Problem | Battery Problem | Battery Replaced | 2009-01-05 |
| A0705 | Battery Problem | Electrical /Electronic Property Problem |
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| | Variable | Label | Type | Role | Origin |
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| PIIMDRCD | IMDR Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | PIIMDRL2 | IMDR Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | PIIMDRL1 | IMDR Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown for brevity.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | AESEQ | AELNKID | AETERM | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY |
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| 1 | TB005 | AE | 3067 | 1 | 1 | SKIN REDNESS |
STUDY ADMINSISTRATION| EXPOSURE | 2009-01-05 | 2009-01-07 | 14 | 18 |
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The RELREC dataset was used to record the relationship between the Product Events in PI and reported AE represented in AE dataset.
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