CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Protocol Deviation
Sub-Domain: Additional Proposed Instruments
CRF: Protocol Deviation
17 results.
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59134 | Protocol deviation reportable qualification code | PrtclDevRprtQualCode | Code indicating whether the event qualifies as a reportable protocol deviation or violation. | Code indicating whether the event qualifies as a reportable protocol deviation or violation. | Does the event qualify as a reportable protocol deviation/violation? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 15:45:24.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRQUAL | |||||||||||||||||||||||||||
| C59145 | Protocol deviation violation require additional training CAPA specify text | PrtclDvVioltnRqAddTrnCAPSpyTxt | Text specifying the type of re-training or Corrective Action Preventive Action (CAPA) needed for the protocol deviation or violation | Text specifying the type of re-training or Corrective Action Preventive Action (CAPA) needed for the protocol deviation or violation | If the event requires additional site re-training or a CAPA, specify: | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-29 12:48:39.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other | 250 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRCAPSP | ||||||||||||||||||||||||||||
| C59135 | Protocol deviation violation category code | PrtclDevVioltnCatCode | Code indicating the protocol deviation or violation category | Code indicating the protocol deviation or violation category | Confirm deviation/violation category: | 01;02;03;04;05;06;07;08;09;10;99 | Treatment Assignment;Treatment Administration;Unblinding;Eligibility;Consent Related;Assessment/Procedure Non-compliance;Protocol-prohibited Agent or Treatment;Data Breach;Documentation;PI Oversight;Other, specify | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 15:53:07.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRCATEG | |||||||||||||||||||||||||||
| C59146 | Protocol deviation violation review complete code | PrtclDevVioltnRvwCmpltCode | Code indicating whether the protocol deviation or violation review has been completed | Code indicating whether the protocol deviation or violation review has been completed | Review complete? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-29 12:54:10.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRRECOM | |||||||||||||||||||||||||||
| C59136 | Protocol deviation violation number | PrtclDevVioltnNum | Number indicating whether the protocol deviation or violation is the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th or 10th of the day. | Number indicating whether the protocol deviation or violation is the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th or 10th of the day. | Deviation/Violation Num | 01;02;03;04;05;06;07;08;09;10 | 1st Deviation/Violation of the Day;2nd Deviation/Violation of the Day;3rd Deviation/Violation of the Day;4th Deviation/Violation of the Day;5th Deviation/Violation of the Day;6th Deviation/Violation of the Day;7th Deviation/Violation of the Day;8th Deviation/Violation of the Day;9th Deviation/Violation of the Day;10th Deviation/Violation of the Day | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:01:15.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDSEQNUM | |||||||||||||||||||||||||||
| C59147 | Protocol deviation violation reviewed BMTCTN Project Director code | PrtclDevVioltnRevBMTCTNPDCode | Code indicating whether the protocol deviation or violation was reviewed by the Bone Marrow Transplant Clinical Trials Network (BMTCTN) project director | Code indicating whether the protocol deviation or violation was reviewed by the Bone Marrow Transplant Clinical Trials Network (BMTCTN) project director | BMT CTN Project Director reviewed? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-29 13:11:21.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRPDREV | |||||||||||||||||||||||||||
| C59137 | Protocol deviation violation specify text | PrtclDevVioltnSpcfyTxt | Text indicating the specific type of protocol deviation or violation | Text indicating the specific type of protocol deviation or violation | Specify other: | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:27:51.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRCATSP | ||||||||||||||||||||||||||||
| C59138 | Protocol deviation violation reason confirmation code | PrtclDevVioltnRsnConfCode | Code confirming the reason for the protocol deviation or violation | Code confirming the reason for the protocol deviation or violation | Confirm reason for deviation/violation: | 01;02;03;04;05;99 | Clinic Error;Pharmacy Error;Physician or PI Decision;Subject Refusal;Subject Compliance Error;Other, specify | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:30:35.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRREASN | |||||||||||||||||||||||||||
| C59139 | Protocol deviation violation reason specify text | PrtclDevVioltnRsnSpcfyTxt | Text indicating the specifc other reason a protocol deviation or violation occurred | Text indicating the specifc other reason a protocol deviation or violation occurred | Specify other: | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:43:17.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRRSNSP | ||||||||||||||||||||||||||||
| C59140 | Protocol deviation violation reportable code | PrtclDevVioltnRprtblCode | Code indicating whether a protocol deviation or violation is reportable to the Data Safety Monitoring Board (DSMB) | Code indicating whether a protocol deviation or violation is reportable to the Data Safety Monitoring Board (DSMB) | Is this event reportable to the DSMB? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:45:25.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRDSMSF | |||||||||||||||||||||||||||
| C59141 | Protocol deviation violation DSMB reported code | PrtclDevVioltnDSMBRprtCode | Code indicating whether the protocol deviation or violation was reported to the Data Safety Monitoring Board (DSMB) in the Spring or Fall. | Code indicating whether the protocol deviation or violation was reported to the Data Safety Monitoring Board (DSMB) in the Spring or Fall. | Date to be reported to the DSMB: | Spring;Fall | Spring;Fall | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:48:40.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRDSMSF | |||||||||||||||||||||||||||
| C18027 | Comment text | CmmntTxt | Provide any additional information that pertains to the question. | Provide any additional information that pertains to the question. | Comments: | Alphanumeric | Adult;Pediatric | Proposed | 3.00 | 2013-07-16 14:01:43.01 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C59142 | Protocol deviation violation DSMB report date | PrtclDevVioltnDSMBRprtDate | Year indicating when the protocol deviation or violation was reported to the Data Safety Monitoring Board (DSMB) | Year indicating when the protocol deviation or violation was reported to the Data Safety Monitoring Board (DSMB) | Date to be reported to the DSMB year: | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:51:37.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRDSMYR | |||||||||||||||||||||||||||||
| C59132 | Protocol deviation violation reviewed date | PrtclDevVioltnRvwdDate | Date indicating when the protocol deviation or violation event was reviewed | Date indicating when the protocol deviation or violation event was reviewed | Date event reviewed: | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 15:32:32.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDREVDT | |||||||||||||||||||||||||||||
| C59143 | Protocol deviation violation included Core Consortia Center Performance Report Code | PrtclDevVioltnInclCCCPRCode | Code indicating wthether the protocol deviation or violation will be included in the Core Consortia Center Performance Report | Code indicating wthether the protocol deviation or violation will be included in the Core Consortia Center Performance Report | Will this event be included in the Core Consortia Cneter Performance Report? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 17:58:09.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRCCCPR | |||||||||||||||||||||||||||
| C59133 | Protocol deviation event summary text | ProtDevEvtSumTxt | Text summarizing the protocol deviation or violation event | Text summarizing the protocol deviation or violation event | Event summary: | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-28 15:41:12.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other | 250 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDREVSUM | ||||||||||||||||||||||||||||
| C59144 | Protocol deviation violation require additional site retraining or CAPA code | PrtclDevVioltnRqAddStRtCAPCode | Code indicating whether the protocol deviation or violation requires additional site re-training or a Corrective Action Preventive Action (CAPA) | Code indicating whether the protocol deviation or violation requires additional site re-training or a Corrective Action Preventive Action (CAPA) | Does this event require additional site re-training or a CAPA? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-29 12:25:24.0 | Protocol Deviation/Violation Review Form (PDR) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Review Form (PDR) | PDRCAPA |
17 results.