Sub-Domain: Additional Proposed Instruments
CRF: Study Discontinuation
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (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 / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02203 | Off study reason | OffStdyRsn | Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). | Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). | Off study reason | Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died;Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died | Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died;Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died | Alphanumeric |
Choose one. Specify the status of the participant/ subject at his/her last study-related contact. If the final study contact status is "Dead" then a Death Report Form may need to be completed for this participant/ subject. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-18 16:35:19.49 | Study Discontinuation/Completion | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
2979313 | DeBaun Forms | |||||||||||||||||||||||||||
| 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 | Reason for premature intervention discontinuation | 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 | 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 most appropriate answer. Choose one. Specify the participant's/ subject's primary reason for intervention discontinuation. If the primary reason for interventions discontinuation is "Adverse Event" then an Adverse Event CRF must be completed for this participant/subject. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-20 10:21:25.65 | Study Discontinuation/Completion | Additional Proposed Instruments | Other |
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 most appropriate answer. Choose one. Specify the participant's/ subject's primary reason for intervention discontinuation. If the primary reason for interventions discontinuation is "Adverse Event" then an Adverse Event CRF must be completed for this participant/subject. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF. |
No references available | Adult;Pediatric | Proposed | 1.00 | 2014-05-27 13:34:46.0 | Study Discontinuation/Completion | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
2956831 | |||||||||||||||||||||||||||||
| C02200 | Last study intervention date and time | LstStdyIntrvntDateTime | Date (and time, if applicable) of the last known study intervention that the participant/subject received | Date (and time, if applicable) of the last known study intervention that the participant/subject received | Date of last known intervention | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-18 16:35:19.49 | Study Discontinuation/Completion | Additional Proposed Instruments | Other |
Free-Form Entry |
23 | ||||||||||||||||||||||||||||||
| 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 | Did participant subject discontinue intervention before planned end of study? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. Record whether or not the participant/ subject discontinued the study intervention before the planned end of the study. This CDE is meaningful for clinical trials only. If this study is not a clinical trial it should be removed from the CRF. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-20 10:21:25.65 | Study Discontinuation/Completion | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
3180300 | ||||||||||||||||||||||||||||
| C02202 | Off study date and time | OffStdyDateTime | Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment) | Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment) | Off study date | Date or Date & Time |
Record the date (and time) of the participant's/ subject's last study related-contact. This may be the study completion visit or follow-up visit/phone call. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. |
No references available | Adult;Pediatric | Proposed | 3.00 | 2013-07-18 14:26:06.9 | Study Discontinuation/Completion | Additional Proposed Instruments | Other |
Free-Form Entry |
2003605 |
