CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Protocol Deviation
Sub-Domain: Additional Proposed Instruments
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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) - BMTCTN 15070 | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Form (PDV) | PDVCORRC | |||||||||||||||||||||||||||
| 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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
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) - 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 | 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) - 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 Form (PDV) - BMTCTN 15070 | Additional Proposed Instruments | Other | 100 |
Free-Form Entry |
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) - BMTCTN 15070 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Protocol Deviation/Violation Form (PDV) | PDVIDTDT |
14 results.