CDE Detailed Report

Disease: General (For all diseases)
Sub-Domain: Protocol Deviations
CRF: Protocol Deviations

Displaying 1 - 3 of 3
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 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 factors. 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 study. 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
CSV