CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Protocol Experience
CRF: Protocol Deviation

14 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
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 Form (PDV) Protocol Experience Protocol Deviations

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Review Form (PDR) PDSEQNUM
C59155 Protocol deviation violation corrective action text PrtclDevVioltnCrctvActnTxt Text recording the protocol deviation or violation corrective action that was taken Text recording the protocol deviation or violation corrective action that was taken Record corrective action: Alphanumeric Adult;Pediatric Proposed 1.00 2019-01-29 16:03:29.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations 255

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BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVCORSP
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 Form (PDV) Protocol Experience Protocol Deviations 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 Record 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 Form (PDV) Protocol Experience Protocol Deviations

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 Form (PDV) Protocol Experience Protocol Deviations 100

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BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Review Form (PDR) PDRRSNSP
C59148 Protocol deviation violation identified date PrtclDevVioltnIdnDate Date which indicating when the protocol deviation or violation was identified. Date which indicating when the protocol deviation or violation was identified. Date deviation/violation identified: Date or Date & Time Adult;Pediatric Proposed 1.00 2019-01-29 15:20:58.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations

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BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVIDTDT
C59149 Protocol deviation violation description text PrtclDevVioltnDesTxt Text describing the protocol deviation or violation Text describing the protocol deviation or violation Deviation/violation description: Alphanumeric Adult;Pediatric Proposed 1.00 2019-01-29 15:32:48.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations 255

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BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVDESCR
C59150 Protocol deviation violation result discontinuation study therapy code PrtclDvVltnRsltDscStdyThpyCode Code indicating whether the protocol deviation or violation resulted in the discontinuation of the study therapy Code indicating whether the protocol deviation or violation resulted in the discontinuation of the study therapy Did the deviation/violation result in the discontinuation of study therapy? 1;2;1;2 Yes;No;Yes;No Numeric Values

The patient must still be followed for all endpoints regardless of whether the patient continues to receive study therapy.

Adult;Pediatric Proposed 1.00 2019-01-29 15:35:20.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVSTDIS
C59151 Protocol deviation violation meet IRB record reporting requirements code PrtclDvVltnMtIRBRcrdRptReqCode Code indicating whether the protocol deviation or violation meets the Institutional Review Board of record reporting requirements Code indicating whether the protocol deviation or violation meets the Institutional Review Board of record reporting requirements Does the deviation/violation meet IRB of record reporting requirements? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2019-01-29 15:47:55.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVIRBRE
C59152 Protocol deviation violation IRB notification code PrtclDevVioltnIRBNotCode Code indicating the specific type of protocol deviation or violation notification to the Institutional Review Board per institutional policy Code indicating the specific type of protocol deviation or violation notification to the Institutional Review Board per institutional policy Specify type of notification to the IRB per institutional policy: 1;2 Expedited Reporting;Reportable at Time of Annual Review Numeric Values Adult;Pediatric Proposed 1.00 2019-01-29 15:53:34.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVIRBOU
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 Form (PDV) Protocol Experience Protocol Deviations 4000

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DeBaun Forms
C59153 Protocol deviation violation expedited reporting date PrtclDevVioltnExpRprtDate Date indicating the protocol deviation or violation expedited reporting Date indicating the protocol deviation or violation expedited reporting Expedited reporting date: Date or Date & Time Adult;Pediatric Proposed 1.00 2019-01-29 15:57:52.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations

Free-Form Entry

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVIRBDT
C59135 Protocol deviation violation category code PrtclDevVioltnCatCode Code indicating the protocol deviation or violation category Code indicating the protocol deviation or violation category Record 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 Form (PDV) Protocol Experience Protocol Deviations

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Review Form (PDR) PDRCATEG
C59154 Protocol deviation violation corrective action taken code PrtclDevVioltnCrctvActnTknCode Code indicating whether a corrective action was taken for the protocol deviation or violation Code indicating whether a corrective action was taken for the protocol deviation or violation Was any corrective action taken? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2019-01-29 16:00:35.0 Protocol Deviation/Violation Form (PDV) Protocol Experience Protocol Deviations

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Protocol Deviation/Violation Form (PDV) PDVCORRC
14 results.
CSV