CDE Detailed Report
Disease: Traumatic Brain Injury
Subdomain Name: Off Treatment/Off Study
CRF: Study Discontinuation
Displaying 1 - 3 of 3
Subdomain Name: Off Treatment/Off Study
CRF: Study Discontinuation
Displaying 1 - 3 of 3
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02201 | Off study intervention prematurely indicator | OffStdyIntrvntPrematureInd | Indicator that participant/subject discontinued study intervention before planned end of study | Indicator that participant/subject discontinued study intervention before planned end of study | Indicates that participant/subject prematurely discontinued study intervention | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Study Discontinuation/Completion | Off Treatment/Off Study | Protocol Experience |
Single Pre-Defined Value Selected |
3180300 | |||||||
| C02222 | Off study intervention prematurely reason | OffStdyIntrvntPrematurRsn | Primary reason participant/subject discontinued study intervention before planned end of study | Primary reason participant/subject discontinued study intervention before planned end of study | Primary reason participant/subject prematurely discontinued study intervention | Adverse event;Other clinical decision (e.g., investigator decision, primary care provider decision, etc.) OR other reason specified by the protocol (i.e., institutionalization, pregnancy, etc.);Death;Participant's/Subject's decision (e.g., unwilling/unable to commit time and/or resources, moved from area, etc.);Lost to follow-up;Other, specify | Adverse event;Other clinical decision (e.g., investigator decision, primary care provider decision, etc.) OR other reason specified by the protocol (i.e., institutionalization, pregnancy, etc.);Death;Participant's/Subject's decision (e.g., unwilling/unable to commit time and/or resources, moved from area, etc.);Lost to follow-up;Other, specify | Alphanumeric |
Choose all that apply. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Study Discontinuation/Completion | Off Treatment/Off Study | Protocol Experience |
Single Pre-Defined Value Selected |
2956831 | |||||||
| C18740 | Off study intervention prematurely other text | OffStdyIntrvntPrematurOTH | The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study | The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study | Other, specify | Alphanumeric |
Choose all that apply. |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Study Discontinuation/Completion | Off Treatment/Off Study | Protocol Experience | 4000 |
Free-Form Entry |
2956831 |
