CDE Detailed Report
Sub-Domain: Protocol Deviations
CRF: Protocol Deviations
Displaying 1 - 3 of 3
| CDE ID | CDE Name | Variable Name | Definition | Short Description | 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 | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02204 | Protocol deviation occurrence date and time | ProtocolDeviatnOccurDateTime | Date (and time, if applicable and known) on which the protocol deviation occurred | Date (and time, if applicable and known) on which the protocol deviation occurred | Date Deviation Occurred | Date or Date & Time |
Record the date the protocol deviation occurred. 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 | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Protocol Deviations | Protocol Deviations | Protocol Experience |
Free-Form Entry |
2434998 | |||||||||
| C02205 | Protocol deviation description text | ProtocolDeviatnDescripTxt | Description of the protocol deviation which includes reasons and contributing factors | Description of the protocol deviation which includes reasons and contributing factor | Description of Protocol Deviation | Alphanumeric |
Record what occurred and why. For example, an expired drug was used by a new coordinator who did not check the expiration date because of incomplete training on the protocol. The description should also include remedies taken. In this case, the participant/subject was called to return the drug and was issued unexpired medication. Further, the coordinator received complete training and was certified on the protocol. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Protocol Deviations | Protocol Deviations | Protocol Experience | 4000 |
Free-Form Entry |
2435038 | ||||||||
| C02206 | Protocol deviation occurrence indicator | ProtocolDeviatnOccurInd | Indicator of whether any protocol deviations took place during the participant's/subject's involvement in the study | Indicator of whether any protocol deviations took place during the participant's/subject's involvement in the stud | Were there any deviations from the protocol that occurred during the care of this participant/subject, after enrollment and before participant/subject exited the study? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one. If this question is answered YES then at least one protocol deviation should be recorded. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Protocol Deviations | Protocol Deviations | Protocol Experience |
Single Pre-Defined Value Selected |
3181141 |
