CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Protocol Experience
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
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) Protocol Experience Study Management 100

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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) Protocol Experience Study Management

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) Protocol Experience Study Management

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) Protocol Experience Study Management 4000

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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) Protocol Experience Study Management

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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) Protocol Experience Study Management

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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) Protocol Experience Study Management

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) Protocol Experience Study Management 250

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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) Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Review Form (PDR) PDRCAPA
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) Protocol Experience Study Management

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) Protocol Experience Study Management 250

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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) Protocol Experience Study Management

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) Protocol Experience Study Management

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) Protocol Experience Study Management

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) Protocol Experience Study Management

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) Protocol Experience Study Management 100

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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) Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Review Form (PDR) PDRREASN
17 results.
CSV