Form:DCP Protocol Deviation v1.0


CDE IDCDE Description
* 421EDRN Participant ID (Go To: 1105)
* 1105Date site learned of protocol deviation (MM/DD/YYYY): (Go To: 423)
* 423EDRN Protocol ID (Go To: 422)
* 422EDRN Site ID (Go To: 929)
* 929EDRN Staff ID of the person who collected the data: (Go To: 1106)
* 1106Type(s) of protocol deviation(s): (Check all that apply.) (Go To: 1097)
 
Permissible Values (value):Participant did not sign a consent form (1)
 
 Participant did not meet all inclusion/exclusion criteria (2)
 
 Specimen(s) collected without documentation of approval (6)
 
 Specimen(s) processed outside of protocol (7)
 
 Other, specify: (97) (Go To: 1107)
   1107Type of protocol deviation (Other, specify): (Go To: 1097)
   1097Comments (do not include any participant identifiers) (Go To: End of Form)